Procoralan 7.5mg tablets

País: Reino Unido

Idioma: inglés

Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes activos:

Ivabradine hydrochloride

Disponible desde:

Servier Laboratories Ltd

Código ATC:

C01EB17

Designación común internacional (DCI):

Ivabradine hydrochloride

Dosis:

7.5mg

formulario farmacéutico:

Tablet

Vía de administración:

Oral

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 02060300; GTIN: 5017476151209

Ficha técnica

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