Salcrozine (mesalazine) – UK

Prescribing Information

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Salcrozine 500 mg & 1000 mg gastro-resistant tablets (mesalazine). Please refer to the Summaries of Product Characteristics (SmPCs) before prescribing.
Abbreviated Prescribing Information.
Presentation: Orange, oblong gastro-resistant tablets containing 500 mg or 1000 mg mesalazine.
Indications: Treatment of the acute phase of mild or moderate ulcerative colitis. Maintenance treatment of remission in ulcerative colitis.
Dosage and administration: Adults: The dosage should be adjusted according to patient response. The following dosage is recommended: Ulcerative colitis (acute phase): 1.5 - 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. The effect of the treatment should be evaluated 8 weeks after initiation. Ulcerative colitis (maintenance): 1.5 – 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 and for those who required higher doses during acute phase. Elderly: 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 <18 years 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. Modified release of mesalazine is dependent on an intact coating. The tablets should not be divided, chewed or crushed.
Contraindications: Hypersensitivity to the active substance or to any of the excipients. Pre-existing hypersensitivity to salicylic acid and its derivatives. Severe impairment of hepatic and renal function. Haemorrhagic diathesis.
Warnings and Precautions: Patients with severe liver or renal insufficiency. As mesalazine is eliminated mainly by acetylation and subsequent urinary excretion, patients with impaired liver function or renal failure should be closely monitored – it is advisable to perform liver and renal function tests before and regularly during treatment. Treatment 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. Ensure adequate fluid intake during treatment. There have been reports of increases in liver enzyme levels in patients taking preparations with mesalazine. 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. Carefully monitor patients with pulmonary diseases, particularly asthma. Cardiac hypersensitivity reactions induced by mesalazine have been rarely reported. Caution should be exercised when treating patients with conditions that predispose them to myocarditis or pericarditis. If there is a suspicion of a cardiac hypersensitivity reaction, products containing mesalazine should not be re-administered. Perform haematological investigations if patients suffer unexplained haemorrhages, bruises, purpura, anaemia, fever or pharyngolaryngeal pain. Stop treatment in case of suspected blood dyscrasia. Use with caution in patients with gastric or duodenal ulcers. Blood tests (differential blood count; liver function tests such as ALT and serum creatinine) should be determined prior to and during treatment. Severe cutaneous adverse reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported. Stop treatment immediately at first signs and symptoms of severe skin reactions. Mesalazine may produce red-brown urine discoloration after contact with sodium hypochlorite bleach (e.g., in toilets cleaned with sodium hypochlorite contained in certain bleaches). Salcrozine is considered high in sodium. This should be particularly taken into account for those on a low salt diet. Salcrozine 500 mg & 1000 mg gastro-resistant tablets contain 49 mg and 98 mg sodium per tablet, respectively, which is equivalent to 2.5 % and 5 % of the WHO recommended maximum daily dietary intake of 2 g sodium for an adult, respectively.
Interactions: Mesalazine can: reduce the anticoagulant activity of anticoagulants derived from coumarin, such as warfarin; enhance the glucose-lowering effects of sulfonylureas; antagonize the uricosuric effects of probenecid and sulfinpyrazone; express the toxicity of salicylates at lower doses than usual when administered with furosemide; increase the risk of adverse renal reactions with the concomitant use of known nephrotoxic agents, including NSAIDs and azathioprine; decrease the natriuretic effect of spironolactone; delay the excretion of methotrexate; increase the myelosuppressive effects of azathioprine, 6-mercaptopurine or thioguanine – use caution with concomitant use and monitor haematological parameters regularly. Lactulose-type laxatives or similar can prevent the release of mesalazine from the gastro-resistant tablet, which would reduce its effect.
Fertility, pregnancy and lactation: Only to be used during pregnancy and lactation when the potential benefits outweigh the possible hazards. There are no adequate and well controlled studies of mesalazine use in pregnant women. There are no or limited data on the effect of mesalazine on fertility in humans. Refer to the SmPCs for full information.
Effects on ability to drive and use machines: Salcrozine is considered to have negligible influence on the ability to drive and use machines.
Undesirable effects: Rare (≥ 1/10 000 to < 1/1 000): Headache, dizziness, myocarditis, pericarditis, discomfort, nausea, abdominal pain, diarrhoea, flatulence, vomiting, photosensitivity (more severe reactions have been reported in patients with pre-existing skin conditions, such as atopic dermatitis and atopic eczema.). Very rare (< 1/10 000): Altered blood counts (agranulocytosis, pancytopenia, leukopenia, neutropenia, thrombocytopenia, aplastic anaemia), hypersensitivity reactions such as allergic exanthema, drug fever, lupus erythematosus syndrome, pancolitis, peripheral neuropathy, allergic lung reactions (dyspnoea, cough, allergic alveolitis, eosinophilic pneumonia, lung infiltration, pneumonitis), acute pancreatitis, worsening of colitis symptoms, changes in liver function parameters (increase in transaminases and cholestasis parameters), hepatitis, cholestatic hepatitis, alopecia, erythema multiforme, myalgia, arthralgia, interstitial nephritis, renal insufficiency, nephrotic syndrome, oligospermia (reversible). Not known: Severe cutaneous adverse reactions (including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), nephrolithiasis. Consult the SmPC in relation to other adverse reactions.
Overdose: Refer to SmPCs.
Legal Category: POM.
NHS Price: 500 mg gastro-resistant tablets: Pack of 100 tablets: £21.52
1000 mg gastro-resistant tablets: Pack of 60 tablets: £25.82.
Marketing Authorisation Holder: Faes Farma, S.A. Máximo Aguirre, 14 48940 - Leioa (Bizkaia), Spain
MA Number: 500 mg gastro-resistant tablets: PL 18945/0002. 1000 mg gastro-resistant tablets: PL 18945/0006.
Full prescribing information available from: Galen Limited, Seagoe Industrial Estate, Craigavon, BT63 5UA, UK.
Date of Preparation: January 2023.

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