Cinacalcet Accord 60mg film-coated tablets

Country: Malta

Language: English

Source: Malta Medicines Authority

Active ingredient:

CINACALCET HYDROCHLORIDE

Available from:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

ATC code:

H05BX01

INN (International Name):

CINACALCET HYDROCHLORIDE 60 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

CINACALCET HYDROCHLORIDE 60 mg

Prescription type:

POM

Therapeutic area:

CALCIUM HOMEOSTASIS

Authorization status:

Withdrawn

Authorization date:

2015-09-25

Patient Information leaflet

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CINACALCET ACCORD 30 MG FILM-COATED TABLETS
CINACALCET ACCORD 60 MG FILM-COATED TABLETS
CINACALCET ACCORD 90 MG FILM-COATED TABLETS
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 Accord is and what it is used for
2.
What you need to know before you take Cinacalcet Accord
3.
How to take Cinacalcet Accord
4.
Possible side effects
5.
How to store Cinacalcet Accord
6.
Contents of the pack and other information
1.
WHAT CINACALCET ACCORD IS AND WHAT IT IS USED FOR
Cinacalcet Accord works by controlling the levels of parathyroid
hormone (PTH), calcium and
phosphorus 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 Accord 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 Accord 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 pr

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Cinacalcet Accord 30 mg film-coated tablets.
Cinacalcet Accord 60 mg film-coated tablets.
Cinacalcet Accord 90 mg film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 30 mg cinacalcet (as hydrochloride).
Each film-coated tablet contains 60 mg cinacalcet (as hydrochloride).
Each film-coated tablet contains 90 mg cinacalcet (as hydrochloride).
Excipient(s) with known effect:
Each film coated tablet contains 67.2 mg of lactose monohydrate.
Each film coated tablet contains 134.3 mg of lactose monohydrate.
Each film coated tablet contains 202.0 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Light green, oval, biconvex film-coated tablet of 9.6-10.0 mm length
debossed ‘C’ on one side and ‘30’ on the
other.
Light green, oval, biconvex film-coated tablet of 12.3-12.7 mm length
debossed ‘C’ on one side and ‘60’ on
the other.
Light green, oval, biconvex film-coated tablet of 14.05-14.45 mm
length debossed ‘C’ on one side and ‘90’ on
the other.
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
3years 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 Accord 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