CORALAN 7.5 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

IVABRADINE AS HYDROCHLORIDE

Available from:

MEDISON PHARMA LTD

ATC code:

C01EB17

Pharmaceutical form:

FILM COATED TABLETS

Composition:

IVABRADINE AS HYDROCHLORIDE 7.5 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

LES LABORATOIRES SERVIER, FRANCE

Therapeutic group:

IVABRADINE

Therapeutic area:

IVABRADINE

Therapeutic indications:

Symptomatic treatment of chronic stable angina pectoris in patients with normal sinus rhythm, who have a contra-indication or intolerance for beta-blockers.Treatment of chronic heart failureIvabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.

Authorization date:

2014-12-31

Patient Information leaflet

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) 1986
This medicine is to be supplied by physician’s prescription only
CORALAN 5MG
CORALAN 7.5MG
FILM-COATED TABLETS
ACTIVE INGREDIENTS:
Active ingredient: IVABRADINE (AS HYDROCHLORIDE).
Each Coralan 5 mg film-coated tablet contains: 5 mg ivabradine
(equivalent to 5.390mg ivabradine as
hydrochloride).
Each Coralan 7.5 mg film-coated tablet contains: 7.5 mg ivabradine
(equivalent to 8.085mg ivabradine
as hydrochloride).
Inactive ingredients and allergens: See section 6 “Additional
information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet contains essential
information about this medicine. If you have any further questions,
refer to the physician or the
pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm them
even if it seems to you that their illness is similar.
Coralan is not intended for use in children and adolescents younger
than 18 years.
1. WHAT IS THIS MEDICINE FOR?
This medicine is used to treat:
-
Stable angina pectoris, when treatment with Beta-Blockers is not
suitable. The medicine should
be only used in patients whose heart rate is 70 bpm or more.
-
Chronic heart failure in patients whose heart rate is equal to or over
75 beats per minute. It is
used in combination with standard therapy, including beta-blocker
therapy or when beta-
blockers are contraindicated or not suitable.
THERAPEUTIC GROUP: Cardiac therapy, other cardiac preparations
.
About stable angina pectoris (usually referred to as “angina”):
Stable angina is a heart disease which happens when the heart does not
receive enough oxygen. It
usually appears between 40 and 50 years of age. The most common
symptom of angina is chest pain
or discomfort. Angina is more likely to happen when the heart beats
faster in situations such as
exercise, emotion, exposure to the cold or after eating. This increase
in heart rate can cause the chest
pain in people who suffer fr

Summary of Product characteristics

1
THE FORMAT WAS APPROVED BY THE ISRAELI MINISTRY OF HEALTH IN MARCH
2015
1. NAME OF THE MEDICINAL PRODUCT
Coralan 5 mg film-coated tablets
Coralan 7.5 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet of Coralan 5 contains 5 mg ivabradine
(equivalent to 5.390 mg
ivabradine as hydrochloride).
One film-coated tablet of Coralan 7.5 contains 7.5 mg ivabradine
(equivalent to 8.085 mg
ivabradine as hydrochloride).
Excipient with known effect:
Coralan 5mg: 63.91 mg lactose monohydrate
Coralan 7.5mg: 61.215 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
Coralan 5mg: Salmon-coloured, oblong, film-coated tablet scored on
both sides, engraved
with “5” on one face and
on the other face.
The tablet can be divided into equal halves.
Coralan 7.5mg: Salmon-coloured, triangular, film-coated tablet,
engraved with “7.5” on one
face and
on the other face.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic treatment of chronic stable angina pectoris in patients
with normal sinus
rhythm, who have a contra-indication or intolerance for beta-blockers.
Treatment of chronic heart failure
Ivabradine is indicated in chronic heart failure NYHA II to IV class
with systolic
dysfunction, in patients in sinus rhythm and whose heart rate is ≥
75 bpm, in combination
with standard therapy including beta-blocker therapy or when
beta-blocker therapy is
contraindicated or not tolerated. (see section 5.1)
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
2
For the different doses, film-coated tablets containing 5 mg and 7.5
mg ivabradine are
available.
Symptomatic treatment of chronic stable angina pectoris
It is recommended that the decision to initiate or titrate treatment
takes place with the
availability of serial heart rate measurements, ECG or ambulatory
24-hour monitoring.
The starting dose of ivabradine should not exceed 5 mg twice daily in
patients aged below 75
years. After three to four weeks of treatment, if