Enalapril Maleate 10mg Tablets
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Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again
• If you have any further questions, ask your doctor or pharmacist
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist
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. How to store Enalapril
6. Further information
1. What Enalapril is and what it is used for
The name of this medicine is Enalapril Maleate 10mg Tablets or Enalapril Maleate 20mg Tablets referred to as Enalapril throughout this leaflet.
Enalapril maleate belongs to a group of medicines called ACE (angiotensin converting enzyme) inhibitors which work by widening your blood vessels. This makes it easier for your heart to pump blood through them and helps to reduce high blood pressure (hypertension). If you have heart failure Enalapril will help your heart to work better.
Enalapril has been prescribed for you for one of the following:
• High blood pressure
• 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 exercise, breathlessness and swelling of the ankles and legs.
• Enalapril may prevent your heart failure with symptoms, from getting worse. Therefore it may be less likely that you go to hospital for treatment.
• Enalapril may help prevent your heart from weakening further if you have early stage heart failure with no symptoms or have had a heart attack (that is, to help prevent you from developing heart failure).
Enalapril being taken if you have heart failure (with or without symptoms) may lessen your risk of heart attack.
2. Before you take Enalapril
Do not take Enalapril if:
• you are allergic (hypersensitive) to enalapril maleate or any of the other ingredients in this medicine (listed in Section 6)
• you are more than 3 months pregnant. (It is also better to avoid Enalapril in early pregnancy - see ‘Pregnancy’ section 2.)
• you have ever suffered serious allergic reaction which caused swelling of the face or throat from previously using another ACE inhibitor
• you have a condition called 'aortic stenosis' or 'outflow obstruction' (conditions where the heart blood flow is not normal)
• you are under 18 years of age
• if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
Take special care with Enalapril if:
Check with your doctor or pharmacist before taking your medicine if any of the following
apply to you. You may need to be given a different dose or a different medicine:
• you have kidney problems or undergo dialysis
• you are on a restricted salt intake diet or suffer with excessive vomiting or diarrhoea
• you have an ischaemic heart (reduced blood supply to the heart muscle)
• you have cerebrovascular disease (brain diseases associated with blood supply)
• you have diabetes
• you have severe heart failure
• you have heart failure associated with low or normal blood pressure
• you are taking diuretics (water tablets)
• you have a history of angioedema (serious allergic reaction causing swelling of the face or throat)
• you are to have desensitisation treatment, to reduce the effects of an allergy to bee or wasp stings
• you are to have LDL apheresis treatment, to remove cholesterol from your blood by a machine
• you are to have any surgery or receive anaesthetics (even at the dentist)
• you must tell your doctor if you think you are (or might become) pregnant. Enalapril maleate 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).
• if you are taking any of the following medicines used to treat high blood pressure:
o an angiotensin II receptor blocker (ARBs) (also known as sartans- for example valsartan, telmisartan, irbesartan, etc.), in particular if you have diabetes-related kidney problems o aliskiren
Your doctor may check your kidney function, blood pressure, and the amount of the electrolytes (e.g. potassium) in your blood at regular intervals.
See also information under heading "Do not take Enalapril".
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Enalapril.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription or herbal medicines. This is because Enalapril can affect the way some other medicines work. Also some other medicines can affect the way Enalapril works.
Please tell your doctor or pharmacist if you are taking any of the following:
• medication to treat heart failure or high blood pressure such as bisoprolol, nifedipine, prazosin
• lithium, used for the treatment of some mental illnesses
• medicines used to treat kidney problems that contain potassium such as potassium supplements or potassium containing salt substitutes
• diuretics (water tablets), such as furosemide or thiazide and including potassium sparing diuretics such as spironolactone or amiloride
• medication for diabetes such as insulin or oral anti- diabetic drugs
• narcotics, for the treatment of moderate to severe pain such as morphine or methadone
• antipsychotics, used to treat mental disorders like severe anxiety
• allopurinol, used to treat gout
• immunosuppressant medicines, used in rheumatoid arthritis or after organ transplant surgery to suppress the body’s immune reactions
• medicines for the treatment of cancer such as doxorubicin or cyclophosphamide
• corticosteroids such as prednisolone or bethamethasone, used internally to treat various conditions including arthritis, allergic conditions, asthma or skin diseases
• procainamide, used to treat irregular heart rhythm
• non-steroidal anti-inflammatory drugs (NSAIDs) such as diclofenac or ibuprofen, used to relieve pain in muscles, bones and joints,
• antacids, used for the relief of acid indigestion
• antidepressants, used for depression such as amitriptyline
• sympathomimetic medicines such as ephedrine used in some cough and cold remedies or medicines used for the treatment of a condition of hypersensitivity to certain foreign proteins, high blood pressure, heart failure, asthma, allergies and nasal congestion such as adrenaline, salbutamol or dopamine
Your doctor may need to change your dose and/or take other precautions:
• if you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also information under the headings "Do not take Enalapril" and "Take special care")
Tests and operations
If you are going to have an operation or any form of surgery (even at the dentist) please inform your doctor and ensure that the anaesthetist or dentist and other relevant medical personnel know that you are taking Enalapril.
