Skip to Content

UK Edition. Click here for US version.

PERINDOPRIL TERT-BUTYLAMINE 8MG TABLETS

Active substance(s): PERINDOPRIL TERT-BUTYLAMINE SALT / PERINDOPRIL TERT-BUTYLAMINE SALT / PERINDOPRIL TERT-BUTYLAMINE SALT

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

1
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 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. See section 4.
In this leaflet:
1. What Perindopril tert-butylamine is and what it is
used for
2. What you need to know before you take
Perindopril tert-butylamine
3. How to take Perindopril tert-butylamine
4. Possible side effects
5. How to store Perindopril tert-butylamine
6. Contents of the pack and other information
1. WHAT PERINDOPRIL TERT-BUTYLAMINE IS
AND WHAT IT IS USED FOR
Perindopril is an angiotensin converting enzyme
(ACE) inhibitor. These work by widening the blood
vessels, which makes it easier for your heart to
pump blood through them.
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. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE PERINDOPRIL TERT-BUTYLAMINE
Do not take Perindopril tert-butylamine
- if you are allergic to perindopril tert-butylamine
or any of the other ingredients of this medicine
(listed in section 6).
- if you have experienced symptoms such as
wheezing, swelling of the face, tongue or throat,
intense itching or severe skin rash 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)
- 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 you have diabetes or impaired kidney function
and you are treated with a blood pressure
lowering medicine containing aliskiren.
Warnings and precautions
If any of the following apply to you please talk to
your doctor or pharmacist or nurse before taking
Perindopril tert-butylamine:
- 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),
- if you have any other heart problems,
- if you have liver problems,
- if you have kidney problems or if you are
receiving dialysis,
- if you suffer from a collagen vascular disease
(disease of the connective tissue) such as
systemic lupus erythematosus or scleroderma,
- if you have diabetes,
- if you are on a salt restricted diet or use salt
substitutes which contain potassium,
- if you are to undergo anaesthesia and/or major
surgery,
- if you are to undergo LDL apheresis (which is
removal of cholesterol from your blood by a
machine),
- if you are going to have desensitisation
treatment to reduce the effects of an allergy to
bee or wasp stings,
- if you have recently suffered from diarrhoea or
vomiting, or are dehydrated,
- if you have been told by your doctor that you
have an intolerance to some sugars,
- if you are taking any of the following medicines
used to treat high blood pressure.
• an “angiotensin II receptor blocker” (ARBs)
(also known as sartans - for example
valsartan, telmisartan, irbesartan), in
particular if you have diabetes-related kidney
problems.
• Aliskiren
• if you are taking any of the following
medicines, the risk of angioedema is
increased:
racecadotril (used to treat diarrhea),
- sirolimus, everolimus, temsirolimus
and other drugs belonging to the class of
so-called mTor inhibitors (used to avoid
rejection of transplanted organs)
Your doctor may check your kidney function,
blood pressure, and the amount of electrolytes
(e.g. potassium) in your blood at regular
intervals.
See also information under the heading “Do not
take Perindopril tert-butylamine”
- if you are of black origin since you may have a
higher risk of angioedema and this medicine may
be less effective in lowering your blood pressure
than in non-black patients.
Angioedema
Angioedema (a severe allergic reaction with
swelling of the face, lips, tongue or throat with
difficulty in swallowing or breathing) has been
reported in patients treated with ACE inhibitors,
including Perindopril tert-butylamine. This may
occur at any time during treatment. If you develop
such symptoms, you should stop taking Perindopril
tert-butylamine and see a doctor immediately. See
also section 4.
You must tell your doctor if you think you are
(or might become) pregnant. Perindopril tertbutylamine 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).

