PHARMACOR CINACALCET cinacalcet (as hydrochloride) 90 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cinacalcet hydrochloride, Quantity: 99 mg (Equivalent: cinacalcet, Qty 90 mg)

Available from:

Pharmacor Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: lactose monohydrate; magnesium stearate; hyprolose; crospovidone; microcrystalline cellulose; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350; indigo carmine aluminium lake

Administration route:

Oral

Units in package:

10, 28

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Cinacalcet may be used to treat the biochemical manifestations of secondary hyperparathyroidism in patients with end stage renal disease, receiving dialysis. Cinacalcet should be used as adjunctive therapy. ,Cinacalcet is indicated for the treatment of hypercalcaemia in patients with parathyroid carcinoma. ,Cinacalcet may be used to treat the biochemical manifestations of primary hyperparathyroidism in patients for whom parathyroidectomy is not a treatment option.

Product summary:

Visual Identification: Light green colored, oval shaped, film coated tablets debossed with "A35" on one side and "90" on other side.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2019-01-08

Patient Information leaflet

Pharmacor Cinacalcet Ver: 03 1
PHARMACOR CINACALCET TABLETS
_Cinacalcet hydrochloride _
_ _
Pharmacor Cinacalcet 30 mg Tablets
Pharmacor Cinacalcet 60 mg Tablets
Pharmacor Cinacalcet 90 mg Tablets
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Pharmacor Cinacalcet. It does
not contain all the available
information. It does not take the
place of talking to your doctor,
nurse or pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you taking
Pharmacor Cinacalcet against
the benefits he/she expects it
will have for you.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING PHARMACOR
CINACALCET, ASK YOUR DOCTOR,
NURSE OR PHARMACIST.
READ THIS LEAFLET CAREFULLY
BEFORE YOU START PHARMACOR
CINACALCET AND KEEP IT WITH
THE MEDICINE. YOU MAY NEED TO
READ IT AGAIN.
WHAT PHARMACOR
CINACALCET IS USED
FOR
Pharmacor Cinacalcet is used to
treat:

a condition called secondary
hyperparathyroidism (high-
per-para-THIGH-royd-izm)
in people with kidney disease
who require dialysis
treatment.

a condition called primary
hyperparathyroidism when
surgical removal of the
parathyroid gland is not a
treatment option.

high blood calcium levels in
people with cancer of the
parathyroid gland.
SECONDARY
HYPERPARATHYROIDISM
Kidney disease can cause a
condition called secondary
hyperparathyroidism, which can
have a big impact on your
health. Four small glands
located behind the thyroid gland
in your neck are called
parathyroid glands. They make
a hormone called parathyroid
hormone (PTH). Normally, PTH
makes sure you have just
enough calcium and phosphorus
in your blood to keep your
bones, heart, muscles, nerves
and blood vessels working well.
When your kidneys are working
properly, PTH keeps your
calcium and phosphorus levels
normal by moving the right
amounts of calcium and
phosphorus in and out of your
bones.
When your kidneys aren't
working properly, the calcium
and phosphorus balance in your
body is upset, and your
parathyroid glands send out too
much PTH to

Summary of Product characteristics

Pharmacor Cinacalcet
Ver: 03
1
AUSTRALIAN PRODUCT INFORMATION
PHARMACOR CINACALCET (CINACALCET HYDROCHLORIDE) FILM-COATED TABLETS
1.
NAME OF THE MEDICINE
Cinacalcet hydrochloride.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pharmacor Cinacalcet 30 mg tablets:
Each film-coated tablet contains Cinacalcet hydrochloride 33 mg
equivalent to Cinacalcet
30 mg.
Pharmacor Cinacalcet 60 mg tablets:
Each film-coated tablet contains Cinacalcet hydrochloride 66 mg
equivalent to Cinacalcet
60 mg.
Pharmacor Cinacalcet 90 mg tablets:
Each film-coated tablet contains Cinacalcet hydrochloride 99 mg
equivalent to Cinacalcet
90 mg.
List of excipients with known effect:
Sugars (as lactose monhydrate)
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Film-coated Tablets
Pharmacor Cinacalcet 30 mg tablets:
Light green colored, oval shaped, film coated tablets debossed with
'A33' on one side and '30'
on other side.
Pharmacor Cinacalcet 60 mg tablets:
Light green colored, oval shaped, film coated tablets debossed with
'A34' on one side and '60'
on other side.
Pharmacor Cinacalcet
Ver: 03
2
Pharmacor Cinacalcet 90 mg tablets:
Light green colored, oval shaped, film coated tablets debossed with
'A35' on one side and
‘90’ on other side.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cinacalcet
may
be
used
to
treat
the
biochemical
manifestations
of
secondary
hyperparathyroidism (HPT) in patients with end stage renal disease,
receiving dialysis (see
section 5.1 Pharmacodynamic properties, Clinical trials). Cinacalcet
should be used as
adjunctive therapy.
Cinacalcet is indicated for the treatment of hypercalcaemia in
patients with parathyroid
carcinoma.
Cinacalcet
may
be
used
to
treat
the
biochemical
manifestations
of
primary
hyperparathyroidism in patients for whom parathyroidectomy is not a
treatment option.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE (DOSE AND INTERVAL)
PATIENTS WITH END STAGE RENAL DISEASE RECEIVING DIALYSIS
Pharmacor Cinacalcet reduces parathyroid hormone (PTH) while
simu