ProHance Vials

1. Name Of The Medicinal Product

ProHance

2. Qualitative And Quantitative Composition

Gadoteridol 279.3mg/ml (0.5M)

3. Pharmaceutical Form

Sterile solution for intravenous injection

4. Clinical Particulars

4.1 Therapeutic Indications

Using Magnetic Resonance Imaging (MRI), ProHance provides contrast enhancement of the brain, spine and surrounding tissues resulting in improved visualization (compared with unenhanced MRI) of lesions with abnormal vascularity or those thought to cause a disruption of the normal blood-brain barrier.

ProHance can also be used for whole body MRI including the head, neck, liver, breast, muscoloskeletal system and soft tissue pathologies.

4.2 Posology And Method Of Administration

Adults

The recommended dose of ProHance for imaging most brain and spinal pathologies is 0.1 mmol/kg. However, doses of 0.3 mmol/kg have been shown to be useful in patients suspected of having cerebral metastases or other poorly enhancing lesions.

The recommended dose for whole body MRI is 0.1 mmol/kg.

Children (2 years and above)

The recommended dose of ProHance for brain imaging and spine pathologies is 0.1 mmol/kg (0.2 ml/kg).

ProHance has been used in only a limited number of children aged between 6 months and 2 years. If an MRI procedure must be performed in this group, particular caution should be exercised.

The safety and efficacy of doses higher than 0.1 mmol/kg and sequential or repeat procedures have not been established.

To ensure complete injection of the contrast medium, the injection should be followed by a 5 ml normal saline flush. The imaging procedure should be completed within 1 hour after injecting ProHance.

Special Populations

Impaired renal function

ProHance should only be used in patients with severe renal impairment (GFR < 30 ml/min/1.73m²) and in patients in the perioperative liver transplantation period after careful risk/benefit assessment and if the diagnostic information is essential and not available with non-contrast enhanced MRI (see section 4.4). If it is necessary to use ProHance, the dose should not exceed 0.1 mmol/kg body weight. More than one dose should not be used during a scan. Because of the lack of information on repeated administration, ProHance injections should not be repeated unless the interval between injections is at least 7 days.

Infants from 6 months to 1 year of age

Due to immature renal function in infants up to 1 year of age, ProHance should only be used in patients 6 to 12 months of age after careful consideration at a dose not exceeding 0.1 mmol/kg body weight. More than one dose should not be used during a scan. Because of the lack of information on repeated administration, ProHance injections should not be repeated unless the interval between injections is at least 7 days.

Use of ProHance is not recommended in children less than 6 months of age.

Use for whole body MRI is not recommended in children less than 18 years of age

Elderly (aged 65 years and above)

No dosage adjustment is considered necessary. Caution should be exercised in elderly patients (see section 4.4).

4.3 Contraindications

A history of previous hypersensitivity to ProHance, its constituents or other gadolinium-based contrast. ProHance is contraindicated in children under 6 months of age.

4.4 Special Warnings And Precautions For Use

Anaphylactic reactions have been observed following the use of gadoteridol. Appropriate drugs and instruments for emergency measures must be readily available.

Transitory changes in serum iron (within normal range in the majority of cases) have been observed in some patients after administration of ProHance and these changes were shown not to be clinically significant.

Since Gadoteridol is renally cleared from the body, caution should be exercised in patients with severely impaired renal function.

Impaired renal function

Prior to administration of ProHance, it is recommended that all patients are screened for renal dysfunction by obtaining laboratory tests.

There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of some gadolinium-containing contrast agents in patients with acute or chronic severe renal impairment (GFR < 30 ml/min/1.73m2). Patients undergoing liver transplantation are at particular risk since the incidence of acute renal failure is high in this group. As there is a possibility that NSF may occur with ProHance, it should therefore only be used in patients with severe renal impairment and in patients in the perioperative liver transplantation period after careful risk/benefit assessment and if the diagnostic information is essential and not available with non-contrast enhanced MRI.

Haemodialysis shortly after ProHance administration may be useful at removing ProHance from the body. There is no evidence to support the initiation of haemodialysis for prevention or treatment of NSF in patients not already undergoing haemodialysis.

Infants from 6 months to 1 year of age

Due to immature renal function in infants up to 1 year of age, ProHance should only be used in patients 6 to 12 months of age after careful consideration.

Elderly

As the renal clearance of gadoteridol may be impaired in the elderly, it is particularly important to screen patients aged 65 years and older for renal dysfunction.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

There are no known drug interactions with gadoteridol. No clinically significant changes or trends in laboratory tests were seen in clinical trials with ProHance.

4.6 Pregnancy And Lactation

Pregnancy

There are no data from the use of gadoteridol in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). ProHance should not be used during pregnancy unless the clinical condition of the woman requires use of gadoteridol.

Lactation

Gadolinium containing contrast agents are excreted into breast milk in very small amounts (see section 5.3). At clinical doses, no effects on the infant are anticipated due to the small amount excreted in milk and poor absorption from the gut. Continuing or discontinuing breast feeding for a period of 24 hours after administration of ProHance, should be at the discretion of the doctor and lactating mother.

4.7 Effects On Ability To Drive And Use Machines

There are no known effects of ProHance on the ability to drive or operate machinery.

4.8 Undesirable Effects

The accepted safety considerations and procedures that are required for Magnetic Resonance Imaging are applicable when ProHance is used for contrast enhancement.

Side effects: Taste disturbance (primarily metallic taste) nausea, urticaria, pain at injection site, convulsions and hypotension have been reported. Headache and chest pain have been rarely reported. These occurrences were transient and resolved without residual effect. The occurrences were not related to age, gender, rate of injection or dose administered.

Isolated cases of nephrogenic systemic fibrosis (NSF) have been reported with ProHance, most of which were in patients co-administered other gadolinium-containing contrast agents (see section 4.4).

4.9 Overdose

There have been no cases of overdose reported to date, consequently, neither signs nor symptoms of overdosage have been identified. In the event of overdosage occurring, the patient should be observed and treated symptomatically.

ProHance can be removed by haemodialysis. However there is no evidence that haemodialysis is suitable for prevention of nephrogenic systemic fibrosis (NSF).

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Gadoteridol is a non-ionic paramagnetic contrast medium for Magnetic Resonance Imaging.

When placed in a magnetic field, gadoteridol decreases T1 relaxation times in targeted areas. At recommended doses, the effect is observed with greatest sensitivity in the T1-weighted sequences.

Gadoteridol does not cross the intact blood-brain barrier and, therefore, does not accumulate in normal brain or in lesions that have a normal blood-brain barrier, e.g. cysts, mature post-operative scars, etc. However, disruption of the blood-brain barrier or normal vascularity allows penetration of gadoteridol into lesions such as neoplasms, abscesses, and subacute infarcts.

5.2 Pharmacokinetic Properties

The pharmacokinetics of intravenously administered gadoteridol in normal subjects conforms to a two- compartment open model with mean distribution and elimination half-lives (reported as mean ± SD) of about 0.20 ± 10.04 hours and 1.57 ± 10.08 hours, respectively.

