PACKAGE LEAFLET: INFORMATION FOR THE USER

Perindopril arginine 10 mg film-coated tablets

perindopril arginine

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 Perindopril arginine is and what it is used for

2.    Before you take Perindopril arginine

3.    How to take Perindopril arginine

4.    Possible side effects

5.    How to store Perindopril arginine

6.    Further information

1.    WHAT PERINDOPRIL ARGININE IS AND WHAT IT IS USED FOR

Perindopril arginine belongs to a group of medicines known as angiotensin converting enzyme (ACE) inhibitors. These work by making your blood vessels wider, which makes it easier for your heart to pump blood through them.

Perindopril arginine is used:

•    to treat high blood pressure (hypertension)

•    to reduce the risk of cardiac events, such as heart attack, in patients with stable coronary artery disease (a condition where the blood supply to the heart is reduced or blocked) and who have already had a heart attack and/or an operation to improve the blood supply to the heart

2.    BEFORE YOU TAKE PERINDOPRIL ARGININE Do not take Perindopril arginine

•    if you are allergic (hypersensitive) to perindopril or to any of the other ingredients of Perindopril arginine or to any other ACE inhibitor (see section 6 - ‘Further Information’)

•    if you have experienced symptoms such as wheezing, swelling of the face, tongue or throat, intense itching or severe skin rashes with previous ACE inhibitor treatment, or if you or a member of your family have had these symptoms in any other circumstances (a condition called angioedema)

•    if you are more than 3 months pregnant (It is also better to avoid Perindopril arginine in early pregnancy - see pregnancy section)

•    Perindopril arginine contains soya oil. If you are allergic to peanut or soya do not use this medicinal product.

Take special care with Perindopril arginine

You should tell your doctor before taking this medicine if you:

•    have aortic stenosis (narrowing of the main blood vessel leading from the heart) or hypertrophic cardiomyopathy (heart muscle disease) or renal artery stenosis (narrowing of the artery supplying the kidney with blood)

•    have any other heart problems

•    have liver problems

•    have kidney problems or if you are receiving dialysis

•    suffer from a collagen vascular disease (disease of the connective tissue) such as systemic lupus erythematosus or scleroderma

•    have diabetes

•    are on a salt restricted diet or use salt substitutes which contain potassium

•    are to undergo anaesthesia and/or major surgery

•    are to undergo LDL apheresis (which is removal of cholesterol from your blood by a machine)

•    are going to have desensitisation treatment to reduce the effects of an allergy to bee or wasp stings

•    have recently suffered from diarrhoea or vomiting, or are dehydrated

•    have been told by your doctor that you have an intolerance to some sugars

You must tell your doctor if you think that you are (or might become) pregnant. Perindopril arginine 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).

Perindopril arginine is not recommended for use in children and adolescents.

Taking other medicines

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

Perindopril arginine can affect the way some other medicines work and some medicines can have an effect on Perindopril arginine. In particular, tell your doctor if you are using any of the following medicines:

•    other medicines for high blood pressure, including diuretics (medicines which increase the amount of urine produced by the kidneys)

•    potassium-sparing diuretics (spironolactone, triamterene or amiloride), potassium supplements or potassium-containing salt substitutes

•    lithium (a medicine for mental health problems)

•    non-steroidal anti-inflammatory drugs (e.g. ibuprofen) for pain relief or high dose aspirin

•    medicines to treat diabetes (such as insulin or metformin)

•    medicines to treat mental disorders such as depression, anxiety or schizophrenia (e.g. tricyclic antidepressants, antipsychotics)

•    immunosuppressants (medicines which reduce the defence mechanism of the body), used for the treatment of auto-immune disorders or following transplant surgery (e.g. ciclosporin)

•    medicines for the treatment of gout (e.g. allopurinol)

•    medicines for the treatment of an irregular heart beat (e.g. procainamide)

•    products that make the blood vessels become wider (e.g. vasodilators including nitrates)

•    medicines used to thin blood (e.g. heparin)

•    medicines used for the treatment of low blood pressure, shock or asthma (e.g. ephedrine, noradrenaline or adrenaline)

Taking Perindopril arginine with food and drink

It is recommended to take Perindopril arginine before a meal.

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 Perindopril arginine before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Perindopril arginine. Perindopril arginine 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. Perindopril arginine is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Perindopril arginine usually does not affect alertness but dizziness or weakness due to low blood pressure may occur in certain patients. If you are affected in this way, your ability to operate machinery may be impaired.

Important information about some of the ingredients of Perindopril arginine

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

Perindopril arginine contains soya oil. If you are allergic to peanut or soya do not use this medicinal product.

