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:

2016-11-10

Patient Information leaflet

_Amlo-Denk 10_
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 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 sub-
stance 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 ox
-
ygen and as a result chest pain is prevent-
ed. This medicine does not provide im
-
mediate 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 (list-
ed in section 6), or to any other calcium
antagonists. This may be itching, redden-
ing of the skin or difficulty in breathing.
•
have severe low blood pressure (hypo-
tension).
• have narrowing of the aortic heart

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.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet
Amlo-Denk 10 are white to off-white, round, biconvex and scored on one
side tablets.
The tablet 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
_ _
_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 sl