SALOFALK GASTRO- RESISTANT PROLONGED-RELEASE GRANULES 1G/ SACHET [SIN14427P]

Product Info

SALOFALK GASTRO- RESISTANT PROLONGED-RELEASE GRANULES 1G/ SACHET

[SIN14427P]

4.1 Therapeutic indications

For the treatment of acute episodes and the maintenance of remission of ulcerative colitis.

4.2 Posology and method of administration

Posology

Adults and the elderly
For the treatment of acute episodes of ulcerative colitis
Once daily, 1 sachet of Salofalk granules 3g, 1–2 sachets of Salofalk granules 1.5g, 3 sachets of Salofalk granules 1g or 3 sachets of Salofalk granules 500mg (equivalent to 1.5–3.0 g 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 Salofalk granules 500mg 3 times daily or 1 sachet of Salofalk granules 1g 3 times daily) if this is more convenient to the patient.

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.

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
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 duration of use is determined by the physician.

4.3 Contraindications

Salofalk granules are contra-indicated in patients with

• hypersensitivity to the active substance, to salicylates or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

• severe impairment of hepatic or renal function.