MECOLZINE Suppository Ref.[50655] Active ingredients: Mesalazine

Therapy with Mecolzine 500 mg suppositories 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.

Patients with impaired renal function and/or impaired hepatic function should be carefully monitored. In case of renal function deterioration during treatment, mesalazine-induced nephrotoxicity should be considered.

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.

In patients with respiratory disease, in particular asthma, strict medical monitoring is recommended during mesalazine therapy.

In patients with a history of hypersensitivity to sulfasalazine, Mecolzine 500 mg suppositories 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.

Cardiac hypersensitivity reactions (myocarditis, and pericarditis) induced by mesalazine have been rarely reported.

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.

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

Severe cutaneous adverse reactions (SCARs), including 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.

No specific interaction studies have been performed.

Concomitant use of nephrotoxic medicines such as NSAIDs and azathioprine may increase the risk of renal toxicity.

Mesalazine may increase the myelosuppressive effects of azathioprine, 6-mercaptopurine, and thioguanine.

Mesalazine may reduce the effect of warfarin.

Mesalazine should not be used during pregnancy and lactation except when the potential benefits of the treatment outweigh the possible hazards in the opinion of the physician. The underlying condition itself (Inflammatory bowel disease (IBD)) may increase risks for the pregnancy outcome.

Pregnancy

Mesalazine is known to cross the placental barrier and its concentration in umbilical cord plasma is lower than the concentration in maternal plasma. The metabolite acetyl-mesalazine is found at similar concentrations in umbilical cord and maternal plasma. Animal studies on oral mesalazine do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition or postnatal development. There are no adequate and well controlled studies of /…/ use in pregnant women. Limited published human data on mesalazine show no increase in the overall rate of congenital malformations. Some data show an increased rate of preterm birth, stillbirth, and low birth weight; however, these adverse pregnancy outcomes are also associated with active inflammatory bowel disease.

Blood disorders (leucopenia, thrombocytopenia, anaemia) have been reported in new-borns of mothers being treated with Quintasa Sachet.

In one single case after long-term use of a high dose of mesalazine (2-4g, orally) during pregnancy, renal failure in a neonate was reported.

Breast-feeding

Mesalazine is excreted in breast milk. The mesalazine concentration in breast milk is lower than in maternal blood, whereas the metabolite – acetyl-mesalazine – appears in similar or increased concentrations. No controlled studies with mesalazine during breast-feeding have been carried out. Only limited experience during lactation in women after oral application is available to date. Hypersensitivity reactions like diarrhoea can not be excluded. If the infant develops diarrhoea, breastfeeding should be discontinued.

Fertility

Animal data on Mesalazine show no effect on male and female fertility.

The effects on the ability to drive and the use of machines have not been studied.

The frequency of undesirable effects listed below has been defined on the basis of the following convention (MedDRA Convention): 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)).

^* Photosensitivity
More severe reactions are reported in patients with pre-existing skin conditions such as atopic dermatitis and atopic eczema.
^** Frequency not known: nephrolithiasis (see section 4.4 for further information).
^*** Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in association with mesalazine treatment (see section 4.4).

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. Healthcare professionals are asked to report any suspected adverse reactions via the ADR Reporting Website: www.medicinesauthority.gov.mt/adrportal. By reporting side affects you can help provide more information on the safety of this medicine.

Not applicable.