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PERINDOPRIL 8 MG TABLETS

Active substance(s): PERINDOPRIL TERT-BUTYLAMINE / PERINDOPRIL TERT-BUTYLAMINE

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Package leaflet: Information for the patient
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.
2.
3.
4.
5.
6.

What Perindopril Tablets are and what they are used for
What you need to know before you take Perindopril Tablets
How to take Perindopril Tablets
Possible side effects
How to store Perindopril Tablets
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 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 is increased (rapid swelling under
the skin in area such as the throat):
- racecadotril (used to treat diarrhea),
- sirolimus, everolimus, temsirolimus and other drugs belonging to the class of so-called mTor inhibitors
(used to avoid rejection of transplanted organs),
● 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.
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-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);

● 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’.
 co-trimoxazole also known as trimethoprim/sulfamethoxazole.
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 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.
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:
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
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 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, 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 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
Ostravskà 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: March 2017

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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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