Posology : מינונים

4.2            Posology and method of administration

Posology:
Adults and elderly:

For the treatment of acute episodes of ulcerative colitis:

Once daily 1 sachet of Rafassal 3 gram Granules, 1 or 2 sachets of Rafassal 1.5 gram Granules, or 3 sachets of Rafassal 1 gram Granules (equivalent to 1.5- 3 gram mesalazine daily) preferably to be taken in the morning according to the individual clinical requirement.

It is also possible to take the prescribed daily dose in three divided doses (1 sachet of Rafassal 1 gram Granules three times daily) if this is more convenient to the patient.

For the maintenance of remission of ulcerative colitis:
Total dose of 1.5 gram mesalazine per day as a single daily dose. For patients known to be at increased risk for relapse for medical reasons, the dosing schedule can be adapted to 3 gram 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/day once daily preferably in the morning or in divided doses. Maximum dose: 75 mg/kg/day.
The total dose should not exceed the maximum adult dose.
Maintenance treatment: To be determined individually, starting with 15-30 mg/kg/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
The contents of the sachets of Rafassal 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, Rafassal Granules should be used on a regular basis and consistently in order to achieve the desired therapeutic effects.

The duration of use is determined by the physician.