OCTASA

Posology Adults and older people:

Acute treatment One Octasa 1 g Suppository once daily (equivalent to 1 g mesalazine daily) inserted into the rectum. Maintenance treatment One Octasa1 g 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. Method of administration For rectal administration only. Octasa 1 g Suppositories should be administered preferably at bedtime.

Treatment with Octasa 1 g Suppositories must be administered regularly and consistently, because only in this way can healing be successfully achieved. Duration of treatment The duration of use is determined by the physician.

In clinical studies involving 248 participants, approximately 3% experienced adverse reactions while receiving mesalazine 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 or 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. Octasa 1 g Suppositories 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. Idiopathic intracranial hypertension Idiopathic intracranial hypertension (pseudotumor cerebri) has been reported in patients receiving mesalazine.

Patients should be warned for signs and symptoms of idiopathic intracranial hypertension, including severe or recurrent headache, visual disturbances or tinnitus. If idiopathic intracranial hypertension occurs, discontinuation of mesalazine should be considered.

Patients with pulmonary disease, in particular asthma, should be very carefully monitored during a course of treatment with Octasa 1 g Suppositories. 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 Octasa 1 g Suppositories.

Should Octasa 1 g Suppositories cause acute intolerance reactions such as abdominal cramps, acute abdominal pain, fever, severe headache and rash, therapy should be discontinued immediately. g. in toilets cleaned with sodium hypochlorite contained in certain bleaches).

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.

1 - severe impairment of hepatic or renal function