PERINDOPRIL TERT-BUTYLAMINE 4MG TABLETS

Active substance: PERINDOPRIL TERT-BUTYLAMINE SALT

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Perindopril tert-butylamine 2 mg Tablets
Perindopril tert-butylamine 4 mg Tablets
Perindopril tert-butylamine 8 mg Tablets
Perindopril tert-butylamine
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 gets 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 tert-butylamine Tablets are and
what they are used for
2. Before you take Perindopril tert-butylamine Tablets
3. How to take Perindopril tert-butylamine Tablets
4. Possible side effects
5. How to store Perindopril tert-butylamine Tablets
6. Further information
1. WHAT PERINDOPRIL TERT-BUTYLAMINE
TABLETS ARE AND WHAT THEY ARE USED FOR
Perindopril belongs to a group of medicines called
ACE inhibitors. These work by widening the blood
vessels. This makes it easier for your heart to pump
blood through the body.
Perindopril tert-butylamine Tablets are used to:
- treat high blood pressure (hypertension).
- treat heart failure (a condition where the heart is
unable to pump enough blood to meet the body’s
needs).
- 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 TERTBUTYLAMINE TABLETS
Do not take Perindopril tert-butylamine Tablets
- if you are allergic (hypersensitive) to perindopril
or any of the other ingredients of Perindopril
tert-butylamine Tablets (see Further Information,
section 6).
- if you have had symptoms such as wheezing,
swelling of the face, tongue or throat, intense
itching, skin rash, fainting or feeling dizzy.
If you have had these symptoms when you have
taken an ACE inhibitor in the past or at any other
time, this may be angioedema. If so, do not take
Perindopril tert-butylamine Tablets.
- if you are more than 3 months pregnant (It is also
better to avoid Perindopril tert-butylamine Tablets
in early pregnancy – see pregnancy section.)..
If any of the above applies to you, talk to your doctor
and do not take Perindopril tert-butylamine Tablets.
Take special care with Perindopril tert-butylamine
Tablets

