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PACKAGE LEAFLET: INFORMATION FOR THE USER

Perindopril 8 mg tablets

Perindopril tert-butylamine

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 get 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 is and what it is used for

2.    Before you take Perindopril

3.    How to take Perindopril

4.    Possible side effects

5.    How to store Perindopril

6.    Further information

1. What Perindopril is and what it is used for

The active substance of Perindopril tablets belongs to the group of angiotensin converting

enzyme (ACE) inhibitors.

Perindopril tablets are 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 blood supply to the heart by widening the vessels that supply it.

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2. Before you take Perindopril

Do not take Perindopril

•    if you are allergic ( hypersensitive) to perindopril, to any of the other ingredients of Perindopril, or to any other ACE inhibitor;

•    if you have in the past a hypersensitivity reaction (sudden swelling of the lips and face, neck, possibly also of the hands and feet, or suffocation or hoarseness (with angioedema) after use of an ACE inhibitor;

•    If someone in your family has had angioedema or you have had angioedema in any other circumstance;

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

•    Take special care with Perindopril

•    It is possible that Perindopril is not convenient for you, or a personal control is needed regularly. Therefore, before starting to take Perindopril tablets, inform your doctor on the following:

•    if you have been told that your heart muscle is enlarged or you have problems with valves of your heart;

•    if you have been told that you have narrowing of the artery supplying the kidney with blood (renal artery stenosis);

•    if you have diabetes;

•    if you are suffering from any other kidney, liver, or heart disease;

•    if you are receiving hemodialysis or have had recent kidney transplantation;

•    if you have a collagen disease such as systemic lupus erythematosus or scleroderma;

•    if you are adhering to a salt restriction diet or have suffered from severe vomiting or diarrhoea, or have used medicines that increase the amount of urine (diuretics);

•    if you are taking lithium, medicine used for the treatment of mania or depression;

•    if you are taking potassium supplements or potassium containing salt substitutes.

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 pregnancy section).

During treatment with Perindopril tablets

•    If you develop any of the following symptoms you should let your doctor know immediately:

•    You feel dizzy after your first dose. A few people react to their first dose or when their dose is increased by feeling dizzy, weak, faint and sick.

•    Sudden swelling of the lips and face, neck, possibly also hands and feet, or wheezing or hoarseness. This condition is called ‘angioedema’. This may occur at any time during treatment. ACE inhibitors cause a higher rate of angioedema in black than in non-black patients.

^rFeverrsor? throat; or mouth ulcers (these may beeymptoms of infection,eausedby tho ^-lowering of the number of white blood cells).

•    Yellowing of the skin and whites of eyes (jaundice) that may be sign of liver disease.

•    A dry, cough which is persistent for a long time. Cough has been reported with the use of ACE inhibitors but may be also a symptom of other upper respiratory tract disease.

At the beginning of treatment and/or during the period of dosage adjustment, increasing the frequency of medical check-ups may be necessary. You should not skip these visits even if you feel well. Your doctor will determine the frequency of control examinations.

To pervent any possible complications during treatment with Perindopril, you should also inform your doctor that you are taking Perindopril tablets:

•    If you are to undergo anaesthesia and/or surgery (even at the dentist);

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

•    If you are to undergo haemodialysis or LDL cholesterol apheresis (which is removal of cholesterol from your body, using a machine).

This product is usually not recommended during the first trimester of pregnancy.

Taking other medicines

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

Do not take non-prescription medicines without consulting your doctor. This mainly applies to:

•    cold remedies which contain pseudoephedrine or phenylephrine as active substances;

•    pain relievers, including acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever, as well as to prevent blood clotting);

•    medicines that increase the amount of urine (diuretic) which spare potassium;

•    potassium supplements and potassium-containing salt substitutes.

Please tell your doctor if you are taking any of the following to be sure that it is safe to take

Perindopril at the same time:

•    other medicines for treating high blood pressure and/or heart failure, including medicines that increase the amount of urine (diuretic) ;

•    medicines for the treatment of irregular heartbeat (procainamide);

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

•    medicines for gout (allopurinol);

•    non-steroidal anti-inflammatory drugs (NSAIDs such as ibuprofen, diclofenac), including aspirin for pain;

•    anti-inflammatory agents (systemic corticosteroids);

•    medicines for suppression of tumour growth (cytotoxic agents);

•    medicines for lowering the body's immune response (immunosuppressive agents);

•    medicines with a stimulant action on a certain part of the nervous system (such as ephedrine, noradrenaline or adrenaline (sympathomimetics));

•    medicines for the treatment of mania or depression (lithium);

•    medicines for mental illness such as depression, anxiety, schizophrenia or other psychosis (tricyclic antidepressants and antipsychotics;

•    potassium tablets;

•    gold by injection for treatment of arthritis (sodium aurothiomalate).

Taking Perindopril with food and drink

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

Drinking alcohol with Perindopril may make you feel dizzy or light-headed. You should check with your doctor whether drinking is advisable for you.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any 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.

Breastfeeding

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

You are advised not to drive a car or operate machinery until you know how Perindopril affects you. Individual reactions such as dizziness or weariness may occur in some patients, particularly at the start of treatment or in combination with another antihypertensive medication. As a result the ability to drive or operate machinery may be impaired.

Important information about some of the ingredients of Perindopril Perindopril tablets contain lactose. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.

