PENTASA Prolonged Release Tablets 1 g

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

MESALAZINE

Boleh didapati daripada:

Ferring Sdn. Bhd.

INN (Nama Antarabangsa):

MESALAZINE

Unit dalam pakej:

60 Tablets

Dikeluarkan oleh:

Ferring International Center SA

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
_ _
PENTASA
®
PROLONGED RELEASE TABLETS
Mesalazine 500mg and 1g
1
WHAT IS IN THIS LEAFLET:
1.
What PENTASA
®
is used for
2.
How PENTASA
®
works
3.
Before you use PENTASA
®
4.
How to use PENTASA
®
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of PENTASA
®
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
1.
WHAT PENTASA
®
IS USED FOR
PENTASA
®
Prolonged Release Tablets
are used to treat mild to moderate
ulcerative colitis (an inflammation
condition of the gut) and Crohn’s
disease (a condition that causes
inflammation of the wall of the gut.
Any part of the gut can be affected).
2.
HOW PENTASA
®
WORKS
PENTASA
®
contains the active
ingredient mesalazine
_. _
The prolonged
release tablets release the active
ingredient slowly which then acts
locally to reduce the inflammation and
help relieve or stop the pain.
3.
BEFORE YOU USE PENTASA
®
_When you must not use it _
DO NOT take PENTASA
®
•
If you are allergic to mesalazine,
other salicylic acid or its derivatives
or to any of the other ingredients of
PENTASA
®
.
•
If you have severe liver and/or
kidney impairment.
If this applies to you, do not take
PENTASA
®
and tell your doctor
immediately.
_Before you start to use it _
WARNING AND PRECAUTIONS
•
Tell your doctor or pharmacist if
you have or have had any of the
following conditions:
-
Intolerant or hypersensitive to
sulphasalazine
- With impaired liver function
- With kidney impairment
- With lung disease, in particular
asthma.
- Suddenly develop abdominal cramps,
abdominal pain, fever, severe headache
and rash.
- Kidney stones may develop with use of
mesalazine.
Symptoms
may
include
pain in sides of abdomen and blood in
urine.
Take
care
to
drink
sufficient
amount of liquid during treatment with
mesalazine.
- If you have ever developed a severe
skin
rash
or
skin
peeling,
blistering
and/or
mouth
sores
after
using
mesalazine.
Mesalazine may produce red-brown
urine discoloration after

Ciri produk

PROPOSED PACKAGING MATERIAL
Code
PENTAB500,1-I-MY,BN-05.01
Size
Submission
☐
NDA
☐
Renewal
☒
Variation change detail no.: #220753_ _
Code of previous version
PENTAB500,1-I-MY,BN-04.01
Changes
CCDS 18: Updates following PRAC recommendation - warning added on
urine discolouration,&
DRESS
☒
CCDS version: 18
☐
Core PIL version:
☐
SPC country/version/date:
☐
LAC no.:
Name & Date
JIWO, 11-Sep-2023
PENTASA
®
PROLONGED RELEASE TABLETS 500 MG
PROLONGED RELEASE TABLETS 1G
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg mesalazine.
Each tablet contains 1g mesalazine.
Excipients: Magnesium stearate, talc, ethylcellulose, povidone,
microcrystalline cellulose.
PHARMACEUTICAL FORM
Prolonged release tablet.
APPEARANCE
500mg: White grey to pale brown, speckled round tablets. Breakmark and
embossing: 500 mg on one
side, PENTASA on the other side.
1g: White-grey to pale brown, speckled, oval tablets. Embossing on
both sides: PENTASA.
THERAPEUTIC INDICATIONS
Treatment of mild to moderate ulcerative colitis and Crohn’s
disease.
POSOLOGY AND METHOD OF ADMINISTRATION
ULCERATIVE COLITIS
TREATMENT OF ACTIVE DISEASE:
Adults: Individual dosage, up to 4g given once daily or in divided
doses.
Children 6 years of age and older: To be determined individually,
starting with 30-50 mg/kg/day in
divided doses. Maximum dose: 75 mg/kg/day in divided doses. The total
dose should not exceed 4
g/day (maximum adult dose).
MAINTENANCE TREATMENT:
Adults: Individual dosage. Recommended dosage, 1.5g to 2g mesalazine
once daily. Can also be taken
in divided doses.
Children 6 years of age and older: To be determined individually,
starting with 15-30 mg/kg/day in
divided doses. The total dose should not exceed 2 g/day (recommended
adult dose).
CROHN’S DISEASE
TREATMENT OF ACTIVE DISEASE:
Adults: Individual dosage, up to 4g daily in divided doses.
Children 6 years of age and older: To be determined individually,
starting with 30-50 mg/kg/day in
divided doses. Maximum dose: 75 mg/kg/day in divided doses. The total
dose sho