Ivabradine 7.5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ivabradine hydrochloride

Available from:

Mylan

ATC code:

C01EB17

INN (International Name):

Ivabradine hydrochloride

Dosage:

7.5mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02060300; GTIN: 5016695008233

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
IVABRADINE 5 MG FILM-COATED TABLETS
IVABRADINE 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 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
when
the
heart
beats
faster
in
situations
such
as
exercise, emotion, exposure to the cold or after eating. This increa

Summary of Product characteristics

OBJECT 1
IVABRADINE OXALATE TABLETS 5 MG
Summary of Product Characteristics Updated 05-Jun-2018 | Generics UK
T/A Mylan
1. Name of the medicinal product
Ivabradine 5 mg film-coated tablets
Ivabradine 7.5 mg film-coated tablets
2. Qualitative and quantitative composition
Ivabradine 5 mg film-coated tablets
One film-coated tablet contains 5 mg ivabradine (equivalent to 5.961
mg ivabradine as oxalate).
Ivabradine 7.5 mg film-coated tablets
One film-coated tablet contains 7.5 mg ivabradine (equivalent to 8.941
mg ivabradine as oxalate).
Ivabradine 5 mg film-coated tablets
Excipient with known effect: 70.965 mg Lactose anhydrous
Ivabradine 7.5 mg film-coated tablets
Excipient with known effect: 106.449 mg Lactose anhydrous
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Ivabradine 5 mg film-coated tablets
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.
Ivabradine 7.5 mg film-coated tablets
Orange-yellow coloured, round (6.5 mm), biconvex, film-coated tablets
debossed with ´7.5´ on one side.
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 administratio