PENTASA

Land: Indonesien

Sprog: indonesisk

Kilde: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Enheder i pakken:

Dus, 10 Blister @ 10 Tablet Pelepasan Lambat

Autorisation dato:

2022-06-10

Produktets egenskaber

PROPOSED PACKAGING MATERIAL
Code
PENTAB05-I-ID-01.02
Size
NA
Submission
☒
NDA
☐
Renewal
☐
Variation change detail no.:
Code of previous version
NA
Changes
NA
Reference
☒
CCDS version: CCDS Ver.17 (Jan 2021)
☐
Core PIL version:
☐
SPC country/version/date:
☐
LAC no.:
Name & Date
IRM, 24-Jan-2022
1
PENTASA
®
MESALAZINE
Prolonged release tablets 500 mg
COMPOSITION
Each tablet contains 500 mg mesalazine.
Excipients: Magnesium stearate, talc, ethylcellulose, povidone,
microcrystalline cellulose.
PHARMACEUTICAL DOSAGE FORM
Prolonged release tablets.
White grey to pale brown, speckled round tablets. Breakmark and
embossing: 500 mg on one side,
PENTASA on the other side.
INDICATIONS
Treatment of mild to moderate ulcerative colitis.
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
_Posology: _
ULCERATIVE COLITIS
Treatment of active disease:
Adults: Individual dosage, up to 4 g given once daily or in divided
doses.
Maintenance treatment:
Adults: Individual dosage. Recommended dosage, 2 g mesalazine once
daily. Can also be taken in
divided doses.
_Method of administration: _
PENTASA tablets must not be chewed. To facilitate swallowing, the
tablets may be dispersed in 50 ml
of cold water. Stir and drink immediately.
CONTRAINDICATIONS
Hypersensitivity to mesalazine, any of the excipients, or salicylates.
Severe liver or renal impairment.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Most patients who are intolerant or hypersensitive to sulphasalazine
are able to take PENTASA
without risk of similar reactions. However, caution is recommended
when treating patients allergic to
sulphasalazine (risk of allergy to salicylates). Severe cutaneous
adverse reactions, including Stevens-
Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been
reported in association
with mesalazine treatment. In case of acute intolerance reactions such
as abdominal cramps, acute
abdominal pain, fever and severe headache and/or the first appearance
of signs and symptoms of
severe skin reactions, such as skin rash, mucosal lesions, or any