Procoralan 7.5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ivabradine hydrochloride

Available from:

Servier Laboratories 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: 5017476151209

Summary of Product characteristics

OBJECT 1
PROCORALAN
Summary of Product Characteristics Updated 05-Mar-2018 | Servier
Laboratories Limited
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
Procoralan 5 mg film-coated tablets
Procoralan 7.5 mg film-coated tablets
2. Qualitative and quantitative composition
Procoralan 5 mg
One film-coated tablet contains 5 mg ivabradine (equivalent to 5.390
mg ivabradine as hydrochloride).
Excipient with known effect: 63.91 mg lactose monohydrate
Procoralan 7.5 mg
One film-coated tablet contains 7.5 mg ivabradine (equivalent to 8.085
mg ivabradine as hydrochloride).
Excipient with known effect: 61.215 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Procoralan 5 mg: salmon-coloured, oblong, film-coated tablet scored on
both sides, engraved with “5” on
one face and
on the other face.
The tablet can be divided into equal doses.
Procoralan 7.5 mg: salmon-coloured, triangular, film-coated tablet
engraved with “7.5” on one face and
on the other face.
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