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PERINDOPRIL 2 MG FILM-COATED TABLETS

Active substance(s): PERINDOPRIL ERBUMINE MONOHYDRATE / PERINDOPRIL ERBUMINE MONOHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Perindopril 2 mg, 4 mg & 8 mg Film-coated Tablets
Perindopril Erbumine Monohydrate

Read all of this leaflet carefully before you start taking this medicine
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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 getserious, 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 name of your medicine is Perindopril 2 mg or 4 mg or 8 mg Film-coated Tablets. The tablets are
available in three strengths. In the rest of this leaflet your medicine is called Perindopril.
Perindopril belongs to a group of medicines called ACE inhibitors. These work by widening the blood
vessels, which makes it easier for your heart to pump blood through them.
Perindopril is used:
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2.

Keep this leaflet. You may need to read it again.
to treat 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
BEFORE YOU TAKE PERINDOPRIL

Do not take Perindopril:
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if you are allergic (hypersensitive) to perindopril or any of the other ACE inhibitors or to any of
the other ingredients in the tablets (see section 6 Further information).
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 ( a condition called angioedema)
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 breastfeeding (see section “Pregnancy and breast-feeding”)

Perindopril should not be given to children
If you think any of the above situations applies to you do not take the tablets. Consult your doctor and
take his/her advice.

Take special care with Perindopril
You should check with your doctor BEFORE taking Perindopril:
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if you have narrowing of the main blood vessel leading from the heart (aortic stenosis ) or
cardiac muscle disease (hypertrophic cardiomyopathy ) or narrowing of the artery supplying the
kidney with blood (renal artery stenosis);
if you have any other heart problems or liver problems or kidney problems, or if you are
receiving dialysis;
if you suffer from a 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

You should also inform your doctor or the medical staff that you are taking Perindopril:
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if you are to undergo anaesthesia and/or surgery;
if you have suffered from recent diarrhoea or vomiting or are dehydrated;
if you are going to have desensitisation treatment to reduce the effects of an allergy to bee or
wasp stings;
if you are to undergo LDL apheresis (which is removal of cholesterol from your blood by a
machine).

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).

Perindopril is not recommended for use in children and adolescents.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription. In particular, you should check with
your doctor if you are taking any of the following to be sure that it is safe to take Perindopril at the
same time:
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other medicines for treating high blood pressure including diuretics (water tablets);
potassium-sparing diuretics (e.g. spironolactone, triamterene or amiloride); potassium
supplements and potassium-containing salt substitutes;
medicines for the treatment of diabetes (insulin or tablets such as metformin) to lower blood
sugar;
lithium for mania or depression;
medicines for the treatment of mental disorders such as depression, anxiety, schizophrenia or
other psychoses; (e.g. tricyclic antidepressants, antipsychotics),
allopurinol used for the treatment of gout;
immunosuppressants used for the treatment of auto-immune disorders (e.g. rheumatoid
arthritis) or following transplant surgery;
procainamide, a treatment for irregular heartbeat;
non-steroidal anti-inflammatory drugs (e.g. ibuprofen) for pain relief or aspirin;
medicines used for the treatment of low blood pressure, shock or asthma (e.g. ephedrine,
noradrenaline or adrenaline);
vasodilators including nitrates (products that make the blood vessels become wider);
heparin (used to thin the blood).

Ask your doctor if you are not sure what these medicines are. If you go into hospital, let the medical
staff know you are taking perindropil.

Taking Perindopril with food and drink
It is recommended that Perindopril should be taken before a meal.

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 at that stage.
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 machinery if you experience dizziness or weariness while taking Perindopril. If
this occurs you should talk to your doctor.

3.

HOW TO TAKE PERINDOPRIL

Always take Perindropil exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
Your doctor will decide on the right starting dose for you and on any increase in the dose depending
on your condition and whether you are taking any other medicines. Do not change your dosage unless
your doctor tells you to do so. Perindopril may be used on their own or with other medicines which
lower blood pressure.
Method of administration:
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.
The usual dosages for Perindopril Tablets are as follows:
High blood pressure:
Adults: the usual starting and maintenance dose for treatment is 4 mg once a day. After a
month, this can be increased to 8 mg a day which is the maximum recommended dose.
Elderly (65 years or over): the usual starting dose is 2 mg once a day. After a month, this can
be increased to 4 mg a day and if necessary to 8 mg a day.
Heart failure:
Adults & the elderly: treatment should be started under close medical supervision with 2 mg
once a day. After two weeks, it can be increased to 4 mg once a day which is the maximum
recommended dose for heart failure.
Stable coronary artery disease:
Adults: 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 which is the maximum recommended dose in
this indication.
Elderly (65 years 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.
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 than you should
If you take too many tablets, contact your nearest hospital accident and emergency department or tell
your doctor immediately. The most likely effect of an overdose is low blood pressure which can
make you feel faint or dizzy. If this happens, laying down on your back with your legs raised can
help.
If you forget to take Perindopril
It is important to take your medicine as your doctor has told you. However, if you forget to take one
or more doses, take the next dose at the usual time and then carry on as normal. Do not take a double
dose to make up for a dose which you forgot.

