Bosentan 125mg tablets

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Bosentan monohydrate

זמין מ:

Milpharm Ltd

קוד ATC:

C02KX01

INN (שם בינלאומי):

Bosentan monohydrate

כמות:

125mg

טופס פרצבטיות:

Oral tablet

מסלול נתינה (של תרופות):

Oral

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 02050100; GTIN: 8901175029693

עלון מידע

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 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
l

מאפייני מוצר

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