Bosentan 62.5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Bosentan monohydrate

Available from:

Accord-UK Ltd

ATC code:

C02KX01

INN (International Name):

Bosentan monohydrate

Dosage:

62.5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02050100; GTIN: 5055565703892

Patient Information leaflet

1
ACCORD LOGO
PACKAGE LEAFLET: INFORMATION FOR THE USER
BOSENTAN 62.5MG AND 125MG FILM-COATED TABLETS
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.
-
The full name of this medicine is Bosentan 62.5mg, 125mg Film-coated
Tablets but within the
leaflet it will be referred to as Bosentan Tablets.
WHAT IS IN THIS LEAFLET
1.
What Bosentan Tablets are and what they are used for
2.
What you need to know before you take Bosentan Tablets
3.
How to take Bosentan Tablets
4.
Possible side effects
5.
How to store Bosentan Tablets
6.
Contents of the pack and other information
1.
WHAT BOSENTAN TABLETS ARE AND WHAT THEY ARE USED FOR
Bosentan Tablets contain bosentan which blocks naturally occurring
hormone called endothelin-1 (ET-
1), which causes blood vessels to narrow. Bosentan Tablets therefore
causes blood vessels to expand
and belongs to the class of medicines called “endothelin receptor
antagonists”.
Bosentan Tablets are 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
Tablets 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 Tablets are used to treat patients with class III pulmonary
arterial

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Bosentan 62.5mg Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 62.5 mg bosentan (as monohydrate).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
Pale yellow coloured, (6 mm), round, biconvex, debossed with “111”
on one side and
“A” on the 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 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 pulmonary arterial hypertension.
_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 year to 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 frequen