Cinacalcet PharmSol 30mg film-coated tablets

Riik: Malta

keel: inglise

Allikas: Medicines Authority

Toimeaine:

CINACALCET HYDROCHLORIDE

Saadav alates:

PharmSol Europe Limited The Victoria Centre Unit 2, Lower Ground Floor, Valletta Road, Mosta MST 9012 , Malta

ATC kood:

H05BX01

INN (Rahvusvaheline Nimetus):

CINACALCET HYDROCHLORIDE 30 mg

Ravimvorm:

FILM-COATED TABLET

Koostis:

CINACALCET HYDROCHLORIDE 30 mg

Retsepti tüüp:

POM

Terapeutiline ala:

CALCIUM HOMEOSTASIS

Toote kokkuvõte:

Licence number in the source country: NOT APPLICAPABLE

Volitamisolek:

Authorised

Loa andmise kuupäev:

2020-11-12

Infovoldik

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PACKAGE LEAFLET: INFORMATION FOR THE USER
CINACALCET PHARMSOL 30 MG FILM-COATED TABLETS
CINACALCET PHARMSOL 60 MG FILM-COATED TABLETS
CINACALCET PHARMSOL 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 PharmSol is and what it is used for
2.
What you need to know before you take Cinacalcet PharmSol
3.
How to take Cinacalcet PharmSol
4.
Possible side effects
5.
How to store Cinacalcet PharmSol
6.
Contents of the pack and other information
1.
WHAT CINACALCET PHARMSOL IS AND WHAT IT IS USED FOR
Cinacalcet PharmSol 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 PharmSol 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 PharmSol 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 the

Toote omadused

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1.
NAME OF THE MEDICINAL PRODUCT
Cinacalcet PharmSol 30 mg film-coated tablets
Cinacalcet PharmSol 60 mg film-coated tablets
Cinacalcet PharmSol 90 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 30 mg, 60 mg or 90 mg cinacalcet (as
hydrochloride).
Excipient(s) with known effect:
_Cinacalcet PharmSol_
_30 mg film-coated tablets _
Each 30 mg tablet contains 2.24 mg of lactose monohydrate.
_Cinacalcet PharmSol_
_60 mg film-coated tablets_
Each 60 mg tablet contains 4.48 mg of lactose monohydrate.
_Cinacalcet PharmSol_
_90 mg film-coated tablets_
Each 90 mg tablet contains 6.72 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Cinacalcet PharmSol 30 mg film-coated tablets
Green, oblong, biconvex film-coated tablets, engraved with ‘30’on
one side and plain on the
other side with a length of 9.8 mm (±0.2 mm) and a width of 6.2 mm
(±0.2 mm).
Cinacalcet PharmSol 60 mg film-coated tablets
Green, oblong, biconvex film-coated tablets, engraved with ‘60’ on
one side and plain on the
other side with a length of 12.4 mm (±0.2 mm) and a width of 7.8 mm
(±0.2 mm).
Cinacalcet PharmSol 90 mg film-coated tablets
Green, oblong, biconvex film-coated tablets, engraved with ‘90’on
one side and plain on the
other side with a length of 14.2 mm (±0.2 mm) and a width of 8.9 mm
(±0.2 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 _
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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 PharmSol may be used as part of a therapeutic regimen
including phosphate binders
and/