IVABRADINE MYLAN

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

IVABRADINE OXALATE

Dostupné z:

McDermott Laboratories Ltd t/a Gerard Laboratories

ATC kód:

C01EB17

INN (Medzinárodný Name):

IVABRADINE OXALATE

Dávkovanie:

5 Milligram

Forma lieku:

Film Coated Tablet

Typ predpisu:

Product subject to prescription which may be renewed (B)

Terapeutické oblasti:

ivabradine

Stav Autorizácia:

Not Marketed

Dátum Autorizácia:

2016-12-16

Príbalový leták

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IVABRADINE MYLAN 5 MG FILM-COATED TABLETS
IVABRADINE MYLAN 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 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 Ivabradine Mylan is and what it is used for
2.
What you need to know before you take Ivabradine Mylan
3.
How to take Ivabradine Mylan
4.
Possible side effects
5.
How to store Ivabradine Mylan
6.
Contents of the pack and other information
1.
WHAT IVABRADINE MYLAN IS AND WHAT IT IS USED FOR
Ivabradine Mylan (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 when the heart beats
faster in situations such as
exerci

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ivabradine Mylan 5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 5 mg ivabradine (equivalent to 5.961
mg ivabradine as oxalate).
Excipient with known effect: 70.965 mg Lactose anhydrous
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Yellow coloured, round (6.0 mm), film-coated tablets debossed with
´5´ on one side and scored on other side. 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 and if resting heart rate remains
above 60 bpm, the dose