Cinacalcet Rafarm 60 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

CINACALCETHYDROCHLORIDE 66,1 mg/stuk SAMENSTELLING overeenkomend met ; CINACALCET 60 mg/stuk

Beschikbaar vanaf:

Rafarm S.A. 12 Korinthou street, N. Psihico 154 51 ATHENE (GRIEKENLAND)

ATC-code:

H05BX01

INN (Algemene Internationale Benaming):

CINACALCETHYDROCHLORIDE 66,1 mg/stuk SAMENSTELLING overeenkomend met ; CINACALCET 60 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; LACTOSE 1-WATER ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171) ; ZETMEEL, GEPREGELATINEERD, CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE (E 464) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; LACTOSE 1-WATER ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171) ; ZETMEEL, GEPREGELATINEERD

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Cinacalcet

Autorisatie datum:

2019-02-26

Bijsluiter

December 2020
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CINACALCET RAFARM 30 MG FILMOMHULDE TABLETTEN
CINACALCET RAFARM 60 MG FILMOMHULDE TABLETTEN
CINACALCET RAFARM 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 is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
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).
is used in adults:
•
to treat secondary hyperparathyroidism in patients 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
parathyroid cancer.
•
to reduce high levels of calcium in the blood (hypercalcaemia) in
adult patients with
primary hyperparathyroidism when removal of the gland is not possible.

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 clear their blood of waste products, whose condition is
not

Productkenmerken

1.
NAME OF THE MEDICINAL PRODUCT
Cinacalcet Rafarm 30 mg film-coated tablets.
Cinacalcet Rafarm 60 mg film-coated tablets.
Cinacalcet Rafarm 90 mg film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains cinacalcet hydrochloride corresponding to 30 mg
of cinacalcet.
Each tablet contains cinacalcet hydrochloride corresponding to 60 mg
of cinacalcet.
Each tablet contains cinacalcet hydrochloride corresponding to 90 mg
of cinacalcet.
Excipient with known effect:
Each 30 mg tablet contains 0.3 mg of lactose.
Each 60 mg tablet contains 0.6 mg of lactose.
Each 90 mg tablet contains 0.9 mg of lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
is a light green film-coated tablet. They are oval-shaped
and have “30” marked on one
side. (Width: 4.4 to 4.7 mm; Length: 6.9 to 7.2 mm)
is a light green film-coated tablet. They are oval-shaped
and have “60” marked on one
side. (Width: 5.5 to 5.7 mm; Length: 8.7 to 8.9 mm)
is a light green film-coated tablet. They are oval-shaped
and have “90” marked on one
side. (Width: 6.5 to 6.7 mm; Length: 9.9 to 10.2 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).
may be used as part of a therapeutic regimen including
phosphate binders and/or Vitamin
D sterols, as appropriate (see section 5.1).
Parathyroid carcinoma and primary hyperparathyroidism in adults
Reduction of hypercalcaemia in adult patients with:
•
parathyroid carcinoma.
•
primary HPT for whom parathyroidectomy would be