Ivabradine 7.5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ivabradine hydrochloride

Available from:

Aspire Pharma Ltd

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: 5060209731919

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IVABRADINE 2.5MG FILM-COATED TABLETS
IVABRADINE 5 MG FILM-COATED TABLETS
IVABRADINE 7.5 MG FILM-COATED TABLETS
ivabradine
This medicine is subject to additional monitoring. This will allow
quick identification of new safety
information. You can help by reporting any side effects you may get.
See the end of section 4 for how
to report side effects.
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

Summary of Product characteristics

OBJECT 1
IVABRADINE ASPIRE 7.5MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 04-May-2018 | Aspire Pharma
Ltd
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1. Name of the medicinal product
Ivabradine Aspire 7.5 mg film-coated tablets
2. Qualitative and quantitative composition
One film-coated tablet contains 7.5 mg ivabradine (equivalent to 8.085
mg ivabradine as hydrochloride).
Excipient with known effect: 79.04 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Light salmon, round, biconvex film-coated tablet 7 mm in diameter and
3.9 ± 0.2 mm in thickness.
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 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 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 2.5 mg, 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 m