PERINDOPRIL 4 MG TABLETS

Active substance: PERINDOPRIL TERT-BUTYLAMINE

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

Read all of this leaflet carefully before you start taking this medicine.
x Keep this leaflet. You may need to read it again.
x If you have any further questions, ask your doctor or pharmacist.
x 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.
x 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 Tablets are and what they are used for
2. Before you take Perindopril Tablets
3. How to take Perindopril Tablets
4. Possible side effects
5. How to store Perindopril Tablets
6. Further 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.

BEFORE YOU TAKE PERINDOPRIL TABLETS

Do not take Perindopril Tablets:
x if you are more than 3 months pregnant. (It is also better to avoid Perindopril in early pregnancy –

see pregnancy section.)
Ɣ if you are allergic to Perindopril Tablets or any other ACE inhibitor, or to any of the other ingredients in
the tablet;
Ɣ 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);
Ɣ if you are breast-feeding.
Perindopril Tablets should not be given to children.

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Take special care with Perindopril Tablets

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).
Please tell your doctor or pharmacist before you start to take Perindopril Tablets if you:
Ɣ 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);
Ɣ have any other heart or liver or kidney problems, if you are receiving dialysis, or if you have undergone a
kidney transplant;
Ɣ suffer from collagen disease such as systemic lupus erythematosus or scleroderma;
Ɣ are on a salt restricted diet or use salt substitutes which contain potassium;
Ɣ suffer from diabetes. The sugar in your blood should be closely monitored during the first month of
treatment.
x are a black patient: you are more likely to suffer from angioedema (allergic reaction causing swelling of
face, lips, mouth, tongue or throat);
x develop infections repeatedly, please contact your physician;
x are undergoing LDL-apheresis (which is removal of cholesterol from your blood by a machine);
x are to undergo anaesthesia and/or surgery;
x are going to have desensitisation treatment to reduce the effects of an allergy to bee or wasp stings;
x suffer from cough.
Taking other medicines
Please tell your doctor or pharmacist if you are taking any of the following:
Ɣ other medicines for treating high blood pressure including diuretics (water tablets);
Ɣ potassium-sparing diuretics (eg spironolactone, triamterene or amiloride); potassium supplements and
potassium- containing salt substitutes;
Ɣ medicines for the treatment of diabetes (insulin or tablets) or to lower blood sugar;
Ɣ lithium for mania or depression;
Ɣ medicines for the treatment of mental disorders such as depression, anxiety schizophrenia or other
psychoses;
Ɣ allopurinol used for the treatment of gout;
Ɣ immunosuppressants used for the treatment of auto-immune disorders (eg rheumatoid arthritis) or
following transplant surgery;
Ɣ procainamide, a treatment for irregular heartbeat;
Ɣ non-steroidal anti-inflammatory drugs (NSAIDs) for pain relief, including aspirin;
Ɣ medicines used for the treatment of low blood pressure, shock or asthma (eg ephedrine, noradrenaline or
adrenaline);
Ɣ vasodilators including nitrates (products that make the blood vessels become wider);
Ɣ heparin (used to thin the blood).
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:
Ɣ have suffered from recent diarrhoea or vomiting;
x Are to undergo haemodialysis
Taking 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.
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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 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
Do not drive or use any tools or machines whilst taking Perindopril Tablets, as you may experience dizziness
or weariness while taking Perindopril Tablets.
Important information about some of the ingredients of Perindopril Tablets
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 tablets as your doctor has told you to. You should 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 usual
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.
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
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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 product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Perindopril tablets can cause side effects, although not everybody gets them.
Common (affecting fewer than one person in 10 but more than one person in 100):
Ɣ cough, shortness of breath;
Ɣ 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);
Ɣ headache, dizziness, vertigo, weakness, lethargy, pins and needles, muscle cramps, visual disturbances (eg
blurred vision, eye pain), tinnitus (sensation of noises in the ears);
Ɣ nausea, vomiting, abdominal pain, changes in your sense of taste, feeling of indigestion, diarrhoea,
constipation;
Ɣ skin rashes, itching.
Uncommon (affecting fewer than one person in 100 but more than one person in 1,000):
Ɣ changes in mood or sleep;
Ɣ bronchospasm (tightening of chest, wheezing and shortness of breath);
Ɣ dry mouth;
Ɣ kidney problems;
Ɣ impotence;
Ɣ sweating;
If you experience any of the following effects, stop taking your tablets at once and tell your doctor
immediately:
Ɣ angiodema (swelling of the face, lips, mouth,
tongue or throat);
Ɣ difficulty in breathing;
Ɣ dizziness or fainting;
Ɣ 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 (affecting fewer than one person in 10,000):
Ɣ confusion;
Ɣ irregular heart beat, angina, heart attack and stroke (these have been reported with ACE inhibitors in
association with low blood pressure);
Ɣ eosinophilic pneumonia (a rare type of pneumonia), rhinitis (blocked up or runny nose);
Ɣ pancreatitis (inflammation of the pancreas);
Ɣ hepatitis (inflammation of the liver);
Ɣ erythema multiforme (skin reaction like allergy);
x Acute renal failure
Ɣ 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.

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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 TABLETS
Keep out of the reach and sight 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
25ºC.
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 Perindopril tablets after the expiry date that is stated on the carton. 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 Tablets contain:
x 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.
x
-

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.

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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
Ostravskà 29,
747 70 Opava-Komarov, Czech Republic
Or
Pharmacemie B.V.
Swensweg 5, Postbus 552, 2003 RN Haarlem
The Netherlands
This medicinal product is authorised in the member states of the EEA under the following names:
2 mg:
Bulgaria: Perindopril Teva Ɍɚɛɥɟɬɤɢ
Germany: Perindopril Teva 2 mg Tablett
Estonia: Perindopril Teva
Luxemburg: PERINDOPRIL Teva 2 mg comprimes
Netherlands: Perindopril tert-butylamine 2 mg PCH, tabletten
Slovenia: Perindopril Teva 2 mg tablete
United Kingdom: Perindopril 2 mg Tablets
4 mg:
Austria: Perindopril Teva 4 mg Tabletten
Bulgaria: Perindopril Teva Ɍɚɛɥɟɬɤɢ
Germany: Perindopril Teva 4 mg Tabletten
Estonia: Perindopril Teva
Greece: Perindopril Teva 4 mg tablets
Spain: Perindopril Teva 4 mg comprimidos EFG
Ireland: Perindopril Teva
Italy: Perindopril Teva 4 mg compresse
Luxemburg: PERINDOPRIL Teva 4 mg comprimés
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:
Austria: Perindopril Teva 8 mg Tabletten
Bulgaria: Perindopril Teva Ɍɚɛɥɟɬɤɢ
Germany: Perindopril Teva 8 mg Tabletten
Estonia: Perindopril Teva
Greece: Perindopril Teva 8 mg tablets
Ireland: Perindopril Teva
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Luxemburg: PERINDOPRIL Teva 8 mg comprimés
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: January 2011

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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