Bosentan Ferrer 125 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

BOSENTAN 1-WATER SAMENSTELLING overeenkomend met ; BOSENTAN

Beschikbaar vanaf:

Ferrer International S.A. Gran Via Carlos III, 94 08028 BARCELONA (SPANJE)

ATC-code:

C02KX01

INN (Algemene Internationale Benaming):

BOSENTAN 1-WATER COMPOSITION corresponding to ; BOSENTAN

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

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 ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMZETMEELGLYCOLAAT ; POLOXAMEER 188 ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), 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 ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMZETMEELGLYCOLAAT (E468) ; POLOXAMEER 188 ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Bosentan

Product samenvatting:

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; MAÏSZETMEEL, GEPREGELATINEERD; NATRIUMZETMEELGLYCOLAAT (E468); POLOXAMEER 188; POVIDON K 30 (E 1201); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisatie datum:

2018-02-08

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
BOSENTAN FERRER 62,5 MG FILMOMHULDE TABLETTEN
BOSENTAN FERRER 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 Ferrer is and what it is used for
2. What you need to know before you take Bosentan Ferrer]
3. How to take Bosentan Ferrer
4. Possible side effects
5. How to store Bosentan Ferrer
6. Contents of the pack and other information
1.
WHAT BOSENTAN FERRER IS AND WHAT IT IS USED FOR
Bosentan Ferrer tablets contain bosentan, which blocks a naturally
occurring hormone called
endothelin-1 (ET-1), which causes blood vessels to narrow. Bosentan
Ferrer therefore causes blood
vessels to expand and belongs to the class of medicines called
“endothelin receptor antagonists”.
Bosentan Ferrer 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 Ferrer 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 Ferrer is used to treat patients with class III pulmonary
arterial hypertension (PAH)
to improve exercise capacity (the ability to carry out physical
activity) and sy

Productkenmerken

1
1.
NAME OF THE MEDICINAL PRODUCT
Bosentan Ferrer 62,5 mg filmomhulde tabletten
Bosentan Ferrer 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 Ferrer 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 Ferrer 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 Ferrer after treatment
interruption (see section 4.4).
_Paediatric population _
Paediatric pharmacokinetic data have shown that bosentan plasma
concentrations in chi