Bosentan Accord 125mg Film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

BOSENTAN

Available from:

Accord Healthcare Limited

ATC code:

C02KX01

INN (International Name):

BOSENTAN

Pharmaceutical form:

FILM-COATED TABLET

Composition:

BOSENTAN 125 mg

Prescription type:

POM

Therapeutic area:

ANTIHYPERTENSIVES

Authorization status:

Authorised

Authorization date:

2015-04-09

Patient Information leaflet

Page 1 of 10
PACKAGE LEAFLET: INFORMATION FOR THE USER
BOSENTAN ACCORD 62.5 MG FILM-COATED TABLETS
BOSENTAN ACCORD 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 Accord is and what it is used for
2.
What you need to know before you take Bosentan Accord
3.
How to take Bosentan Accord
4.
Possible side effects
5.
How to store Bosentan Accord
6.
Contents of the pack and other information
1.
WHAT BOSENTAN ACCORD IS AND WHAT IT IS USED FOR
Bosentan Accord contain bosentan,
which blocks a naturally occurring hormone called endothelin-
1 (ET-1), which causes blood vessels to narrow. Bosentan Accord
therefore causes blood vessels to
expand and belongs to the class of medicines called “endothelin
receptor antagonists”.
Bosentan Accord 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 Accord 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 Accord is used to treat patients with class III pulmonary
arterial hypertension (PAH) to
improve exercise capacity (the ability to carry out physical activity)
and sympto

Summary of Product characteristics

Page 1 of 27
SUMMARY OF PRODUCT CHARACHTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Bosentan Accord 62.5 mg film-coated tablets
Bosentan Accord 125 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 62.5 mg of bosentan (as monohydrate).
Each film-coated tablet contains 125 mg of bosentan (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet:
Light orange, round, approximately 6.20mm in diameter, biconvex,
film-coated tablet debossed with “IB1”
on one side and plain on other side.
Light orange, oval, approximately 11.00mm in length, 5.00mm in width,
biconvex, film-coated tablet
debossed with “IB2” on one side and plain on other side.
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 tablets are 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
Method of administration
Tablets are to be taken orally morning and evening, with or without
food. The film-coated tablets are to be
swallowed with water.
Page 2 of 27
Posology
Pulmonary arterial hypertension
Treatment should only be initiated and monitored by a physician
experienced in the treatment of
pulmonary arterial hypertension.
Adults
In adult patients, bosentan treatment should be initiated at a dose of
62.5 mg twice dai