Amlocim 5mg tablets

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

amlodipine (amlodipine besilate)

Available from:

Acino Pharma AG

ATC code:

C08CA01

INN (International Name):

amlodipine (amlodipine besilate)

Dosage:

5mg

Pharmaceutical form:

tablets

Units in package:

(30/3x10/) and (100/10x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2018-11-07

Patient Information leaflet

Amlocim 5 mg and 10 mg Tablets

Version: 01 AM Originator: Pfizer (Norvasc) November 2014
1 / 3
INFORMATION FOR THE PATIENT
Read this package leaflet carefully before you take or use this
medicine.
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.
Keep this leaflet. You may need to read it again.
AMLOCIM 5 MG
AMLOCIM 10 MG
WHAT AMLOCIM IS AND WHAT IT IS USED FOR
On medical prescription.
Amlocim can be used alone or in combination with other blood
pressure-lowering medicines
for the treatment of excessively high blood pressure. The blood
pressure falls slowly after a
tablet is taken and therefore there is no sudden drop in blood
pressure. One tablet daily is
sufficient to lower the blood pressure for 24 hours. Amlocim is used
alone or together with
other medicines to treat oxygen deficiency of the heart muscle, known
as angina pectoris.
Taking Amlocim once a day increases the length of time for which your
heart can work hard
and reduces the number of angina pectoris attacks.
WHEN NOT TO USE AMLOCIM
Do not use Amlocim if you are hypersensitive to the active substance
in the product, to any
of the ingredients or to other dihydropyridines.
TAKE SPECIAL CARE WITH AMLOCIM
Because of its possible side effects, this medicine may affect your
reactions and your ability
to drive or to use tools or machines.
Amlocim should not be taken together with grapefruit or grapefruit
juice, as this can cause an
increased fall in blood pressure.
Tell your doctor or pharmacist if you are suffering from other
diseases, particularly a liver
disease, have any allergies or are taking or externally using any
other medicines (including
those bought over the counter).
2 of 3
TAKING AMLOCIM DURING PREGNANCY AND BREAST-FEEDING
In general, Amlocim should not be taken during pregnancy. Tell your
doctor if you are
pregnant or want to become pregnant. Only your doctor can decide
whether in very specific
circumstances you may nevertheless take Amlocim.
Do not bre

Summary of Product characteristics

Amlocim 5mg and 10mg, Tablets

Version: 01 AM

Originator: Pfizer (Norvasc) November 2014
1 / 8
_ _
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Amlocim 5 mg
Amlocim 10 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active substance:_ amlodipine (as amlodipine besilate).
_Excipients: _povidone K30, microcrystalline cellulose (E 460),
anhydrous calcium hydrogen phosphate
(E 341), crospovidone, magnesium stearate (E 470b).
3.
PHARMACEUTICAL FORM
1 Amlocim 5 mg tablet contains: 5 mg amlodipine (as 7 mg amlodipine
besilate).
1 Amlocim 10 mg tablet contains: 10 mg amlodipine (as 14 mg amlodipine
besilate).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_ _
_1. Arterial hypertension_
Amlocim is indicated for the basic treatment of hypertension.
Combination therapy may be of
advantage in patients who have insufficiently responded to
monotherapy. Amlocim has been used
together with thiazide diuretics, with alpha-blockers, with
beta-blockers and with ACE inhibitors.
_2. Prophylaxis of attacks in stable angina pectoris _
caused by fixed vasoconstriction.
_3. Prinzmetal’s or vasospastic angina_
which is caused by coronary vasospasm.
Amlocim may be used in those cases where the clinical picture suggests
a vasospasm component but
this has not been confirmed. Amlocim may be administered as
monotherapy or in combination with
other anti-anginal medicinal products in patients whose angina
pectoris does not sufficiently respond
to nitrates and/or adequate doses of beta-blockers.
N.B.: Amlocim is not suitable for treating an acute attack of angina
pectoris (attack suppression)
because of its slow onset of action.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For both indications – hypertension and angina pectoris –
treatment is usually started with a dose of
5 mg Amlocim once daily. Depending on the individual response of the
patient, the dose may be
increased to 10 mg Amlocim once daily.
2 / 8
An adjustment in the dose of Amlocim is not necessary when
co-administered with thiazide diuretics,
be