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3. How to take Perindopril

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 starting and maintenance dose for the treatment of high blood pressure is 4 mg perindopril (one Perindopril 4 mg tablet) once daily. When necessary, after one month this dose may be increased to 8 mg perindopril (one Perindopril 8 mg or two Perindopril 4 mg tablets) once daily, which is the maximum recommended dose.

The usual starting dose for the treatment of stable coronary artery disease is 4 mg perindopril (one Perindopril 4 mg tablet) once daily; after two weeks if it is well tolerated this dose may be increased to 8 mg perindopril (one Perindopril 8 mg or two Perindopril 4 mg tablets) once daily. Take your tablet with a glass of water, preferably at the same time each day, in the morning, before a meal.

During the course of treatment, your doctor will adjust the dosage according to the effect of treatment as well as to your needs.

Kidney problems

Your doctor may prescribe a lower dose.

Liver problems

No dosage adjustment is necessary Elderly

The dose recommendation in the elderly is depending on renal function.

Your doctor will determine the duration of treatment on the basis of your medical condition.

Efficacy and safety of perindopril use in children and adolescents under the age of 18 has not been established. Therefore, use in children and adolescents is not recommended.

If you have the impression that the effect of this medicine is too strong or too weak, consult your doctor or pharmacist.

If you take more Perindopril tablets than you should

If you have taken too many tablets, consult with your doctor or pharmacist immediately.

The most likely sign of overdosage is a sudden drop in blood pressure (hypotension). Other symptoms may include fast or slow heartbeat (tachy- or bradycardia), unpleasant sensation of irregular and/or forceful heartbeat (palpitations), excessive rate and depth of respiration, dizziness, anxiety and/or cough.

If your blood pressure decreases substantially, you should lie down, prop up your lower extremities, and use only a small pillow as headrest.

If you forget to take Perindopril

It is important to take your medicine every day.

However, if you forget to take one dose, just carry on with the next one as normal. Do not take a double dose to make up for a forgotten individual dose. If you forget to take more than one dose, take another as soon as you remember and then go on as prescribed by your doctor.

If you stop taking Perindopril prematurely

Upon discontinuation of treatment, your blood pressure may increase again and this can increase the risk of hypertensive complications due to high blood pressure, especially in the heart, brain and kidneys. Therefore, if you consider to stop taking Perindopril, you should discuss this with your doctor first.

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

4. Possible side effects

Like all medicines, Perindopril can cause side effects, although not everybody gets them. The adverse reactions were categorized according to incidence, as follows:

Common

•    headache, dizziness, spinning sensation (vertigo), tingling or pins and needles like sensation in the hands or feet (paraesthesia),

•    vision disturbance,

•    ringing, buzzing, roaring, clicking sound in the ears, etc. (tinnitus),

•    low blood pressure (hypotension) and effects related to hypotension,

•    cough, shortness of breath (dyspnoea),

•    feeling sick (nausea), being sick (vomiting), abdominal pain, changes in taste (dysgeusia), indigestion (dyspepsia), diarrhoea, and constipation,

•    rash, itching (pruritus),

•    muscle cramps,

•    weakness (asthenia).

Uncommon

•    mood or sleep disturbances,

•    wheezing (bronchospasm),

•    dry mouth,

•    hypersensitivity reaction with sudden swelling of face, neck, lips, mucous membranes, tongue or throat (with hoarseness or suffocation), possibly also swelling of hands and feet, (angioedema), hives (urticaria),

•    reduced kidney function,

•    inability to achieve or sustain a penile erection (impotence),

•    sweating.

Very rare

•    confusion,

•    abnormal heart rhytm (arrhythmia), chest pain (angina pectoris), heart attack and stroke possibly due to excessive lowering of blood pressure in high-risk patients,

•    inflammation in the lungs associated with accumulation of certain blood cells (eosinophils) into lung tissue (eosinophilic pneumonia), inflammation of the mucous membrane of the nose (rhinitis),

•    inflammation of the pancreas (pancreatitis),

•    inflammation of the liver (hepatitis),

•    allergic rash appearing as pink-red flat spots (erythema multiforme),

•    acute kidney failure.

Not known

•    low blood sugar (hypoglycaemia),

•    inflammation of blood vessels, often with skin rash (vasculitis).

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. How to store Perindopril

Keep out of the reach and sight of children.

Store in the original package in order to protect from moisture. Store below 30°C.

Do not use Perindopril tablets after the expiry date printed on the packaging. 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 contains

The active substance is perindopril tert-butylamine.

Each tablet contains 8 mg perindopril tert-butylamine salt, corresponding to 6.68 mg perindopril.

The other ingredients are: lactose monohydrate, cellulose, microcrystalline (E460), sodium hydrogen carbonate, silica, colloidal anhydrous, magnesium stearate (E572).

What Perindopril look like and contents of the pack

White, round, slightly biconvex tablet with bevelled edges, scored on one side. The tablet can be divided into equal halves.

Blisters (PVC/PE/PVDC/AI) of 7, 14, 28, 30, 50, 60, 90 or 100 tablets, in cardboard box. Not all packs sizes may be marketed.

Marketing Authorisation Holder

KRKA Polska Sp.z.o.o, ul. Rownolegla 5, 02-235 Warsaw, Poland Manufacturer

KRKA Polska Sp.z.o.o, ul. Rownolegla 5, 02-235 Warsaw, Poland or

KRKA, d.d., Novo mesto, Smarjeska cesta 6, Novo mesto, Slovenia or

TAD Pharma GmbH, Heinz-Lohmann-Str.5, 27472 Cuxhaven, Germany This leaflet was last approved in 12/2010

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