SALOFALK

Posology Adults and older people One Salofalk 1g Suppository once daily (equivalent to 1 g mesalazine daily) inserted into the rectum. Paediatric population There is little experience and only limited documentation for an effect in children.

Duration of treatment The treatment of acute episodes of ulcerative colitis usually lasts 8 weeks. The duration of use is determined by the physician. Method of administration For rectal administration only. Salofalk 1g Suppositories should be administered preferably at bedtime.

Treatment with Salofalk 1g Suppositories must be administered regularly and consistently, because only in this way can healing be successfully achieved.

In clinical studies involving 248 participants, approximately 3% experienced adverse reactions while receiving Salofalk 1g suppositories. 4% each). 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 1g suppositories should be discontinued immediately. Cases of nephrolithiasis have been reported with the use of mesalazine including stones with a 100% mesalazine content. , 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 1g suppositories 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 1g suppositories 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