Cinacalcet Apotex 60 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

CINACALCETHYDROCHLORIDE SAMENSTELLING overeenkomend met ; CINACALCET

Beschikbaar vanaf:

Apotex Europe B.V. Darwinweg 20 2333 CR LEIDEN

ATC-code:

H05BX01

INN (Algemene Internationale Benaming):

CINACALCETHYDROCHLORIDE COMPOSITION corresponding to ; CINACALCET

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

BRILJANTBLAUW FCF ALUMINIUMLAK (E133) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ZWART (E 172) ; MACROGOL 8000 ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; NATRIUMZETMEELGLYCOLAAT ; POLYVINYLALCOHOL (E1203) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), BRILJANTBLAUW FCF ALUMINIUMLAK (E133) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ZWART (E 172) ; MACROGOL 8000 ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; NATRIUMZETMEELGLYCOLAAT (E468) ; POLYVINYLALCOHOL (E1203) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Cinacalcet

Product samenvatting:

Hulpstoffen: BRILJANTBLAUW FCF ALUMINIUMLAK (E133); CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); IJZEROXIDE GEEL (E 172); IJZEROXIDE ZWART (E 172); MACROGOL 8000; MAGNESIUMSTEARAAT (E 470b); MANNITOL (D-) (E 421); NATRIUMZETMEELGLYCOLAAT (E468); POLYVINYLALCOHOL (E1203); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisatie datum:

2017-09-27

Bijsluiter

CINACALCET APOTEX 30 MG, 60 MG AND 90 MG, FILMOMHULDE TABLETTEN –
RVG 118361-2-3
MODULE 1.3
Product Information
Version: 2019-10-11
MODULE 1.3.1
Package Leaflet
Replaces: 2018-05-17
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
_ _
Cinacalcet Apotex 30 mg, filmomhulde tabletten
Cinacalcet Apotex 60 mg, filmomhulde tabletten
Cinacalcet Apotex 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 Apotex is and what it is used for
2.
What you need to know before you take Cinacalcet Apotex
3.
How to take Cinacalcet Apotex
4.
Possible side effects
5.
How to store Cinacalcet Apotex
6.
Contents of the pack and other information
1.
WHAT
CINACALCET APOTEX
IS AND WHAT IT IS USED FOR
Cinacalcet Apotex 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 Apotex 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 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.
Cinacalcet Apotex is used

Productkenmerken

CINACALCET APOTEX 30 MG, 60 MG AND 90 MG, FILMOMHULDE TABLETTEN –
RVG 118361-2-3
MODULE 1.3
Product Information
Version: 2019-10-11
MODULE 1.3.1
Summary of Product Characteristics
Replaces: 2018-05-17
1
1.
NAME OF THE MEDICINAL PRODUCT
Cinacalcet Apotex 30 mg, filmomhulde tabletten
Cinacalcet Apotex 60 mg, filmomhulde tabletten
Cinacalcet Apotex 90 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 30 mg tablet contains 30 mg of cinacalcet (as hydrochloride)
Each 60 mg tablet contains 60 mg of cinacalcet (as hydrochloride)
Each 90 mg tablet contains 90 mg of cinacalcet (as hydrochloride)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Light green colored, oval shaped (9.525 x 5.95 mm), biconvex
film-coated tablets, engraved “APO” on one
side and “C30” on the other side
Light green colored, oval shaped (
11.90 x 7.50 mm)
, biconvex film-coated tablets, engraved “APO” on
one side and “C60” on the other side
Light green colored, oval shaped (
13.493 x 8.35 mm)
, biconvex film-coated tablets, engraved “APO” on
one side and “C90” on the other side
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).
Cinacalcet Apotex 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:
CINACALCET APOTEX 30 MG, 60 MG AND 90 MG, FILMOMHULDE TABLETTEN –
RVG 118361-2-3
MODULE 1.3
Product Information