SALOFALK

Negara: Indonesia

Bahasa: Bahasa Indonesia

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

Bahan aktif:

MESALAZINE

Tersedia dari:

DARYA-VARIA LABORATORIA TBK - Indonesia

INN (Nama Internasional):

MESALAZINE

Dosis:

250 MG

Bentuk farmasi:

TABLET SALUT ENTERIK

Unit dalam paket:

DUS, 10 BLISTER @ 10 TABLET SALUT ENTERIK

Diproduksi oleh:

DR. FALK PHARMA GMBH - Germany

Tanggal Otorisasi:

2016-10-12

Karakteristik produk

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
SALOFALK
®
Mesalazine (5-aminosalicylic acid)
Enteric-coated tablet 250 mg
2
COMPOSITION
Each tablet contains 250 mg mesalazine.
Excipients with known effect: sodium carbonate
For the full list of excipients, see section “Pharmaceutical
particulars” further down.
3
DOSAGE FORM
Enteric-coated tablet
Appearance: round, butter-yellow to ochre, enteric-coated tablets,
matt with smooth surface; they are not
scored.
4
CLINICAL PARTICULARS
4.1
INDICATIONS
Ulcerative colitis, for treatment of mild to moderate acute phases and
prevention of recurrences.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults and elderly
Depending upon the clinical requirements in individual cases, the
following daily doses are
recommended.
For treatment of acute episodes: 1,5g to 3,0g mesalazine daily in
three divided doses (six to 12 tablets
daily in three divided doses).
For the maintenance of remission: 1,5g mesalazine in three divided
doses (six tablets daily in three
divided doses – two 250 mg tablets three times a day).
Method of Administration: Oral
General instructions for use
Salofalk tablets should be taken in the morning, at midday and in the
evening, 1 hour before meals. They
should be swallowed whole, not chewed and taken with plenty of fluid.
DISETUJUI OLEH BPOM: 01/06/2023
ID REG: EREG10008712100115
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Treatment with Salofalk tablets should be administered regularly and
consistently, both in the acute
inflammatory stage and during maintenance therapy in order to achieve
the desired therapeutic effect.
The duration of use is determined by the physician.
4.3
CONTRAINDICATIONS
Salofalk tablets are contraindicated in cases of
-
Hypersensitivity to the active substance, salicylates or to any of the
excipients listed in section
“Pharmaceutical particulars”.
-
Severe impairment of hepatic or renal function.
-
Gastric and duodenal ulcers
-
Haemorrhagic diathesis (presdisposition to bleeding)
-
Infants and young children
4.4
WARNINGS AND PRECAUTIONS
Bloo