MECOLZINE Gastro-resistant tablet Ref.[50654] Active ingredients: Mesalazine

Patients with severe liver or renal insufficiency. 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 Mecolzine 500 mg gastro-resistant tablets 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.

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 Mecolzine 500 mg gastro-resistant tablets is given to patients with hepatic impairment. (see 4.3 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 mesalazine with 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.

In rare occasions, serious blood dyscrasias have been reported after treatment with mesalazine. Hematological investigations should be performed if patient suffering unexplained haemorrhages, bruises, purpura, anaemia, fever or pharyngolaryngeal pain. Treatment with Mecolzine 500 mg gastro-resistant tablets should be discontinued in case of suspected blood dyscrasia (see sections 4.3 and 4.5).

Caution is recommended when treating patients with active gastric or duodenal ulcer.

Mecolzine 500 mg gastro-resistant tablets should not be administered concomitantly with lactose-type laxatives or the like, since it lowers the pH of the faeces and may prevent the release of the active ingredient.

Blood tests (differential blood count; liver function tests such as ALT and serum creatinine) should be determined prior to and during treatment, at the discretion of the treating physician.

This medicine contains 49 mg sodium (main component of cooking/table salt) in each tablet. This is equivalent to 2.5% of the recommended maximum daily dietary intake of sodium for an adult.

In common with other salicylates, 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 sulfinpirazone.
• Express the toxicity of salicylates at lower doses than usual when administered with furosemide due to competition for renal excretion sites.
• Increase the risk of adverse renal reactions with the concomitant use of known nephrotoxic agents, including nonsteroidal anti-inflammatory drugs (NSAIDs) and azathioprine.
• Increase the myelosuppressive effects of azathioprine, 6-mercaptopurine or thioguanine. Caution is advised in patients treated with azathioprine, 6-mercaptopurine or thioguanine and mesalazine since it may increase the possibility of blood dyscrasias. The haematological parameters (especially leukocytes and thrombocytes) should be monitored regularly, especially at the beginning of such a therapeutic combination.
• Decrease the natriuretic effect of spironolactone.
• Mesalazine may delay the excretion of methotrexate.
• Lactose-type laxatives or similar can prevent the release of mesalazine from the tablet, which would reduce its effect (see section 4.4 Special warnings and special precautions for use).

Pregnancy

Limited experience with mesalazine in pregnancy does not indicate an increased risk of drug induced congenital malformations. Mesalazine crosses the placental barrier, but provides foetal concentrations much lower than those seen with adult therapeutic use. Animal studies do not indicate harmful effects of mesalazine in pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3). Mesalazine should be used during pregnancy only if the potential benefit outweighs the possible risk. Caution should be exercised when using high doses of mesalazine.

Breast-feeding

Mesalazine is excreted in breast milk at low concentration. Acetylated form of mesalazine is excreted in breast milk at higher concentration. Caution should be exercised if using Mesalazine while breastfeeding and only if the benefit outweighs the risks. Sporadically acute diarrhoea has been reported in breast fed infants, in this instance breast-feeding should be discontinued.

Fertility

Studies in animals have shown no effects of mesalazine on fertility (see section 5.3). There are no or limited data on the effect of mesalazine on fertility in humans.

No studies on the effects on the ability to drive and use machines have been performed. Mecolzine 500 mg gastro-resistant tablets is considered to have negligible influence on these abilities.

^* With unknown frequency, the following disorders have been described: erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis.
On very rare occasions, (<1/10,000) exacerbation of colitis symptoms has been observed.
^** Photosensitivity

More severe reactions have been 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. Healthcare professionals are asked to report any suspected adverse reactions via ADR Reporting Website: www.medicinesauthority.gov.mt/adrportal.

Not applicable.