Bosentan Sandoz 125 mg, filmomhulde tabletten

Țară: Țările de Jos

Limbă: olandeză

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

Ingredient activ:

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

Disponibil de la:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

Codul ATC:

C02KX01

INN (nume internaţional):

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

Forma farmaceutică:

Filmomhulde tablet

Compoziție:

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,

Calea de administrare:

Oraal gebruik

Zonă Terapeutică:

Bosentan

Rezumat produs:

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;

Data de autorizare:

1900-01-01

Prospect

Sandoz B.V.
Page 1/8
Bosentan Sandoz
®
62,5 / 125 mg, filmomhulde
tabletten
RVG 117029-117030
1313-V11
1.3.1.3 Bjisluiter
Januari 2022
BIJSLUITER: INFORMATIE VOOR DE PATIËNT
BOSENTAN SANDOZ
® 62,5 MG, FILMOMHULDE TABLETTEN
BOSENTAN SANDOZ
® 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 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 [Nationally completed name] is and what it is used for
2. What you need to know before you take [Nationally completed name]
3. How to take [Nationally completed name]
4. Possible side effects
5. How to store [Nationally completed name]
6. Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[Nationally completed name] tablets contain bosentan, which blocks a
naturally occurring hormone
called endothelin-1 (ET-1), which causes blood vessels to narrow.
[Nationally completed name]
therefore causes blood vessels to expand and belongs to the class of
medicines called “endothelin
receptor antagonists”.
[Nationally completed name] 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.
[Nationally completed name] widens the pulmonary arteries, making it
easier for the heart to
pump blood through

Caracteristicilor produsului

Sandoz B.V.
Page 1/23
Bosentan Sandoz 62,5 / 125 mg, filmomhulde
tabletten
RVG 117029-1172030
1311-v10
1.3.1.1 Samenvatting van de Productkenmerken
December 2022
1.
NAAM VAN HET GENEESMIDDEL
Bosentan Sandoz 62,5 mg, filmomhulde tabletten
Bosentan Sandoz 125 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 62.5 mg of bosentan (corresponding to
64.541 mg bosentan
monohydrate)
Each film-coated tablet contains 125 mg of 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) PAH
•
PAH secondary to scleroderma without significant interstitial
pulmonary disease
•
PAH associated with congenital systemic-to-pulmonary shunts and
Eisenmenger’s physiology
Some improvements have also been shown in patients with PAH WHO
functional class II (see section
5.1).
[Nationally completed name] 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
Sandoz B.V.
Page 2/23
Bosentan Sandoz 62,5 / 125 mg, filmomhulde
tabletten
RVG 117029-1172030
1311-v10
1.3.1.1 Samenvatting van de Productkenmerken
December 2022
Treatment should only be initiated and monitored by a physician
experienced in the treatment of PAH.
A Patient Alert Card providing important safety information that
patients need to be aware of before
and during treatment with [Nationally completed name] is included in
the pack.
_Adults _
In adult patients, [N