Cinacalcet Rowex 30 mg Film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Cinacalcet hydrochloride

Available from:

Rowex Ltd

ATC code:

H05BX; H05BX01

INN (International Name):

Cinacalcet hydrochloride

Dosage:

30 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Other anti-parathyroid agents; cinacalcet

Authorization status:

Not marketed

Authorization date:

2018-01-26

Patient Information leaflet

SANDOZ
Business use only
Page 1 of 9
1.3.1 spc-label-pl - common-pl - 10,415
(DK/H/2470/001-002-003/IB/006)
20190314
CINACALCET HYDROCHLORIDE 30 MG 60 MG 90 MG FILM-
COATED TABLET
722-2372.00 722-2373.00
722-2374.00
PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
{[NATIONALLY COMPLETED NAME] 30 MG FILM-COATED TABLETS}
{[NATIONALLY COMPLETED NAME] 60 MG FILM-COATED TABLETS}
{[NATIONALLY COMPLETED NAME] 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 or 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 or pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What [nationally completed name] is and what it is used for
2. What you need to know before you take [nationally completed name]
3. How to take [nationally completed name]
4. Possible side effects
5. How to store [nationally completed name]
6. Contents of the pack and other information
1. WHAT {NATIONALLY COMPLETED NAME} IS AND WHAT IT IS USED FOR
{Nationally completed 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).
{Nationally completed name} 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.
SANDOZ
Business use only
Page 2 of 9
1.3.1 sp

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cinacalcet Rowex 30 mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 30 mg cinacalcet (as hydrochloride).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Green oval biconvex film-coated tablets (dimension: 4.5 x 7 mm),
debossed with ‘C9CC’ on one side and ‘30’ 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 Rowex 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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Secondary hyperparathyroidism
_Adults and elderly (> 65 years)_
The recommended starting dose for adults is 30 mg once per day.
Cinacalcet should be titrated every 2 to 4 weeks to a
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