PERINDOPRIL ERBUMINE 8 MG TABLETS

Active substance: PERINDOPRIL TERT-BUTYLAMINE

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180 mm
Children and adolescents
Perindopril Erbumine is not recommended for use in
children and adolescents.

PACKAGE LEAFLET: INFORMATION FOR THE USER

PERINDOPRIL ERBUMINE
8 mg TABLETS
(perindopril tert-butylamine)

The recommended dose for Perindopril Erbumine is:
High blood pressure
The recommended starting and maintenance dose is
4 mg once daily. After one month, this can be
increased to 8 mg once a day if required. The
maximum recommended dose for high blood
pressure is 8 mg a day.

Other medicines and Perindopril Erbumine
Tell your doctor or pharmacist if you are taking, have
recently taken, or might take any other medicines.

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.

Perindopril Erbumine can affect the way some other
medicines work and some medicines can have an
effect on Perindopril Erbumine. In particular, tell your
doctor if you are using any of the following
medicines:
• Other medicines for high blood pressure, including
diuretics (medicines which increase the amount of
urine produced by the kidneys).
• Potassium-sparing diuretics (spironolactone,
triamterene or amiloride), potassium supplements
or potassium-containing salt substitutes.
• Lithium (a medicine for mental health problems).
• Non-steroidal anti-inflammatory drugs
(e.g. ibuprofen) for pain relief or high dose aspirin.
• Medicines to treat diabetes (such as insulin or
metformin).
• Medicines to treat mental disorders such as
depression, anxiety or schizophrenia (e.g. tricyclic
antidepressants, antipsychotics).
• Immunosuppressants (medicines which reduce the
defence mechanism of the body), used for the
treatment of auto-immune disorders or following
transplant surgery (e.g. ciclosporin).
• Medicines for the treatment of gout (e.g. allopurinol).
• Medicines for the treatment of an irregular heart
beat (e.g. procainamide).
• Products that make the blood vessels become
wider (i.e. vasodilators, including nitrates).
• Medicines used to thin blood (e.g. heparin).
• Medicines used for the treatment of low blood
pressure, shock or asthma (e.g. ephedrine,
noradrenaline or adrenaline).

What is in this leaflet:
1. What Perindopril Erbumine is and what it is used
for.
2. What you need to know before you take
Perindopril Erbumine.
3. How to take Perindopril Erbumine.
4. Possible side effects.
5. How to store Perindopril Erbumine.
6. Contents of the pack and other information.
1.WHAT PERINDOPRIL ERBUMINE IS AND WHAT IT
IS USED FOR
Perindopril Erbumine belongs to a group of
medicines known as angiotensin converting enzyme
(ACE) inhibitors. These work by making your blood
vessels wider, which makes it easier for your heart to
pump blood through them.
Perindopril Erbumine is used:
• to treat high blood pressure (hypertension)
• 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.

If you are 65 years old or older, the recommended
starting dose is 2 mg once a day. After a month this
can be increased to 4 mg once a day and then, if
necessary, to 8 mg once daily.
Stable coronary artery disease
The recommended starting dose is 4 mg once daily.
After two weeks, this can be increased to 8 mg once
a day, which is the maximum recommended dose for
this indication.
If you are 65 years old or older, the recommended
starting dose is 2 mg once a day. After a week this
can be increased to 4 mg once a day and after a
further week, to 8 mg once daily.
If you take more Perindopril Erbumine than you
should
If you take too many tablets, contact your nearest
accident and emergency department or tell your
doctor immediately. The most likely effect in case of
overdose is low blood pressure, which can make you
feel dizzy or faint. If this happens, lying down with
the legs raised can help.
If you forget to take Perindopril Erbumine
It is important to take your medicine every day as
regular treatment works better. However, if you
forget to take a dose of Perindopril Erbumine, take
the next dose at the usual time. Do not take a double
dose to make up for a forgotten dose.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you
maybe pregnant or are planning to have a baby ask
your doctor or pharmacist for advice before taking
this medicine.

2.WHAT YOU NEED TO KNOW BEFORE YOU TAKE
PERINDOPRIL ERBUMINE
Do not take Perindopril Erbumine:
• If you are allergic (hypersensitive) to perindopril, to
any other ACE inhibitor or to any of the other
ingredients of this medicine (listed in Section 6).
• If you are more than 3 months pregnant (it is also
better to avoid perindopril in early pregnancy - see
'Pregnancy' section).
• If you have experienced symptoms such as
wheezing, swelling of the face, tongue or throat,
intense itching or severe skin rashes with previous
ACE inhibitor treatment or if you or a member of
your family have had these symptoms in any other
circumstances (a condition called angioedema).

4.POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side
effects, although not everybody gets them.

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 Erbumine
before you become pregnant or as soon as you know
you are pregnant and will advise you to take another
medicine instead of Perindopril Erbumine.
Perindopril Erbumine 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.

If you experience any of the following, stop taking
the medicinal product at once and tell your doctor
immediately:
• swelling of the face, lips, mouth, tongue or throat,
difficulty in breathing
• severe dizziness or fainting
• unusual fast or irregular heart beat.

