Patient Information Leaflet
AMLOCOR 5 mg and 10 mg tablets
(Аmlodipine)
Dear patients, please read carefully this leaflet since it contains important information
regarding the effective and safe use of this medicinal product.
- Keep this leaflet. You may need to read it again.
- This medicinal product is prescribed to you and you must not give it or recommend it to
other people. The medicinal product may not be suitable for them and may harm their health
even if their symptoms are same or similar.
 If you have any further questions, please ask your doctor or a pharmacist.
-
This medicine has been prescribed for you personally and you should not pass it on to
others. It may harm them, even if their symptoms are the same as yours.
IN THIS LEAFLET:
 What is AMLOCOR and what is it used for
 Before you take AMLOCOR
 How to take AMLOCOR
 Possible side effects
 Storing AMLOCOR
 Further information
AMLOCOR 5 mg/ 10 mg
Active substance: Each tablet AMLOCOR contains amlodipine besilate, equivalent to 5 mg
or 10 mg аmlodipine respectively.
Excipients: Microcrystalline cellulose; Calcium hydrogen phosphate, anhydrous;
Sodium starch glycolate; Magnesium stearate.
MARKETING AUTHORIZATION HOLDER
ADIPHARM EAD
130, Simeonovsko shosse Blvd.
Sofia 1700, Bulgaria
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1. WHAT IS AMLOCOR AND WHAT IS IT USED FOR
AMLOCOR belongs to a group of drugs called calcium channel blockers (calcium
antagonists).
AMLOCOR is indicated for treatment of:

High blood pressure (hypertension): as a single agent or in combination with other
blood pressure lowering agents.

Angina (various forms of coronary disease in which blood supply to the heart is
disturbed resulting in a chest pain); as a single therapy or in combination with organic
nitrates or beta blockers for treatment of Prinzmetal angina (variant angina).
2. BEFORE YOU TAKE AMLOCOR
Do not take AMLOCOR:

if you are hypersensitivity to аmlodipine or other dihydropyridine derivatives (e.g.
nifedipinе, nitrendipinе) as well as hypersensitivity to any of the excipients.

are pregnant or become to be pregnant; are breast-feeding;

if you have unstable angina, cardiogenic shock and aortic stenosis.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or
pharmacist.
The medicinal product should be used with caution in patients with liver failure since its
elimination depends on liver function. Usually no special dose adjustment is required.
The use of AMLOCOR in patients with acute myocardial infarction as well as for a month
thereafter is not recommended.
The consumption of grapefruit, grapefruit juice as well as food supplements containing
grapefruit extracts is strictly prohibited during treatment with AMLOCOR due to a risk of
clinically significant inhibition of drug metabolism and the respective increase of the risk of
potentiation of the active substance effect and adverse drug reactions occurrence.
No dose adjustment is required in case of renal failure since the elimination of the drug is not
significantly changed.
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Usually no dose adjustment is required in elderly patients. due to a possible delay of the
elimination of amlodipine in these patients, careful monitoring is necessary. it is
recommended to avoid administration of doses higher than 5 mg once daily.
Taking AMLOCOR with food and drink
 It is recommended to stop using grapefruits and grapefruit juice during treatment with
AMLOCOR. the use of products containing grapefruit extracts (allowed as food
supplements) is contraindicated during treatment with AMLOCOR.
 Pregnancy and lactation
Ask your doctor or pharmacist for advice before taking any medicine.
The use of the medicinal product in these groups of patients is contraindicated.

Driving and using machines
The present clinical experience with AMLOCOR shows no effect of the medicinal product
on the ability for driving and use of machines or any other activities requiring alertness.
 Taking other medicines
There is no risk taking this medicinal product simultaneously with other drugs however if
you are using other medicinal products or you have to start taking other drugs, please inform
your doctor.
Please inform your doctor or pharmacist if you taking or have recently taken any other
medicines, even those not prescribed.
3. HOW TO TAKE AMLOCOR
Dosage and duration of treatment are determined by your doctor. Take the medicinal
product following the instructions below if your doctor has not prescribed any other dosage
regime.
AMLOCOR is taken orally with sufficient quantity of water. Food has no effect on the
absorption of the active substance.
Adult patients: The usual dosage for treatment of high blood pressure and angina is 5 mg
once daily which can be increased by your doctor to a single dose of 10 mg daily.
In combination pharmacotherapy, simultaneous administration of thiazide diuretics and
analogues, angiotensin-converting enzyme inhibitors or beta-adrenergic antagonists does not
require dose adjustment.
Elderly patients: The usual dosage regimen is recommended.
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Children: The use of AMLOCOR in children is contraindicated.
Method of administration
Oral use.
If you have the impression that the effect of AMLOCOR is too strong or too weak, talk to
your doctor or pharmacist.
If you take more AMLOCOR than you should:
In case of overdose severe peripheral vasodilation with prolonged hypotension and possible
complications from the cardiovascular system may occur. Due to the risk of severe reactions
seek medical attention in every case of intentional or inadvertent overdose.
If you forget to take AMLOCOR:
AMLOCOR has a long-lasting effect and therefore it is safer to rather wait for the time of the
next intake (on the next day after the missed dose) than to disregard the dosing regime,
especially the interval between the intakes and take the missed dose within the same day.
4. POSSIBLE SIDE EFFECTS
Like all drugs, AMLOCOR tablets may induce some undesirable effects. The most common
ones are: drowsiness, headache, palpitations, flushing, stomach pain, nausea, peripheral
edema, fatigue.
If the adverse drug reactions cause you discomfort and/or last more than a few days please
inform your doctor.
The following reactions are rarely observed in patients taking AMLOCOR: itching, rash,
larynx edema, skin pigmentation (red spots on the skin). Severe allergic reactions are
extremely rare. You should immediately inform your doctor about every sudden occurrence
of wheezing, disturbed breathing, swelling of the eyelids, face or lips, rash or itching
(especially over your whole body).
If you have an effect that is not described in this leaflet, please inform your doctor or a
pharmacist.
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5. STORING AMLOCOR
Keep out of the reach and sight of children.
Do not store above 25oC.
Do not take this medicinal product after the expiry date noted on the package.
6. FURTHER INFORMATION
For any information about this medicinal product, please contact the local representative of
the Marketing Authorization Holder.
Date of the last text revision
December, 2006
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