SALOFALK

Adults and elderly:

Two administrations once a day at bedtime. 4. The canister is first fitted with an applicator and then shaken for about 20 seconds before the applicator is inserted into the rectum as far as comfortable. To administer a dose of Salofalk, the pump dome is fully pushed down and released.

Note that the spray will only work properly when held with the pump dome pointing down. Following the first or second activation depending upon need (see below) the applicator should be held in position for 10-15 seconds before being withdrawn from the rectum.

If the patient has difficulty in holding this amount of foam, the foam can also be administered in divided doses: one at bedtime and the other during the night (after evacuation of the first single dose) or in the early morning. The best results are obtained when the intestine is evacuated prior to administration of Salofalk rectal foam.

In general, an acute episode of a mild ulcerative colitis subsides after 4-6 weeks. , Salofalk prolonged release granules at a dosage recommended for this preparation.

Paediatric population:

There is little experience and only limited documentation for an effect in children. Duration of treatment The duration of use is determined by the physician. Method of Administration rectal.

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. Mesalazine should not be used in patients with impaired renal function. Mesalazine-induced renal toxicity should be considered if renal function deteriorates during treatment.

If this is the case, Salofalk rectal foam should be discontinued immediately. 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). Serious blood dyscrasias have been reported very rarely with mesalazine. Hematological investigations should be performed if patients suffer from unexplained haemorrhages, bruises, purpura, anaemia, fever or pharyngolaryngeal pain.

Salofalk rectal foam should be discontinued in case of suspected or confirmed blood dyscrasia. Cardiac hypersensitivity reactions (myocarditis, and pericarditis) induced by mesalazine have been rarely reported. Salofalk rectal foam should then be discontinued immediately Patients with pulmonary disease, in particular asthma, should be very carefully monitored during a course of treatment with mesalazine 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.

1 - severe impairment of hepatic or renal function Caution: Asthmatics should be treated with care with Salofalk since sulphite contained in the foam may cause hypersensitivity reactions