Implicor Film-Coated Tablets 50mg/5mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

METOPROLOL TARTRATE, IVABRADINE HYDROCHLORIDE

Available from:

Les Laboratoires Servier 50 Rue Carnot, 92284 Suresnes Cedex, France

ATC code:

C07F

INN (International Name):

METOPROLOL TARTRATE 50 mg IVABRADINE HYDROCHLORIDE 5.390 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

METOPROLOL TARTRATE 50 mg IVABRADINE HYDROCHLORIDE 5.390 mg

Prescription type:

POM

Therapeutic area:

BETA BLOCKING AGENTS

Product summary:

Licence number in the source country: N/A

Authorization status:

Withdrawn

Authorization date:

2015-05-29

Patient Information leaflet

PACKAGE LEAFLET
Page
2
of
10
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IMPLICOR 50MG/5MG FILM-COATED TABLETS
IMPLICOR 50MG/7.5MG FILM-COATED TABLETS
Metoprolol tartrate /ivabradine
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 Implicor is and what it is used for
2.
What you need to know before you take Implicor
3.
How to take Implicor
4.
Possible side effects
5.
How to store Implicor
6.
Contents of the pack and other information
1.
WHAT IMPLICOR IS AND WHAT IT 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 in the same strength.
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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE IMPLICOR
DO NOT TAKE IMPLICOR:
-
if you are allergic to ivabradine, metoprolol or any of the other
ingredients of this medicine
(listed in section 6), or

Summary of Product characteristics

1
_ _
SUMMARY OF PRODUCT CHARACTERISTICS
Page 2 of 21
1.
NAME OF THE MEDICINAL PRODUCT
[Implicor 50mg/5mg film-coated tablets]
[Implicor 50mg/7.5mg film-coated tablets]
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
[Each film-coated tablet contains 50 mg of metoprolol tartrate and 5
mg of ivabradine (equivalent to
5.390 mg ivabradine as hydrochloride).]
[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.
[White, round, film-coated tablet (50/5mg) of 8.5 mm diameter engraved
with
on one face and
on the other.]
[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
The recommended dose of Implicor is one tablet twice daily, once in
the morning and once in the
evening.
Implicor should only be used in patients controlled on stable doses of
the monocomponents given
concurrently when metoprolol is at the optimal dose.
It is recommended that the decision to titrate treatment takes place
with the availability of serial heart
rate measurements, ECG or ambulatory 24-hour monitoring and titration
should be done with the
individual components metoprolol and ivabradine, ensuring the patient
is maintained at an optimal
dose of metoprolol and ivabradine. If during treatment, heart rate
decreases below 50 beats per minute
at rest or the patient experiences symptoms related to bradycardia
such as dizziness, fatigue or
hypotension, down titration should be done with the individual
monocomponents metoprolol and
ivabradine, ensuring the patien