Talk to your doctor or pharmacist before taking
Perindopril Erbumine if you:
• Have aortic stenosis (narrowing of the main blood
vessel leading from the heart) or hypertrophic
cardiomyopathy (heart muscle disease) or renal
artery stenosis (narrowing of the artery supplying
the kidney with blood).
• Have any other heart problems.
• Have liver problems.
• Have kidney problems or if you are receiving
dialysis.
• Suffer from a collagen vascular disease (disease of
the connective tissue) such as systemic lupus
erythematosus or scleroderma.
• Have diabetes.
• Are on a salt restricted diet or use salt substitutes
which contain potassium.
• Are to undergo anaesthesia and/or major surgery.
• Are to undergo LDL apheresis (which is removal of
cholesterol from your blood by a machine).
• Are going to have desensitisation treatment to
reduce the effects of an allergy to bee or wasp
stings.
• Have recently suffered from diarrhoea or vomiting,
or are dehydrated.

Keep this medicine out of the sight and reach of
children. Do not store above 25 °C. Do not use this
medicine after the expiry date, which is stated on the
carton and blister after 'EXP'. 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 to protect the environment.
6.CONTENTS OF THE PACK AND OTHER
INFORMATION
What Perindopril Erbumine contains
The active substance is perindopril tert-butylamine.
One 8 mg tablet contains 8 mg of perindopril
tert-butylamine, equivalent to 6.676 mg of
perindopril.
The other ingredients are:
Lactose anhydrous, magnesium stearate, silica,
hydrophobic colloidal, cellulose, microcrystalline,
sodium hydrogen carbonate, aluminium lake of
sodium copper chlorophyllin E141.
What Perindopril Erbumine looks like and contents
of the pack
Perindopril Erbumine 8 mg tablets are green
mottled, round, tablets debossed with 'PT8' on one
side of the tablet and 'M' on the other side.
Perindopril Erbumine is available in blisters of 14, 30,
60, 90 and 100 tablets. Not all pack sizes may be
marketed.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL, United
Kingdom.
Manufacturers
Gerard Laboratories, 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland.
Generics [UK] Limited, Potters Bar, Hertfordshire,
EN6 1TL, United Kingdom.
Mylan Hungary Kft, H-2900 Komarom, Mylan utca 1,
Hungary.

Common (may affect up to 1 in 10 people):
• headache, dizziness, vertigo, pins and needles
• vision disturbances
• tinnitus (sensation of noises in the ears)
• light-headedness due to low blood pressure
• cough, shortness of breath
• gastro-intestinal disorders (nausea, vomiting,
abdominal pain, taste disturbances, dyspepsia difficulty of digestion, diarrhoea, constipation)
• allergic reactions (such as skin rashes, itching)
• muscle cramps
• tiredness.

Driving and using machines
Perindopril Erbumine usually does not affect
alertness but dizziness or weakness due to low blood
pressure may occur in certain patients. If you are
affected in this way, your ability to drive or to operate
machinery may be impaired.

Uncommon (may affect up to 1 in 100 people):
• mood swings or sleep disturbances
• tightening of the chest, wheezing and shortness of
breath (bronchospasm)
• dry mouth
• angioedema (symptoms such as wheezing, swelling
of the face, tongue or throat, intense itching or
severe skin rashes)
• kidney problems
• impotence
• sweating.

Perindopril Erbumine contains lactose
Perindopril Erbumine contains lactose. If you have
been told by your doctor that you have an
intolerance to some sugars, such as lactose, contact
your doctor before taking this medicine.
3.HOW TO TAKE PERINDOPRIL ERBUMINE
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.

Very rare (may affect up to 1 in 10,000 people):
• confusion
• cardiovascular disorders (irregular heart beat,
angina, heart attack and stroke)
• eosinophilic pneumonia (a rare type of pneumonia)
• rhinitis (blocked up or runny nose)
• erythema multiforme
• disorders of the blood, pancreas or liver.

Swallow your tablet with a glass of water, preferably
at the same time each day, in the morning and before
a meal. Your doctor will decide on the correct dose
for you.

You must tell your doctor if you think that you are (or
might become) pregnant. Perindopril Erbumine 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).

5.HOW TO STORE PERINDOPRIL ERBUMINE

In decreasing order of frequency, side effects can
include:

Breast-feeding
Tell your doctor if you are breast-feeding or about
to start breast-feeding. Perindopril Erbumine 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.

Warnings and precautions

If you get any side effects talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet.

04-MAR-2013

Job No. 37007428v1

This leaflet was last revised in: 03/2013.
Code No.: MH/DRUGS/25/NKD/89

DD-MMM-20YY

product category Perindopril Erbumine
market UK
packing site Matrix
product Perindopril Erbumine 8 mg Tablets x 28
component type Leaflet

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artwork code 10004885
superseded code 10003755

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180 mm x 400 mm
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If you stop taking Perindopril Erbumine
As the treatment with Perindopril Erbumine is
usually life-long, you should discuss with your doctor
before stopping this medicinal product.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

Taking Perindopril Erbumine with food and drink
It is recommended to take Perindopril Erbumine
before a meal.

In case of diabetic patients, hypoglycaemia (very low
blood sugar level) can occur. Vasculitis (inflammation
of blood vessels) has been reported.

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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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