Bosentan 62.5mg tablets

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Bosentan monohydrate

Tilgængelig fra:

Zentiva Pharma UK Ltd

ATC-kode:

C02KX01

INN (International Name):

Bosentan monohydrate

Dosering:

62.5mg

Lægemiddelform:

Oral tablet

Indgivelsesvej:

Oral

Klasse:

No Controlled Drug Status

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF: 02050100; GTIN: 5000283658894

Indlægsseddel

PACKAGE LEAFLET: INFORMATION FOR THE USER
Bosentan 62.5 mg film-coated tablets
Bosentan 125 mg film-coated tablets
bosentan
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 bosentan is and what it is used for
2. What you need to know before you take bosentan
3. How to take bosentan
4. Possible side effects
5. How to store bosentan
6. Contents of the pack and other information
1. WHAT BOSENTAN IS AND WHAT IT IS USED FOR
The name of your medicine is Bosentan 62.5 mg film-coated
tablets or Bosentan 125 mg film-coated tablets (called bosentan
throughout this leaflet). Bosentan tablets contain bosentan,
which blocks a naturally occurring hormone called endothelin-1
(ET-1), which causes blood vessels to narrow. Bosentan therefore
causes blood vessels to expand and belongs to the class of
medicines called “endothelin receptor antagonists”.
Bosentan is used to treat:
− Pulmonary arterial hypertension (PAH): PAH is a disease of
severe narrowing of the blood vessels in the lungs resulting in
high blood pressure in the blood vessels (the pulmonary arteries)
that carry blood from the heart to the lungs. This pressure
reduces the amount of oxygen that can get into the blood in the
lungs, making physical activity more difficult. Bosentan widens
the pulmonary arteries, making it easier for the heart to pump
blood through them. This lowers the blood pressure and relieves
the symptoms.
Bosentan is used to treat patients with class III PAH to improve
exercise capacity (the ability to carry out physic

Produktets egenskaber

OBJECT 1
BOSENTAN ZENTIVA 62.5 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 07-Jun-2018 | Zentiva
1. Name of the medicinal product
Bosentan Zentiva 62.5 mg, film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 62.5 mg bosentan (as 64.54 mg
bosentan monohydrate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Description: round, biconvex-shaped, light orange coloured film coated
tablets with the diameter approx.
6.1 mm.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of pulmonary arterial hypertension (PAH) to improve exercise
capacity and symptoms in
patients with WHO functional class III. Efficacy has been shown in:
• Primary (idiopathic and heritable) PAH,
• PAH secondary to scleroderma without significant interstitial
pulmonary disease,
• PAH associated with congenital systemic-to-pulmonary shunts and
Eisenmenger's physiology.
Some improvements have also been shown in patients with PAH WHO
functional class II (see section
5.1).
Bosentan is also indicated to reduce the number of new digital ulcers
in patients with systemic sclerosis
and ongoing digital ulcer disease (see section 5.1).
4.2 Posology and method of administration
Posology
Pulmonary arterial hypertension
Treatment should only be initiated and monitored by a physician
experienced in the treatment of PAH.
_Adults_
In adult patients, bosentan treatment should be initiated at a dose of
62.5 mg twice daily for 4 weeks and
then increased to the maintenance dose of 125 mg twice daily. The same
recommendations apply to re-
introduction of bosentan after treatment interruption (see section
4.4).
_Paediatric population_
Paediatric pharmacokinetic data have shown that bosentan plasma
concentrations in children with PAH
aged from 1 – 15 years were on average lower than in adult patients
and were not increased by increasing
the dose of bosentan above 2 mg/kg body weight or by increasing the
dosing frequency from twice daily
to thre