PERINDOPRIL/AMLODIPINE 4MG /5 MG TABLETS

Active substance: PERINDOPRIL TERT-BUTYLAMINE

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Perindopril/Amlodipine tbl prva stran

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.
• 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/Amlodipine is and what it is used for
2. Before you take Perindopril/Amlodipine
3. How to take Perindopril/Amlodipine
4. Possible side effects
5. How to store Perindopril/Amlodipine
6. Further 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

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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.

• 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.

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.

Take special care with 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).

2. Before you take Perindopril/Amlodipine
Do not take Perindopril/Amlodipine
• if you are allergic (hypersensitive) to perindopril
tert-butylamine or any other ACE inhibitor, amlodipine
besilate or any other dihydropyridines, or any of the other
ingredients of Perindopril/Amlodipine (see section 6 for list
of ingredients),
• 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),

You must tell your doctor if you think you are (or might
become) pregnant. Perindopril/Amlodipine 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).
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.
Perindopril/Amlodipine is not recommended for use in
children and adolescents.

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

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• 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).
Taking Perindopril/Amlodipine with food and drink
Perindopril/Amlodipine should be taken before a meal.

Navodila prepognjena na sredini z vidno prvo stranjo (naslovom);
pharma kodi, ki izhajata iz sredine navodila, morata biti vidni!

- PMS-433U-KRKA

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any
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.

smer branja kode

DPMockUp016985/5

Emb. mat.: Na. Perindopril/Amlodipine tbl

GB
Izdelal: D. Primc
Datum: 25.07.2011

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130 mm ± 0,5 mm

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
Always take Perindopril/Amlodipine exactly as your
doctor has told you. You should 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. This will
normally be one tablet per day. 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.

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If you stop taking Perindopril/Amlodipine
As the treatment with Perindopril/Amlodipine is usually lifelong, you should discuss with your doctor before you stop
taking your tablets.
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/Amlodipine can cause side
effects, although not everybody gets them.
Side effects are classified into the following groups in order of
frequency:
Very common:
Common:
Uncommon:
Rare:
Very rare:
Not known:

Affects more than 1 user in 10
Affects 1 to 10 users in 100
Affects 1 to 10 users in 1,000
Affects 1 to 10 users in 10,000
Affects less than 1 users in 10,000
Frequency cannot be estimated from
available data

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.
Other side effects include:
• Common side effects (occur in less than 1 in 10 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 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,
• Very rare side effects (occur in less than 1 in 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.
The following side effects have also been reported by patients
taking Perindopril/Amlodipine: hypoglycaemia (very low blood
sugar level), vasculitis (inflammation of blood vessels).
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/Amlodipine
Keep out of the reach and sight of children.
Do not use Perindopril/Amlodipine 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 medicinal product does not require any special
temperature storage conditions.
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. Further information
What Perindopril/Amlodipine contains
Perindopril/Amlodipine 4 mg/5 mg tablets
Each tablet contains 4 mg perindopril tert-butylamine (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 tert-butylamine (equivalent
to 3.34g perindopril) and 10 mg amlodipine (as besilate).
Perindopril/Amlodipine 8 mg/5 mg tablets
Each tablet contains 8 mg perindopril tert-butylamine (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 tert-butylamine (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).

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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 scoreline
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 halves.
The tablets are available in carton boxes of 5, 7, 10, 14, 20,
28, 30, 50, 60 and 100 tablets in blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6,
8501 Novo mesto, Slovenia
Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6,
8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Str. 5, D-27472
Cuxhaven, Germany
This leaflet was last approved in
07/2011

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Perindopril/Amlodipine tbl druga stran

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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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