Cinacalcet Pharmazac 90 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

CINACALCETHYDROCHLORIDE 99,2 mg/stuk SAMENSTELLING overeenkomend met ; CINACALCET 90 mg/stuk

Beschikbaar vanaf:

Pharmazac S.A. 31, Naoussis str., Votanikos 10447 ATHENS (GRIEKENLAND)

ATC-code:

H05BX01

INN (Algemene Internationale Benaming):

CINACALCETHYDROCHLORIDE 99,2 mg/stuk SAMENSTELLING overeenkomend met ; CINACALCET 90 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; IJZEROXIDE GEEL (E 172) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Cinacalcet

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); IJZEROXIDE GEEL (E 172); INDIGOKARMIJN ALUMINIUMLAK (E 132); MACROGOL 4000; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEPREGELATINEERD; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203); POVIDON K 30 (E 1201); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisatie datum:

2018-05-22

Bijsluiter

Cinacalcet (as hydrochloride) 30, 60, 90 mg
Film-coated tablets
M1.3.1_03.CCC.hcl.tab.003.01.core
Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CINACALCET PHARMAZAC 30 MG, FILMOMHULDE TABLETTEN
CINACALCET PHARMAZAC 60 MG, FILMOMHULDE TABLETTEN
CINACALCET PHARMAZAC 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 Pharmazac is and what it is used for
2.
What you need to know before you take Cinacalcet Pharmazac
3.
How to take Cinacalcet Pharmazac
4.
Possible side effects
5.
How to store Cinacalcet Pharmazac
6.
Contents of the pack and other information
1
WHAT CINACALCET PHARMAZAC IS AND WHAT IT IS USED FOR
Cinacalcet Pharmazac 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 Pharmazac 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
patients with parathyroid cancer.

to
reduce
high
levels
of
calcium
in
the
blood
(hypercalcaemia)
in
patients
with
primary
hyperparathyroidism when removal of the gland is not possible.
Cinacalcet Pharmazac is used in children aged 3 years to less than 18
years of a

Productkenmerken

Cinacalcet (as hydrochloride) 30, 60, 90 mg
Film-coated tablets
M1.3.1_01.CCC.hcl.tab.003.01.core
Page 1 of 17
1.
NAME OF THE MEDICINAL PRODUCT
Cinacalcet Pharmazac 30 mg, filmomhulde tabletten
Cinacalcet Pharmazac 60 mg, filmomhulde tabletten
Cinacalcet Pharmazac 90 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 30 mg cinacalcet (as hydrochloride).
Each tablet contains 60 mg cinacalcet (as hydrochloride).
Each tablet contains 90 mg cinacalcet (as hydrochloride).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Green oval biconvex coated tablets (approximately 4.5 x 7 mm),
debossed with C9CC on one side and
30 on the other side
Green oval biconvex coated tablets (approximately 5.5 x 9 mm),
debossed with C9CC on one side and
60 on the other side
Green oval biconvex coated tablets (approximately 6.5 x 10.5 mm),
debossed with C9CC on one side
and 90 on the other side
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Secondary hyperparathyroidism
_Adults _
Treatment of secondary hyperparathyroidism (HPT) in 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 (as hydrochloride) 30, 60, 90 mg
Film-coated tablets
M1.3.1_01.CCC.hcl.tab.003.01.core
Page 2 of 17
Cinacalcet Pharmazac(as hydrochloride) 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 adultspatients with:
• parathyroid carcinoma.
• primary HPT for whom parathyroidectomy would be indicated on the
basis of serum calcium levels
(as defined by relevant treatment guidelines), bu