Gadoteridol is exclusively eliminated in the urine with 94.4 ± 4.8% (mean ± SD) of the dose excreted within 24 hours post injection. There is no detectable biotransformation or decomposition of gadoteridol.

The renal and plasma clearance rates (1.41 ± 0.33 ml/min/kg and 1.50 ± 0.35 ml/min/kg, respectively) of gadoteridol are essentially identical, indicating no alteration in elimination kinetics on passage through the kidneys and that the drug is essentially cleared through the kidney. The volume of distribution (204 ± 58 ml 1 kg) is equal to that of extra cellular water, and clearance is similar to that of substances which are subject to glomerular filtration.

No serum protein binding was detected in rats.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Calteridol Calcium

Tromethamine USP

Hydrochloric Acid Ph Eur

Sodium Hydroxide Ph Eur

Water for Injections Ph Eur

6.2 Incompatibilities

ProHance should not be admixed with any other drug.

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

Store at room temperature (15-30°C.), protect from light. ProHance should not be frozen.

6.5 Nature And Contents Of Container

Vials: Type 1 glass vials with grey butyl stoppers and aluminium seals containing 5,10, 15 or 20ml.

6.6 Special Precautions For Disposal And Other Handling

The peel-off tracking label on the vials should be stuck onto the patient record to enable accurate recording of the gadolinium contrast agent used. The dose used should also be recorded.

7. Marketing Authorisation Holder

Bracco International B.V.

Strawinskylaan 3051

1077 ZX Amsterdam

The Netherlands

8. Marketing Authorisation Number(S)

14447/0001

9. Date Of First Authorisation/Renewal Of The Authorisation

29/10/1992

10. Date Of Revision Of The Text

28/09/2010

Sorilux Topical

Generic Name: calcipotriene (Topical route)

kal-si-poe-TRYE-een

Commonly used brand name(s)

In the U.S.

• Calcitrene


• Dovonex


• Sorilux

Available Dosage Forms:

• Cream


• Foam


• Ointment


• Solution

Therapeutic Class: Antipsoriatic

Pharmacologic Class: Vitamin D3, Synthetic

Uses For Sorilux

Calcipotriene is used on the skin and scalp to treat plaque psoriasis. It is a form of vitamin D that works by changing how the skin cells are made in the areas affected by psoriasis.

This medicine is available only with your doctor's prescription.

Before Using Sorilux

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of calcipotriene in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of calcipotriene in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Hypercalcemia (high calcium in the blood)—Should not be used in patients with this condition.

• Skin irritation in psoriasis areas—May make this condition worse.

Proper Use of calcipotriene

This section provides information on the proper use of a number of products that contain calcipotriene. It may not be specific to Sorilux. Please read with care.

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.

This medicine should only be used on the skin. Do not get it in your eyes, nose, mouth, or vagina. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

To help clear up your skin problem completely, it is very important that you keep using calcipotriene for the full time of treatment. Do not miss any doses.

This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other skin conditions, especially if you think that a skin infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns.

To use the cream or ointment:

• Wash your hands with soap and water before and after using this medicine. If the skin on your hands is being treated with the medicine, only wash the skin that is not affected.


• Apply a thin layer to the affected area of the skin. Rub it in gently until it disappears into the skin.


• Do not get any medicine on your face or in your eyes.

To use the scalp solution:

• Wash your hands with soap and water before and after using this medicine.


• Before using the medicine, comb your dry hair to remove any skin flakes. Part your hair so you can see the scalp lesions.


• Apply the solution only to the scalp lesions. Rub it in gently until it disappears into the scalp.


• Do not get any medicine on your forehead or in your eyes.


• Do not use this medicine near heat, an open flame, or while smoking.

To use the foam:

• This medicine comes with a patient information insert. Read and follow the instructions carefully.


• Wash your hands with soap and water before and after using this medicine. If the skin on your hands is being treated with the medicine, only wash the skin that is not affected.


• Break the tiny plastic piece on the nozzle of the foam can.


• Shake the can before each use.


• Turn the can upside down and place a small amount into the palm of your hand.


• Apply a thin layer to the affected area of the skin. Rub it in gently until it disappears into the skin.


• Do not use the medicine in or near your eyes, mouth, or vagina. If the foam does get in your eyes, wash them right away with water.


• Do not use this medicine near heat, an open flame, or while smoking.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For topical dosage form (cream, foam, ointment, scalp solution):
  
  • For plaque psoriasis:
    
    • Adults—Apply to the affected area of the skin or scalp once per day or two times per day as directed by your doctor.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

The scalp solution and foam are flammable. Keep them away from an open flame or heat. Do not smoke when you are applying the medicine. Do not poke holes in the foam canister or throw it into a fire, even if the canister is empty. Do not keep the foam inside a car where it could be exposed to extreme heat.

Precautions While Using Sorilux

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for any unwanted effects.

Stop using this medicine and check with your doctor right away if you have a skin rash, burning, stinging, redness, swelling, or irritation on the skin.

If your psoriasis does not improve within a few weeks or becomes worse, check with your doctor.

Calcipotriene may make your skin more sensitive to sunlight. Use a sunscreen and wear protective clothing, including a hat, when you are outdoors. Avoid sunlamps and tanning beds.

Do not use cosmetics or other skin care products on the treated areas unless directed to do so by your doctor.

Sorilux Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Skin redness, swelling, or itching


• skin rash


• worsening of psoriasis

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Burning, dryness, irritation, peeling, or redness of the skin

Less common or rare

• Darker color in treated areas of the skin


• pus in the hair follicles

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Sorilux Topical side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Sorilux Topical resources

• Sorilux Topical Side Effects (in more detail)
• Sorilux Topical Use in Pregnancy & Breastfeeding
• Sorilux Topical Drug Interactions
• Sorilux Topical Support Group
• 0 Reviews for Sorilux Topical - Add your own review/rating

Compare Sorilux Topical with other medications

• Psoriasis

VAQTA Adult (Sanofi Pasteur MSD Limited)

1. Name Of The Medicinal Product

VAQTA^® Adult

Hepatitis A Vaccine, Purified Inactivated, for Adults

2. Qualitative And Quantitative Composition

Each 1 millilitre dose contains approximately 50U of hepatitis A virus antigen adsorbed onto approximately 0.45 milligram of aluminium provided as aluminium hydroxide, and 70 micrograms of sodium borate as a pH stabiliser, in 0.9% sodium chloride. Neomycin and formaldehyde are used in the manufacturing process.

3. Pharmaceutical Form

VAQTA^® Adult is a sterile suspension for intramuscular use.

4. Clinical Particulars

4.1 Therapeutic Indications

VAQTA^® Adult is indicated for active pre-exposure prophylaxis against disease caused by hepatitis A virus. Vaccination is recommended in healthy adults who are at risk of contracting or spreading infection or who are at risk of life-threatening disease if infected.

