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Perindopril 4 Mg Tablets

Document: leaflet MAH GENERIC_PL 00530-0765 change

Patient information leaflet Perindopril 2 mg Tablets Perindopril 4 mg Tablets Perindopril 8 mg Tablets Perindopril tert-butylamine

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 side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Perindopril Tablets are and what they are used for

2.    What you need to know before you take Perindopril Tablets

3.    How to take Perindopril Tablets

4.    Possible side effects

5.    How to store Perindopril Tablets

6.    Contents of the pack and other information

1.    What Perindopril Tablets are and what they are used for

Perindopril Tablets are used:

-    in the treatment of high blood pressure (hypertension).

-    to treat heart failure (a condition where 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 blood supply to the heart by widening the vessels that supply it.

Perindopril Tablets belong to a class 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 more than 3 months pregnant. (It is also better to avoid Perindopril in early pregnancy - see section: Pregnancy and breast-feeding)

•    if you are allergic to perindopril or any other ACE inhibitor, or any of the other ingredients of this medicine (listed in section 6),;

•    if you have had 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);

•    if you are breast-feeding.

if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering

medicine containing aliskiren

Perindopril Tablets should not be given to children.

Warnings and precautions You must tell your doctor if you think you are (or might become) pregnant. Perindopril 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 section: Pregnancy and breastfeeding).

Talk to your doctor or pharmacist before taking Perindopril Tablets:

•    if you have aortic or mitral stenosis (heart valve disease leading to narrowing of

the aortic or mitral valves) or hypertrophic cardiomyopathy (cardiac muscle disease) or renal artery stenosis (narrowing of the artery supplying the kidney with blood);

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

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

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

•    if you suffer from diabetes. The sugar in your blood should be closely monitored during the first month of treatment.

•    if you are a black patient: you are more likely to suffer from angioedema (allergic reaction causing swelling of face, lips, mouth, tongue or throat);

•    if you develop infections repeatedly, please contact your physician;

•    if you are undergoing LDL-apheresis (which is removal of cholesterol from your blood by a machine);

•    if you are to undergo anaesthesia and/or surgery;

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

•    if you suffer from cough.

•    if you 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 Perindopril Tablets’.

Other medicines and Perindopril Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines:

•    other medicines for treating high blood pressure including diuretics (water tablets);

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

•    medicines for the treatment of diabetes (insulin or tablets) or 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;

•    immunosuppressants used for the treatment of auto-immune disorders (eg 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 (eg ephedrine, noradrenaline or adrenaline);

•    vasodilators including nitrates (products that make the blood vessels become wider);

•    heparin (used to thin the blood).

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 Perindopril Tablets’ and ‘Warnings and precautions’).

If you see another doctor or visit a hospital, remember to tell them what medicines you are already taking. If in doubt take your medicines with you.

Please tell your doctor or pharmacist that you are taking Perindopril Tablets if you:

•    have suffered from recent diarrhoea or vomiting;

•    Are to undergo haemodialysis

Perindopril Tablets with food and drink

It is recommended that Perindopril Tablets should be taken on an empty stomach in order to reduce the influence of food on the way in which the medicine works. Drinking alcohol with Perindopril Tablets may make you feel dizzy or light-headed. You should check with your doctor whether drinking is advisable for you.

Pregnancy and breast-feeding

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

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 before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Perindopril. Perindopril 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 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.

Driving and using machines

Do not drive or use any tools or machines whilst taking Perindopril Tablets, as you may experience dizziness or weariness while taking Perindopril Tablets.

Perindopril Tablets contain lactose

Patients who are intolerant to lactose should note that Perindopril tablets contain a small amount of lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Perindopril Tablets

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

Perindopril tablets may be used on its own or with other medicines which lower blood pressure. The recommended dosages for Perindopril Tablets are as follows:

High blood pressure: the usual starting and maintenance dose for treatment in adults is 4mg once a day.

After a month, this can be increased to 8mg a day which is the maximum recommended dose.

In the elderly, the usual starting dose is 2mg once a day. After a month, this can be increased to 4mg a day and if necessary to 8mg a day.

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

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.

Treatment for these conditions is usually life-long.

Use in children

Perindopril Tablets are not suitable for use in children.

If you take more Perindopril Tablets than you should

If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. An overdose is likely to cause hypotension, circulatory shock, electrolyte disturbances, renal failure, hyperventilation, tachycardia, palpitations, bradycardia, dizziness, anxiety, and cough. Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.

