MESALAZINE DR FALK PHARMA 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: Therapy and prophylaxis of acute attacks of mild ulcerative colitis, especially in the rectum and sigmoid colon and also in the descending colon.
Verbatim from this product's MHRA label. Tap a section to expand.
Adults and the Elderly: 1 enema once a day at bedtime. The action of Mesalazine Dr Falk Pharma enema is enhanced if the patient lies on the left side when introducing the enema. The dosage should be adjusted to suit the progress of the condition.
Do not discontinue treatment suddenly. The treatment of acute episodes of ulcerative colitis usually last 8 weeks. Paediatric population There is little experience and only limited documentation for an effect in children. Method of administration Rectal The best results are achieved if the bowels are emptied before administration of the enema.
The patient should be advised to: - Shake the bottle for 30 seconds. - Remove the protective cap. - Hold the bottle at the top and bottom and keep it upright to avoid spillage. - Lie down comfortably on the left side with the left leg stretched out and the right leg bent.
If more convenient, lie on the right side with the right leg stretched out and with the left leg bent. In this case, turn to the left side after application of the enema. - Insert the applicator deep into the rectum keeping the bottle tipped downwards slightly.
- Slowly squeeze the bottle until empty. - Slowly withdraw the applicator from the rectum. - Lie on the left side for at least 30 minutes to allow the contents of the enema to spread. - If possible, retain the enema all night.
4). Photosensitivity More severe reactions are reported in patients with pre-existing skin conditions such as atopic dermatitis and atopic eczema. Reporting of suspected adverse reactions Reporting of suspected reactions after authorisation of the medicinal product is important.
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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, 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, tests should be performed immediately.
Caution is recommended in patients with impaired hepatic function. Mesalazine should not be used in patients with impaired renal function. Mesalazine-induced renal toxicity should be considered if renal function deteriorates during treatment.
If this is the case, Mesalazine Dr Falk Pharma enema should be discontinued immediately. 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 toilets cleaned with sodium hypochlorite contained in certain bleaches). Serious blood dyscrasias have been reported very rarely with mesalazine. Hematological investigations should be performed if patients suffer from unexplained haemorrhages, bruises, purpura, anaemia, fever or pharyngolaryngeal pain.
Mesalazine Dr Falk Pharma enema should be discontinued in case of suspected or confirmed blood dyscrasia. Cardiac hypersensitivity reactions (myocarditis, and pericarditis) induced by mesalazine have been rarely reported. Mesalazine Dr Falk Pharma enema should then be discontinued immediately.
Patients with pulmonary disease, in particular asthma, should be very carefully monitored during a course of treatment with mesalazine. 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.
1. • Severe impairment of renal or hepatic function.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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. 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.
Patients with a history of adverse drug reactions to preparations containing sulphasalazine should be kept under close medical surveillance on commencement of a course of treatment with mesalazine. Should the enema cause acute intolerance reactions such as abdominal cramps, acute abdominal pain, fever, severe headache and rash, therapy should be discontinued immediately.
Mesalazine Dr Falk Pharma enemas contain potassium metabisulphite, which may rarely cause severe hypersensitivity reactions and bronchospasm. This medicinal product contains 60 mg sodium benzoate in each Mesalazine Dr Falk Pharma enema.
Sodium benzoate may cause local irritation.