Subjects at high risk of hepatitis A infection include those travelling to, or living in, medium or high endemicity areas. Other high risk groups include recent close contacts of infected individuals and potential contacts of cases such as childcare or healthcare workers. In the event of a case contact, human normal immunoglobulin should be given simultaneously with VAQTA^® Adult at different sites. Individuals who potentially play a key role in transmitting infection, e.g. food-handlers, might also be considered for vaccination.

VAQTA^® Adult will not prevent hepatitis caused by infectious agents other than hepatitis A virus.

4.2 Posology And Method Of Administration

VAQTA^® Adult should be injected INTRAMUSCULARLY in the deltoid region. The vaccine should not be administered subcutaneously or intradermally since administration by these routes may result in a less than optimal antibody response.

VAQTA^® Adult should never be administered intravenously.

The vaccination series consists of one primary dose and one booster dose given according to the following schedule:

Adults, 18 years of age and older, should receive a single 1.0 millilitre (~50U) dose of vaccine at an elected date and a booster dose of 1.0 millilitre (~50U) 6 to 12 months later.

Interchangeability of the Booster Dose

A booster dose of VAQTA^®Adult may be given at 6 to 12 months following the initial dose of other inactivated hepatitis A vaccines.

Use with Other Vaccines

VAQTA^®Adult may be given concomitantly with yellow fever and polysaccharide typhoid vaccines. Data on concomitant use with other vaccines are limited. Separate injection sites and syringes should be used for concomitant administration of injectable vaccines.

Known or Presumed Exposure to HAV/Travel to Endemic Areas /Use with Immunoglobulin

VAQTA^® Adult may be administered concomitantly with immunoglobulin using separate sites and syringes. The vaccination regimen for VAQTA^® Adult should be followed as stated above. Consult the appropriate Summary of Product Characteristics/Data Sheet for the dosage of immunoglobulin. A booster dose of VAQTA^® Adult should be administered at the appropriate time as outlined above (see 4.5 Interaction with other Medicinal Products and other forms of Interaction).

4.3 Contraindications

Hypersensitivity to any component of the vaccine.

Vaccination should be delayed in subjects with current severe febrile infections.

VAQTA^® Adult is not to be used in individuals under 18 years of age.

4.4 Special Warnings And Precautions For Use

Individuals who develop symptoms suggestive of hypersensitivity after an injection of VAQTA^® Adult should not receive further injections of the vaccine (see 4.3 Contraindications).

Duration of antibodies:

The long-term duration of serum antibodies to hepatitis A virus is unknown. In cases of doubt, the serum anti-hepatitis A antibody titre should be determined. However, immune memory persists in seroconverted vaccinees even if antibody titres wane to undetectable levels, and such individuals generally respond anamnestically to a booster.

Testing for antibodies to hepatitis A prior to a decision on immunisation should be performed in patients born in areas of high endemicity and/or with a history of jaundice.

VAQTA^® Adult does not cause immediate protection against hepatitis A, and there may be a period of 2 to 4 weeks before antibody induction occurs.

VAQTA^® Adult will not prevent hepatitis caused by infectious agents other than hepatitis A virus. Because of the long incubation period (approximately 20 to 50 days) for hepatitis A, it is possible for unrecognised hepatitis A infection to be present at the time the vaccine is given. The vaccine may not prevent hepatitis A in such individuals.

As with any vaccine, adequate treatment provisions, including epinephrine (adrenaline), should be available for immediate use should an anaphylactic or anaphylactoid reaction occur.

As with any vaccine, vaccination with VAQTA^® Adult may not result in a protective response in all susceptible vaccinees.

As no studies have been performed with VAQTA^® Adult in subjects with liver disease the use of this vaccine in such subjects should be considered with care.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

If VAQTA^® Adult is used in individuals with malignancies or those receiving immunosuppressive therapy or who are otherwise immunocompromised, the expected immune response may not be obtained.

Use with Immunoglobulin

For individuals requiring either post exposure prophylaxis or combined immediate and longer term protection (e.g. travellers departing on short notice to endemic areas), VAQTA^® Adult may be administered concomitantly with immunoglobulin using separate sites and syringes (see 4.2 Posology and Method of Administration).

Use with Other Vaccines

VAQTA^®Adult may be given concomitantly at separate injection sites with yellow fever and polysaccharide typhoid vaccines (see 4.2 Posology and Method of Administration and 5. Pharmacological Properties).

Interaction studies other than with yellow fever and polysaccharide typhoid vaccines are not yet available; however, interactions with other vaccines are not anticipated when vaccines are administered at different injection sites.When concurrent administration is necessary, VAQTA^® Adult must not be mixed with other vaccines in the same syringe, and other vaccines should be administered at different sites.

4.6 Pregnancy And Lactation

Animal reproduction studies have not been conducted with VAQTA^® Adult.

It is not known whether VAQTA^® Adult can cause foetal harm when administered to a pregnant woman, or can affect reproduction capacity. VAQTA^® Adult is not recommended in pregnancy unless there is a high risk of hepatitis A infection, and the attending physician judges that the possible benefits of vaccination outweigh the risks to the foetus.

It is not known whether VAQTA^® Adult is excreted in human milk, and the effect on breastfed infants following administration of VAQTA^® Adult to mothers has not been studied. Hence, VAQTA^® Adult should be used with caution in women who are breastfeeding.

4.7 Effects On Ability To Drive And Use Machines

There are no specific data. However, asthenia/fatigue and headache have been reported following administration of VAQTA^® Adult.

4.8 Undesirable Effects

Injection-site complaints, like tenderness, pain, warmth, swelling, and erythema were most frequently reported (>10%) and were generally mild and transient. Ecchymosis at the injection site was reported. Asthenia/fatigue, fever, myalgia, stiffness, headaches, arm pain, and back pain were observed. Gastrointestinal symptoms such as abdominal pain, nausea, vomiting, diarrhoea and isolated cases of elevated liver enzymes were reported. Allergic reactions, i.e. pruritis, rash and urticaria were rarely reported. Should anaphylactic reactions occur, see section 4.4. Special Warnings and Precautions for Use.

As with other vaccines, single cases of central or peripheral affections of the nervous system including Guillain-Barré Syndrome and haematologic autoimmune diseases like thrombocytopaenia have been reported.

4.9 Overdose

There are no data with regard to overdose.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

VAQTA^® Adult is derived from hepatitis A virus grown in cell culture in human MRC-5 diploid fibroblasts. It contains inactivated virus of a strain which was originally derived by further serial passage of a proven attenuated strain. The virus is grown, harvested, highly purified, formalin inactivated and then adsorbed onto aluminium hydroxide. Within the limits of the current assay variability, the 50U dose of VAQTA^®Adult contains less than 0.1 microgram of non-viral protein, less than 4 x 10^-6 microgram of DNA, less than 10^-4 microgram of bovine albumin and less than 0.8 microgram of formaldehyde. Other process chemical residuals are less than 10 parts per billion (ppb).

5.2 Pharmacokinetic Properties

The onset of seroconversion following a single dose of VAQTA^® Adult was shown to parallel the onset of protection against clinical hepatitis A disease.

Clinical studies showed seroconversion rates of 95% in adults within 4 weeks after the recommended primary dose.

