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Salofalk

Salofalk Dosage/Direction for Use

mesalazine

Manufacturer:

Dr. Falk

Distributor:

Zuellig

Marketer:

A. Menarini
Full Prescribing Info
Dosage/Direction for Use
Tablet: Take one tablet in the morning, at midday and in the evening one (1) hour before meals which should be swallowed whole with sufficient liquid.
The duration of therapy is determined by the physician.
In patients with bowel resection of the ileocoecal region with resection of the ileocoecal valve, in rare cases it was observed that Salofalk 500 mg Enteric-coated tablets were excreted undissolved with the faeces due to the too fast intestinal passage. In case of this observation, please contact the physician.
Granules: Dosage: Adults and the elderly: For the treatment of acute episodes of ulcerative colitis: Once daily, 1-2 sachets of Salofalk (equivalent to 1.5-3.0 g mesalazine daily) preferably to be taken in the morning according to the individual clinical requirement.
For the maintenance of remission of ulcerative colitis: The standard treatment is 0.5 g mesalazine 3 times daily (in the morning, at midday and in the evening) corresponding to a total dose of 1.5 g mesalazine per day.
For patients known to be at increased risk for relapse for medical reasons or due to difficulties to adhere to application of three daily doses, the dosing schedule can be adapted to 3.0 g mesalazine given as a single daily dose, preferably in the morning.
Paediatric population: There is only limited documentation for an effect in children (age 6-18 years).
Children 6 years of age and older: Active disease: To be determined individually, starting with 30-50 mg/kg bw/day once daily preferably in the morning or in divided doses. Maximum dose: 75 mg/kg bw/day. The total dose should not exceed the maximum adult dose.
Maintenance treatment: To be determined individually, starting with 15-30 mg/kg bw/day in divided doses. The total dose should not exceed the recommended adult dose.
It is generally recommended that half the adult dose may be given to children up to a body weight of 40 kg and the normal adult dose to those above 40 kg.
Method of administration: Granules: The contents of the sachets of Salofalk granules should not be chewed. The granules should be taken on the tongue and swallowed, without chewing, with plenty of liquid. Both in the treatment of acute inflammatory episodes and during long term treatment, Salofalk granules should be used on a regular basis and consistently in order to achieve the desired therapeutic effects.
The treatment of acute episodes of ulcerative colitis usually lasts 8 weeks. The duration of use is determined by the physician.
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