Company: Dr Falk Pharma UK Ltd.
Legal category: Prescription. GMS. Sport permitted.
Active ingredient: Mesalazine 1.5g.
Description: Gastro-resistant prolonged-release granules in sachets.
Presentation: 60, €56.05.
Indications: Treatment of acute episodes and maintenance of remission of ulcerative colitis.
Pharmacology: The mechanism of the anti-inflammatory action is unknown. The results of in vitro studies indicate that inhibition of lipoxygenase may play a role. Effects on prostaglandin concentrations in the intestinal mucosa have also been demonstrated. Mesalazine (5-aminosalicylic acid / 5-ASA) may also function as a radical scavenger of reactive oxygen compounds.
Dosage: Adult: Acute treatment: 3 sachets of Salofalk 500mg/1g, 1 or 2 sachets of Salofalk 1.5g or 1 sachet of Salofalk 3g once daily preferably in the morning; alternatively 1 sachet of Salofalk 500mg or 1g 3 times daily (equiv. 1.5-3g daily) as required. Maintenance: 1 sachet of Salofalk 500mg 3 times daily or 3g once daily in patients at increased risk for relapse. Swallow without chewing, with plenty of liquid. Elderly: As per adults. Children: Under 6 years, not recommended. 6 years and older, acute treatment: 30-50mg/kg/day once daily preferably in the morning or in divided doses, maximum 75mg/kg/day; maintenance: Initially, 15-30 mg/kg/day in divided doses. Usually: Up to 40kg, half adult dose; over 40kg, normal adult dose.
Contraindications: Hypersensitivity to the active ingredient or to any of the excipients. Severe hepatic or renal impairment.
Special precautions: Caution: Hepatic impairment. Renal impairment (do not use); consider renal toxicity if renal function deteriorates during treatment. Determine differential blood count, liver function, serum creatinine and urinary status prior to and during treatment (14 days after initiation, then two to three tests at 4 week intervals); if findings are normal follow up every 3 months; test immediately if additional symptoms occur. Acute intolerability reactions (discontinue immediately). Pulmonary disease (especially asthma), history of adverse drug reactions to sulphasalazine; carefully monitor. Contains aspartame, sucrose. Pregnancy, lactation (discontinue if infant develops diarrhoea); only if benefit outweighs risk.
Drug interactions: Caution: Azathioprine, 6-mercaptopurine, thioguanine. Warfarin, lactulose or similar preparations which lower stool pH.
Adverse drug reactions: None common.
Full prescribing information and references available from Dr Falk Pharma UK Ltd. Telephone: (0044) 1628 536600. E-mail: office@drfalkpharma.co.uk