Seropositivity was shown to persist up to 6 months in adults (studies ongoing). Persistence of immunologic memory was demonstrated with an anamnestic antibody response to a booster dose given 6 to 12 months after the primary dose.

A mathematical model predicts duration of protection lasting for many years after the booster.

Concurrent administration to healthy adults (18-39 years of age) of 50 U/1.0 millilitre of VAQTA^® Adult with immunoglobulin (immunoglobulin, 0.06 millilitre/kilogram) was evaluated in a clinical study. The seroconversion rate at week 24 in the vaccine alone group (97%) was higher than in the vaccine plus immunoglobulin group (92% p = 0.050) but rose to 100% in both groups one month post booster.

In studies of healthy adults who received two doses (50U) of VAQTA^®Adult at 0 and 6 months, the hepatitis A antibody response to date has been shown to persist for up to 4 years. The GMTs tend to decline over time.

Studies are ongoing to evaluate longer term persistence and the need, if any, for additional booster doses.

Interchangeability of the Booster Dose

A clinical study in 537 healthy adults, 18 to 83 years of age, evaluated the immune response to a booster dose of VAQTA^®Adult and a comparable licensed inactivated hepatitis A vaccine given at 6 or 12 months following the initial dose of the comparator vaccine. When VAQTA^®Adult was given as a booster dose in this case it produced an equivalent immune response and was generally well tolerated (see 4.2 Posology and Method of Administration).

Use with Other Vaccines

A controlled clinical study was conducted with 240 healthy adults, 18 to 54 years of age, who were randomised to receive either

• VAQTA^®Adult, yellow fever and polysaccharide typhoid vaccines concomitantly at separate injection sites or

• yellow fever and polysaccharide typhoid vaccines concomitantly at separate injection sites or

• VAQTA^®Adult alone

The seropositivity rate for hepatitis A when VAQTA^®Adult, yellow fever and polysaccharide typhoid vaccines were administered concomitantly was generally similar to when VAQTA^®Adult was given alone. The antibody response rates for yellow fever and typhoid were equivalent when yellow fever and polysaccharide typhoid vaccines were administered concomitantly with and without VAQTA^®Adult. The concomitant administration of these three vaccines at separate injection sites was generally well tolerated (see 4.2 Posology and Method of Administration).

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

VAQTA^® Adult contains aluminium hydroxide, sodium borate, and sodium chloride.

6.2 Incompatibilities

Do not mix with other vaccines/drugs.

6.3 Shelf Life

36 months when stored between +2°C and +8°C.

Expiry date has been printed on the package (month followed by year) and is applicable only if the vaccine has been stored between +2°C and +8°C. Potency of this vaccine is not significantly affected after exposure to temperatures up to 28°C for up to 3 months. However this is NOT a storage recommendation and if kept longer than three months at this temperature it should not be used.

6.4 Special Precautions For Storage

Store vaccine between +2°C and +8°C (+36°F and +46°F).

DO NOT FREEZE since freezing destroys potency.

6.5 Nature And Contents Of Container

Single dose prefilled syringe is available as a single unit pack and a pack of 10.

6.6 Special Precautions For Disposal And Other Handling

The vaccine should be used as supplied; no reconstitution is necessary.

Shake well immediately before use. Thorough agitation is necessary to maintain suspension of the vaccine.

Parenteral drug products should be inspected visually for extraneous particulate matter and discoloration prior to administration. After thorough agitation, VAQTA^® Adult is a slightly opaque white suspension.

7. Marketing Authorisation Holder

Aventis Pasteur MSD Limited

Mallards Reach

Bridge Avenue

Maidenhead

Berkshire

SL6 1QP

8. Marketing Authorisation Number(S)

PL 6745/0065

9. Date Of First Authorisation/Renewal Of The Authorisation

15 August 1996

10. Date Of Revision Of The Text

August 2000

11. LEGAL CATEGORY

POM

® Registered trademark

4006774/VAQ/RA331/0800/A

Enalapril 2.5mg, 5mg, 10mg, 20mg Tablets

ENALAPRIL MALEATE TABLETS 2.5 mg

ENALAPRIL MALEATE TABLETS 5 mg

ENALAPRIL MALEATE TABLETS 10 mg

ENALAPRIL MALEATE TABLETS 20 mg

(Enalapril Maleate)

Please read this entire leaflet carefully before you start to take your medicine, even if you have just refilled your prescription. Some of the information in the previous leaflet may have changed.

• Keep this leaflet. You may need to read it again.


• If you have further questions, please ask your doctor or your pharmacist.


• This medicine has been prescribed for you personally and you should not pass it onto others. It may harm them, even if their symptoms are the same as yours.

In this leaflet:

• 1. What 'ENALAPRIL' is and what it is used for


• 2. Before you take 'ENALAPRIL'


• 3. How to take 'ENALAPRIL'


• 4. Possible side effects


• 5, Storing 'ENALAPRIL'

The name of this medicine is ENALAPRIL MALEATE TABLETS (referred to as 'ENALAPRIL' throughout this leaflet).

The active substance in your tablet is enalapril maleate.

The other ingredients are lactose monohydrate, maize starch, sodium bicarbonate, pregelatinised maize starch, and magnesium stearate. The 10 mg and 20 mg tablets also contain iron oxide (E172).

The Marketing Authorisation Holder/The Manufacturer is:

Dexcel-Pharma Ltd.

1 Cottesbrooke Park

Heartland Business Park Daventry

Northamptonshire

NN11 8YL

England

What 'enalapril' Is And What It Is Used For

Description of the tablet

Each tablet contains 2.5 mg, 5 mg, 10 mg or 20 mg of enalapril maleate.

ENALAPRIL MALEATE TABLETS 2.5 mg and ENALAPRIL MALEATE TABLETS 5 mg are white, round, biconvex tablets, bisected on one side. The 2.5 mg tablets are of smaller size than the 5 mg tablets.

ENALAPRIL MALEATE TABLETS 10 mg and ENALAPRIL MALEATE TABLETS 20 mg are pink, round, biconvex tablets, quadrisected on one side. The 10 mg tablets are of smaller size than the 20 mg tablets.

All strengths of tablets are available in packs of 28 tablets in foil blister strips (4 calendar blister packs of 7 tablets each).

How your medicine works

'ENALAPRIL' belongs to a group of medicines known as angiotensin converting enzyme (ACE) inhibitors. These medicines work by widening your blood vessels to make it easier for the heart to pump blood through them to all parts of your body. This helps to reduce high blood pressure. 'ENALAPRIL' will also help your heart to work better if you have a damaged heart muscle.

What your medicine is used for

Your doctor has probably prescribed 'ENALAPRIL' for you for one of the following reasons which will have been explained to you:

• Your blood pressure is too high.


• You have a heart condition sometimes referred to as 'heart failure'. This means that your heart is not working as well as it used to in order to pump blood around your body, leading to tiredness after light physical activity, breathlessness and swelling of your ankles and feet. 'ENALAPRIL' may help treat these symptoms.


• In many patients with a damaged heart muscle, but who have no symptoms, 'ENALAPRIL' may help to prevent the appearance of symptoms such as shortness of breath and swelling.

