REGPARA TABLETS 25 MG

Země: Malajsie

Jazyk: angličtina

Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktivní složka:

CINACALCET HYDROCHLORIDE

Dostupné s:

Kyowa Kirin Malaysia Sdn. Bhd.

INN (Mezinárodní Name):

CINACALCET HYDROCHLORIDE

Jednotky v balení:

100 tablets per boxtablet Tablets

Výrobce:

Ohara Pharmaceutical Co., Ltd (Kami Factory)

Informace pro uživatele

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP_)
REGPARA
® TABLETS
CINACALCET HCL (25 MG)
Page
1
of
2
WHAT IS IN THIS LEAFLET
This leaflet contains the following;
1.
What REGPARA is used for
2.
How REGPARA works
3.
Before you use Regpara
4.
How to take REGPARA
5.
While you are using Regpara
6.
Side effects
7.
Storage and Disposal of Regpara
8.
Product description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of Revision
12.
Serial number
WHAT REGPARA IS USED FOR
Regpara is used for treatment of
secondary hyperparathyroidism in
patients with serious kidney disease
who need dialysis to clear their blood
of waste products.
In secondary hyperparathyroidism, too
much parathyroid hormone (PTH) is
produced by the parathyroid glands.
“Secondary” means that the
hyperparathyroidism is caused by
another condition, e.g., kidney disease.
Secondary hyperparathyroidism can
cause the loss of calcium in the bones,
which can lead to bone pain and
fractures, problems with blood and
heart vessels, kidney stones, mental
Illness and coma.
HOW REGPARA WORKS
Regpara works by controlling the
levels of PTH, calcium and
phosphorous in your body. It is used to
treat problems with organs call
parathyroid glands.
The parathyroids are four small glands
in the neck near the thyroid gland, that
product PTH.
BEFORE YOU USE REGPARA
-
_When you must not take Regpara _
_ _
You must not Regpara when you
are
ALLERGIC
(hypersensitive) to
cinacalcet or any of the other
ingredients of Regpara.
-
_Before you start to take Regpara _
Tell your doctor if you have or
have ever had:
SEIZURES
(fits or
convulsions). The risk of having
seizures is higher if you have had
them before
; LIVER PROBLEMS;
HEART FAILURE.
-
_Taking other medicines _
Please tell your doctor or
pharmacist if you are taking or
have recently taken any other
medicines, including medicines
obtained without a prescription.
Please tell your doctor if you are
taking the following medicines.
Following can affect how Regpara
works:
• medicines to treat
SKIN
and
FUNGAL INFECTIONS

Charakteristika produktu

Page 1 of 14
(#71795.REGPARA MY PIV6d1)
XXXXXXXXXXX
ATC code
Revised: Aug 2022
H05BX01
- DRUG FOR TREATMENT OF SECONDARY HYPERPARATHYROIDISM –
(CALCIUM RECEPTOR AGONIST)
Prescription drug: Caution – Use only as directed by a physician.
REGPARA
® TABLETS 25MG
< Cinacalcet Hydrochloride Tablets>
STORAGE
Regpara Tablets 25 mg
STORE BELOW 30
°
C.
PROTECT FROM LIGHT.
Approval No.
21900AMX01750
Date of listing in the NHI
reimbursement price
December 2007
Date of initial marketing
in Japan
January 2008
EXPIRATION DATE
International birth date
March 2004
Specified on the outer package.
CONTRAINDICATIONS (REGPARA IS CONTRAINDICATED IN THE FOLLOWING
PATIENTS.)
Patients with a history of hypersensitivity to any of the ingredients
in Regpara.
DESCRIPTION
Brand name
Regpara Tablets 25 mg
Active ingredients
(per tablet)
Cinacalcet hydrochloride
27.55 mg (including 25 mg of cinacalcet)
Additives
Partly pregelatinized starch, microcrystalline cellulose,
povidone, crospovidone, light anhydrous silicic acid, talc,
magnesium stearate, lactose hydrate, hypromellose,
titanium oxide, triacetine, macrogol 400, yellow ferric oxide,
blue No. 2 aluminium lake
Colour
Light-green to light-yellowish green
Dosage form
Film-coated tablets
Appearance
Diameter
8 mm
Thickness
4 mm
Weight
ca. 207 mg
Identification code
KR02
Page 2 of 14
(#71795.REGPARA MY PIV6d1)
INDICATIONS
Secondary hyperparathyroidism in patients undergoing maintenance
dialysis
DOSAGE AND ADMINISTRATION
The starting dosage for adults is 25 mg of cinacalcet once daily, to
be orally administered.
With careful management of the patient’s serum parathyroid hormone
(PTH) and calcium
levels, the dose may then be adjusted within a range of 25-75 mg once
daily. If no
improvement is found in PTH, the dose may be increased up to 100 mg
once daily. If dose
increase is required, dose should be increased by 25 mg at a time, at
intervals of at least 3
weeks.

1.
Regpara has an effect of decreasing calcium in blood. Therefore, it
shoul