015728_1701.indd 1

Children and adolescents
Perindopril tert-butylamine Tablets should not be
given to children and adolescents.
Other medicines and Perindopril tert-butylamine
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
Treatment with Perindopril tert-butylamine Tablets
can be affected by other medicines. Your doctor
may need to change your dose and/or to take other
precautions. These include:
- other medicines for high blood pressure,
including angiotensin II receptors blockers
(ARB), aliskiren (see also information under
the headings “Do not take Perindopril tertbutylamine Tablets” and “Warning and
precautions”) or diuretics (medicines which
increase the amount of urine produced by the
kidneys),
- potassium-sparing drugs (e.g.triamterene,
amiloride), potassium supplements or
potassium-containing salt substitutes,
- potassium-sparing drugs used in treatment of
heart failure: eplerenone and spironolactone at
doses between 12.5 mg and 50 mg per day,
- lithium for mania or depression,
- non-steroidal anti-inflammatory drugs (e.g.
ibuprofen) for pain relief or high dose aspirin,
- medicines to treat diabetes (insulin or metformin
and gliptins such as linagliptin, saxagliptin,
sitagliptin, vildagliptin),
- baclofen (used to treat muscle stiffness in
diseases such as multiple sclerosis),
- medicines to treat mental disorders such as
depression, anxiety, schizophrenia etc. (e.g.
tricyclic antidepressants, antipsychotics),
- immunosupressants (medicines which reduce
the defence mechanism of the body) used for the
treatment of auto-immune disorders or following
after transplant surgery (e.g. ciclosporin,
tacrolimus),
- trimethoprim (for the treatment of infections),
- estramustine (used in cancer therapy),
- allopurinol (for the treatment of gout),
- procainamide (for the treatment of an irregular
heartbeat),
- vasodilators including nitrates (medicines that
make the blood vessels wider)
- heparin (medicines used to thin the blood),
- medicines used for the treatment of low blood
pressure, shock or asthma (e.g.ephedrine,
noradrenaline or adrenaline),
- gold salts especially with intravenous
administration (used to treat symptoms of
rheumatoid arthritis).
- medicines, which is most often used to treat
diarrhea (racecadotril) or avoid rejection of
transplanted organs (sirolimus, everolimus,
temsirolimus and other drugs belonging to the
class of so-called mTor inhibitors). See section
“Warnings and precautions”
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. It is preferable to take your
Perindopril tert-butylamine Tablets before a meal.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this 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 tertbutylamine 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 tert-butylamine Tablets. Perindopril tertbutylamine 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 breastfeed, especially if your baby is newborn, or was
born prematurely.
Driving and using machines
Perindopril tert-butylamine 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.
Perindopril tert-butylamine tablets contains
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.
3. HOW TO TAKE PERINDOPRIL TERTBUTYLAMINE
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Swallow your tablet with a glass of water,
preferably at the same time each day, in the
morning, before a meal. Your doctor will decide on
the correct dose for you.
The recommended dosages are as follows:
High blood pressure: the usual starting and
maintenance dose is 4 mg once daily. After one
month, this can be increased to 8 mg once a
day if required. 8 mg a day is the maximum

16-01-17 10:50

2
recommended dose for high blood pressure.
If you are 65 or older, the usual 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.
Heart failure: the usual starting dose is 2 mg
once daily. After two weeks, this can be increased
to 4 mg once a day, which is the maximum
recommended dose for heart failure.
Stable coronary artery disease: the usual starting
dose is 4 mg once daily. After two weeks, this
can be increased to 8 mg once daily, which is the
maximum recommended dose in this indication.
If you are 65 or older, the usual 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.
Use in children and adolescents
Use in children and adolescent is not
recommended
If you take more Perindopril tert-butylamine
Tablets 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 tert-butylamine
Tablets
It is important to take your medicine every day as
regular treatment works better. However, if you
forget to take a dose of Perindopril tert-butylamine,
take the next dose at the usual time. Do not take a
double dose to make up for a forgotten tablet.
If you stop taking Perindopril tert-butylamine
Tablets
As the treatment with Perindopril tert-butylamine
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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Stop taking the medicine and see a doctor
immediately, if you experience any of the
following side effects that can be serious:
- swelling of the face, lips, mouth, tongue or
throat difficulty in breathing (angioedema) (See
section 2 “Warnings and precautions”),
- severe dizziness or fainting due to low blood
pressure,
- unusual fast or irregular heartbeat or chest pain
(angina) or heart attack,
- weakness of arms or legs, or problems speaking
which could be sign of a possible stroke,
- sudden wheeziness, chest pain, shortness
of breath, or difficulty in breathing
(bronchospasm),
- inflamed pancreas which may cause severe
abdominal and back pain accompanied with
feeling very unwell,
- yellowing of the skin or eyes (jaundice) which
could be a sign of hepatitis,
- skin rash which often starts with red itchy
patches on your face, arms or legs (erythema
multiforme).

Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via The Yellow Card
Scheme at www.mhra.gov.uk/yellowcard. By
reporting side effects you can help provide more
information on the safety of this medicines.
5. HOW TO STORE PERINDOPRIL TERTBUTYLAMINE
Keep this medicine out of the sight and reach of
children.
Store below 25°C and in the original package
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.
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 protect the environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Perindopril tert-butylamine Tablets contains
- The active substance is perindopril tertbutylamine.
- 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, biconvex tablets, engraved “APO” on one
side and “PE2” on the other.
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
This leaflet was last revised in October 2016

Stop taking the medicine and tell your doctor if
you notice any of the following side:
- kidney problems,
- changes in blood tests such as high levels of
potassium reversible on discontinuation or low
levels of sodium,
- chest infection (eosinophilic pneumonia),
- unexplained bruising or bleeding,
- recurring fevers or infections,
- feeling tired or breathless more than usual,
- changes in blood values such as a lower number
of white and red blood cells, lower haemoglobin,
lower number of blood platelets.
Other side effects:
Common (may affect up to 1 in 10 people):
- headache,
- dizziness,
- vertigo,
- pins and needles,
- vision disturbances,
- tinnitus (sensation of noises in the ears),
- cough,
- shortness of breath (dyspnoea),
- gastro-intestinal disorders (nausea, vomiting,
abdominal pain, taste disturbances, dyspepsia or
difficulty of digestion, diarrhoea, constipation),
- allergic reactions (such skin rashes, itching),
- muscle cramps,
- feeling of weakness.
Uncommon (may affect up to 1 in 100 people):
- mood swings,
- sleep disturbances,
- dry mouth,
- intense itching or severe skin rashes,
- formation of blister clusters over the skin,
- impotence,
- sweating,
- excess of eosinophils (a type of white blood
cells),
- somnolence,
- fainting,
- palpitations,
- tachycardia,
- vasculitis (inflammation of blood vessels),
- photosensitivity reaction (increased sensitivity of
the skin to sun),
- arthralgia (joint pain),
- myalgia (muscle pain),
- chest pain,
- malaise,
- oedema peripheral,
- fever,
- fall,
- change in laboratory parameters: hypoglycaemia
(very low blood sugar level) in case of diabetic
patients, increased blood urea, and increased
blood creatinine.
Rare (may affect up to 1 in 1,000 people):
- Changes in laboratory parameters: Increased level
of liver enzymes, high level of serum bilirubin.
- Psoriasis worsening
Very rare (may affect up to 1 in 10,000 people):
- confusion,
- rhinitis (blocked up or runny nose).
1701

015728_1701.indd 2

Code: 015728

16-01-17 10:50

Itemnummer: 015728_1701
Formaat:

148 x 560 mm

Bedrukking:

1/1

1e proef: 09-01-2017
2e proef: 16-01-2017 C:
3e proef:
C:
4e proef:
C:

√ • Zwart
A: √ (voor- en achterzijde)
A:
A:

5e proef:
6e proef:

C:

A:

C:

A:

7e proef:
8e proef:

C:

A:

C:

A:

Als u een print maakt van deze PDF zijn de kleuren niet representatief voor het uiteindelijke resultaat in druk.
Uw handtekening is de goedkeuring voor inhoud en lay-out.

3

Expand Transcript

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.

Hide