Before You Take 'enalapril'

Do not take 'ENALAPRIL' if you:

• 1. are more than 3 months pregnant (it is also better to avoid 'ENALPRIL' in early pregnancy - see pregnancy section ).


• 2. have suffered from a reaction to 'ENALAPRIL' or similar medicines (i.e. ACE inhibitors) in the past, or to any of the ingredients in the past or have experienced the following types of reactions even if the cause is unknown: itching, nettle rash, wheezing or swelling of the hands, throat, mouth or eyelids.


• 3. have a history of angioedema (symptoms such as itching, nettle rash, wheezing or swelling of the hands, throat, mouth or eyelids) while taking enalapril or any other ACE inhibitors.


• 4 .have suffered from hereditary or idiopathic angioedema.

If any of the above applies to you then you should speak to your doctor.

Take special care and check with your doctor before you take 'ENALAPRIL' if you:

• 1. think you are (or might become) pregnant. 'ENALAPRIL' is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).


• 2. have kidney disease, are a dialysis patient, are taking diuretics (water tablets), are on a salt restriction diet, or have suffered from excessive vomiting or diarrhoea,


• 3. have a condition called aortic stenosis, hypertrophic cardiomyopathy or outflow obstruction.


• 4. have had a recent kidney transplantation.


• 5. have collagen vascular disease, are taking immunosuppressant therapy (used for the treatment of autoimmune disorders such as rheumatoid arthritis or following transplant surgery), are taking allopurinol (used for the treatment of gout), or are taking procainamide (used to treat abnormal heart rhythms). Your doctor may periodically take a blood sample to check your white cell count. If any of these apply to you and you develop an infection (symptoms may be high temperature, feverish), you should let your doctor know immediately.


• 6. are taking antidiabetic agents or insulin to control your diabetes; your glycaemic control should be closely monitored during the first month of treatment.


• 7. are taking potassium supplements or potassium containing salt substitutes.


• 8. are taking lithium, used for the treatment of some psychiatric illnesses.

While taking 'ENALAPRIL', if you develop any of the following symptoms you should let your doctor know immediately:

• 1. jaundice (yellowing of the skin and whites of the eyes).


• 2. a dry cough which is persistent for a long time.

If you are about to undergo any of the following procedures, you should tell your doctor who is treating you that you are taking 'ENALAPRIL':

• 1. a treatment called LDL apheresis, which is removal of cholesterol from your blood by a machine.


• 2. desensitisation treatment, that is treatment to reduce the effect of an allergy to bee or wasp stings.


• 3. undergo any surgery or receive anaesthetics (even at the dentist).

Routine tests

When you first start to take 'ENALAPRIL', your doctor will monitor your blood pressure frequently to ensure you have been given the correct dose. In addition, for some patients the doctor may want to do some tests to measure your potassium and creatinine (a waste product found in urine) or liver enzyme levels.

Children

Information on the use of 'ENALAPRIL' in children over 6 years old who have high blood pressure is limited, but for children with heart problems there is no information. 'ENALAPRIL' should not be used in babies or children with reduced kidney function.

Taking 'ENALAPRIL' with food and drink

'ENALAPRIL' can be taken with or without food. However, if you drink alcohol while taking 'ENALAPRIL', it may cause your blood pressure to drop and you may experience dizziness, lightheadedness or faintness. You should also keep your alcohol intake to a minimum.

Pregnancy and Breast feeding

Pregnancy

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking 'ENALAPRIL' before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of 'ENALAPRIL'. 'ENALAPRIL' is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast feeding

Tell your doctor if you are breast feeding or about to start breast feeding. Breast feeding newborn babies (first few weeks after birth), and especially premature babies, is not recommended whilst taking 'ENALAPRIL'.

In the case of an older baby your doctor should advise you on the benefits and risks of taking 'ENALAPRIL' whilst breast feeding, compared with other treatments.

Driving and using machines

Individual responses to medication may vary. Certain side effects that have been reported with 'ENALAPRIL' may affect some patients' ability to drive or operate machinery. Occasionaly dizziness or weariness may occur (see section 4 "Possible side effects").

Important information about some of the ingredients of 'ENALAPRIL'

This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Taking other medicines

Before starting your treatment, you should always inform your doctor about all medicines you are taking or plan to take, including those obtained without a prescription.

If you are taking any of the following drugs, you should talk to your doctor before you first start taking 'ENALAPRIL' as your doctor may need to alter the dosage of your medication.

• Potassium sparing diuretics such as spironolactone, triamterene or amiloride; potassium supplements, or potassium-containing salt substitutes. 'ENALAPRIL' may increase the levels of potassium in your blood leading to hyperkalaemia. Mild hyperkalaemia cause few, if any symptoms and is usually diagnosed by a blood test or on an electrocardiogram.


• Diuretics such as thiazides, loop diuretics such as furosemide, bumetanide, other antihypertensive agents and nitroglycerine, other nitrates, and other vasodilators; concomitant use with 'ENALAPRIL' may cause hypotension (low blood pressure).


• Lithium, a drug used for the treatment of some psychiatric illnesses. 'ENALAPRIL' should not be taken with this drug.


• Tricyclic antidepressants such as amitriptyline (used for treating depression), antipsychotics such as phenothiazine derivatives (for alleviating severe anxiety), narcotics such as morphine (used to treat moderate and severe pain), or anaesthetics. Additional lowering of your blood pressure may be seen when these drugs are taken with 'ENALAPRIL'.


• Non-steroidial anti-inflammatory drugs (NSAIDs) such as diflunisal or diclofenac, used to relieve pain, stiffness and inflammation associated with painful conditions, particularly those affecting the muscles, bones and joints. These drugs, taken with 'ENALAPRIL' may prevent your blood pressure from being well controlled and may increase the level of potassium in your blood.


• Sympathomimetics, drugs such as ephedrine, noradrenaline or adrenaline used for the treatment of hypotension, shock, cardiac failure, asthma or allergies. Taken with 'ENALAPRIL' these drugs may keep your blood pressure elevated.


• Antidiabetic agents such as insulin, used to lower blood sugar levels. 'ENALAPRIL' may cause your blood sugar levels to drop even further when taken with antidiabetic drugs.

How To Take 'enalapril'

Always take 'ENALAPRIL' exactly as your doctor has instructed dose you. You should check with your doctor or pharmacist if you are unsure. You can swallow your tablets with or without food. Most people take 'ENALAPRIL' with a drink of water.

Dosage for high blood pressure

The initial dose is 5 mg per day up to 20 mg per day depending on your blood pressure. In patients with blood pressure levels slightly above normal the recommended dose is 5-10 mg per day. For patients with kidney problems, heart problems, low salt and/or fluid levels a starting dose of 5 mg or lower should be used.

If you are currently taking high dose diuretics (water tablets), your doctor may ask you to stop taking them 2-3 days prior to taking 'ENALAPRIL'. A starting dose of 5 mg or lower is recommended.

Once your blood pressure is under control, the usual maintenance dose is 20 mg daily up to a maximum of 40 mg daily.

