Amlocim 10mg

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

amlodipine (amlodipine besilate)

Available from:

Acino Pharma AG

INN (International Name):

amlodipine (amlodipine besilate)

Dosage:

10mg

Pharmaceutical form:

tablets

Prescription type:

Prescription

Patient Information leaflet

Patient information leaflet
_Read this leaflet carefully before taking or using this _
_medicine._
_This medicine has been prescribed for you and you _
_should not pass it on to others. The medicine 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, 10 mg
Amlodipine besilate tablets
What Amlocim is and what it is used for
On prescription from a doctor.
Amlocim can be used alone or in combination with
other
antihypertensive
medicines
(medicines
that
lower blood pressure) to treat blood pressure that is
too high. The blood pressure is lowered slowly after a
tablet is taken so that there cannot be a sudden ex-
cessive drop in blood pressure. One tablet a day is
enough to lower the blood pressure for a period of 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 your heart
can work harder and reduces the number of angina
pectoris attacks.
Do not use Amlocim
Do not take Amlocim if you are hypersensitive (aller-
gic) to the active substance in the preparation, any of
the other ingredients or other dihydropyridines.
Take special care with Amlocim
This medicine may impair your reactions and your
ability to drive or use tools or machines on account of
its possible side effects.
Amlocim should not be taken together with
grape-
fruit or grapefruit juice as this may lead to an
increase in the blood-pressure-lowering effect.
Tell your doctor or pharmacist if you have any other
illnesses, especially liver disease, have any allergies
or if you are taking or applying externally any other
medicines (including those you may have bought
yourself).
Pregnancy and breast-feeding
In general, Amlocim should not be taken during preg-
nancy. Tell your doctor if you are pregnant or want to
become pregnant. Only your doctor can decide if, in
very specific circumstances, you may still take Amlo-
cim.
You must not breast

Summary of Product characteristics

Version Amlo_TA_FI_291211_e_mtg_final_CIS_acino
Source: Amlo_TA_FI_291211_d genehmigt am 29.12.2011 (Originator:
Norvasc, SdI: Mai 2010) + translation/ proofreading by m-tg
18.02.2013
Page 1 SUMMARY OF PRODUCT CHARACTERISTICS
__________________________________________________________________________________
1.
NAME OF THE MEDICINAL PRODUCT
Amlocim 5 mg
Amlocim 10 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 (non-divisible) Amlocim 5 mg tablet contains: 5 mg amlodipine as 7.0
mg amlodipine besilate.
1 Amlocim 10 mg tablet contains: 10 mg amlodipine as 14.0 mg
amlodipine besilate.
_ _
_Excipients:_ For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
_Amlocim 5 mg tablets: _
White round, biconvex, uncoated tablets, plain on both sides
_Amlocim 10 mg tablets: _
White round, biconvex, uncoated tablets, break scores on both sides
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_1. Arterial hypertension _
Amlocim is indicated as a first-line therapeutic agent for
hypertension. In patients who have not
adequately responded to monotherapy, combination therapy may be of
benefit. Amlocim has been
used together with thiazide diuretics, alpha-blockers, beta-blockers
and ACE inhibitors.
_ _
_2. Prophylaxis against episodes in stable angina pectoris _
caused by fixed coronary artery stenosis.
_ _
_3. Prinzmetal’s or vasospastic angina, _
caused by spastic vasoconstriction of the coronary vessels.
Amlocim can be used when the clinical picture suggests a component of
spastic vasoconstriction, but
which is not confirmed Amlocim can be administered as a single
therapeutic agent or in combination
with other anti-anginal agents in patients whose angina pectoris does
not adequately respond to
nitrates and/or adequate beta-blocker doses.
Version Amlo_TA_FI_291211_e_mtg_final_CIS_acino
Source: Amlo_TA_FI_291211_d genehmigt am 29.12.2011 (Originator:
Norvasc, SdI: Mai 2010) + translation/ proofreading by m-tg
18.02.2013
Page 2
N.B.: For the treatment of an acute episodes of angina pectoris
(rescue medication)