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Document: leaflet MAH GENERIC_PL 00289-0462 change

• leaflet MAH GENERIC_PL 00289-0462
• leaflet MAH GENERIC_PL 04569-0537

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PAGE 1: FRONT FACE (INSIDE OF REEL)

Quinapril 5 mg, 10 mg, 20 mg and 40 mg Film-Coated Tablets

PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

•    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 only.

Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any of the side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4..

WHAT IS INTHIS LEAFLET:

1.    What Quinapril is and what it is used for

2.    What you need to know before you take Quinapril

3.    How to take Quinapril

4.    Possible side effects

5.    How to store Quinapril

6.    Contents of the pack and other information

OWHAT QUINAPRIL IS AND WHAT IT IS USED FOR

Quinapril belongs to a group of drugs called Angiotensin Converting Enzyme (ACE) Inhibitors, which are vasodilators (drugs which widen the blood vessels, reduce blood pressure and make it easier for the heart to pump blood around the body).

Quinapril is used to treat:

• high blood pressure

• congestive heart failure (a condition where the heart no longer pumps blood as effectively as it should).

©WHAT YOU NEED TO KNOW BEFORE YOU TAKE QUINAPRIL

DO NOT take Quinapril and contact your doctor immediately if you :

• are allergic (hypersensitive) to quinapril or any of the other ingredients of this medicine • have suffered an allergic reaction to any other ACE inhibitors e.g. captopril, enalapril, which has led to swelling of the face, lips, tongue and/or throat • have a condition known as hereditary angioedema which is a serious allergic reaction which causes swelling of the face or throat, or have ever had a similar unexplained allergic reaction • are more than 3 months pregnant. (It is also better to avoid Quinapril in early pregnancy - see pregnancy section.)

• have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

Warnings and precautions

Talk to your doctor before you start to take this

medicine if you:

• have any of the following heart problems:

narrowing of your heart valves, a condition called hypertrophic cardiomyopathy (inflammation of the heart muscle fibres leading to less efficient pumping of blood around the body), or ischaemic heart disease (a disease characterised by lack of blood flow and oxygen to the heart)

• have kidney problems, or disease of the arteries to the kidneys, or you are undergoing dialysis • recently had a kidney transplant or are suffering from primary hyperaldosteronism (a condition in which too much aldosterone hormone is produced), as Quinapril is not recommended.

• have cerebrovascular disease which is a disorder of the blood vessels of the brain and its covering membranes

• have collagen vascular disease e.g. rheumatoid arthritis, SLE (systemic lupus erythematosus) which is an autoimmune condition which causes joint pain, skin rashes and fever • have been on a low salt diet • are recently suffered vomiting or diarrhoea • are taking any of the following medicines used to treat high blood pressure:

• an angiotensin II receptor blocker (ARBs) (also known as sartans - for example valsartan, telmisartan, irbesartan), in particular if you have diabetes-related kidney problems • aliskiren

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

See also information under the heading "DO NOT take Quinapril and contact your doctor immediately if you" You must tell your doctor if you think you are (or might become) pregnant. Quinapril 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).

Tell your doctor or pharmacist if you:

• are to have haemodialysis, as a different dialysis membrane may be needed • are about to have a treatment called 'LDL apheresis', which is the removal of cholesterol from your blood by a machine. The doctor treating you may wish to stop your medicine temporarily to prevent a possible allergic reaction.

• are to have desensitising therapy to prevent allergy to wasps, ants or bees • are to have an operation requiring an anaesthetic (including treatment at the dentist); tell the doctor or dentist that you are taking Quinapril.

Other important information:

•    Quinapril may not work as well in Afro-Caribbean patients, and they may be at greater risk of certain side effects (see section 4, Possible side effects).

•    Your doctor may monitor you when you first start taking Quinapril. This may involve urine and blood tests.

Other medicines and Quinapril

Tell your doctor or pharmacist if you are taking, have

recently taken or might take any of the following

medicines:

•    diuretics ("water tablets"), as the risk of low blood pressure may be increased

•    other medicines for high blood pressure e.g. atenolol, diltiazem, as the effects of Quinapril may be increased

•    potassium supplements (this includes salt substitutes that often replace potassium), as potassium may increase above expected levels

•    non-steroidal anti-inflammatory drugs (NSAIDs) e.g. aspirin, diclofenac, ibuprofen, piroxicam, as the effectiveness of Quinapril may be reduced

•    antacids (used to treat indigestion and heartburn) e.g. aluminium hydroxide, dimeticone, as the effectiveness of Quinapril may be reduced

•    tetracycline (an antibiotic), as Quinapril may reduce its effectiveness

•    trimethoprim (an antibiotic), as your blood potassium level may be raised

•    procainamide (used to treat an abnormal heartbeat) and cytostatic agents e.g. mercaptopurine, as there is an increased risk of leucopenia

•    medicines for diabetes, including insulin, as your dosage may need to be adjusted

•    lithium (used to help treat mood swings and severe depression), as levels of lithium may be increased

•    barbiturates (sleeping pills) e.g. phenobarbital, as the risk of low blood pressure may be increased

•    narcotic drugs (used to treat moderate or severe pain) e.g. diamorphine, morphine, pethidine, as the risk of low blood pressure may be increased

•    allopurinol (used to treat gout), as there is an increased risk of the blood disorder leucopenia, a reduction in the number of white blood cells which makes infections more likely

•    immunosuppressant drugs e.g. azathioprine, ciclosporin and corticosteroids e.g. prednisolone and hydrocortisone, as there is an increased risk of leucopenia, a reduction in white blood cells which makes infections more likely

•    sympathomimetics e.g. dopamine, terbutaline, salmeterol, salbutamol, ephedrine, adrenaline, or phenylpropanolamine. Phenylpropanolamine and ephedrine may be present in medicines for colds and nasal stuffiness.

Your doctor may need to change your dose and/or to take other precautions:

If you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also information under the headings "DO NOT take Quinapril and contact your doctor immediately if you" and "Warnings and precautions")"

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking Quinapril with food and drink

•    DO NOT take alcohol whilst being treated with Quinapril.

Pregnancy, breast-feeding and fertility

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advise before taking this medicine.

Quinapril 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. Breastfeeding

•    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 Quinapril.

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

Driving and using machines

•    Quinapril may cause dizziness or drowsiness, especially at the beginning of treatment or if taken with alcohol. If you are affected, DO NOT drive or operate machinery.

a HOW TO TAKE QUINAPRIL

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

In some cases, your treatment may be started in hospital so that you can be closely monitored.

The tablets should be swallowed preferably with a glass of water. The usual dose is:

Adults including the elderly

•    High blood pressure

10 mg once daily. Your doctor may, if necessary, increase your dose to 20 to 40 mg a day, taken as one or two doses.

If you are already taking a diuretic ("water tablet"), your doctor may recommend an initial dose of 2.5 mg once daily, gradually increasing this as necessary. Your doctor may have told you to stop taking your diuretic medicine 2 or 3 days before starting Quinapril.

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