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PERINDOPRIL 2MG FILM-COATED TABLETS

Active substance(s): PERINDOPRIL TERT-BUTYLAMINE

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160 mm

PACKAGE LEAFLET: INFORMATION FOR THE USER

PERINDOPRIL 2MG, 4MG AND 8MG FILM-COATED TABLETS
(perindopril tert-butylamine)

Read all of this leafet 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 become serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist.

In this leafet:
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
The information in this leaflet refers to Perindopril
Film-coated Tablets available in 2mg, 4mg and 8mg
strengths.
1. WHAT PERINDOPRIL TABLETS ARE AND
WHAT THEY ARE USED FOR

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Perindopril belongs to a class of medicines called ACE
inhibitors. These work by widening the blood vessels
making it easier for your heart to pump blood through them.
Perindopril Tablets are 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 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 TABLETS
Do not take Perindopril Tablets:
• If you are allergic (hypersensitive) to perindopril or any
other ACE inhibitor, or to any of the other ingredients in
the tablets (see section 6 for a list of ingredients)
• 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 these symptoms in other circumstances (this is a condition called angioedema)
• If you are more than 3 months pregnant.(It is also better
to avoid Perindopril in early pregnancy (see pregnancy
section).
• Perindopril Tablets 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 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)
You should check with your doctor BEFORE taking
Perindopril Tablets:
• If you have aortic stenosis (narrowing of the main blood
vessel leading from the heart) 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,
or if you are receiving dialysis
• If you suffer from a collagen disease such as systemic
lupus erythematosus of scleroderma
• If you are on a salt restricted diet or use salt substitutes
which contain potassium



If you suffer from diabetes which is not well controlled

You should also inform your doctor or the medical staff
that you are taking Perindopril Tablets:
• If you undergo anaesthesia and/or surgery
• If you have suffered from recent diarrhoea or vomiting
• 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)
Taking other medicines
In order to avoid possible interactions between different
medicines, please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including medicines obtained without a prescription.
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
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 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)
Ask your doctor if you are not sure what these medicines
are.
Taking Perindopril Tablets with food and drink
It is recommended that you take Perindopril Tablets before
a meal. This helps reduce the effect 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
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 breastfeeding or about to start
breast feeding. Perindopril i s 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 may experience dizziness or weariness while taking
Perindopril. If this occurs do not drive or use machinery.
You should talk to your doctor.
3.

HOW TO TAKE PERINDOPRIL TABLETS

Always take Perindopril Tablets exactly as your doctor has
told you. You should check with your doctor or pharmacist
if you are not sure.

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Your doctor will decide on the right starting dose for you
and any increase in the dose, depending on your condition,
and whether you are taking any other medicines. Do not
change your dose unless your doctor tells you to. Perindopril Tablets may be used on their own or with other
medicines which lower blood pressure.
How to take your tablets:
Take your tablet(s) with a glass of water in the morning,
preferably at the same time each day 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.







Bronchospasm (tightening of the chest, wheezing and
shortness of breath)
Dry mouth
Kidney problems
Impotence
Sweating
Angioedema (see above).

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 (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 8mg a day.

Very rare (probably afecting less than 1 in 10,000
people)
• Confusion
• Irregular heartbeat, angina, heart attack and stroke
(these have been reported with ACE inhibitors in
association with low blood pressure)
• Eosinophilic pneumonia (a rare type of pneumonia),
rhinitis (blocked up or runny nose)
• Pancreatitis (inflammation of the pancreas)
• Hepatitis (inflammation of the liver)
• Erythema multiforme (skin reaction like an allergy)
• Kidney failure
Changes in the blood: your doctor may decide to carry out
blood tests at intervals to monitor this.

Heart failure
Adults, including the elderly: treatment should be started
under close medical supervision with 2 mg once a day. After
2 weeks it can be increased to 4 mg once a day if required.

If you experience any of the above symptoms and they
persist or become troublesome, you should tell your doctor.
If you notice any other effects not mentioned in this leaflet,
please tell your doctor or pharmacist.

Stable coronary artery disease
Adults: the usual starting dose is 4 mg once daily. After 2
weeks and if 4 mg is well tolerated, this can be increased to
8 mg once daily.
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.

5.

The usual doses of Perindopril Tablets are as follows:

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.
Perindopril is not suitable for use in children.

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If you take more tablets than you should:
If you have taken too many tablets, contact your nearest
hospital accident and emergency department or tell your
doctor IMMEDIATELY.

Store below 25°C.
Store in the original package
Keep out of the reach and sight of children.
Do not use Perindopril Tablets after the expiry date which 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.



4.



Like all medicines, Perindopril Tablets 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
• unusually fast or irregular heartbeat
This is an uncommon but serious reaction which can occur
with all drugs of this type (ACE inhibitors). It must be
treated immediately, usually in hospital
Common (probably afecting up to 1 in 10 people)
• 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 (eg blurred
vision, eye pain) tinnitus (sensation of noises in the ears)
• Nausea, vomiting, abdominal pain, changes in your
sense of taste, feeling of indigestion, diarrhoea,
constipation
• Skin rashes, itching
Uncommon (probably affecting less than 1 in 100
people)
• Changes in mood or sleep

FURTHER INFORMATION

What Perindopril Tablets contain:

If you forget to take your tablets:
It is important to take your medicine every day. However, if
you forget to take one or more doses, take another as soon
as you remember and then go on as prescribed. Do not take
a double dose.
POSSIBLE SIDE EFFECTS

HOW TO STORE PERINDOPRIL TABLETS



The active substance is perindopril tert-butylamine.
Each tablet contains 2, 4 or 8mg of perindopril
tert-butylamine.
The other ingredients are mannitol, sodium starch
glycollate, sodium carbonate anhydrous, hypromellose,
macrogol-6000, siliconised talc and magnesium stearate
The tablet coating contains hypromellose and Opadry
white

What Perindopril Tablets look like and contents of the
pack
The 2mg tablets are circular, white to off-white, plain on
both sides
The 4mg tablets are barrel-shaped, white to off-white, with
a break line on both sides and 'PR' and '4' on one side.
The 8mg tablets are barrel-shaped, white to off-white, with
a break line on both sides and 'PR' and '8' on one side.
The tablets are packed in blister strips and are available in
cartons containing 30 tablets.
This medicinal product is authorised in the Member
States of the EEA under the following names:
Perindopril 2mg Film-coated Tablets, Perindopril 4mg
Film-coated Tablets and Perindopril 8mg Film-coated
Tablets.
Marketing Authorisation Holder:
Strandhaven Ltd trading as Somex Pharma, Seven Kings,
Ilford, Essex, IG3 8BS, UK
Manufacturer:
Strandhaven Ltd trading as Somex Pharma, Seven Kings,
Ilford, Essex, IG3 8RA, UK
This leafet was last approved in 12/2009

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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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