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MESALAZINE TILLOTTS 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 Tillotts 400 mg is indicated in adults, children and adolescents above 6 years for: Ulcerative Colitis: For the treatment of mild to moderate acute exacerbations. For the maintenance of remission. Crohn’s ileo-colitis: For the maintenance of remission.
Verbatim from this product's MHRA label. Tap a section to expand.
4 g (six tablets) once daily or in divided doses, with concomitant corticosteroid therapy to be taken when clinically indicated. 8 g (six to twelve tablets) a day in divided doses, with concomitant corticosteroid therapy where clinically indicated.
4 g may be taken once daily or in divided doses. 4 g daily should be taken in divided doses. 4 g (three to six tablets) taken once daily or in divided doses. The maximum adult dose should not exceed twelve tablets a day and not exceed six tablets taken together at any one time.
4). No studies have been carried out in the elderly population. Paediatric population There is only limited documentation for an effect in children (age 6-18 years).
Children 6 years of age and older • Active disease:
To be determined individually, starting with 30-50 mg/kg/day in divided doses. Maximum dose: 75 mg/kg/day in divided doses. The total dose should not exceed 4 g/day. • Maintenance treatment: To be determined individually, starting with 15-30 mg/kg/day in divided doses.
The total dose should not exceed 2 g/day. It is generally recommended that half the adult dose may be given to children up to a body weight of 40 kg; and the normal adult dose to those above 40 kg.
Method of administration:
Oral. The tablets must be swallowed whole preferably with some liquid before food intake. They must not be chewed, crushed or broken before swallowing. If one or more doses have been missed, the next dose is to be taken as usual.
a) Summary of the safety profile Organ specific adverse drug reactions affecting the heart, lungs, liver, kidneys, pancreas, skin and subcutaneous tissue have been reported. 4. 4). b) Tabulated summary of adverse reactions Undesirable effects relevant for the labeling reported from eight (8) double-blind and five (5) open clinical studies with 739 patients treated with Mesalazine Tillotts 400 mg Modified- release tablets are listed below.
4 for further information c) Description of selected adverse reactions An unknown number of the above mentioned undesirable effects are probably associated to the underlying IBD rather than mesalazine medication. This holds true especially for gastrointestinal undesirable effects, arthralgia, and alopecia.
4. 5. Photosensitivity More severe reactions are reported in patients with pre-existing skin conditions such as atopic dermatitis and atopic eczema. d) Paediatric population There is only limited safety experience with the use of Mesalazine Tillotts 400 mg tablets in the paediatric population.
It is expected that the target organs of possible adverse reactions in the paediatric population are the same as for adults (heart, lungs, liver, kidneys, pancreas, skin and subcutaneous tissue). 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
1. 3 PHARMACEUTICAL FORM Modified-release tablet Red-brown, oblong, modified-release tablet. 1 Therapeutic indications Mesalazine Tillotts 400 mg is indicated in adults, children and adolescents above 6 years for: Ulcerative Colitis: For the treatment of mild to moderate acute exacerbations.
For the maintenance of remission.
Crohn’s ileo-colitis:
For the maintenance of remission. 4 g (six tablets) once daily or in divided doses, with concomitant corticosteroid therapy to be taken when clinically indicated. 8 g (six to twelve tablets) a day in divided doses, with concomitant corticosteroid therapy where clinically indicated.
4 g may be taken once daily or in divided doses. 4 g daily should be taken in divided doses. 4 g (three to six tablets) taken once daily or in divided doses. The maximum adult dose should not exceed twelve tablets a day and not exceed six tablets taken together at any one time.
4). No studies have been carried out in the elderly population. Paediatric population There is only limited documentation for an effect in children (age 6-18 years).
Children 6 years of age and older • Active disease:
To be determined individually, starting with 30-50 mg/kg/day in divided doses. Maximum dose: 75 mg/kg/day in divided doses. The total dose should not exceed 4 g/day. • Maintenance treatment: To be determined individually, starting with 15-30 mg/kg/day in divided doses.
The total dose should not exceed 2 g/day. It is generally recommended that half the adult dose may be given to children up to a body weight of 40 kg; and the normal adult dose to those above 40 kg.
Method of administration:
Oral. The tablets must be swallowed whole preferably with some liquid before food intake. They must not be chewed, crushed or broken before swallowing. If one or more doses have been missed, the next dose is to be taken as usual. 73 m2).
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Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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4 Special warnings and precautions for use Blood tests (differential blood count, liver function parameters such as ALT or AST; serum creatinine) and urinary status (dip sticks) should be determined prior to and during treatment, at the discretion of the treating physician.
As a guideline, follow-up tests are recommended 14 days after commencement of treatment and then every 4 weeks for the following 12 weeks. If the findings are normal, follow-up tests should be carried out every three months. If additional signs appear, these tests should be performed immediately.
Renal impairment Caution should be exercised in patients with raised serum creatinine or proteinuria. The possibility of mesalazine-induced nephrotoxicity should be suspected in patients developing impairment of renal function during treatment.
Patients need to remain well hydrated whilst taking Mesalazine Tillotts 400 mg to reduce the risk of crystalluria and consequential kidney damage. Treatment with MesalazineTillotts 400 mg should be stopped immediately if there is evidence of renal impairment and patients should seek immediate medical advice.
Nephrolithiasis 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. g. in toilets cleaned with sodium hypochlorite contained in certain bleaches).
Severe cutaneous adverse reactions 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.
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. Blood dyscrasia Serious blood dyscrasia have very rarely been reported.
Mesalazine Tillotts 400 mg therapy should be stopped immediately if there is suspicion or evidence of blood dyscrasia (signs of unexplained bleeding, bruising, purpura, anemia, persistent fever or sore throat), and patients should seek immediate medical advice.
Hepatic impairment There have been reports of increased liver enzyme levels in patients taking preparations containing mesalazine. Caution is recommended if Mesalazine Tillotts 400 mg is administered to patients with liver impairment.
Blood tests (liver function parameters such as ALT or AST) should be performed prior to and during treatment, at the discretion of the treating physician. 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 3 months. If additional symptoms occur, these tests should be performed immediately. Cardiac hypersensitivity reactions Mesalazine-induced cardiac hypersensitivity reactions (myo- and pericarditis) have rarely been reported with Mesalazine Tillotts 400 mg.
In case of previous mesalazine- induced cardiac hypersensitivity Mesalazine Tillotts 400 mg must not be reintroduced. Caution should be taken in patients with previous myo- or pericarditis of allergic background regardless of its origin.
Idiopathic intracranial hypertension Idiopathic intracranial hypertension (pseudotumor cerebri) has been reported in […]