Cinacalcet Clonmel 30 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Cinacalcet hydrochloride

Available from:

Clonmel Healthcare Ltd

ATC code:

H05BX01

INN (International Name):

Cinacalcet hydrochloride

Dosage:

30 milligram(s)

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

cinacalcet

Authorization status:

Marketed

Authorization date:

2019-03-15

Patient Information leaflet

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
CINACALCET CLONMEL 30 MG FILM-COATED TABLETS
CINACALCET CLONMEL 60 MG FILM-COATED TABLETS
CINACALCET CLONMEL 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 Clonmel is and what it is used for
2. What you need to know before you take Cinacalcet Clonmel
3. How to take Cinacalcet Clonmel
4. Possible side effects
5. How to store Cinacalcet Clonmel
6. Contents of the pack and other information
1. WHAT CINACALCET CLONMEL IS AND WHAT IT IS USED FOR
Cinacalcet Clonmel 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).
This medicine is used in adults:
•
to treat secondary hyperparathyroidism in patients 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
patients with parathyroid cancer
•
to
reduce
high
levels
of
calcium
in
the
blood
(hypercalcaemia)
in
patients
with
primary
hyperparathyroidism when removal of the gland is not possible
Cinacalcet 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 cond

Summary of Product characteristics

Health Products Regulatory Authority
09 June 2023
CRN00DJ89
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cinacalcet Clonmel 30 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tabletcontains 33.067 mg cinacalcet hydrochloride
equivalent to 30 mg cinacalcet.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cinacalcet Clonmel 30 mg film-coated tablets
Oval, biconvex, green film-coated tablets, length around 10.1 mm and
width around 5.2 mm
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Secondary hyperparathyroidism
_Adults_
Treatment of secondary hyperparathyroidism (HPT) in 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 Clonmel 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 Clonmel 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) assay. PTH
levels should be assessed at least 12 hours after dosing
with Cinacalcet Clonme