Amlo-Denk 10 tablets

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

amlodipine (amlodipine mesilate monohydrate)

Available from:

Denk Pharma GmbH & Co. KG

ATC code:

C08CA01

INN (International Name):

amlodipine (amlodipine mesilate monohydrate)

Dosage:

10mg

Pharmaceutical form:

tablets

Units in package:

(50/5x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2022-03-23

Patient Information leaflet

AMLO-DENK 10
Tablet – oral use
Calcium antagonist
Active substance: amlodipine
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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 Amlo-Denk 10 is and what it is used for
2.
What you need to know before you take Amlo-Denk 10
3.
How to take Amlo-Denk 10
4.
Possible side effects
5.
How to store Amlo-Denk 10
6.
Contents of the pack and other information
1.
WHAT AMLO-DENK 10 IS AND WHAT IT IS USED FOR
Amlo-Denk 10 contains the active substance amlodipine and belongs to a
group of medicines called
calcium antagonists.
Amlo-Denk 10 is used to treat high blood pressure (hypertension) or a
certain type of chest pain called
angina, a rare form of which is Prinzmetal’s or variant angina.
In patients with high blood pressure this medicine works by relaxing
blood vessels, so that blood
passes through them more easily. In patients with angina Amlo-Denk 10
works by improving blood
supply to the heart muscle which then receives more oxygen and as a
result chest pain is prevented.
This medicine does not provide immediate relief of chest pain from
angina.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMLO-DENK 10
DO NOT TAKE AMLO-DENK 10, IF YOU

are allergic to amlodipine or any of the other ingredients of this
medicine (listed in section 6), or
to any other calcium antagonists. This may be itching, reddening of
the skin or difficulty in
breathing.

have severe low blood pressure (hypotension).

have narrowing of the aortic heart valve (aortic stenosis) or
cardio

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Amlo-Denk 10
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: amlodipine
Each tablet contains 12.79 mg amlodipine mesilate 1H
2
O, equivalent to 10 mg amlodipine.
Excipient with known effect: Each tablet contains less than 1 mmol
sodium (23 mg).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White to off-white, round, biconvex tablets, scored on one side.
The tablets can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Hypertension
Chronic stable angina pectoris
Vasospastic (Prinzmetal’s) angina
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
POSOLOGY
Adults
For both hypertension and angina the usual initial dose is 5 mg of
amlodipine once daily which may be
increased to a maximum dose of 10 mg depending on the individual
patient’s response.
In hypertensive patients, amlodipine has been used in combination with
a thiazide diuretic, alpha
blocker, beta blocker, or an angiotensin converting enzyme inhibitor.
For angina, amlodipine may be
used as monotherapy or in combination with other antianginal medicinal
products in patients with
angina that is refractory to nitrates and/or to adequate doses of beta
blockers.
No dose adjustment of amlodipine is required upon concomitant
administration of thiazide diuretics,
beta blockers, and angiotensin-converting enzyme inhibitors.
Special populations_ _
_Elderly _
Amlodipine used at similar doses in elderly or younger patients is
equally well tolerated. Normal
dosage regimens are recommended in the elderly, but increase of the
dosage should take place with
care (see sections 4.4 and 5.2).
_ _
_Hepatic impairment _
Dosage recommendations have not been established in patients with mild
to moderate hepatic
impairment; therefore, dose selection should be cautious and should
start at the lower end of the
dosing range (see sections 4.4 and 5.2). The pharmacokinetics of
amlodipine have not been studied in
2
severe hepatic impairment.