SALOFALK 250 SUPPOSITORIES

מדינה: מלזיה

שפה: אנגלית

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

מרכיב פעיל:

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

זמין מ:

DCH AURIGA (MALAYSIA) SDN. BHD.

INN (שם בינלאומי):

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

יחידות באריזה:

30 Pieces Pieces

תוצרת:

VIFOR AG

מאפייני מוצר

611101001MAL148 x 210 TypoData 2
Instructions for use – please read carefully!
Salofalk ® 250 mg Suppositories
Composition:
1 Salofalk ®250 mg suppository contains:
Mesalazine (5-aminosalicylic acid) 250 mg
Other ingredient:
Hard fat
Indications
Ulcerative colitis (treatment of acute attack, treatment to prevent recurrence).
Contraindications
Salofalk
®250 mg suppositories must not be taken in:
– hypersensitivity to salicylic acid and its derivatives or one of the other ingredient
– severe liver and kidney function disturbances
– gastric and duodenal ulcers
– haemorrhagic diathesis (predisposition to bleeding)
Salofalk
®250 mg suppositories should not be used to treat infants and small children because of
insufficient experience with this age group.
Administration during pregnancy and lactation:
In the first three months of pregnancy mesalazine should only be used if strictly indicated. Wherever possible,
women wishing to have children should wait for a phase when as little as possible or no medication is
required before beginning pregnancy. If the individual's condition allows, treatment should be interrupted
in the last 2 – 4 weeks of pregnancy. As yet there is insufficient experience with the medicament during
breast-feeding. If treatment becomes necessary during lactation, the child should be weaned.
Side effects
Gastrointestinal side effects
Abdominal discomfort, diarrhoea, flatulence, nausea and vomiting have been reported rarely.
Central nervous system side effects
In isolated cases under treatment with mesalazine central nervous phenomena such as headache and
dizziness have been observed.
Hypersensitivity reactions
Hypersensitivity reactions that are not dose-dependent and are common to salicylic acid and its derivatives
such as allergic rush, drug fever, bronchospasm, peri- and myocarditis, acute pancreatitis and interstitial
nephritis are possible in rare cases.
Sporadic cases of allergic alveolitis have been observed during treatment with mesalazine. In isolated
cases pancolitis may