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PERINDOPRIL/AMLODIPINE 8 MG/5 MG TABLETS

Active substance(s): AMLODIPINE BESYLATE / PERINDOPRIL TERT-BUTYLAMINE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Perindopril/Amlodipine 4 mg/5 mg
tablets

Perindopril/Amlodipine 4 mg/10 mg
tablets

Perindopril/Amlodipine 8 mg/5 mg
tablets

Perindopril/Amlodipine 8 mg/10 mg
tablets

Perindopril tert-butylamine/Amlodipine
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.

What is in this leaflet
1. What Perindopril/Amlodipine is and what it is
used for
2. What you need to know before you take
Perindopril/Amlodipine
3. How to take Perindopril/Amlodipine
4. Possible side effects
5. How to store Perindopril/Amlodipine
6. Contents of the pack and other information

1. What Perindopril/Amlodipine is and
what it is used for
Perindopril/Amlodipine is prescribed for treatment
of high blood pressure (hypertension) and/or
treatment of stable coronary artery disease (a
condition where the blood supply to the heart is
reduced or blocked).
Patients already taking perindopril and amlodipine
from separate tablets may instead receive one
tablet of Perindopril/Amlodipine which contains
both ingredients.
Perindopril/Amlodipine is a combination of two
active ingredients, perindopril and amlodipine.
Perindopril is an ACE (angiotensin converting
enzyme) inhibitor. Amlodipine is a calcium
antagonist (which belongs to a class of medicines
called dihydropyridines). Together they work to
widen and relax the blood vessels, which results
in a reduction of blood pressure. Blood can flow
through the body more easily and the heart does
not need to work so hard.

2. Before you take Perindopril/
Amlodipine
Do not take Perindopril/Amlodipine
• if you are allergic to perindopril tert-butylamine
or any other ACE inhibitor, amlodipine besylate
or any other dihydropyridines, or 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/Amlodipine in early
pregnancy – see pregnancy section.),
• if you have experienced symptoms such as
wheezing, swelling of the face or tongue, 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),
• if you have cardiogenic shock (when the heart is
unable to supply sufficient blood to the body),
aortic stenosis (narrowing of the main blood
vessels leading from the heart) or unstable angina
(chest pain that may occur when resting),
• if you have severe low blood pressure (severe
hypotension),
• if you suffer from heart failure (the heart fails to
pump blood adequately resulting in the shortness
of breath or peripheral swellings such as swelling
of the legs, ankles or feet) after an acute heart
attack.
• if you have diabetes or impaired kidney function
and you are treated with a blood pressure
lowering medicine containing aliskiren.

Warnings and precautions
Talk to your doctor or pharmacist before taking
Perindopril/Amlodipine:
• if you have hypertrophic cardiomyopathy
(cardiac muscle disease) or renal artery stenosis
(narrowing of the artery which supplies the kidney
with blood),
• if you have any other heart problems,
• if you have impaired liver function,
• if you have kidney problems or if you are receiving
dialysis,
• if you have 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 (a well
balanced potassium blood level is essential).
• 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

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).
When you are taking Perindopril/Amlodipine, you
should also inform your doctor or the medical staff
if you:
• are going to have a general anaesthetic and/or
major surgery,
• have recently suffered from diarrhoea or vomiting
(being sick),
• are to undergo LDL apheresis (the 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.
Children and adolescents
Perindopril/Amlodipine is not recommended for use
in children and adolescents.
Other medicines and Perindopril/Amlodipine
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.

See also information under the heading “Do not
take Perindopril/Amlodipine “.

You should avoid Perindopril/Amlodipine with:
• lithium (used to treat mania or depression),
• estramustine (used in cancer therapy),
• potassium-sparing diuretics (spironolactone,
triamterene), potassium supplements or salt
substitutes containing potassium.

