SALCROZINE

Posology Individual dose adjustments should be done according to the physician's criteria, depending on the patient's characteristics and intensity of symptoms. The recommended dose in adults in distal Ulcerative Colitis (proctitis) is: - Treatment of mild or moderate acute exacerbations: one suppository twice or thrice daily (corresponding to a daily dose of 1000-1500 mg of mesalazine).

- Maintenance of remission: one suppository once or twice daily (corresponding to a daily dose of 500-1000 mg of mesalazine). Elderly No studies have been carried out. Administration of this medicine in the elderly must be performed with caution and always limited to patients with normal renal function.

Paediatric population The safety and efficacy of Mesalazine in children and adolescents has not been established. Salcrozine is not recommended to be given to children and adolescents. Do not administer to children 5 years or less.

Method of administration:

Salcrozine should be used regularly and consistently, either during the acute phase or during the long-term therapy of the maintenance phase, to achieve the intended effect. It is recommended to empty the bowel before administration of the suppository.

Suppositories should be introduced with the patient lying on the left side, and it is advisable to remain in this position for about 1 hour. Suppositories should be introduced deeply into the anus and should be retained in the rectum for 1-3 hours to increase the efficacy.

Adverse reactions are listed in the table below by system organ class and frequency. Frequencies are defined as: very common (≥1/10); common (≥ 1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare: (<1/10,000); Not known (cannot be estimated from the available data).

System Organ Class MedDRA Frequency Convention Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000); Not Known (Cannot be estimated from the available data) Blood and lymphatic system disorders Altered blood counts (agranulocytosis, pancytopenia, leukopenia, neutropenia, thrombocytopenia, aplastic anaemia).

Hypereosinophilia Immune system disorders Hypersensitivity reactions such as allergic exanthema, drug fever, lupus erythematosus syndrome, pancolitis. Nervous system disorders Headache, dizziness Peripheral neuropathy. 4) Cardiac disorders Myocarditis, pericarditis.

Respiratory, thoracic and mediastinal disorders Allergic lung reactions (dyspnoea, cough, allergic alveolitis, eosinophilic pneumonia, lung infiltration, pneumonitis). Gastrointestinal disorders Discomfort and abdominal pain, diarrhoea, flatulence, nausea, vomiting.

Acute pancreatitis. Worsening of colitis symptoms. Hepatobiliary disorders Changes in liver function parameters (increase in transaminases and cholestasis parameters), hepatitis, cholestatic hepatitis. Skin and subcutaneous tissue disorders Photosensitivity* Alopecia.

Erythema multiforme Drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens- Johnson syndrome (SJS), toxic epidermal necrolysis (TEN)** Musculoskeletal and connective tissue disorders Myalgia, arthralgia. Renal and urinary disorders Interstitial nephritis, renal insufficiency, nephrotic syndrome.

Nephrolithiasis Reproductive system and breast disorders Oligospermia (reversible). *Photosensitivity More severe reactions are reported in patients with pre-existing skin conditions such as atopic dermatitis and atopic eczema. 4). 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.

Therapy with Salcrozine should be performed under medical supervision. - Blood tests (complete blood count, liver function parameters such as transaminases, creatinine) and urine tests, should be performed two weeks after starting therapy and at intervals every 4 weeks for 3 months.

If the findings are normal, follow up tests should be carried out every 3 months. If additional symptoms appear the tests should be performed immediately. - As 5-ASA is eliminated mainly by acetylation and subsequent urinary excretion, patients with impaired liver function or renal failure should be closely monitored, so it is advisable to perform liver and renal function tests before instituting treatment and regularly during it.

Treatment with Salcrozine should be stopped immediately if there is evidence of renal deterioration. In patients who develop renal impairment during treatment, mesalazine-induced nephrotoxicity should be suspected. - 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. - There have been reports of increases in liver enzyme levels in patients taking preparations with mesalazine. Liver function should be evaluated before and during treatment according to medical criteria.

Caution is advised if Salcrozine is given to patients with hepatic impairment. 3 Contraindications). - In patients with a history of hypersensitivity to sulfasalazine, Salcrozine therapy should also be performed under close medical supervision.

If acute signs of intolerance, such as spasms, acute abdominal pain, fever, headache and severe skin rash occur, therapy should be discontinued immediately. - In patients with respiratory disease, in particular asthma, strict medical monitoring is recommended during mesalazine therapy.

- Cardiac hypersensitivity reactions (myocarditis, and pericarditis) induced by mesalazine have been rarely reported. They are generally rapidly reversible on discontinuation of treatment, but uncertainty about the mechanism (direct toxicity or hypersensitivity) formally contraindicates any reintroduction.

- Serious blood dyscrasias have been reported very rarely with mesalazine. Concomitant treatment with mesalazine may increase the risk of blood dyscrasia in patients receiving azathioprine or 6-mercaptopurine. Treatment should be discontinued if there is suspicion or certainty of occurrence of these adverse reactions.

- In rare occasions, serious blood dyscrasias have been reported after treatment with mesalazine. Haematological investigations should be performed if patient suffering unexplained haemorrhages, bruises, purpura, anaemia, fever or pharyngolaryngeal pain.

5). - Caution is recommended when treating patients with active gastric or duodenal ulcer. - 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. , in toilets cleaned with sodium hypochlorite contained in certain bleaches).

- 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.

1. - Pre-existing hypersensitivity to salicylic acid and its derivatives. - Severe renal impairment and severe liver impairment.