SALOFALK

0g 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 500mg granules three times daily, or 1 sachet of Salofalk 1000mg granules three times daily), if this is more convenient to the patient.

5g mesalazine per day. 0g 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 - 50mg/kg/day once daily preferably in the morning or in divided doses. Maximum dose: 75mg/kg/day. The total dose should not exceed the maximum adult dose.

Maintenance treatment:

To be determined individually, starting with 15 - 30mg/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 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). Photosensitivity More severe reactions are reported in patients with pre-existing skin conditions such as atopic dermatitis and atopic eczema. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

Blood tests (differential blood count; liver function parameters such as ALT or AST; serum creatinine) and urinary status (dip sticks) should be determined prior to and during treatment, at the discretion of the treating physician.

As a guideline, follow up tests are recommended 14 days after commencement of treatment, then a further two to three tests at intervals of 4 weeks. If the findings are normal, follow up tests should be carried out every 3 months. If additional symptoms occur, these tests should be performed immediately.

Caution is recommended in patients with impaired hepatic function. Salofalk granules should not be used in patients with impaired renal function. Mesalazine-induced renal toxicity should be considered if renal function deteriorates during treatment.

Cases of nephrolithiasis have been reported with the use of mesalazine including stones with a 100% mesalazine content. It is recommended to ensure adequate fluid intake during treatment. , in toilets cleaned with sodium hypochlorite contained in certain bleaches).

Patients with pulmonary disease, in particular asthma, should be very carefully monitored during a course of treatment with Salofalk granules. Severe cutaneous adverse reactions Severe cutaneous adverse reactions (SCARs), including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in association with mesalazine treatment.

Mesalazine should be discontinued, at the first appearance of signs and symptoms of severe skin reactions, such as skin rash, mucosal lesions, or any other sign of hypersensitivity. Patients with a history of adverse drug reactions to preparations containing sulphasalazine should be kept under close medical surveillance on commencement of a course of treatment with Salofalk granules.

1. • Severe impairment of hepatic or renal function.