You must tell your doctor if you think you are (or
might become) pregnant. Perindopril/Amlodipine is

Treatment with Perindopril/Amlodipine can be
affected by other medicines. Make sure to tell

Your doctor may check your kidney function, blood
pressure, and the amount of electrolytes (e.g.
potassium) in your blood at regular intervals.

your doctor if you are taking any of the following
medicines as special care may be required:
• other medicines for high blood pressure, including
diuretics (medicines which increase the amount of
urine produced by the kidneys),
• non-steroidal anti-inflammatory drugs
(e.g. ibuprofen) for pain relief or high dose
acetylsalicylic acid,
• medicines to treat diabetes (such as insulin),
• medicines to treat mental disorders such as
depression, anxiety, schizophrenia etc. (e.g.
tricyclic antidepressants, antipsychotics,
imipramine-like antidepressants, neuroleptics),
• 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),
• allopurinol (for the treatment of gout),
• procainamide (for the treatment of an irregular
heart beat),
• vasodilators including nitrates (products that
widen the blood vessels),
• heparin (medicines used to thin blood),
• ephedrine, noradrenaline or adrenaline (medicines
used to treat low blood pressure, shock or
asthma),
• baclofen used to treat muscle stiffness in diseases
such as multiple sclerosis,
• some antibiotics such as rifampicin,
• antiepileptic agents such as carbamazepine,
phenobarbital, phenytoin, fosphenytoin,
primidone,
• itraconazole, ketoconazole (medicines used for
treatment of fungal infections),

• alpha-blockers used for the treatment of enlarged

prostate such as prazosin, alfuzosin, doxazosin,
tamsulosin, terazosin,
• amifostine (used to prevent or reduce side effects
caused by other medicines or radiation therapy
that are used to treat cancer),
• corticosteroids (used to treat various conditions
including severe asthma and rheumatoid arthritis),
• gold salts, especially with intravenous
administration (used to treat symptoms of
rheumatoid arthritis).
Your doctor may need to change your dose and/or
to take other precautions:
• If you are taking an angiotensin II receptor blocker

(ARB) or aliskiren (see also information under the
headings “Do not take Perindopril/Amlodipine ”
and “Warnings and precautions”.

Perindopril/Amlodipine with food and drink
Perindopril/Amlodipine should be taken 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/Amlodipine
before you become pregnant or as soon as you
know you are pregnant and will advise you to take

another medicine instead of Perindopril/Amlodipine.
Perindopril/Amlodipine 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/Amlodipine 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
Perindopril/Amlodipine does not affect alertness but
you might experience dizziness or weakness due to
low blood pressure which could affect your ability
to drive or operate machinery. You are advised not
to drive a car or operate machinery until you know
how Perindopril/Amlodipine affects you.

3. How to take Perindopril/Amlodipine

Perindopril/Amlodipine will usually be prescribed for
patients already taking perindopril and amlodipine
from separate tablets.
If you take more Perindopril/Amlodipine than you
should
If you take too many tablets, contact your nearest
accident and emergency department or tell your
doctor immediately. The most likely symptoms of
overdose are low blood pressure which can make
you feel dizzy or faint. If this happens, lying down
with your legs raised can help.
If you forget to take Perindopril/Amlodipine
It is important to take your medicine every day as
regular treatment works better. However, if you
forget to take a dose of Perindopril/Amlodipine, 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/Amlodipine
As the treatment with Perindopril/Amlodipine is
usually life-long, you should discuss with your
doctor before you stop taking your tablets.

Always take this medicine exactly as your doctor
has told you. Check with your doctor or pharmacist
if you are not sure.

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

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. This will normally be one tablet per day.

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

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

joint pain, chest pain, increased need to urinate
especially during the night, malaise (general
feeling of being unwell), bronchospasm (tightening
of the chest, wheezing and shortness of breath),
dry mouth, angioedema (symptoms such as
wheezing, swelling of the face or tongue), kidney
problems, impotence, increased sweating, breast
enlargement in men, weight increase or decrease,

Other side effects include:

• Very rare side effects (occur in less than 1 in

• Common side effects (occur in less than 1 in 10

10,000 users):
confusion, cardiovascular disorders (irregular heart
beat, angina, heart attack and stroke), eosinophilic
pneumonia (a rare type of pneumonia), erythema
multiforme (a skin rash which often starts with
red itchy patches on your face, arms or legs),
disorders of the blood, pancreas, stomach or liver,
peripheral neuropathy (disease that produces loss
of sensations, pain, inability to control muscles),
hypertonia (abnormal increase in muscle tension),
vasculitis (inflammation of blood vessels of the
skin), swelling of the gums, high blood sugar.

