Cinacalcet Rowex 60 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Cinacalcet

Available from:

Rowex Ltd

ATC code:

H05BX01

INN (International Name):

Cinacalcet

Dosage:

60 milligram(s)

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

cinacalcet

Authorization date:

2021-03-26

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CINACALCET ROWEX 30 MG FILM-COATED TABLETS
CINACALCET ROWEX 60 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 Rowex is and what it is used for
2.
What you need to know before you take Cinacalcet Rowex
3.
How to take Cinacalcet Rowex
4.
Possible side effects
5.
How to store Cinacalcet Rowex
6.
Contents of the pack and other information
1.
WHAT CINACALCET ROWEX IS AND WHAT IT IS USED FOR
Cinacalcet Rowex 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 Rowex 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
adults patients with parathyroid
cancer.
-
to reduce high levels of calcium in the blood (hypercalcaemia) in
adults patients with primary
hyperparathyroidism when removal of the gland is not possible.
Cinacalcet Rowex 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 products, whose condition is not
controlled with other treatments.

Summary of Product characteristics

Health Products Regulatory Authority
01 September 2022
CRN00CWP3
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cinacalcet Rowex 60 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 60 mg cinacalcet (as hydrochloride).
Excipient with known effect:
Each 60 mg tablet contains 145.7 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Light green, oval, biconvex, film-coated tablets debossed with 'L84'
on one side and plain on other side (Approximate size 12.4
x 7.8 mm).
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
Secondary hyperparathyroidism
_ _
_Adults and elderly (> 65 years)_
The recommended starting dose for adults is 30 mg once per day.
Cinacalcet Rowex should be titrated every 2 to 4 weeks to a
maximum dose of 180 mg once daily to achieve a target parathyroid
hormone (PTH) in dialysis patients of between 150-300
pg/ml (15.9-31.8 pmol/L) in the intact PTH (iPTH)