PERINDOPRIL 4 MG TABLETS - patient leaflet, side effects, dosage

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
• if you have taken or are currently taking sacubitril/val­sartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling under the skin in an area such as the throat) is increased.

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 breast-feeding).

Talk to your doctor or pharmacist before taking Perindopril Tablets:

• if you are taking any of the following medicines, the risk of angioedema may be increased:

• – racecadotril, a medicine used to treat diarrhoea;

• – medicines used to prevent organ transplant rejection and for cancer (e.g., temsirolimus, sirolimus, everolimus);

• – vildagliptin, a medicine used to treat diabetes.

• 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’.

Children and adolescents

The use of Perindopril Tablets in children and adolescents up to the age of 18 years is not recommended.

Other medicines and Perindopril Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Treatment with Perindopril can be affected by other medicines. Your doctor may need to change your dose and/or to take other precautions. These include:

• other medicines for treating high blood pressure including diuretics (water tablets);
• potassium supplements (including salt substitutes), potassium-sparing diuretics and other medicines that can increase the amount of potassium in your blood (e.g. trimethoprim and co-trimoxazole for infections caused by bacteria; ciclosporin, an immunosuppressant medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin blood to prevent clots)
• 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);
• medicines, which are most often used to treat diarrhea (racecadotril) or avoid rejection of transplanted organs (sirolimus, everolimus, temsirolimus and other drugs belonging to the class of so-called mTor inhibitors). See section ‘Warnings and precautions’.

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

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 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 and adolescents

Perindopril Tablets are not suitable for use in children and adolescents below 18 years of age.

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.

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

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

• tinnitus (sensation of noises in the ears)
• visual disturbances (e.g. blurred vision, eye pain)
• dizziness or fainting
• shortness of breath

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

• bronchospasm (difficulty breathing) (tightening of chest, wheezing and shortness of breath)
• kidney problems
• angiodema (swelling of the face, lips, mouth, tongue or throat)

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

• 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
• sudden weakness of arms or legs with problems speaking could be signs of possible stroke
• pancreatitis (inflammation of the pancreas) which may cause severe abdominal and back pain accompanied with feeling very unwell
• hepatitis (inflammation of the liver) with yellowing of the skin and whites of the eyes (jaundice) and abdominal pain
• changes in the blood: your doctor may decide to carry out blood tests at intervals to monitor for this. If you develop signs of sudden fever, sore throat, mouth ulceration, tiredness or any unexplained bruising or bleeding please tell your doctor immediately
• heart attack

Other side effects

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

• cough
• 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,
• 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
• dry mouth
• impotence
• sweating

Rare ( may affect up to 1 in 1,000 people):

• psoriasis worsening.

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

• confusion
• eosinophilic pneumonia (a rare type of pneumonia), rhinitis (blocked up or runny nose)
• erythema multiforme (skin reaction like allergy);
• acute renal failure

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

Not known (frequency cannot be estimated from available data):

• discoloration, numbness and pain in fingers or toes (Raynaud’s phe­nomenon).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store 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 carton 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

• – 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 30 tablets.

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

Netherlands: Perindopril tert-butylamine 4 mg PCH, tabletten

Slovenia: Perindopril Teva 4 mg tablete

United Kingdom: Perindopril 2 mg Tablets

8 mg:

Netherlands: Perindopril tert-butylamine 8 mg PCH, tabletten

Slovenia: Perindopril Teva 8 mg tablete

United Kingdom: Perindopril 8 mg Tablets

This leaflet was last revised: May 2019