When you first start your treatment with Enalapril and at intervals during your treatment your doctor, in addition to frequently measuring your blood pressure, may wish to test that your kidneys are working properly.
Taking Enalapril with food and drink
Enalapril can be taken with or without food. If you drink alcohol whilst taking Enalapril, it may cause your blood pressure to drop and you may experience light-headedness, faintness or dizziness. Drinking a moderate amount of alcohol may be acceptable when taking Enalapril but ask your doctor if drinking alcohol is safe for you.
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
You should be able to drive while taking Enalapril. However, do not drive or operate machines if you feel dizzy, light-headed, tired or faint all of which are possible side effects of taking Enalapril.
Important information about some of the ingredients of Enalapril
This product 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.
3. How to take Enalapril
Always take Enalapril exactly as your doctor has told you. The doctor, depending on your needs and the condition being treated, will decide the dose of Enalapril. You should check with your doctor or pharmacist if you are not sure.
Taking this medicine
• Swallow the tablets with a glass of water.
• You should take your tablet at the same time each day unless your doctor tells you otherwise.
• If you are taking 2 tablets a day, take one in the morning and one in the evening, unless your doctor has told you otherwise.
• If you have the impression that the effect of Enalapril is too strong or too weak, talk to your doctor or pharmacist.
How much to take - adults & older people
High blood pressure
• T reatment is usually started with 5mg once a day.
• Depending on your circumstances your doctor may start you on a lower dose of 2.5mg a day.
• If you are over 65 years of age the usual starting dose is 2.5 mg once a day.
• Your doctor may decide to increase gradually up to 10-20mg once daily.
• If you have severe high blood pressure your doctor may increase up to 40mg a day
• The maximum dose should not exceed 40mg in one day
Heart failure
• The usual recommended starting dose is 2.5mg a day.
• Your doctor may decide to increase gradually up to 20mg a day, given either once daily or in 2 divided doses of 10mg
• The maximum dose should not exceed 40mg in one day
Patients taking water tablets
• If you are taking water tablets, your doctor may start you on a lower dose of 2.5mg a day.
• If possible, your doctor will ask you to stop taking your water tablets 2- 3 days before starting to take your Enalapril.
Patients with kidney problems
• The usual starting dose is 2.5 mg once a day.
• If you suffer with kidney problems the dose of Enalapril will be adjusted depending on how well your kidneys are functioning. Kidney function is calculated by testing your blood and urine.
• If you are having dialysis treatment your dosage will vary daily. Your doctor will let you know what your dose should be.
Children (less than 18 years of age)
Do not give to children aged less than 18 years of age.
If you take more Enalapril than you should
If you take more Enalapril than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you. Some common signs of overdose are a fall in blood pressure resulting in dizziness or light-headedness; therefore if possible get someone else to drive if necessary.
If you forget to take Enalapril
• If you forget to take a dose, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose
• Do not take a double dose to make up for a forgotten dose
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Enalapril can cause side effects, although not everybody gets them. The following side effects may occur with this medicine.
