Amlo-Denk 5 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:

5mg

Pharmaceutical form:

tablets

Units in package:

(50/5x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2022-03-23

Patient Information leaflet

SPECIFICATION - DENK PHARMA
product name:
Amlo-Denk 5
artwork:
leaflet
language(s):
EN, FR, PT
material number:
50001080/003
storage
conditions:
30°C
revision of text:
04/2020
open format:
600 x 180 mm
fold:
1 x pre-folded (Einbruchfalz)
folded format:
300 x 180 mm
pharma code:
22172
paper grammar:
40 g/m
2
printing colours:
 PANTONE YELLOW C
 BLACK
revision/date:
1 / 13.09.2021, mt-g
2 / 15.09.2021, mt-g
_Amlo-Denk 5_
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 5 IS AND WHAT IT IS
USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE AMLO-DENK 5
3. HOW TO TAKE AMLO-DENK 5
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE AMLO-DENK 5
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
1.
What Amlo-Denk 5 is and what
it is used for
Amlo-Denk 5 contains the active substance
amlodipine and belongs to a group of med-
icines called calcium antagonists.
Amlo-Denk 5 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 5 works
by improving blood supply to the heart mus-
cle 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.

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Amlo-Denk 5
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: amlodipine
Each tablet contains 6.395 mg amlodipine mesilate 1H
2
O, equivalent to 5 mg amlodipine.
Excipient with known effect: Each tablet contains less than 1 mmol (23
mg) sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White to off-white, round, biconvex tablets.
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 _
2
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
severe hepatic impairment. Amlodipine should be initiated at the
lowest dose and titrated slowly