Cinacalcet Genepharm 30 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

CINACALCETHYDROCHLORIDE 33,1 mg/stuk SAMENSTELLING overeenkomend met ; CINACALCET 30 mg/stuk

Beschikbaar vanaf:

Genepharm S.A. 18th km Marathonos Avenue 153 51 PALLINI (GRIEKENLAND)

ATC-code:

H05BX01

INN (Algemene Internationale Benaming):

CINACALCETHYDROCHLORIDE 33,1 mg/stuk SAMENSTELLING overeenkomend met ; CINACALCET 30 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Cinacalcet

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); GLYCEROLTRIACETAAT (E 1518); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); INDIGOKARMIJN ALUMINIUMLAK (E 132); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEPREGELATINEERD; SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);

Autorisatie datum:

1900-01-01

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
CINACALCET GENEPHARM 30 MG FILMOMHULDE TABLETTEN
CINACALCET GENEPHARM 60 MG FILMOMHULDE TABLETTEN
CINACALCET GENEPHARM 90 MG FILMOMHULDE TABLETTEN
Cinacalcet
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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Cinacalcet Genepharm is and what it is used for
2.
What you need to know before you take Cinacalcet Genepharm
3.
How to take Cinacalcet Genepharm
4.
Possible side effects
5.
How to store Cinacalcet Genepharm
6.
Contents of the pack and other information
1.
WHAT CINACALCET GENEPHARM IS AND WHAT IT IS USED FOR
Cinacalcet Genepharm works by controlling the levels of parathyroid
hormone (PTH), calcium
and phosphorous in your body. It is used to treat problems with organs
called parathyroid
glands. The parathyroids are four small glands in the neck, near the
thyroid gland, that produce
parathyroid hormone (PTH).
Cinacalcet Genepharm is used in adults:
•
to treat secondary hyperparathyroidism in adults with serious kidney
disease who need
dialysis to clear their blood of waste products.
•
to reduce high levels of calcium in the blood (hypercalcaemia) in
adult patients with par-
athyroid cancer.
•
to reduce high levels of calcium in the blood (hypercalcaemia) in
adult patients with pri-
mary hyperparathyroidism when removal of the gland is not possible.
Cinacalcet Genepharm is used in children aged 3 years to less than 18
years of age:
•
to treat secondary hyperparathyroidism in patients with serious kidney
disease who need
dialysis to

Productkenmerken

1
_ _
SUMMARY OF PRODUCT CHARACTERISTICS
2
_ _
1.
NAME OF THE MEDICINAL PRODUCT
Cinacalcet Genepharm 30 mg filmomhulde tabletten
Cinacalcet Genepharm 60 mg filmomhulde tabletten
Cinacalcet Genepharm 90 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cinacalcet Genepharm 30 mg: Each Cinacalcet Genepharm film-coated
tablet contains 30 mg
cinacalcet (as hydrochloride).
Cinacalcet Genepharm 60 mg: Each Cinacalcet Genepharm film-coated
tablet contains 60 mg
cinacalcet (as hydrochloride).
Cinacalcet Genepharm 90 mg: Each Cinacalcet Genepharm film-coated
tablet contains 90 mg
cinacalcet (as hydrochloride).
Excipient(s) with known effect:
Each 30 mg tablet contains 2.24 mg of lactose monohydrate
Each 60 mg tablet contains 4.48 mg of lactose monohydrate
Each 90 mg tablet contains 6.72 mg of lactose monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Cinacalcet Genepharm 30 mg: green, oblong, biconvex film-coated
tablets, engraved with
‘30’on one side and plain on the other side, with a length of 9.8
mm (±0.2 mm) and a width of
6.2 mm (±0.2 mm).
Cinacalcet Genepharm 60 mg: green, oblong, biconvex film-coated
tablets, engraved with ‘60’
on one side and plain on the other side, with a length of 12.4 mm
(±0.2 mm) and a width of 7.8
mm (±0.2 mm).
Cinacalcet Genepharm 90 mg: green, oblong, biconvex film-coated
tablets, engraved with
‘90’on one side and plain on the other side, with a length of 14.2
mm (±0.2 mm) and a width
of 8.9 mm (±0.2 mm).
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Secondary hyperparathyroidism
_Adults _
Treatment of secondary hyperparathyroidism (HPT) in adult patients
with end-stage renal
disease (ESRD) on maintenance dialysis therapy.
_Paediatric population _
Treatment of secondary hyperparathyroidism (HPT) in children aged 3
years and older with
end-stage renal disease (ESRD) on maintenance dialysis therapy in whom
secondary HPT is
not adequately controlled with standard of care therapy (see section
4.4