Stop taking your medicine and see a doctor or go to a hospital straight away, if you notice any of the following serious side effects - you may need urgent medical treatment:
• allergic reaction with symptoms such as difficulty breathing, skin rash, itching, swollen or lumpy skin, blisters, swollen face, lips, tongue or throat
• severe dizziness or light-headedness especially at the start of treatment or when your dose is increased or when you stand up (caused by a sudden drop in blood pressure)
Common side effects (affects between 1 in 10 and 1 in 100 patients):
headache, dizziness
Uncommon side effects (affects between 1 in 100 and 1 in 1,000 patients):
• tiredness, loss of strength or feeling weak
• low blood pressure sometimes only when standing, fainting, loss of consciousness
• feeling sick, diarrhoea, rash or cough
• muscle cramps, muscle weakness
• kidney problems with symptoms such as passing less urine
Rare side effects (affects between 1 in 1,000 and 1 in 10,000 patients):
Heart and the blood system
• heart attacks particularly in those patients who suffer from extremely low blood pressure
• chest pain or a strangling pain in the chest, rapid or irregular heartbeat
Stomach & intestines
• disruption to normal bowel movement with symptoms such as constipation, flatulence or excessive belching
• pain around your stomach area associated with radiating pain to the back
• liver problems with symptoms such as pain in the abdomen or jaundice (yellowing of your skin and the whites of your eyes)
• stomach pain, being sick, heartburn, constipation, loss of appetite
• Inflammation of the lining within the mouth including gums, cheek, throat, tongue or lips
• changes to taste, inflamed or colour change of tongue
Nervous system
• general depression, confusion, sleepiness, inability to fall asleep, nervousness
• feeling of numbness and tingling sensation, a feeling of dizziness or ‘spinning’ (vertigo)
Breathing and Lungs
• Problems with the lungs which may cause a feeling of shortness of breath or wheezing, asthma
• feeling of an obstruction in the throat which affects breathing
• runny nose, sore throat or hoarseness.
Skin
• itchy pink blotches or rash on the skin with possible swelling
• inflammation of the skin with scaling
• serious illness with blistering of the skin, mouth eyes and genitals
• skin peeling off in sheets, skin reactions (blistering, itching, hives, rash, flushing)
• excessive sweating, hair loss
Allergic Reactions
• Swelling of the face, fingers or toes, lips, tongue, throat, voice box or vocal cords Changes in blood components
• reduction in white blood cells, which increases risk of infections with onset of sudden fevers or sore throats
• reduction in blood platelets, which increases risk of bleeding or bruising
• reduction in the production of blood cells by bone marrow, which can lead to severe infections
• reduction in red blood cells or haemoglobin, signs include increased breathlessness when carrying out normal activities
• increased blood potassium levels, symptoms may include feeling unwell, muscle weakness
• low blood sodium levels, signs may include vomiting, headache, feeling unwell
• increased liver enzymes, blood ‘bilirubin’, blood urea, plasma creatinine usually detected by a blood test.
Others
• ringing in the ears, blurred vision, sexual inability in men
Others (unknown how many people may be affected)
• a complex side effect has been reported and may include some or all of the following signs:
• fever, swelling of the blood vessels, pain and inflammation of muscles or joints
• changes in blood components or cell counts
• rash, increased sensitivity to sunlight as well as other skin complaints
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
5. How to store Enalapril
• Keep out of the reach and sight of children
• Do not store above 25°C.
• Store in the original container.
• Do not use Enalapril after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required which will help protect the environment.
6. Further information
What Enalapril contains
• The drug substance is enalapril maleate. Each tablet contains 10mg or 20mg of the drug substance enalapril maleate.
• The other ingredients are croscarmellose sodium, lactose monohydrate, magnesium stearate, iron oxide (E172), maize starch pregelatinised and sodium hydrogen carbonate.
What Enalapril Tablets look like and contents of the pack
• Enalapril Maleate 10mg Tablets are circular, peach tablets with a scoreline on one side and marked ‘E 10’ on the reverse
• Enalapril Maleate 20mg Tablets are circular, orange tablets with a scoreline on one side and marked ‘E 20’ on the reverse
Enalapril is only available from your pharmacist on prescription in pack sizes of 28 and 50 tablets.
MA Holder: Zanza Laboratories (Holdings) Limited, Unit 2A, Olympic Way, Sefton Business Park, Liverpool L30 1RD, UK
Distributed by: Zanza Laboratories Limited, Liverpool, UK Date leaflet last revised: August 2014