Dosage for heart disorders

In patients with heart problems, 'ENALAPRIL' is used in addition to diuretics and where appropriate, with digitalis (a drug used in congestive heart failure or for an erratic heartbeat) or beta-blockers (drugs used to treat high blood pressure, angina and heart problems). The initial dose is 2.5 mg and should be gradually increased, to the usual maintenance dose of 20 mg given in a single dose or two divided doses, over a 2 to 4 week period. The maximum dose is 40 mg daily given in two divided doses.

Reduced renal function

In patients with kidney problems, your dose of 'ENALAPRIL' will need to be adjusted depending on how well your kidneys are functioning. Kidney function is calculated by measuring the amount of creatinine (a waste product) in your urine and also by taking a blood test.

If you are having dialysis, your dosage will vary daily. Your doctor will let you know what your dose should be.

Elderly patients

Your dose will be decided by your doctor, and will be based on how well your kidneys are functioning.

Children

Experience with the use of 'ENALAPRIL' in children with high blood pressure is limited. If the child can swallow tablets the dose will be determined based on the child's weight and blood pressure response. The recommended starting dose is 2.5 mg in children 20 to less than 50 kg and 5 mg in children 50 kg and over. 'ENALAPRIL' is given once daily. The dosage should be adjusted according to the needs of the child to a maximum of 20 mg daily in children 20 to less than 50 kg and 40 mg in children 50 kg and over.

Babies and children with kidney problems

'ENALAPRIL' should not be used in babies or children with kidney problems.

If you take more 'ENALAPRIL' than you should

Contact your doctor immediately if you think you have taken more of your tablets than you should. The most common signs and symptoms of overdose are fall in blood pressure and stupor (a state of almost complete lack of consciousness). Other symptoms may include dizziness or lightheadedness due to a fall in blood pressure, forceful and rapid hearbeat, rapid pulse, anxiety, cough, kidney failure, and rapid breathing.

If you forget to take 'ENALAPRIL'

If you miss a dose just carry on with the next one as normal. Do not take an extra one to make up.

Effects when treatment with 'ENALAPRIL' is stopped

If you stop taking your medication, your blood pressure may increase. If your blood pressure becomes too high it may affect the function of your heart and kidneys. Do not stop taking your medicine, unless your doctor has advised you to do so.

Possible Side Effects

Like all medicines, 'ENALAPRIL' may occasionally cause side effects in some patients. It is very important that you stop taking 'ENALAPRIL' immediately and see your doctor if you have severe dizziness, lightheadedness, especially at the start of treatment or when the dose is increased or when you stand up. It is vital to stop taking 'ENALAPRIL' and seek medical attention immediately if you begin to itch, get shortness of breath or wheezy and develop swelling of the hands, mouth, throat, face or eyes.

Below is a list of side effects that have occurred in patients taking 'ENALAPRIL'. The most frequently reported side effects are: blurred vision, dizziness, cough, nausea, weakness, headache, depression, fainting, heart attack or stroke, chest pain, angina, fast heartbeat, difficulty breathing, diarrhoea, abdominal pain, changes in taste, rash, tiredness.

Other side effects that have been reported are: anaemia; anxiety, a sense of heightened awareness or a shaky feeling which may be caused by low blood sugar levels; confusion, sleepy or unable to sleep; nervousness; tingling or pins and needles like sensation in the hands or feet; vertigo (spinning sensation); rapid forceful heartbeat; runny nose or stuffiness; sore throat and hoarseness; asthma; a bloating feeling and cramping pain in the abdomen (may be caused by an obstruction of the gut); severe abdominal pain (may be caused by inflammation of the pancreas); vomiting; indigestion; constipation; loss of appetite; bubbly feeling in the stomach; dry mouth; peptic ulcer (symptoms may be burning, aching pain with an empty feeling and hunger, particularly when the stomach is empty); perspiration; itching; nettle-rash or hives; hair loss; reduced kidney function or kidney failure (symptoms may be lower back pain and reduction in the volume of urine passed); presence of protein in the urine, which is usually detected by a test; impotence, muscle cramps, flushing, ringing in the ears, fever, feeling unwell.

There are, in addition, a few other very rare side effects seen only in a very small minority of patients. These include: blood disorders which affect the cells or elements in the blood and are usually diagnosed by blood tests (symptoms may be tiredness, weakness, shortness of breath, inability to exercise, feeling run down, having constant or re-occurring colds, prolonged bleeding, bruising where cause is unknown); abnormal dreams; sleep disorders; small arteries, usually in the fingers and toes, go into spasm causing the skin to become pale or patchy red to blue colour; fluid on the lung; inflammation and ulceration of the mouth; inflammation of the tongue; intestinal angioedema (symptoms may be nausea, vomiting, abdominal cramps and/or pains, abdominal distension, constipation, diarrhoea); liver failure, inflammation of the liver, reduction or stoppage of bile flow from the bile duct in the liver (symptoms may be yellowing of the skin and whites of the eyes); severe skin reaction (symptoms of which may be excessive redness of the skin, blisters, skin peeling off in sheets); reduction in the amount of urine produced per day; enlargement of breasts in men.

A complex side effect has also been reported which may include some or all of the following: fever, inflammation of the blood vessels, pain and inflammation of muscles and joints, blood disorders affecting the components of the blood and usually detected by a blood test. rash, hypersensitivity to sunlight and other effects on the skin.

If you notice any of the above side effects or if you have any other unusual symptoms or feelings, you should contact your doctor as soon as possible.

Laboratory tests

Some side effects have been reported which affect the blood and are only detected by laboratory tests, These are: high levels of potassium, increases of creatinine or urea (waste products), decreased levels of sodium, elevated liver enzymes, and raised levels of bilirubin.

Storing 'enalapril'

Keep your tablets out of the reach and sight of children.

Do not store above 25°C.

Store in the original package in order to protect from moisture.

Do not put them into another container as they might get mixed up. Keep them in the pack in which they are supplied.

If you have any tablets left over when your doctor tells you to stop taking them, return them to the pharmacist.

Use by date

Do not use 'ENALAPRIL' after the expiry date on the carton and on the blister.

Remember this medicine is for you. Do not share it with anyone else. It may not suit them.

This leaflet was last revised on: March 2009

1221020117-F

Methadose Concentrate

Pronunciation: METH-a-done
Generic Name: Methadone
Brand Name: Methadose

Methadose Concentrate may cause severe and sometimes fatal heart and breathing problems. These problems may occur some time after you take a dose. Tell your doctor right away if you develop any new or worsening symptoms such as slowed or shallow breathing or irregular heartbeat. Your doctor will perform heart and lung function tests to check for side effects while you take Methadose Concentrate. Keep all doctor and laboratory appointments. Talk with your doctor and be sure you understand the risks and benefits of using Methadose Concentrate.

Do not take more than the recommended dose or take Methadose Concentrate more often than prescribed. This can lead to overdose and possible death.

Methadose Concentrate is used for:

Treating a narcotic addiction as part of a treatment program. It may also be used for other conditions as determined by your doctor.

