Cinglan 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:

G.L. Pharma GmbH Schlossplatz 1 A-8502 LANNACH (OOSTENRIJK)

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:

2017-07-20

Bijsluiter

Cinacalcet (as hydrochloride) 30, 60, 90 mg
Film-coated tablets
Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CINGLAN
30 MG FILMOMHULDE TABLETTEN
CINGLAN 60 MG FILMOMHULDE TABLETTEN
CINGLAN
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 [Product name] is and what it is used for
2.
What you need to know before you take [Product name]
3.
How to take [Product name]
4.
Possible side effects
5.
How to store [Product name]
6.
Contents of the pack and other information
1
WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR
[Product
name]
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).
[Product name] is used in adults:

to treat secondary hyperparathyroidism in adult 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.
[Product name] 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 t

Productkenmerken

Cinacalcet (as hydrochloride) 30, 60, 90 mg
Film-coated tablets
Page 1 of 18
1.3.1
Summary of Product Characteristics - Core
1.
NAME OF THE MEDICINAL PRODUCT
Cinglan 30 mg filmomhulde tabletten
Cinglan 60 mg filmomhulde tabletten
Cinglan 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 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 (as hydrochloride) 30, 60, 90 mg
Film-coated tablets
Page 2 of 18
[Product name] 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 indicated on the basis
of serum calcium
levels (as defined by relevant treatment guidelines), but in whom
parathyroidectomy is not
clinically appropriate or is contraindicated.