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:

2016-11-10

Patient Information leaflet

_Amlo-Denk 5_
Tablets – oral use
Calcium antagonist
Active substance: Amlodipine
Package leaflet:
Information for the user
READ ALL OF THIS LEAFLET CAREFULLY BE-
FORE YOU START TAKING THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFOR-
MATION 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 oth-
ers. 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 in-
cludes 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 ves-
sels, so that blood passes through them
more easily. In patients with angina Amlo-
Denk 5 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 5
Do not take Amlo-Denk 5
• if you are allergic to amlodipine or any
of the other ingredients of this medi-
cine (listed in section 6), or to any other
calcium antagonists. This may be itch-
ing, reddening of the skin or difficulty
in breathing.
•
if you have severe low blood pressure
(hypotension).
•
if you have narrowing of the aortic heart
valve

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.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet.
Amlo-Denk 5 are white to off-white, round and 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
_ _
_In 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).
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 severe hepatic impairment. Amlodipine should be
initiated at the lowest dose
and titrated slowly in patients with severe hepatic impairment.
_ _
_Renal impairment