PARMODIA Film-coated Tablets 0.1 mg

Land: Malaysia

Sprog: engelsk

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

Aktiv bestanddel:

Pemafibrate

Tilgængelig fra:

DKSH MALAYSIA SDN. BHD.

INN (International Name):

Pemafibrate

Enheder i pakken:

100 Tablets

Fremstillet af:

Kowa Company, Ltd, Nagoya Factory

Indlægsseddel

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
PARMODIA
® FILM-COATED TABLETS 0.1 MG
Pemafibrate (0.1 mg)
1
WHAT IS IN THIS LEAFLET
1.
What PARMODIA is used for
2.
How PARMODIA works
3.
Before you use PARMODIA
4.
How to use PARMODIA
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
PARMODIA
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT PARMODIA IS USED FOR
PARMODIA is used as adjunctive
therapy to diet or other
nonpharmacological treatment (e.g.
exercise) to reduce triglyceride
(TG) and to increase high-density
lipoprotein cholesterol (HDL-C) in
patients with dyslipidemia
characterised by high TG ≥150
mg/dL, particularly when there is
evidence of associated risk such as
hypertension and smoking.
Dyslipidemia is an abnormal level
of lipids such as TG and
cholesterol, also called fats, in the
blood.
HOW PARMODIA WORKS
PARMODIA contains a medicine
called pemafibrate. Pemafibrate
activates nuclear receptor (PPARα)
by binding to this receptor and
regulates the target gene expression,
leading to decreased TG and
increased HDL-C.
If you have any questions about
how PARMODIA works or why
this medicine has been prescribed to
you, ask your doctor.
BEFORE YOU USE PARMODIA
-
_When you must not use it _
Follow all instructions given to you
by your doctor or pharmacist
carefully, even if they differ from
the general information contained in
this leaflet.
Do not take PARMODIA

If you are allergic
(hypersensitivity) to
pemafibrate or to any of the
excipients (listed in Section
Product Description).

If you have severe liver
problems, moderate or severe
cirrhosis, or biliary
obstruction.

If you have cholelithiasis
(gallstones).

If you are pregnant or possibly
pregnant women.

If you are receiving
cyclosporine or rifampicin.
If any of these apply to you, tell
your doctor and do not take
PARMODIA. If you are not sure,
talk to your doctor or pharmacist
before taking PARMODIA.
-
_Pregnancy and breast-feeding _
Do not ta

Produktets egenskaber

Kowa Company, Ltd.
PARMODIA film-coated tablets 0.1 mg
1.
NAME OF THE MEDICINAL PRODUCT
PARMODIA film-coated tablets 0.1 mg.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 0.1 mg of pemafibrate.
For a full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White round film-coated tablets with a score line debossed ‘Kowa
217’ on one
face and a score line on the reverse.
The tablet can be divided into equal halves.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PARMODIA
is
indicated
as
adjunctive
therapy
to
diet
or
other
nonpharmacological treatment (e.g. exercise) to reduce TG and to
increase HDL-C
in patients with dyslipidemia
characterised by high TG ≥150 mg/dL, particularly
when there is evidence of associated risk such as hypertension and
smoking.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Patients should be on a lipid-lowering diet before the initiation of
PARMODIA,
and should continue dietary control during treatment. Serum lipid
levels should be
monitored
periodically.
If
an
adequate
response
has
not
been
achieved,
complementary or different therapeutic measures should be considered.
POSOLOGY
Adult
The usual adult dose is 0.1 mg twice daily. The dose may be
individualized
according to the patient’s age and symptoms. The maximum dose is 0.2
mg twice
daily.
Elderly
No dose adjustment is necessary.
Since elderly patients often have reduced physiological function,
PARMODIA
should be carefully administered with close monitoring for signs of
adverse
reactions and clinical status of the patient.
Pediatric population
The safety of PARMODIA in low birth weight infants, newborns, infants,
and
children has not been established. No data are available.
Patients with renal impairment
PARMODIA should be used with caution in patients with renal impairment
defined as estimated glomerular filtration rate (eGFR) <30 mL/min/1.73
m
2
. A
lower starting dose or prolonged dosing intervals should be
considered. The
maximum dose is 0.2 mg daily (see section 5.2).