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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, talk to your doctor before taking
Perindopril tert-butylamine Tablets if you are taking:
- medicines for high blood pressure including water
tablets (diuretics)
- water tablets (diuretics) which affect potassium,
such as spironolactone, triamterene or amiloride
- medicines to increase your level of potassium
- heparin (for thinning the blood) can also affect
potassium levels in your blood
- medicines for diabetes (insulin or tablets)
- lithium (for mania or depression)
- medicines for mental illness such as depression,
anxiety, schizophrenia or other psychosis
- allopurinol for gout
- medicines to treat auto-immune disorders (such
as rheumatoid arthritis) or given after transplant
surgery. These are called immunosupressants.
- procainamide (for irregular heartbeat)
- non-steroidal anti-inflammatory drugs (NSAIDs
such as ibuprofen, diclofenac), including aspirin
for pain
- medicines for low blood pressure, shock or asthma
(including ephedrine, noradrenaline or adrenaline)
- medicines that make the blood vessels wider
(vasodilators, such as nitrates)
Ask your doctor if you are not sure what these
medicines are. Tell the doctor if you have taken any
of the medicines listed above in the past, but have
now stopped.
Taking Perindopril tert-butylamine Tablets with
food and drink
Drinking alcohol with Perindopril tert-butylamine
Tablets may make you feel dizzy. Check with your
doctor whether you can drink alcohol when taking
this medicine.
Take your Perindopril tert-butylamine Tablets in the
morning before a meal.
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 tert-butylamine
Tablets before you become pregnant or as soon as
you know you are pregnant and will advise you to
take another medicine instead of Perindopril tertbutylamine Tablets. Perindopril tert-butylamine 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 breast-feeding or about
to start breast-feeding. Perindopril tert-butylamine
Tablets are 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 feel dizzy or tired when taking Perindopril
tert-butylamine Tablets. If this happens, do not drive
or use machines. You must talk to your doctor about
this.
Important information about some of the
ingredients of Perindopril tert-butylamine Tablets
The tablets contain 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.
Information on special patient groups
Perindopril tert-butylamine Tablets should not be
given to children.
3. HOW TO TAKE PERINDOPRIL TERT-BUTYLAMINE
TABLETS
Your doctor will decide on the amount of perindopril
you should start to take. This may be increased
depending on your condition and other medicines you
are taking. Always take Perindopril tert-butylamine
Tablets exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not
sure. Do not change the amount of medicine you take
unless your doctor tells you. Perindopril may be used
on its own, or with other medicines which lower blood
pressure.
- Take Perindopril tert-butylamine Tablets by mouth
only.
- Take them in the morning, before a meal.
- It is best to take your tablet(s) with a glass of water at
the same time each day.
The usual dose is:
High blood pressure:
- 4 mg each day
- after a month, this may be raised to 8 mg each day.
8 mg each day is the highest amount normally used.
In older people with high blood pressure the daily
amounts are usually:
- 2 mg each day
- after a month, this may be raised to 4 mg each day.
8 mg each day is the highest amount used.
If you are taking water tablets (diuretics):
- your doctor may stop them 2 to 3 days before you
start taking Perindopril tert-butylamine Tablets. This
is to prevent a fall in your blood pressure.
- if needed, you can start taking water tablets again
after you have started Perindopril tert-butylamine
Tablets.
- if it is not possible to stop your water tablets, then
you can take 2 mg of perindopril as well.
Your doctor or pharmacist will tell you exactly what you
should do.
The doctor may start you with 2 mg perindopril if:
- your blood pressure is very high
- you have not enough water in your body (dehydrated)
- you have a low level of salt in your blood
- you have a heart problem which means that it has
difficulty in pumping blood through the body (cardiac
decompensation)
- you have high blood pressure due to the blood
vessels in the kidneys being blocked (constriction of
the arteries).
Heart failure:
- 2 mg each day to start
- after 2 weeks, this may be raised to 4 mg each day.
Stable coronary artery disease:
- the usual starting dose is 4 mg once daily
- after two weeks, this may be raised to 8 mg each day.
In older people with stable coronary artery disease the
daily amounts are usually:
- 2 mg each day
- after one week, this may be raised to 4 mg each day
- and after a further week to 8 mg each day which is the
highest amount used.
If you take more Perindopril tert-butylamine Tablets
than you should, talk to a doctor or pharmacist straight
away.
The following effects may happen:
Low blood pressure, shock, kidney problems,
fast breathing, fast heartbeat, uneven heartbeat
(palpitations), slow heartbeat, feeling dizzy or anxious,
cough.
If you forget to take Perindopril tert-butylamine
Tablets
It is important to take your medicine every day. If you
forget to take your tablets, take another as soon as you
remember. Then take the normal amount the next day.
Do not take a double dose to make up for a forgotten
tablet.

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Talk to your doctor before taking Perindopril tertbutylamine Tablets if:
- you have narrowing of the heart valves (aortic
or mitral stenosis) or heart muscle disease
(hypertrophic cardiomyopathy) or narrowing of the
artery supplying the kidney with blood (renal artery
stenosis)
- you have any other heart or liver or kidney problems,
or if you are having dialysis
- you have diabetes which is not well controlled
- you have been told to limit the salt in your diet or to
use a salt-substitute containing potassium
- you have a collagen disease such as systemic lupus
erythematosus or scleroderma.
Tell the doctor or pharmacist that you are taking
Perindopril tert-butylamine Tablets if:
- you are about to have an operation or a general
anaesthetic
- you have recently had diarrhoea or vomitted
- you are going to have treatment to reduce the
effects of an allergy to bee or wasp stings
- you are going to have cholesterol removed from
your blood by a machine (LDL apheresis).
Tell the doctor if any of the situations above have
happened to you in the past.
You must tell your doctor if you think you are (or
might become) pregnant. Perindopril tert-butylamine
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).