Methadose Concentrate is a narcotic analgesic. It works by acting on opiate pain receptors in the brain and on smooth muscle to provide pain relief.

Do NOT use Methadose Concentrate if:

• you are allergic to any ingredient in Methadose Concentrate


• you have slowed breathing or severe asthma, or if you are having an asthma attack


• you have a stomach or bowel blockage or certain severe bowel problems (eg, paralytic ileus)


• you have diarrhea caused by food poisoning or antibiotic use


• you are taking sodium oxybate (GHB)


• if you have taken a monamine oxidase inhibitor type B (MAOI-B) (eg, rasagiline, selegiline) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Methadose Concentrate:

Some medical conditions may interact with Methadose Concentrate. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have lung or breathing problems (eg, asthma), chronic obstructive pulmonary disease (COPD), sleep apnea, stomach or bowel problems (eg, bowel inflammation), stomach pain or constipation, liver or kidney problems, thyroid problems, or Addison disease


• if you have an abnormal curvature of the spine; narrowing of the urethra, trouble urinating, or an enlarged prostate; low blood volume, blood pressure, or blood oxygen levels; low potassium or magnesium blood levels; increased pressure, tumors, or lesions in your head; a recent head injury; or seizures


• if you have a history of heart problems (eg, enlarged heart) or irregular heartbeat


• if you or a family member have a history of mental or mood problems (eg, anxiety, depression), suicidal thoughts or attempts, or alcohol or substance abuse


• if you are elderly, very ill, or very overweight, or if you have recently had stomach or intestine surgery

Some MEDICINES MAY INTERACT with Methadose Concentrate. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Barbiturate anesthetics (eg, thiopental), benzodiazepines (eg, midazolam), cimetidine, MAOI-B (eg, rasagiline, selegiline), other narcotic analgesics (eg, morphine), phenothiazines (eg, promethazine), or sodium oxybate (GHB) because side effects such as sedation and slowed breathing may occur


• Antiarrhythmics (eg, amiodarone, dofetilide, flecainide, propafenone), antipsychotics (eg, haloperidol, paliperidone, ziprasidone), calcium channel blockers (eg, nifedipine), certain antiemetics (eg, dolasetron, droperidol), chloroquine, cisapride, diuretics (eg, furosemide), H₁ antagonists (eg, astemizole), kinase inhibitors (eg, lapatinib, nilotinib), lithium, macrolide antibiotics (eg, clarithromycin), phenothiazines (eg, chlorpromazine), quinolones (eg, ciprofloxacin), streptogramins (eg, quinupristin), tacrolimus, or tricyclic antidepressants (eg, desipramine) because the risk of QT prolongation may be increased


• Azole antifungals (eg, fluconazole, ketoconazole, voriconazole) or certain selective serotonin reuptake inhibitors (SSRIs) (eg, fluvoxamine, sertraline) because they may increase the risk of Methadose Concentrate's side effects


• Abacavir, carbamazepine, efavirenz, HIV protease inhibitors (eg, amprenavir, lopinavir, nelfinavir, ritonavir), narcotic agonists/antagonists (eg, butorphanol, nalbuphine, pentazocine), narcotic antagonists (eg, naloxone, naltrexone), nevirapine, phenobarbital, phenytoin, rifampin, or St. John's wort because they may decrease Methadose Concentrate's effectiveness


• Zidovudine because the risk of its side effects may be increased by Methadose Concentrate


• Nucleoside reverse transcriptase inhibitors (NRTIs) (eg, abacavir, didanosine, stavudine) because their effectiveness may be decreased by Methadose Concentrate

This may not be a complete list of all interactions that may occur. Ask your health care provider if Methadose Concentrate may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Methadose Concentrate:

Use Methadose Concentrate as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Methadose Concentrate by mouth with or without food. Methadose Concentrate is for oral use only and must not be injected.


• Methadose Concentrate must be administered under close medical supervision.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• Methadose Concentrate must be mixed with water or other liquid before you use it. Follow your doctor's instructions on how to mix Methadose Concentrate.


• Take Methadose Concentrate on a regular schedule to get the most benefit from it.


• If Methadose Concentrate is no longer needed, dispose of it as soon as possible. Ask your doctor or pharmacist how to dispose of Methadose Concentrate properly.


• Always keep Methadose Concentrate in a secure place to protect from theft.


• If you miss a dose of Methadose Concentrate and you are using it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If you miss your doses of Methadose Concentrate for more than 2 days, contact your doctor before you start taking Methadose Concentrate again.

Ask your health care provider any questions you may have about how to use Methadose Concentrate.

Important safety information:

• Methadose Concentrate may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Methadose Concentrate with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Methadose Concentrate; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Methadose Concentrate may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Breathing problems may occur some time after you take a dose of Methadose Concentrate. Tell your doctor or seek medical care immediately if you notice trouble breathing (eg, slowed or shallow breathing) while you take Methadose Concentrate.


• Methadose Concentrate may cause constipation. Constipation may be avoided by using a stool softener or fiber laxative.


• The risk of Methadose Concentrate becoming habit-forming may be greater if you take it in high doses or for a long time. Do NOT take more than the recommended dose or use Methadose Concentrate for longer than prescribed without talking with your doctor.


• Tell your doctor or dentist that you take Methadose Concentrate before you receive any medical or dental care, emergency care, or surgery.


• Lab tests, including liver function, lung function, and heart function, may be performed while you use Methadose Concentrate. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Methadose Concentrate with caution in the ELDERLY; they may be more sensitive to its effects.


• Methadose Concentrate should not be used in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Methadose Concentrate may cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Methadose Concentrate while you are pregnant. Methadose Concentrate is found in breast milk. If you are or will be breast-feeding while you use Methadose Concentrate, check with your doctor. Discuss any possible risks to your baby.

When used for long periods of time or at high doses, Methadose Concentrate may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Methadose Concentrate stops working well. Do not take more than prescribed.

Some people who use Methadose Concentrate for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction.

If you stop taking Methadose Concentrate suddenly, you may have WITHDRAWAL symptoms. These may include convulsions, tremor, stomach and muscle cramps, vomiting, and sweating. Do not stop therapy suddenly or change the dosage without asking your doctor. Discuss overuse with your doctor or pharmacist.

Possible side effects of Methadose Concentrate:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; drowsiness; dry mouth; headache; increased sweating; itching; lightheadedness; nausea; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; decreased sexual desire or ability; excessive drowsiness; fainting; fast, slow, or irregular heartbeat; hallucinations; loss of appetite; menstrual changes; mental or mood changes (eg, agitation, disorientation, exaggerated sense of well-being); seizures; severe or persistent dizziness or lightheadedness; shortness of breath; slow or shallow breathing; swelling of the arms, feet, or legs; trouble sleeping; trouble urinating; unusual bruising or bleeding.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Methadose side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include cold and clammy skin; coma; fainting; fast, slow, or irregular heartbeat; muscle weakness; pinpoint pupils; severe dizziness, drowsiness, or lightheadedness; slow, shallow, or difficult breathing.

