Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2023 Publisher: Dr. Falk Pharma GmbH, Leinenweberstr. 5, 79108 Freiburg, Germany, Tel.: +49 (0)761 1514-0, Fax: +49 (0)761 1514-321, E-mail: zentrale@drfalkpharma.de, www.drfalkpharma.de
For the treatment of acute episodes of mild to moderate ulcerative colitis.
The recommended daily dose for the treatment of acute episodes of mild to moderate ulcerative colitis is one Salofalk 1g tablet three times a day (morning, midday and evening, equivalent to 3g of mesalazine daily).
There is only limited documentation for an effect in children (age 6-18 years).
The dose should be determined individually, starting with 30-50 mg/kg/day in divided doses.
Maximum dose: 75mg/kg/day. The total dose should not exceed the maximum adult dose.
It is generally recommended that half the adult dose may be given to children up to a body weight of 40kg and the normal adult dose to those above 40kg.
In children below 40kg, it appears preferable to use mesalazine preparations of lower strengths (e.g., Salofalk 500mg gastro-resistant tablets or Salofalk 500mg gastro-resistant prolonged-release granules).
Salofalk 1g tablets should be taken 1 hour before meals. They should be swallowed whole, not chewed and taken with plenty of fluid.
Therapy with Salofalk 1g tablets should be administered regularly and consistently in order to achieve the desired therapeutic effect.
The duration of use is determined by the physician. Induction of remission is usually achieved within 8 weeks.
Note: The standard treatment of the maintenance of remission is 500mg mesalazine three times daily. For this indication tablets containing 500mg mesalazine (e.g., Salofalk 500mg gastro-resistant tablets) are available.
There are rare data on overdose (e.g. intended suicide with high oral doses of mesalazine), which do not indicate renal or hepatic toxicity. There is no specific antidote and treatment is symptomatic and supportive.
3 years.
This medicinal product does not require any special storage conditions.
Blister: PVC/PVDC (orange-transparent)/aluminium blister foil
Package sizes: Blister packs with 20, 50, 60, 90,100 and 150 Salofalk 1g tablets.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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