Apredonav 7.5mg film-coated Tablets

देश: माल्टा

भाषा: अंग्रेज़ी

स्रोत: Medicines Authority

सक्रिय संघटक:

IVABRADINE

थमां उपलब्ध:

Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus

ए.टी.सी कोड:

C01EB17

INN (इंटरनेशनल नाम):

IVABRADINE 7.5 mg

फार्मास्यूटिकल फॉर्म:

FILM-COATED TABLET

रचना:

IVABRADINE 7.5 mg

प्रिस्क्रिप्शन प्रकार:

POM

चिकित्सीय क्षेत्र:

CARDIAC THERAPY

प्राधिकरण का दर्जा:

Authorised

प्राधिकरण की तारीख:

2019-01-14

सूचना पत्रक

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
APREDONAV 5 MHG FILM-COATED TABLETS
APREDONAV 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 Apredonav is and what it is used for
2.
What you need to know before you take Apredonav
3.
How to take Apredonav
4.
Possible side effects
5.
How to store Apredonav
6.
Contents of the pack and other information
1.
WHAT APREDONAV IS AND WHAT IT IS USED FOR
Apredonav (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.
Page 2 of 8
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. The
most common symptom of angina is chest pain or discomfort.
About chronic heart failure:
Chronic heart failure is a heart disease which happens when your heart
cannot pump enough blood to
the rest of your body. The most common sympto

उत्पाद विशेषताएं

Page 1 of 22
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Apredonav 5 mg film-coated tablets
Apredonav 7.5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Apredonav 5 mg film-coated tablets
One film-coated tablet contains 5 mg ivabradine (equivalent to 5.390
mg ivabradine as
hydrochloride).
Excipient with known effect: 62.61 mg lactose anhydrous
Apredonav 7.5 mg film-coated tablets
One film-coated tablet contains 7.5 mg ivabradine (equivalent to 8.085
mg ivabradine as
hydrochloride).
Excipient with known effect: 93.915 mg lactose anhydrous
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Apredonav 5 mg film-coated tablets
Salmon-orange, oval, biconvex film-coated tablet scored on both sides,
with dimensions of nucleus
8.5 mm x 4 mm.
The tablet can be divided into equal doses.
Apredonav 7.5 mg film-coated tablets
Salmon-orange, round, biconvex film-coated tablet, plain on both
sides, with a diameter of nucleus 7
mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Page 2 of 22
_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
beats per minute (bpm). Ivabradine
is indicated:
-
in adults unable to tolerate or with a contraindication 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 adult
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
_Symptomatic treatment of chronic stable angina pectoris _
It is recommended that the d