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PERINDOPRIL 2 MG FILM-COATED TABLETS

Active substance(s): PERINDOPRIL ERBUMINE MONOHYDRATE

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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 Erbumine Monohydrate

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 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:
-

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.
2. BEFORE YOU TAKE PERINDOPRIL

Do not take Perindopril:
- 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:
- 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;

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.

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.

PHARMACODE AREA

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.

• Very rare (affects less than 1 user 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
- 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.

-

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

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 beforeyou 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.

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High blood pressure:
- Adults: the usual starting and maintenance dose for
treatment is 4 mg once daily. After a month, this can be
increased to 8 mg a day which is the maximum
recommended dose.

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.

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any
medicine.

Perindopril
Film-coated Tablets

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The usual dosages for Perindopril Tablets are as follows:

-

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:
- other medicines for treating high blood pressure including
diuretics (water tablets);
- potassium-sparing diuretics (e.g. spironolactone, triamterene
or amiloride); potassium supplements and potassiumcontaining 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).

PHARMACODE AREA

Perindopril
Film-coated Tablets

You should also inform your doctor or the medical staff that
you are taking Perindopril:
- 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).

Perindopril is not recommended for use in children and
adolescents.

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

4. POSSIBLE SIDE EFFECTS

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 protect from 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


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
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:

-

-


-

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
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)

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
Cipla (EU) Limited, Hillbrow House, Hillbrow Road, Esher,
Surrey, KT10 9NW.
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 October 2012.

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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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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