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:
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
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