Ask your doctor or pharmacist for advice before
taking any medicine.

If you stop taking Perindopril tert-butylamine Tablets
Do not stop taking Perindopril tert-butylamine Tablets
without talking to your doctor. Medicines for high blood
pressure or heart failure will normally have to be taken
for the rest of your life. If you stop taking Perindopril
tert-butylamine Tablets your condition may get worse.
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 tert-butylamine Tablets
can cause side effects, although not everybody gets
them.
If any of the following effects happen, stop taking your
tablets and tell your doctor immediately:
- swelling of the face, lips, mouth, tongue or throat
- difficulty in breathing
- feeling dizzy or faint
- very fast or uneven heartbeat.
This is a very rare but serious reaction called
angioedema, which can happen with all medicines
of this type (ACE inhibitors). You must get treatment
immediately, usually in hospital.
Common (affecting less than 1 person in 10):
- cough, shortness of breath
- feeling faint due to low blood pressure (especially
when you start Perindopril tert-butylamine Tablets,
or when the amount is increased, or when you also
take water tablets)
- headache, feeling dizzy or tired, feeling dizzy with
a spinning sensation (vertigo), pins and -needles,
muscle cramps, blurred vision, eye pain, sensation of
noises in the ears (tinnitus)
- feeling or being sick, stomach pain or indigestion,
changes in your sense of taste, diarrhoea,
-constipation
- skin rash, itching.
Uncommon (affecting less than 1 person in 100):
- changes in mood or sleep
- tight feeling in the chest, wheezing and short of
breath (bronchospasm)
- dry mouth
- kidney problems
- unable to get an erection
- sweating
- wheezing, swelling of the face, tongue or throat,
intense itching, skin rash, fainting or feeling dizzy
(angioedema).

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Very rare (affecting less than 1 person in 10,000):
- feeling confused
- uneven heartbeat, chest pain that happens in heart
disease (angina), heart attack and stroke (these have
happened with ACE inhibitors in people with low
blood pressure)
- chest infection (eosinophilic pneumonia), blocked up
or runny nose (rhinitis)
- inflamed pancreas (pancreatitis)
- inflamed liver (hepatitis)
- skin reaction like an allergy (erythema multiforme)
- changes in the blood. Your doctor may carry out
blood tests to check for this.
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 TERTBUTYLAMINE TABLETS
- Keep out of the reach and sight of children.
- Store below 25°C and in the original package
Use-by date
Do not use Perindopril tert-butylamine Tablets after the
expiry date which is stated on the packet after EXP. 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.

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Perindopril tert-butylamine 4 mg Tablets are white,
capsule shaped tablets, engraved “APO” on one side
and “PE” bisect “4” on the other. The tablets can be
divided into equal halves.
Perindopril tert-butylamine 8 mg Tablets are white,
capsule shaped tablets, engraved “APO” on one side
and “PE” bisect “8” on the other. The tablets can be
divided into equal halves.
Each strength of Perindopril tert-butylamine Tablets is
available in cartons of 4, 7, 14, 15, 28, 30, 50, 56, 60,
90, 100, 112, 120, 500 tablets.
Not all pack sizes may be available.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Apotex Europe B.V., Darwinweg 20, 2333 CR Leiden,
The Netherlands.
Manufacturer
Apotex Nederland B.V.,
Archimedesweg 2, 2333 CN Leiden, The Netherlands
Distributed by: LPC Medical (UK) Limited
30 Chaul End Lane, Luton, Bedfordshire, LU4 8EZ,
United Kingdom
This leaflet was last approved in April 2009.

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6. FURTHER INFORMATION
What Perindopril tert-butylamine Tablets contain

- The active substance is perindopril tert-butylamine.
- The other ingredients are lactose anhydrous and
magnesium stearate.
What Perindopril tert-butylamine Tablets look like
and contents of the pack
Perindopril tert-butylamine 2 mg Tablets are white,
round tablets, engraved “APO” on one side and “PE2”
on the other.

Code: 015728

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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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