3. HOW TO TAKE PERINDOPRIL ARGININE

Always take Perindopril arginine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Swallow your tablet with a glass of water, preferably at the same time each day, preferably in the morning, before a meal. Your doctor will decide on the correct dose for you.

The usual dose for Perindopril arginine is:

High blood pressure:

The usual starting and maintenance dose is 5 mg once daily. After one month, this can be increased to 10 mg once a day if required. 10 mg a day is the maximum recommended dose for high blood pressure.

If you are 65 years old or older, treatment usually starts with 2.5 mg once a day. After a month this can be increased to 5 mg once a day and then if necessary to 10 mg once daily.

Stable coronary artery disease:

The usual starting dose is 5 mg once daily. After two weeks, this can be increased to 10 mg once a day, which is the maximum recommended dose for this indication.

If you are 65 years old or older, the usual starting dose is 2.5 mg once a day. After a week this can be increased to 5 mg once a day and after a further week to 10 mg once daily.

If you take more Perindopril arginine than you should

Contact your nearest accident and emergency department or tell your doctor immediately. The most likely effect in case of overdose is low blood pressure, which can make you feel dizzy or faint. If this happens, lying down with your legs raised can help.

If you forget to take Perindopril arginine

It is important to take your medicine every day as regular treatment works better. However, if you forget to take a dose of Perindopril arginine, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Perindopril arginine

As the treatment with Perindopril arginine is usually life-long, you should discuss with your doctor before stopping this medicinal product.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Perindopril arginine can cause side effects, although not everybody gets them.

If you experience any of the following, stop taking the medicinal product at once and tell your doctor immediately:

•    swelling of the face, lips, mouth, tongue or throat, difficulty in breathing

•    severe dizziness or fainting

•    unusual fast or irregular heart beat

Common: affects 1 to 10 users in 100

•    headache, dizziness, vertigo, pins and needles

•    vision disturbances

•    tinnitus (sensation of noises in the ears)

•    light-headedness due to low blood pressure

•    cough, shortness of breath

•    gastrointestinal disorders (nausea, vomiting, abdominal pain, taste disturbances, dyspepsia or difficulty of digestion, diarrhoea, constipation

•    allergic reactions (such as skin rashes, itching)

•    muscle cramps

•    tiredness

Uncommon: affects 1 to 10 users in 1,000

•    mood swings or sleep disturbances

•    tightening of the chest, wheezing and shortness of breath (bronchospasm)

•    dry mouth

•    angiodema (symptoms such as wheezing, swelling of the face, tongue or throat, intense itching or severe skin rashes

•    kidney problems

•    impotence

•    sweating

Very rare: affects less than 1 user in 10,000

•    confusion

•    cardiovascular disorders (irregular heart beat, angina, heart attack and stroke)

•    eosinophilic pneumonia (a rare type of pneumonia)

•    rhinitis (blocked up or runny nose)

•    erythema multiforme

•    disorders of the blood, pancreas or liver

In case of diabetic patients, hypoglycaemia (very low blood sugar level) can occur.

Vasculitis (inflammation of the blood vessels ) has been reported.

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 PERINDOPRIL ARGININE

This medicinal product does not require any special storage conditions.

Do not use Perindopril arginine after the expiry date, which is stated on the carton, blister or bottle 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. These measures will help to protect the environment.

6. FURTHER INFORMATION What Perindopril arginine contains

The active substance is perindopril arginine.

One 10 mg tablet contains 10 mg of perindopril arginine, equivalent to 6.790 mg of perindopril.

The other ingredients are:

Core:

Lactose monohydrate, Magnesium stearate, Maltodextrin, Silica hydrophobic colloidal, Sodium starch glycolate (type A), Povidone (K 30).

Film-coating:

Lecithin (Soya) (E322), Polyvinyl alcohol, Talc (E553b), Titanium dioxide (E171), Xanthan gum (E415), Quinoline yellow aluminium lake (E104), FD & C Blue no 1/Brilliant blue FCF aluminium lake (E133), Iron oxide yellow (E172).

What Perindopril arginine looks like and contents of the pack

Perindopril arginine 10 mg film-coated tablets are green, round, biconvex, film-coated tablets debossed with “PA3” on one side and “M” on the other side.

Perindopril arginine is available in blisters of 10, 14, 30, 60, 90 and 100 tablets and in plastic bottles of 30, 60, 90 and 100 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Mylan, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.

Manufacturer:

McDermott Laboratories Limited trading as Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.

This leaflet was last approved in 02/2011

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