Bosentan Zentiva 62.5 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Bosentan monohydrate

Available from:

Zentiva k.s.

ATC code:

C02KX01

INN (International Name):

Bosentan monohydrate

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

bosentan

Authorization status:

Not marketed

Authorization date:

2024-02-23

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
BOSENTAN ZENTIVA 62.5 MG FILM-COATED TABLETS
BOSENTAN ZENTIVA 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 Zentiva 62.5 mg film-coated
tablets or Bosentan
Zentiva 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

Summary of Product characteristics

Health Products Regulatory Authority
23 February 2024
CRN00DJK3
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
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) pulmonary arterial hypertension,

Pulmonary arterial hypertension secondary to scleroderma without
significant interstitial pulmonary disease,

Pulmonary arterial hypertension associated with congenital
systemic-to-pulmonary shunts and Eisenmenger's
physiology.
Some improvements have also been shown in patients with pulmonary
arterial hypertension 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.
A Patient Alert Card providing important safety information that
patients need to be aware of before and during treatment
with bosentan is included in the pack.
_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