If you stop taking Perindopril
The taking of perindopril is usually life-long; you should discuss stopping taking your tablets with
your doctor before you stop taking your medicine.
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.
Do not be alarmed by the list below, you may not get any of them.
Stop taking your tablets at once and TELL YOUR DOCTOR IMMEDIATELY if you
experience any of the following effects of angioedema:
swelling of the face, lips, mouth, tongue or throat
difficulty in breathing, dizziness or fainting
unusual fast or irregular heart beat
This is a serious reaction which can occur with all drugs of this type (ACE inhibitors). It must be
treated immediately, usually in hospital.
Other side effects that may occur:

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Common (affects 1 to 10 users in 100)
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, tiredness, pins and needles, muscle cramps, visual disturbances
(e.g. blurred vision, eye pain), sensation of noises in the ears (tinnitus)
nausea, vomiting, abdominal pain, changes in your sense of taste, feeling of indigestion,
diarrhoea, constipation
feeling of weakness
skin rashes, itching


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Uncommon (affects 1 to 10 users in 1,000)
changes in mood or sleep
tightening of the chest, wheezing and shortness of breath (bronchospasm)
dry mouth
kidney problems
impotence
sweating
serious allergic reaction which cause swelling of face, tongue or throat (angioedema )


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Very rare (affects 1 to 10 users in 10,000)
confusion
irregular heartbeat, angina, heart attack and stroke (these have been reported with ACE
inhibitors in association with low blood pressure)
rare type of pneumonia called eosinophilic pneumonia
blocked up or runny nose (rhinitis)
inflammation of the pancreas (pancreatitis)
inflammation of the liver (hepatitis)
skin reaction like an allergy called erythema multiforme
kidney failure

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changes in the blood: your doctor may decide to carry out blood tests at intervals to monitor for
this.
in case of diabetic patients, hypoglycaemia (very low blood sugar level) can occur.
vasculitis (inflammation of blood vessels) has been reported.

If any of the side effects gets 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.
Do not use Perindopril after the expiry date which is stated on the carton after “Exp”. The expiry date
refers to the last day of that month.
Store in original package in order to protectfrom moisture.
Store below 30°C.
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
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The active substance is Perindopril Erbumine Monohydrate. Each tablet contains 2, 4 or 8 mg
of Perindopril Erbumine.

The other ingredients are:
Tablet core: mannitol (E421), sodium starch glycolate (Type A), sodium carbonate anhydrous,
hypromellose (HPMC E-15), macrogol-6000, talc, simeticone, magnesium stearate.
Tablet coating: hypromellose 6cps, , polyvinyl alcohol, titanium dioxide (E171), talc, lecithin
(Soya), xanthan gum.
What Perindopril tablets look like and contents of the pack
Perindopril 2 mg tablets are white to off-white circular, biconvex film coated tablets plain on both
sides.
Perindopril 4 mg tablets are white to off-white, barrel shaped, biconvex film coated tablets, debossed
with ‘PE4’ on one side and a central scoreline on the other. The scoreline is only to enable a tablet to
be broken in half for ease of swallowing, and not to divide into equal doses.
Perindopril 8 mg tablets are white to off-white, barrel shaped, biconvex film coated tablets,debossed
with ‘PE8’ on one side and a central scoreline on the other. The scoreline is only to enable a tablet to
be broken in half for ease of swallowing, and not to divide into equal doses.
The tablets are supplied in blister packs (Aluminium laminated foil) of 7, 10, 14, 15, 20, 28, 30, 50,
56, 60, 90, 100, 112, 120, 500 tablets per pack.
Not all pack sizes may be marketed

Marketing Authorisation Holder
Torrent Pharma (UK) Ltd.
Unit 4, Charlwood Court
County Oak Way
Crawley
West Sussex
RH11 7XA
United Kingdom

Manufacturer
APC Pharmaceuticals & Chemicals (Europe) Limited, 9th Floor, CP House, 97-107 Uxbridge Road,
Ealing, London W5 5TL.

Distributed By:
APC Pharmaceuticals & Chemicals (Europe) Limited, 9th Floor, CP House, 97-107 Uxbridge Road,
Ealing, London W5 5TL

This leaflet was last revised in 03/2017

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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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