For UK Healthcare Professionals Only
Please refer to full SmPC text before prescribing. Adverse events should be reported.
Reporting forms and information can be found at: www.mhra.gov.uk/yellowcard or by searching for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Zydus Pharmaceuticals UK
Zyduco® XL 1200 mg Gastro-Resistant Prolonged-Release Tablet prescribing information
(Please refer to the full SmPC before prescribing - Click Here)
Prescribing Information: Zyduco® XL 1200 mg Gastro-Resistant Prolonged-Release Tablet.
Composition: Each tablet contains 1200 mg Mesalazine and <1mmol sodium (23 mg) per 4 tablets, essentially 'sodium-free'.
Always refer to the full Summary of Product Characteristics (SmPC) before prescribing.
Indication: Adults, including the elderly (>65 Years) - For induction and maintenance of clinical and endoscopic remission in patients with mild to moderate, active ulcerative colitis. Children and adolescents (weighing >50 kg and age ≥10 years) - For the induction and maintenance of clinical and endoscopic remission in patients with mild to moderate, active ulcerative colitis.
Dosage & Administration: Zyduco® XL is intended for once daily, oral administration. The tablets must not be crushed or chewed and should be taken with food. Adults, including the elderly (>65 years) - For induction of remission: 2.4 g to 4.8 g (2-4 tablets) should be taken once daily. The highest dose of 4.8g/day is recommended for patients not responding to lower doses of mesalazine. When using the highest dose (4.8 g/day), the effect of the treatment should be evaluated at 8 weeks. For maintenance of remission: 2.4 g (2 tablets) should be taken once daily. Children and adolescents (weighing >50 kg and age ≥10 years) - For induction of remission (initial 8 weeks): 2.4 g to 4.8 g (2-4 tablets) should be taken once daily.
For maintenance of remission: 2.4 g (two tablets) should be taken once daily. Mesalazine 1200mg tablets should not be used by paediatric patients weighing ≤50 kg and should not be used in paediatric patients <10 years of age.
Contraindications: History of hypersensitivity to salicylates (including Mesalazine) or any excipients of Zyduco® XL. Severe renal impairment (GFR <30 mL/min/1.73m2) and/or severe hepatic impairment.
Precautions and Warnings: Use cautiously in patients with mild to moderate renal impairment - renal function evaluations recommended before and during treatment. Patients with chronic lung impairment, especially asthma, should be monitored closely due to risk of hypersensitivity. Rarely, serious blood dyscrasias have been reported. If unexplained bleeding, bruising, or other symptoms occur, perform haematological investigations and terminate treatment if blood dyscrasia is suspected. Severe cutaneous adverse reactions (SCARs) like DRESS, SJS, and TEN have been reported - discontinue at the first sign of severe skin reactions. Nephrolithiasis has been reported with the use of Mesalazine, including stones with a 100% Mesalazine content. Ensure adequate fluid intake during treatment.
Interactions: Use caution when combining Mesalazine with nephrotoxic agents (e.g., NSAIDs, azathioprine) due to increased risk of renal adverse reactions. Concurrent use with azathioprine, 6-mercaptopurine, or other myelotoxic substances can increase the risk of blood dyscrasias and bone marrow failure. Combining mesalazine with coumarin-type anticoagulants (e.g., warfarin) may decrease anticoagulant activity. Monitor prothrombin time closely if this combination is necessary.
Pregnancy and lactation: Should be used during pregnancy only when the benefits outweigh risks. Exercise caution when using high doses of mesalazine. Exercise caution if using mesalazine while breast-feeding and only if the benefit outweighs the risks. Sporadically, acute diarrhoea is reported in breast fed infants.
Effects on ability to drive and use machinery: Zyduco® XL is considered to have negligible influence on these abilities. Adverse Events: Abdominal pain, headache, diarrhoea and nausea are the most frequently reported adverse events. Pancreatitis, pericarditis, skin rash that may be severe (eg, toxic epidermal necrolysis), and pneumonitis have been reported.
Overdose: In case of overdose, correct hypoglycaemia, fluid and electrolyte imbalance by administration of appropriate therapy. Maintain adequate renal function. Please refer to SmPC for full information on adverse events and management of overdose.
Legal Category: POM Price: 60 tablets Blister Pack £31.35 | 120 tablets Bottle Pack £60.95. Marketing Authorization Number: PLGB 58839/0018 Marketing Authorization Holder: Zydus Pharmaceuticals UK Ltd., Sandretto Building, Cavalry Hill Industrial Park, Weedon, Northampton, England NN74PP, UK
Date of Preparation: March 2025 code: ZUK/ZXL/API/25/03/01