users but in more than 1 in 100 users):
headache, dizziness, vertigo, pins and needles,
somnolence (sleepiness), vision disturbances,
tinnitus (sensation of noises in the ears),
palpitations (very fast heartbeat), flushing (hot
or warm feeling in your face), light-headedness
due to low blood pressure, cough, shortness of
breath, nausea (feeling sick), vomiting (being sick),
abdominal pain, taste disturbances, dyspepsia
or difficulty of digestion, diarrhoea, constipation,
allergic reactions (such as skin rashes, itching),
muscle cramps, feeling of tiredness, oedema
(swelling of your legs or ankles),
• Uncommon side effects (occur in less than 1 in

100 users but in more than 1 in 1000 users):
mood swings, sleep disturbances, trembling,
syncope (temporary loss of consciousness), loss
of pain sensation, rhinitis (blocked up or runny
nose), changed bowel habits, hair loss, red or
discoloured patches on skin, back, muscle or

The following side effects have also been reported
by patients taking Perindopril/Amlodipine:
hypoglycaemia (very low blood sugar level),
vasculitis (inflammation of blood vessels).
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Perindopril/Amlodipine
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date which
is stated on the packaging. The expiry date refers to
the last day of that month.
Store in the original package in order to protect
from light and moisture.
This medicine does not require any special
temperature storage conditions.
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/Amlodipine contains
• The active substances are perindopril tertbutylamine and amlodipine.
Perindopril/Amlodipine 4 mg/5 mg tablets
Each tablet contains 4 mg perindopril tertbutylamine (equivalent to 3.34 mg perindopril)
and 5 mg amlodipine (as besilate).
Perindopril/Amlodipine 4 mg/10 mg tablets

Each tablet contains 4 mg perindopril tertbutylamine (equivalent to 3.34 mg perindopril)
and 10 mg amlodipine (as besilate).
Perindopril/Amlodipine 8 mg/5 mg tablets
Each tablet contains 8 mg perindopril tertbutylamine (equivalent to 6.68 mg perindopril)
and 5 mg amlodipine (as besilate).
Perindopril/Amlodipine 8 mg/10 mg tablets
Each tablet contains 8 mg perindopril tertbutylamine (equivalent to 6.68 mg perindopril)
and 10 mg amlodipine (as besilate).
• The other ingredients are sodium hydrogen
carbonate, microcrystalline cellulose (E460),
pregelatinised maize starch, sodium starch
glycolate (type A), colloidal anhydrous silica and
magnesium stearate (E572).
What Perindopril/Amlodipine looks like and
contents of the pack
Perindopril/Amlodipine 4 mg/5 mg tablets:
this medicinal product is presented as white to
almost white, round, slightly biconvex tablets with
bevelled edges.
Perindopril/Amlodipine 4 mg/10 mg tablets:
this medicinal product is presented as white to
almost white, capsule shaped, biconvex tablets
scored on one side. The score line is only to
facilitate breaking for ease of swallowing and not
to divide into equal doses.
Perindopril/Amlodipine 8 mg/5 mg tablets:
this medicinal product is presented as white to
almost white, round, biconvex tablets with
bevelled edges.

Perindopril/Amlodipine 8 mg/10 mg tablets:
this medicinal product is presented as white to
almost white, round, biconvex tablets with
bevelled edges and a score line on one side.
The tablet can be divided into equal doses.
The tablets are available in carton boxes of 5, 7, 10,
14, 20, 28, 30, 50, 60, 90 and 100 tablets in blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6,
8501 Novo mesto, Slovenia
Manufacturers
KRKA, d.d., Novo mesto, Šmarješka cesta 6,
8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5,
27472 Cuxhaven, Germany
Distributed by:
Consilient Health (UK) Ltd.,
No.1 Church Road, Richmond upon Thames,
Surrey. TW9 2QE.
This leaflet was last revised 02/2015

P0350

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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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