Pentasa Sachet Prolonged Release Granules 2g

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

5-AMINO SALICYLIC ACID(5-ASA),MESALAZINE

Boleh didapati daripada:

Ferring Sdn. Bhd.

INN (Nama Antarabangsa):

5-AMINO SALICYLIC ACID(5-ASA),MESALAZINE

Unit dalam pakej:

60Units Units

Dikeluarkan oleh:

Ferring International Center SA

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
_ _
PENTASA
®
SACHET PROLONGED RELEASE GRANULES
Mesalazine 1g and 2g
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
®
Sachet Prolonged Release
Granules 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 granules 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 a

Ciri produk

PROPOSED PACKAGING MATERIAL
Code
PENSAC1, 2-I-MY-04.01
Size
Submission
☐
NDA
☐
Renewal
☒
Variation change detail no.: #220753_ _
Code of previous version
PENSAC1, 2-I-MY-03.02
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
®
SACHET PROLONGED RELEASE GRANULES 1G
SACHET PROLONGED RELEASE GRANULES 2G
QUALITATIVE AND QUANTITATIVE COMPOSITION
PENTASA
®
sachet 1g:
Each sachet contains 1 g mesalazine.
Excipients: Ethylcellulose, povidone.
PENTASA
®
sachet 2g:
Each sachet contains 2 g mesalazine.
Excipients: Ethylcellulose, povidone.
PHARMACEUTICAL FORM
Prolonged release granules
APPEARANCE
White-grey to pale white-brown granules.
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 4 g 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, 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
should not exceed 4 g/day (maximum
adult dose).
MAINTENANCE TREATMENT:
Adults: Individual dosage, up to 4g daily in divided doses.
PROPOSED PACKAGING MATER