Document: leaflet MAH GENERIC_PL 20417-0068 change

• leaflet MAH BRAND_PL 05815-0018
• leaflet MAH GENERIC_PL 05815-0018
• leaflet MAH GENERIC_PL 18909-0207
• leaflet MAH GENERIC_PL 20075-0295
• leaflet MAH GENERIC_PL 20417-0068
• leaflet MAH GENERIC_PL 25847-0002
• leaflet MAH GENERIC_PL 30306-0174
• leaflet MAH GENERIC_PL 41043-0001
• leaflet MAH GENERIC_PL 43870-0039
• leaflet TEVA UK_PL 25847-0002

---

PATIENT INFORMATION LEAFLET

PERINDOPRIL TABLETS 2, 4 & 8 mg TABLETS

(Perindopril erbumine)

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 further questions, please ask your doctor or your pharmacist or nurse.

•    This medicine has been prescribed for you. 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 side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effect not listed in this leaflet. See Section 4.

Perindopril Tablets are used to treat

•    high blood pressure (hypertension),

•    heart failure ( a condition here the heart is unable to pump enough blood to meet the body's needs),

•    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 blo od supplyto the heart by widening the vessels that supply it.

Perindopril is one of a group of medicines called ACE inhibitors. These work by widening the blood vessels, which makes it easier for your heart to pump blood through them.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PERINDOPRIL TABLETS'

Do not take Perindopril Tablets if:

•    you are allergic (hypersensitive) to perindopril, other ACE inhibitors, or to any of the other ingredients in the tablets (these are listed in Section 6, Contents of the pack and other information);

•    you have experienced symptoms such as wheezing, swelling of the face, tongue or throat, intense itching, skin rashes, fainting or dizziness with previous ACE inhibitor treatment or have had these symptoms in any other circumstances (this is a condition called angioedema);

•    you are more than 3 months pregnant. (It is also better to avoid Perindopril Tablets in early pregnancy - see Warning and precautions )

•    you have diabetes mellitus or kidney problems and you are treated with aliskiren.

Warning and precautions

•    Talk to your doctor or pharmacist or nurse before taking Perindopril Tablets if you have: have aortic stenosis (narrowing of the main blood vessel leading from the heart) or hypertrophic cardiomyopathy (cardiac muscle disease) or renal artery stenosis (narrowing of the artery supplying the kidney with blood);

•    have any other heart or liver or kidney problems, or if you are receiving dialysis;

•    suffer from a collagen disease such as systemic lupus erythematosus or scleroderma;

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

•    suffer from diabetes which is not well controlled;

•    are to undergo anaesthesia and/or surgery;

•    have suffered from recent diarrhoea or vomiting; are going to have desensitisation treatment to reduce the effects of an allergy to bee or wasp stings;

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

You must tell your doctor if you think you are (or might become) pregnant. Perindopril Tablets are not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as they may cause serious harm to your baby if used at that stage (see pregnancy section).

Taking other medicines

You should tell your doctor if you are taking or have taken any of the following medicines as they may decrease or increase the effect of your Perindopril Tablets.

Treatment with Perindopril Tablets can be affected by other medications

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

•    potassium-sparing diuretics (e.g. spironolactone, triamterene or amiloride); potassium supplements and potassium-containing salt substitutes;

•    potassium-sparing drugs used in the treatment of heart failure: eplerenone and spironolactone at

•    doses between 12.5mg to 50mg per day;

•    medicines for the treatment of diabetes (insulin or metformin tablets) to lower blood sugar;

•    lithium for mania or depression;

•    medicines for the treatment of mental disorders such as depression, anxiety, schizophrenia or other psychoses;

•    allopurinol used for the treatment of gout (painful joints due to a build up of uric acid);

•    estramustine (used in cancer therapy);

•    trimethoprim (for the treatment of infections);

•    immunosuppressant’s used for the treatment of auto-immune disorders (e.g. rheumatoid arthritis) or following transplant surgery;

•    procainamide, a treatment for irregular heartbeat;

•    non-steroidal anti-inflammatory drugs (NSAIDs) for pain relief, including aspirin;

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

•    vasodilators including nitrates (products that make the blood vessels become wider) heparin (used to thin the blood).

•    gold salts, especially with intravenous administration used to treat rheumatoid arthritis..

It may still be all right for you to take Perindopril Tablets and your doctor will be able to decide what is suitable for you. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking your medicine with food and alcohol:

It is recommended that Perindopril Tablets should be taken before a meal in order to reduce the influence of food on the way in which the medicine works.

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 Tablets before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Perindopril Tablets. Perindopril Tablets are not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as they 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 Tablets are 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 doctors or pharmacist for advice before taking any medicine.

Driving and using machines

Perindopril Tablets do not usually 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 drive or to operate machinery may be impaired.

Your doctor will decide on the right starting dose for you and on any increase in the dose depending on your condition and whether you are taking any other medicines. Do not change your dosage unless your doctor tells you to do so. Perindopril Tablets may be used on its own or with other medicines which lower blood pressure.

Always take Perindopril Tablets exactly as your doctor has told you. You should check with your doctor

or pharmacist if you are not sure.

The usual dosages for Perindopril Tablets are as follows:

High blood pressure:

•    the usual starting and maintenance dose for treatment in adults is 4 mg once a day. After a month, this can be increased to 8 mg a day which is the maximum recommended dose.

•    If you are 65 or over, the usual starting dose is 2 mg once a day. After a month, this can be increased to 4mg a day and if necessary to 8mg a day. Your doctor may give you a blood test to check that your kidneys are working properly before increasing the dose to 8 mg.

