Bosentan 125mg 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:

125mg

Lægemiddelform:

Oral tablet

Indgivelsesvej:

Oral

Klasse:

No Controlled Drug Status

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF: 02050100; GTIN: 5000283658900

Indlægsseddel

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
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 pulmonary arterial
hypertension (PAH) to
improve exercise capacity (the ability to carry out physical activity)
and symptoms. The
‘class’ reflects the seriousness of the disease: ‘class III’
involves marked limitation of
physical activit

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Bosentan 125 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 125 mg Bosentan (as monohydrate)
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
125 mg:
Orange, oval, biconvex, film coated tablets of about 11 mm x 5.1 mm,
debossed with
“A54” on one side and Plain 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 weigh