SALOFALK

Country: Indoneżja

Lingwa: Indoneżjan

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

Ingredjent attiv:

MESALAZINE

Disponibbli minn:

DARYA-VARIA LABORATORIA TBK - Indonesia

INN (Isem Internazzjonali):

MESALAZINE

Dożaġġ:

500 MG

Għamla farmaċewtika:

SUPPOSITORIA

Unitajiet fil-pakkett:

DUS, 6 STRIP @ 5 SUPPOSITORIA

Manifatturat minn:

DR. FALK PHARMA GMBH - Germany

Data ta 'l-awtorizzazzjoni:

2017-01-31

Karatteristiċi tal-prodott

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
SALOFALK
®
Mesalazine (5-aminosalicylic acid)
Suppositories 500 mg
2
COMPOSITION
Each Salofalk suppository contains 500 mg mesalazine.
Excipient with known effect: cetyl alcohol
For the full list of excipients, see section “Pharmaceutical
particulars” further down.
3
DOSAGE FORM
Suppository
White to cream-coloured torpedo shaped suppositories, even consistency
and undamaged smooth surface
4
CLINICAL PARTICULARS
4.1
INDICATIONS
Treatment of acute episodes of mildly to moderately active ulcerative
proctitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Posology
Adults and the elderly:
One Salofalk
®
500 suppository three times daily (equivalent to 1500 mg mesalazine
daily) inserted into the rectum,
according to the individual clinical requirement.
The dosage should be adjusted to suit the progress of the condition.
Do not discontinue treatment suddenly.
Method of administration
Rectal
4.3
CONTRAINDICATIONS
Salofalk
suppositories are contraindicated in cases of
-
Severe impairment of renal or hepatic function.
-
Hypersensitivity to the active substance, salicylates or to any of the
excipients listed in section
“Pharmaceutical Particulars”.
-
Gastric and duodenal ulcers.
-
Haemorrhagic diathesis (presdisposition to bleeding).
DISETUJUI OLEH BPOM: 01/06/2023
ID REG: EREG10008712100119
Salofalk® 500 suppositories should not be used to treat infants and
small children because of insufficient experience
with this age group.
4.4
WARNINGS AND PRECAUTIONS
Blood tests (differential blood count; liver function parameters such
as ALT or AST; serum creatinine) and urinary
status (dip-sticks) should be determined prior to and during
treatment, at the discretion of the treating physician. As
a guideline, follow-up tests are recommended 14 days after
commencement of treatment, then a further two to three
tests at intervals of 4 weeks.
If the findings are normal, follow-up tests should be carried out
every 3 months. If additional symptoms occur, these
te