Heart failure:

•    treatment should be started under close medical supervision with 2 mg once a day. After two weeks, it can be increased to 4 mg once a day if required.

Stable coronary artery disease:

•    the usual starting dose is 4 mg once daily. After two weeks and if 4 mg is well tolerated, this can be increased to 8 mg once daily.

•    If you are 65 or over, the usual starting dose is 2 mg once daily. After one week, this can be increased to 4 mg once daily and after a further week to 8 mg once daily. Your doctor may give you a blood test to check that your kidneys are working properly before increasing the dose to 8 mg.

Treatment for these conditions is usually life-long.

Method of Administration

Take your tablet(s) with a glass of water, preferably at the same time each day, in the morning, before a meal. If you are taking water tablets (diuretics), your doctor may decide to reduce or even discontinue these at the beginning of your treatment with Perindopril Tablets.

Perindopril Tablets are not suitable for use in children (under the age of 18).

If you take more Perindopril Tablets than you should:

If you have accidentally taken more than your prescribed dose, contact your casualty emergency department or tell your doctor or pharmacist immediately. Remember to take the pack and any remaining tablets with you. The most common signs and symptoms of overdose are a fall in blood pressure (causing dizziness and light-headedness) and stupor (a state of almost complete lack of consciousness). Other symptoms may include a forceful and rapid heartbeat, rapid pulse, anxiety, cough and rapid breathing.

If you forget to take Perindopril Tablets:

It is important to take your medicine every day. However, if you forget to take one or more doses, take another as soon as your remember and then go on as prescribed. 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.

Stop taking the medicinal product and see a doctor immediately, if you experience any of the following side effects;

•    Swelling of the face, lips, mouth, tongue or throat, difficulty in breathing (angioedema)

•    Severe dizziness or fainting,

•    Unusual fast or irregular heart beat or chest pain,

•    Severe abdominal or back pain which could be a sign of inflammation of the pancreas

•    Hepatitis (inflammation of the liver), which may present as yellowing of the eyes or skin (jaundice)

•    Cardiovascular disorders (heart attack and stroke)

•    Severe skin rashes (erythema multiforme)

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

In decreasing order of frequency, side effects can include:

Common (may affect up to 1 in 10 people):

•    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

•    gastro-intestinal disorders (nausea, vomiting, abdominal pain, taste disturbances, dyspepsia or difficulty of digestion, diarrhoea, constipation)

•    allergic reactions (such as skin rashes, itching),

•    muscle cramps,

•    feeling of tiredness.

Uncommon (may affect up to 1 in 100 people):

•    Mood swings

•    sleep disturbances

•    dry mouth

•    intense itching

•    formation of blister clusters over the skin

•    kidney problems

•    impotence(erectile dysfunction)

•    sweating

•    an excess of eosinophils (a type of white blood cells)

•    drowsiness

•    fainting

•    palpitations

•    rapid heart rate

•    vasculitis (inflammation of blood vessels)

•    photosensitivity reaction ( increased sensitivity of skin to sun)

•    arthralgia (joint pain)

•    myalgia (muscle pain)

•    feeling sick

•    swelling of the limbs

•    fever

•    fall

•    change in laboratory parameters; high blood level of potassium reversible on discontinuation, low level of sodium, hypoglycaemia (very low blood sugar level) in case of diabetic patient, increased blood urea, and increased blood creatinine

Rare (may affect up to 1 in 1000 people)

•    Changes in laboratory parameters: increased level of liver enzymes, high level of serum bilirubin.

Very rare (may affect 1 in 10,000 people)

•    Confusion,

•    eosinophilic pneumonia (a rare type of pneumonia)

•    rhinitis (blocked up or runny nose)

•    acute renal failure

•    changes in blood values such as lower number of white blood cells, lower haemoglobin, lower number of blood platelets

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: http://www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

Do not store your tablets above 30°C. Store in the original package to protect the tablets from moisture. Do not take this medicine after the expiry date shown on the carton. The expiry date refers to the last day of that month.

Keep all medicines out of the sight and reach of children.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help protect the environment._

6. CONTENTS OF THE PACK AND OTHER INFORMATION

The active substance is perindopril erbumine (as monohydrate). Each tablet contains 2, 4 & 8 mg of perindopril erbumine.

The other ingredients are mannitol, sodium starch glycolate, sodium carbonate, hypromellose, macrogol, talc, simeticone, magnesium stearate, lecithin, titanium dioxide (E171), xanthan gum and polyvinyl alcohol.

What Perindopril Erbumine Tablets look like and the contents of the pack:

Perindopril 2 mg Tablets are white to off white circular, biconvex film coated tablets plain on both sides.

Perindopril 4 mg Tablets are white to off white, barrel shaped, biconvex film coated tablets, one side debossed with ‘PR’ and ‘4’ on either side of a central scoreline and with a central scoreline on the other side.

Perindopril 8 mg Tablets are white to off white, barrel shaped, biconvex film coated tablets, one side debossed with ‘PR’ and ‘8’ on either side of a central scoreline and with a central scoreline on the other side. The score line is only to enable a tablet to be broken in half for ease of swallowing and not to divide into equal doses.

Your medicine is available in blister packs or bottles of 28 or 30 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Fannin (UK) Limited, 42-46 Booth Drive, Park Farm South, Wellingborough, NN8 6GT Manufacturer responsible for batch release:

Kent Pharmaceuticals Limited, Crowbridge Road, Ashford, Kent, TN24 0GR, U.K.

Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K.

This leaflet was last revised in July 2015.