Proper storage of Methadose Concentrate:

Store Methadose Concentrate at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Methadose Concentrate out of the reach of children and away from pets.

General information:

• If you have any questions about Methadose Concentrate, please talk with your doctor, pharmacist, or other health care provider.


• Methadose Concentrate is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Methadose Concentrate. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Methadose resources

• Methadose Side Effects (in more detail)
• Methadose Use in Pregnancy & Breastfeeding
• Drug Images
• Methadose Drug Interactions
• Methadose Support Group
• 21 Reviews for Methadose - Add your own review/rating

Compare Methadose with other medications

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Imipramine Capsules

Pronunciation: im-IP-ra-meen
Generic Name: Imipramine
Brand Name: Tofranil-PM

Antidepressants may increase the risk of suicidal thoughts or actions in children, teenagers, and young adults. However, depression and certain other mental problems may also increase the risk of suicide. Talk with the patient's doctor to be sure that the benefits of using Imipramine Capsules outweigh the risks.

Family and caregivers must closely watch patients who take Imipramine Capsules. It is important to keep in close contact with the patient's doctor. Tell the doctor right away if the patient has symptoms like worsened depression, suicidal thoughts, or changes in behavior. Discuss any questions with the patient's doctor.

Imipramine Capsules is used for:

Treating depression. It may also be used for other conditions as determined by your doctor.

Imipramine Capsules is a tricyclic antidepressant. It works by increasing the activity of certain chemicals in the brain that help elevate mood.

Do NOT use Imipramine Capsules if:

• you are allergic to any ingredient in Imipramine Capsules or to similar medicines


• you have taken furazolidone, linezolid, methylene blue, or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days, or you are taking astemizole, droperidol, or terfenadine


• you are recovering from a recent heart attack

Contact your doctor or health care provider right away if any of these apply to you.

Video: Treatment for Depression

Treatments for depression are getting better everyday and there are things you can start doing right away.

Before using Imipramine Capsules:

Some medical conditions may interact with Imipramine Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you drink alcohol-containing beverages daily or you have a history of alcohol abuse


• if you take thyroid medicine or you have a history of overactive thyroid, glaucoma, heart problems, kidney or liver problems, diabetes, seizures, the blood disease porphyria, or difficulty urinating


• if you have a history of suicidal thoughts or behavior, bipolar disorder, or any other mental disorders; you are undergoing electroshock therapy; or you are scheduled to have any surgery

Some MEDICINES MAY INTERACT with Imipramine Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Azole antifungals (eg, fluconazole), cimetidine, duloxetine, flecainide, methylphenidate, mibefradil, phenothiazines (eg, chlorpromazine), propafenone, quinidine, selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), or terbinafine because they may increase the risk of Imipramine Capsules's side effects


• Arsenic, astemizole, droperidol, furazolidone, linezolid, MAOIs (eg, phenelzine), methylene blue, pimozide, streptogramins (eg, dalfopristin), terfenadine, or tramadol because the risk of high blood pressure, serious heart problems (eg, irregular heartbeat), or seizures may be increased


• Barbiturates (eg, phenobarbital) or phenytoin because they may decrease Imipramine Capsules's effectiveness


• Anticholinergics (eg, benztropine), carbamazepine, or sympathomimetics (eg, phenylephrine) because the risk of their side effects may be increased by Imipramine Capsules


• Clonidine, guanethidine, or guanfacine because their effectiveness may be decreased by Imipramine Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Imipramine Capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Imipramine Capsules:

Use Imipramine Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Imipramine Capsules comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Imipramine Capsules refilled.


• Take Imipramine Capsules by mouth with or without food.


• Taking Imipramine Capsules at bedtime may help reduce side effects (eg, daytime drowsiness). Discuss this possibility with your doctor.


• It may take 1 to 3 weeks before you notice the effect of Imipramine Capsules. Continue to use Imipramine Capsules even if you feel well. Do not miss any doses.


• If you miss a dose of Imipramine Capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If you take 1 dose daily at bedtime, do not take the missed dose the next morning.

Ask your health care provider any questions you may have about how to use Imipramine Capsules.

Important safety information:

• Imipramine Capsules may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Imipramine Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Imipramine Capsules; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Imipramine Capsules may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Do not become overheated in hot weather or while you are being active; heatstroke may occur.


• Children, teenagers, and young adults who take Imipramine Capsules may be at increased risk for suicidal thoughts or actions. Watch all patients who take Imipramine Capsules closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.


• Imipramine Capsules may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Imipramine Capsules. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Tell your doctor or dentist that you take Imipramine Capsules before you receive any medical or dental care, emergency care, or surgery.


• Lab tests, including blood counts, may be performed while you use Imipramine Capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Imipramine Capsules with caution in the ELDERLY (especially those with cardiac disease); they may be more sensitive to its effects.


• Imipramine Capsules should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: It is not known if Imipramine Capsules can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Imipramine Capsules while you are pregnant. It is not known if Imipramine Capsules is found in breast milk. Do not breast-feed while taking Imipramine Capsules.

If you suddenly stop taking Imipramine Capsules, you may experience WITHDRAWAL symptoms, including headache, nausea, and tiredness.

Possible side effects of Imipramine Capsules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; drowsiness; dry mouth; excitement; headache; impotence; nausea; nightmares; pupil dilation; sensitivity to sunlight; sweating; tiredness; upset stomach; vomiting; weakness; weight loss or gain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; changes in sex drive; chest pain; confusion; constipation; fainting; fast, slow, or irregular heartbeat; fever; frequent or difficult urination; hallucinations; impulsive behavior or other unusual changes in behavior; jaw, neck, or muscle spasms; mental or mood changes (eg, increased anxiety, mood swings, agitation, irritability, nervousness, restlessness); panic attacks; ringing in the ears; seizures; severe dizziness or drowsiness; sore throat; stomach pain; suicidal thinking or behavior; swelling of the testicles; tremor; trouble sleeping; trouble walking or keeping your balance; twitching of the face or tongue; uncontrolled movements of arms and legs or stiffness; unusual bleeding or bruising; worsening of depression; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Imipramine side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include agitation; bluish skin or mucous membranes; breathing problems; chest pain; coma; confusion; dry mouth; enlarged pupils; excess sweating; fainting; fast or irregular heartbeat; flushing; incoordination; involuntary movements; loss of consciousness; restlessness; rigid muscles; seizures; severe drowsiness; shock; stupor; vomiting.

Proper storage of Imipramine Capsules:

Store Imipramine Capsules at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store in a tightly sealed container. Stored away from heat, moisture, and light. Do not store in the bathroom. Keep Imipramine Capsules out of the reach of children and away from pets.

General information:

• If you have any questions about Imipramine Capsules, please talk with your doctor, pharmacist, or other health care provider.


• Imipramine Capsules is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Imipramine Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Imipramine resources

• Imipramine Side Effects (in more detail)
• Imipramine Dosage
• Imipramine Use in Pregnancy & Breastfeeding
• Drug Images
• Imipramine Drug Interactions
• Imipramine Support Group
• 13 Reviews for Imipramine - Add your own review/rating

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