Cinacalcet Mylan

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

cinacalcet hydrochloride

Available from:

Mylan Pharmaceuticals Limited

ATC code:

H05BX01

INN (International Name):

cinacalcet

Therapeutic group:

Calcium homeostasis

Therapeutic area:

Hyperparathyroidism, Secondary; Hypercalcemia

Therapeutic indications:

Treatment of secondary hyperparathyroidism (HPT) in patients with end-stage renal disease (ESRD) on maintenance dialysis therapy.Cinacalcet Mylan may be used as part of a therapeutic regimen including phosphate binders and/or vitamin D sterols, as appropriate.Reduction of hypercalcaemia in patients with:parathyroid carcinomaprimary HPT for whom parathyroidectomywould 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. 

Product summary:

Revision: 15

Authorization status:

Authorised

Authorization date:

2015-11-19

Patient Information leaflet

38
B. PACKAGE LEAFLET
39
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CINACALCET MYLAN 30 MG FILM-COATED TABLETS
CINACALCET MYLAN 60 MG FILM-COATED TABLETS
CINACALCET MYLAN 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 Mylan is and what it is used for
2.
What you need to know before you take Cinacalcet Mylan
3.
How to take Cinacalcet Mylan
4.
Possible side effects
5.
How to store Cinacalcet Mylan
6.
Contents of the pack and other information
1.
WHAT CINACALCET MYLAN IS AND WHAT IT IS USED FOR
Cinacalcet Mylan contains the active ingredient cinacalcet, which
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 Mylan 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 parathyroid gland is not
possible.
Cinacalcet Mylan is used in children aged 3 years to less than 18
years of age:
•
to treat secondary hyperparathyroidism in patients with serious kidn

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Cinacalcet Mylan 30 mg film-coated tablets.
Cinacalcet Mylan 60 mg film-coated tablets.
Cinacalcet Mylan 90 mg film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cinacalcet Mylan 30 mg film-coated tablets
Each film-coated tablet contains 30 mg of cinacalcet (as
hydrochloride).
Cinacalcet Mylan 60 mg film-coated tablets
Each film-coated tablet contains 60 mg of cinacalcet (as
hydrochloride).
Cinacalcet Mylan 90 mg film-coated tablets
Each film-coated tablet contains 90 mg of cinacalcet (as
hydrochloride).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Cinacalcet Mylan 30 mg film-coated tablets
10.0 mm x 6.4 mm, green, film-coated, oval, biconvex, bevelled edge
tablet debossed with M on one
side of the tablet and CI30 on the other side.
Cinacalcet Mylan 60 mg film-coated tablets
12.5 mm x 8.0 mm, green, film-coated, oval, biconvex, bevelled edge
tablet debossed with M on one
side of the tablet and CI60 on the other side.
Cinacalcet Mylan 90 mg film-coated tablets
14.3 mm x 9.0 mm, green, film-coated, oval, biconvex, bevelled edge
tablet debossed with M on one
side of the tablet and CI90 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.
3
_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 Mylan 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:
•
parathyroi