Cinacalcet Teva 30 mg film-coated tablets

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Cinacalcet hydrochloride; TALC PH.EUR.

Dostupné z:

Teva B.V.

ATC kód:

H05B

INN (Medzinárodný Name):

Cinacalcet hydrochloride; TALC PH.EUR.

Dávkovanie:

30 milligram(s)

Forma lieku:

Film-coated tablet

Typ predpisu:

Product subject to prescription which may be renewed (B)

Terapeutické oblasti:

ANTI-PARATHYROID AGENTS

Stav Autorizácia:

Marketed

Dátum Autorizácia:

2016-02-05

Príbalový leták

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Cinacalcet Teva 30mg, 60mg,
90mg FC Tabs All TEI KS V2
58950
Leaflet
190x380mm
NA
Univers
Body Size 9pt
AM
21-03-19
5.0
YA
15-6-20
CINACALCET TEVA 30 MG
FILM-COATED TABLETS
CINACALCET TEVA 60 MG
FILM-COATED TABLETS
CINACALCET TEVA 90 MG
FILM-COATED TABLETS
CINACALCET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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 TEVA IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CINACALCET
TEVA
3. HOW TO TAKE CINACALCET TEVA
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE CINACALCET TEVA
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1 WHAT CINACALCET TEVA IS AND WHAT IT IS
USED FOR
Cinacalcet Teva 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 Teva 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 gland
is not possible.
Cinacalcet Teva is used in children aged 3 years t

Súhrn charakteristických

Health Products Regulatory Authority
12 March 2024
CRN00F595
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cinacalcet Teva 30 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 30 mg cinacalcet (as hydrochloride).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Light green to green, film-coated, oval shaped tablet (10 mm X 6 mm),
debossed with C30 on one side of the tablet and plain
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 Teva 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 Teva 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 Te