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MESALAZINE FERRING is a brand name for Mesalamine (also known as Mesalazine). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Mesalazine Ferring Enema is indicated for the treatment of ulcerative colitis affecting the distal colon and rectum.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology:
Ulcerative Colitis Adult dose: The recommended dosage is one enema at bedtime.
Paediatric population:
There is little experience and only limited documentation for an effect in children Method of administration: For rectal use. A visit to the toilet is recommended before administration, see separate instructions for use. Shake the enema container well before use.
The enema is protected by an aluminium foil bag and should be used immediately after opening of the bag
8. Mesalazine-induced cardiac hypersensitivity reactions (myo- and pericarditis) have been reported rarely. 5). Blood tests for differential blood counts is recommended prior to and during treatment, at the discretion of the treating physician.
Treatment should be discontinued on suspicion or evidence of these adverse reactions. Idiopathic intracranial hypertension Idiopathic intracranial hypertension (pseudotumor cerebri) has been reported in patients receiving mesalazine.
Patients should be warned for signs and symptoms of idiopathic intracranial hypertension, including severe or recurrent headache, visual disturbances or tinnitus. If idiopathic intracranial hypertension occurs, discontinuation of mesalazine 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. As a guideline, follow-up tests are recommended 14 days after commencement of treatment, then a further two to three tests at intervals of 4 weeks.
If the findings are normal, follow-up tests should be carried out every three months. If additional symptoms occur, these tests should be performed immediately. If a patient develops dehydration while on treatment with mesalazine, normal electrolyte levels and fluid balance should be restored as soon as possible.
g. in toilets cleaned with sodium hypochlorite contained in certain bleaches). 5 Interaction with other medicinal products and other forms of interaction No interaction studies have been performed. Combination therapy with Mesalazine Ferring and azathioprine, or 6-mercaptopurine, or thioguanine, have shown a higher frequency of myelosuppressive effects, and an interaction cannot be ruled out, however, the mechanism behind the interaction is not established.
Caution is recommended when treating patients allergic to sulphasalazine (risk of allergy to salicylates). Severe cutaneous adverse reactions (SCARs), including Drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in association with mesalazine treatment.
e. abdominal cramps, abdominal pain, fever and severe headache, and/or the first appearance of signs and symptoms of severe skin reactions, such as skin rash, mucosal lesions, or any other signs of hypersensitivity, the treatment should be discontinued immediately.
Caution is recommended in patients with impaired liver function. Liver function parameters like ALT or AST should be assessed prior to and during treatment, at the discretion of the treating physician. Renal impairment The drug is not recommended for use in patients with impaired renal function and in patients with haemorrhagic diathesis.
Baseline renal function measurement is required in all patients initiating treatment with mesalazine. Urinary status (dip sticks) should be determined prior to and during treatment at the discretion of the treating physician. g. serum creatinine), especially during the initial phase of treatment based on clinical judgment taking baseline renal function into account.
Mesalazine induced nephrotoxicity should be suspected in patients developing renal dysfunction during treatment. Mesalazine treatment should be discontinued immediately if renal function deteriorates. The concurrent use of other known nephrotoxic agents, such as NSAIDs and azathioprine, may increase the risk of renal reactions.
Treatment should be discontinued if renal function deteriorates. 8. Mesalazine-induced cardiac hypersensitivity reactions (myo- and pericarditis) have been reported rarely. 5). Blood tests for differential blood counts is recommended prior to and during treatment, at the discretion of the treating physician.
1 - patients with severe liver and/or renal impairment
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Regular monitoring of white blood cells is recommended and the dosage regimen of thiopurine should be adjusted accordingly. There is weak evidence that mesalazine might decrease the anticoagulant effect of warfarin. 6 Fertility, pregnancy and lactation Mesalazine Ferring should not be used during pregnancy and lactation except when the potential benefit of the treatment outweighs the possible hazards in the opinion of the physician.
The underlying condition itself (Inflammatory bowel disease (IBD)) may increase risks for adverse 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 Mesalazine Ferring 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 Mesalazine Ferring. In one single case after long-term use of a high dose of mesalazine (2-4 g, 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 Ferring 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 cannot be excluded. If the infant develops diarrhoea, breast-feeding should be discontinued. 7 Effects on ability to drive and use machines Mesalazine Ferring has no or negligible influence on the ability to drive and/or use machines.
8 Undesirable effects Summary of the safety profile The most frequent adverse reactions seen in clinical trials are diarrhoea, nausea, abdominal pain, headache, vomiting, and rash. 4). Following rectal administration local reactions such as pruritus, rectal discomfort and urge may occur.
Frequency of adverse effects, based on clinical trials and reports from post- marketing surveillance SOC Common ≥1/100 to <1/10 Rare ≥1/10,000 to ≤1/1,000 Very rare ≤1/10,000 Not known (cannot be estimated from the available data).
Blood and the lymphatic system disorders Altered blood counts (anaemia, aplastic anaemia, agranulocytosis, neutropenia, leukopenia (incl. granulocytopenia), pancytopenia, thrombocytopenia, and eosinophilia (as part of an allergic reaction)).
4) Cardiac disorders Myocarditis* Pericarditis* Respiratory, thoracic and mediastinal disorders Allergic alveolitis, allergic and fibrotic lung reactions (incl. dyspnoea, coughing, bronchospasm, pulmonary […]
Treatment should be discontinued on suspicion or evidence of these adverse reactions. Idiopathic intracranial hypertension Idiopathic intracranial hypertension (pseudotumor cerebri) has been reported in patients receiving mesalazine.
Patients should be warned for signs and symptoms of idiopathic intracranial hypertension, including severe or recurrent headache, visual disturbances or tinnitus. If idiopathic intracranial hypertension occurs, discontinuation of mesalazine 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. As a guideline, follow-up tests are recommended 14 days after commencement of treatment, then a further two to three tests at intervals of 4 weeks.
If the findings are normal, follow-up tests should be carried out every three months. If additional symptoms occur, these tests should be performed immediately. If a patient develops dehydration while on treatment with mesalazine, normal electrolyte levels and fluid balance should be restored as soon as possible.
g. in toilets cleaned with sodium hypochlorite contained in certain bleaches).