IMPLICOR 50MG/5MG FILM-COATED TABLETS

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

METOPROLOL TARTRATE; IVABRADINE HYDROCHLORIDE

Boleh didapati daripada:

SERVIER MALAYSIA SDN BHD

INN (Nama Antarabangsa):

METOPROLOL TARTRATE; IVABRADINE HYDROCHLORIDE

Unit dalam pakej:

14tablet Tablets; 28tablet Tablets; 56tablet Tablets

Dikeluarkan oleh:

LES LABORATOIRES SERVIER INDUSTRIE

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
IMPLICOR FILM-COATED TABLETS_ _
_Metoprolol tartrate/ivabradine _
_25mg/5mg, 50mg/5mg, 25mg/7.5mg, 50mg/7.5mg _
WHAT IS IN THIS LEAFLET
1.
What IMPLICOR is used for
2.
How IMPLICOR works
3.
Before you use IMPLICOR
4.
How to use IMPLICOR
5.
While you are using it
6.
Side effects
7.
Storage and disposal of
IMPLICOR
8.
Product description
9.
Manufacturer and Product
registration holder
10. Date of revision
1. WHAT IMPLICOR IS USED FOR
IMPLICOR is used to treat
symptomatic stable angina pectoris
in adults (which causes chest pain).
Instead of taking ivabradine and
metoprolol as separate tablets you
will receive one tablet of
IMPLICOR which contains both
ingredients..
2. HOW IMPLICOR WORKS
IMPLICOR is a combination of two
active ingredients, metoprolol
tartrate and ivabradine. Metoprolol
is a beta blocker. Beta-blockers slow
the heartbeat, lessen the force with
which the heart muscle contracts and
reduces the blood vessel contraction
in the heart, brain and throughout
the body. Ivabradine works mainly
by reducing the heart rate by a few
beats per minute. This lowers the
heart’s need for oxygen especially in
the situations when an angina attack
is more likely to happen. In this
way, metoprolol and ivabradine help
to control and reduce the number of
angina attacks.
3. BEFORE YOU USE IMPLICOR
When you must not use it
_DO NOT TAKE IMPLICOR IF_:
-
you are allergic to ivabradine,
metoprolol or any of the other
ingredients of this medicine
(listed in Ingredients section), or
to other beta blockers.
-
you have a resting heart rate
before treatment that is too slow
-
you feel weak, have decreased
level of consciousness,
shortness of breath, hypotension
or chest pain (due to
symptomatic bradycardia)
-
you are suffering from
cardiogenic shock (a serious
heart condition caused by very
low blood pressure, treated in
hospitals)
-
you suffer from a heart rhythm
disorder (irregular heart beat)
-
you are having a heart attack or
a suspected heart attack
complicated by the followin

Ciri produk

1
1. NAME OF THE MEDICINAL PRODUCT
I mplicor 25mg/ 5mg film -coated tablets
Implicor 50mg/5mg film -coated tablets
Implicor 25mg/7.5mg film -coated tablets
Implicor 50mg/ 7.5mg film -coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Implicor 25mg/5mg film -coated tablets: Each film- coated tablet c ontains 25mg of metoprolol tartrate and
5mg of ivabradine (equivalent to 5.390 mg ivabradine as hydrochloride).
Implicor 50mg/5mg film -coated tablets : Each film-coated tablet contains 50 mg of metopro lol tartrate and 5
mg of ivabradine (equivalent to 5.390 mg ivabradine as hydrochloride).
Implicor 25mg/7.5mg film -coated tablets : Each film-coated tablet contains 25 mg of metoprolol tartrate and
7.5 mg of ivabradine (equivalent to 8.085 mg ivabradine as hydrochloride).
Implicor 50mg/7.5mg film -coated tablets : Each film-coated tablet contains 50 mg of metoprolol tartrate and
7.5 mg of ivabradine (equivalent to 8.085 mg ivabradine as hydrochloride).
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Film -coated tablet.
I mplicor 25mg/5mg film -coated tablets : White, round, film -coated tablet (25/5 mg ) of 7.3mm diameter
engraved with on one face and on the other.
Implicor 50mg/5mg film -coated tablets: White, round, film -coated tablet (50/5mg) of 8.5 mm diameter
engraved with on one face and on the other.
Implicor 25mg/7.5mg film -coated tablets : White, oblong film -coated tablet (25/7.5 mg) of 9.3 mm long and
5.8 mm wide engraved with on one face and on the other.
Implic or 50mg/7.5mg film -coated tablets: White, oblong film -coated tablet (50/7.5mg) of 10.8 mm long and
6.7 mm wide, engraved with on one face and on the other.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Implicor is indicated for the symptomatic treatment of chronic stable angina pectoris as substitution therapy
in adult patients with normal sinus rhythm already controlled by metoprolol and ivabradine taken
concomitantly at the same dose level.
4.2 Posology and method of administration
Posology
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