SALCROZINE

Posology During the acute inflammatory phase and in long-term maintenance therapy, the patient must accurately follow the treatment established by the doctor to ensure the intended therapeutic effect. Adults The dosage should be adjusted according to patient response.

5 - 4 g mesalazine daily, once daily or in divided doses. The dose of 4 g is recommended for patients who do not respond to lower doses of mesalazine. The effect of the treatment should be evaluated 8 weeks after initiation. 5 – 3 g mesalazine daily, once daily or in divided doses.

The dose of 3 g is recommended for patients who do not respond to lower doses of mesalazine and for those who required higher doses during acute phase. Elderly No studies have been carried out. Administration of Salcrozine 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 aged younger than 18 years of age has not been established. Do not administer to children under 5 years. Method of administration Oral use. The tablets must be administered before meals and must be taken whole with some fluid.

Salcrozine gastro-resistant tablets consist of a mesalazine-containing core and an inert coating. Modified release of mesalazine is dependent on an intact coating. For this reason, the tablets should not be divided, chewed or crushed.

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) and not known (cannot be estimated from the available data).

Frequency According to MedDRA ConventionOrgan Class System 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 Altered blood counts (agranulocytosis, pancytopenia, disorders leukopenia, neutropenia, thrombocytopenia, aplastic anaemia) Immune system disorders Hypersensitivity reactions such as allergic exanthema, drug fever, lupus erythematosus syndrome, pancolitis.

4) Cardiac disorders Myocarditis, pericarditis. Respiratory, thoracic and mediastinal disorders Allergic lung reactions (dyspnoea, cough, allergic alveolitis, eosinophilic pneumonia, lung infiltration, pneumonitis). Gastrointesti nal disorders Discomfort, nausea, abdominal pain, diarrhoea, flatulence, 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)** Musculoskele tal and connective tissue disorders Myalgia, arthralgia. Renal and Interstitial nephritis, Nephrolithiasis urinary disorders renal insufficiency, nephrotic syndrome.

Reproductive system and breast disorders Oligospermia (reversible). * Photosensitivity More severe reactions have been 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.

• Patients with severe liver or renal insufficiency. As mesalazine, also known as 5-aminosalicylic acid (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). • Patients with a history of hypersensitivity to sulfasalazine should be kept under close medical surveillance. In case of acute intolerance reactions, such as abdominal cramps, acute abdominal pain, fever, severe headache and rashes, treatment should be discontinued immediately.

• Patients with pulmonary diseases, particularly asthma, should be carefully monitored during treatment. • Cardiac hypersensitivity reactions induced by mesalazine (myo- and pericarditis) have been rarely reported. Caution should be exercised when treating patients, with conditions that predispose them to myocarditis or pericarditis, with mesalazine.

If there is a suspicion of a cardiac hypersensitivity reaction, products containing mesalazine should not be re- administered. • In rare occasions, serious blood dyscrasias have been reported after treatment with mesalazine. Haematological investigations should be performed if patients suffer unexplained haemorrhages, bruises, purpura, anaemia, fever or pharyngolaryngeal pain.

1 - Pre-existing hypersensitivity to salicylic acid and its derivatives - Severe impairment of hepatic and renal function - Haemorrhagic diathesis