If you forget to take Perindopril Tablets

Do not take a double dose to make up for a forgotten tablet.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

•    cough, shortness of breath;

•    light-headedness due to low blood pressure (particularly after the first few doses, if the dose is increased or when water tablets are also taken);

•    headache, dizziness, vertigo-weakness, lethargy, pins and needles, muscle cramps, visual disturbances (eg blurred vision, eye pain), tinnitus (sensation of noises in the ears);

•    nausea, vomiting, abdominal pain, changes in your sense of taste, feeling of indigestion, diarrhoea, constipation;

•    skin rashes, itching.

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

•    changes in mood or sleep;

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

•    dry mouth;

•    kidney problems;

•    impotence;

•    sweating;

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

•    angiodema (swelling of the face, lips, mouth, tongue or throat);

•    difficulty in breathing;

•    dizziness or fainting;

•    unusually fast or irregular heartbeat. This is very rare but serious reaction which can occur with all drugs of this type (ACE inhibitors). It must be treated immediately, usually in hospital.

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

•    confusion;

•    irregular heart beat, angina, heart attack and stroke (these have been reported with ACE inhibitors in association with low blood pressure);

•    eosinophilic pneumonia (a rare type of pneumonia), rhinitis (blocked up or runny nose);

•    pancreatitis (inflammation of the pancreas);

•    hepatitis (inflammation of the liver);

•    erythema multiforme (skin reaction like allergy);

• Acute renal failure

•    changes in the blood: your doctor may decide to carry out blood tests at intervals to monitor for this.

If you experience any of the above symptoms and they persist or become troublesome, you should tell your doctor.

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: www.mhra.gov.uk/yellowcard

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

5. How to store Perindopril Tablets

Keep this medicine out of the sight and reach of children.

If your medicine is in a foil pouch:

Keep the blister in the foil pouch in the outer carton in order to protect from moisture. Do not store above 25°C.

After first opening of foil pouch, use within 30 days.

Pack contains a desiccant. Do not swallow.

If your medicine is in a blister:

Keep the blister in the outer caron in order to protect from moisture.

Do not store above 25oC.

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

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

What Perindopril Tablets contain:

•    The active substance is perindopril tert-butylamine.

Each 2 mg tablet contains 2 mg perindopril tert-butylamine equivalent to 1.669 mg perindopril.

Each 4 mg tablet contains 4 mg perindopril tert-butylamine equivalent to 3.338 mg perindopril.

Each 8 mg tablet contains 8 mg perindopril tert-butylamine equivalent to 6.8676 mg perindopril.

•    The other ingredients are:

-    cellulose, microcrystalline (E460)

-    lactose, anhydrous

-    silica colloidal anhydrous

-    magnesium stearate (E572)

-    and maize starch.

What Perindopril Tablets look like and contents of the pack:

Perindopril 2mg Tablets are white, round, uncoated, biconvex tablets with 'P2' engraved on one side of the tablet and the other side plain.

Perindopril 4mg Tablets are white, capsule shaped, uncoated, biconvex tablets with 'P4' engraved on one side of the tablet and the other side plain.

Perindopril 8mg Tablets are white, round, uncoated, biconvex tablets with 'P8' engraved on one side of the tablet and the other side plain.

Each strength of Perindopril is available in cartons of 14, 15, 30, 60, 90 and 120 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

MA Holder:

IVAX Pharmaceuticals UK, Ridings Point, Castleford WF10 5HX

The Manufacturer:

Teva UK Limited Brampton Road, Hampden Park,

Eastbourne, East Sussex BN22 9AG, United Kingdom

Or

Teva Czech s.r.o Ostravska 29,

747 70 Opava-Komarov, Czech Republic Or

Pharmacemie B.V.

Swensweg 5, Postbus 552, 2003 RN Haarlem The Netherlands

Or

Merckle GmbH Ludwig-Merckle Str. 3 89143 Blaubeuren,

Germany

This medicinal product is authorised in the member states of the EEA under the following names:

2 mg:

Netherlands: Perindopril tert-butylamine 2 mg PCH, tabletten Slovenia: Perindopril Teva 2 mg tablete United Kingdom: Perindopril 2 mg Tablets

4 mg:

Spain: Perindopril Teva 4 mg comprimidos EFG Italy: Perindopril Teva 4 mg compresse Netherlands: Perindopril tert-butylamine 4 mg PCH, tabletten Romania: Perindopril Teva 4 mg comprimate

Slovenia: Perindopril Teva 4 mg tablete United Kingdom: Perindopril 2 mg Tablets

8 mg:

Netherlands: Perindopril tert-butylamine 8 mg PCH, tabletten Romania: Perindopril Teva 8 mg comprimate Slovenia: Perindopril Teva 8 mg tablete United Kingdom: Perindopril 8 mg Tablets

This leaflet was last revised: July 2015