Bosentan ABDI 125 mg, filmomhulde tabletten

Pays: Pays-Bas

Langue: néerlandais

Source: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Ingrédients actifs:

BOSENTAN 1-WATER 129,08 mg/stuk SAMENSTELLING overeenkomend met ; BOSENTAN 125 mg/stuk

Disponible depuis:

DOC Generici S.r.l. Via Filippo Turati 40 20121 MILANO (ITALIË)

Code ATC:

C02KX01

DCI (Dénomination commune internationale):

BOSENTAN 1-WATER 129,08 mg/stuk SAMENSTELLING overeenkomend met ; BOSENTAN 125 mg/stuk

forme pharmaceutique:

Filmomhulde tablet

Composition:

ETHYLCELLULOSE (E 462) ; GLYCEROLDIBEHENAAT ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; NATRIUMZETMEELGLYCOLAAT ; POLOXAMEER 188 ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; ZETMEEL, GEPREGELATINEERD, ETHYLCELLULOSE (E 462) ; GLYCEROLDIBEHENAAT ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; NATRIUMZETMEELGLYCOLAAT (E468) ; POLOXAMEER 188 ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; ZETMEEL, GEPREGELATINEERD,

Mode d'administration:

Oraal gebruik

Domaine thérapeutique:

Bosentan

Descriptif du produit:

Hulpstoffen: ETHYLCELLULOSE (E 462); GLYCEROLDIBEHENAAT; GLYCEROLTRIACETAAT (E 1518); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); IJZEROXIDE ZWART (E 172); MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; NATRIUMZETMEELGLYCOLAAT (E468); POLOXAMEER 188; POVIDON K 30 (E 1201); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171); ZETMEEL, GEPREGELATINEERD;

Date de l'autorisation:

1900-01-01

Notice patient

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
BOSENTAN ABDI 62,5 MG, FILMOMHULDE TABLETTEN
BOSENTAN ABDI 125 MG, FILMOMHULDE TABLETTEN
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, please 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 of the 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 ABDI is and what it is used for
2. What you need to know before you take Bosentan ABDI
3. How to take Bosentan ABDI
4. Possible side effects
5. How to store Bosentan ABDI
6. Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
Bosentan ABDI tablets contain bosentan, which blocks a naturally
occurring hormone called
endothelin-1 (ET-1), which causes blood vessels to narrow. Bosentan
ABDI therefore causes blood
vessels to expand and belongs to the class of medicines called
“endothelin receptor antagonists”.
Bosentan ABDI 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 ABDI 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 ABDI 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. T

Résumé des caractéristiques du produit

1
1.
NAME OF THE MEDICINAL PRODUCT
Bosentan ABDI 62,5 mg, filmomhulde tabletten
Bosentan ABDI 125 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 62.5 mg bosentan (corresponding to
64.541 mg bosentan
monohydrate)
Each film-coated tablet contains 125 mg bosentan (corresponding to
129.082 mg bosentan
monohydrate)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet:
62.5 mg: Light orange, round, biconvex film-coated tablets of 6 mm
125 mg: Light orange, oval, biconvex film-coated tablets of 11 x 5 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 ABDIis 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.
Posology
Pulmonary arterial hypertension
Treatment should only be initiated and monitored by a physician
experienced in the treatment of
pulmonary arterial hypertension. A Patient Alert Card providing
important safety information
that patients need to be aware of before and during treatment with
Bosentan ABDIis included in
the pack.
_Adults _
2
In adult patients, Bosentan ABDI treatment should be initiated at a
dose of
62.5 mg tw