Ivabradine Chanelle Medical 5 mg Film-coated Tablets

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Ivabradine

Διαθέσιμο από:

Chanelle Medical

Φαρμακολογική κατηγορία (ATC):

C01EB; C01EB17

INN (Διεθνής Όνομα):

Ivabradine

Δοσολογία:

5 milligram(s)

Φαρμακοτεχνική μορφή:

Film-coated tablet

Τρόπος διάθεσης:

Product subject to prescription which may be renewed (B)

Θεραπευτική περιοχή:

Other cardiac preparations; ivabradine

Καθεστώς αδειοδότησης:

Not marketed

Ημερομηνία της άδειας:

2017-01-27

Φύλλο οδηγιών χρήσης

ID: PL 177-178M (Core Text)
VERSION: 02
REVISION DATE: 23/08/17
Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
IVABRADINE CHANELLE MEDICAL 5 MG FILM-COATED TABLETS
IVABRADINE CHANELLE MEDICAL 7.5 MG FILM-COATED TABLETS
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. 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 Ivabradine is and what it is used for
2.
What you need to know before you take Ivabradine
3.
How to take Ivabradine
4.
Possible side effects
5.
How to store Ivabradine
6.
Contents of the pack and other information
1.
WHAT IVABRADINE IS AND WHAT IT IS USED FOR
Ivabradine is a heart medicine used to treat:
-
Symptomatic stable angina pectoris (which causes chest pain) in adult
patients whose heart
rate is over or equal to 70 beats per minute. It is used in adult
patients who do not tolerate or cannot
take heart medicines called beta-blockers. It is also used in
combination with beta-blockers in adult
patients whose condition is not fully controlled with a beta-blocker.
-
Chronic heart failure in adult patients whose heart rate is over or
equal to 75 beats per minute.
It is used in combination with standard therapy, including
beta-blocker therapy or when beta-
blockers are contraindicated or not tolerated.
_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 whe

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ivabradine Chanelle Medical 5 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 5 mg ivabradine (equivalent to 5.96 mg
ivabradine oxalate).
Excipient with known effect: 1.60 mg hydrogenated castor oil.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Salmon coloured,
oblong shaped,
biconvex film-coated tablet
with a breakline on one side and plain on the other.
Approximately 8.1 mm long and 4.3 mm wide.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic treatment of chronic stable angina pectoris.
Ivabradine is indicated for the symptomatic treatment of chronic
stable angina pectoris in coronary artery disease adults
with normal sinus rhythm and heart rate
70 bpm. Ivabradine is indicated:
-in adults unable to tolerate or with a contra-indication to the use
of beta-blockers
-or in combination with beta-blockers in patients inadequately
controlled with an optimal beta-blocker dose.
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
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 the patient
is still
symptomatic,
if the initial
dose is well
tolerated a