Prescribing Information Salofalk Granules IE

Salofalk prolonged-release granules
Presentation: Stick-formed or round, greyish white prolonged-release granules in sachets containing 500mg, 1000mg, 1.5g or 3g mesalazine per sachet. Indications: treatment of acute episodes and the maintenance of remission of mild to moderate ulcerative colitis. Dosage: adults: once daily 1 sachet of 3g granules, 1 or 2 sachets of 1.5g granules or 3 sachets of 1000mg or 500mg granules (equivalent to 1.5 – 3.0g mesalazine daily) preferably taken in the morning, according to individual clinical requirement. May be taken in three divided doses (1 sachet of 500mg granules three times daily or 1 sachet of 1000mg granules three times daily) if more convenient. Maintenance: 0.5g mesalazine three times daily (morning, midday and evening) corresponding to a total dose of 1.5g mesalazine per day. For patients known to be at increased risk for relapse for medical reasons or due to difficulties to adhere to three daily doses, give 3.0g mesalazine as a single daily dose, preferably in the morning. Children: 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 30-50mg/kg/day once daily preferably in the morning or in divided doses. Maximum dose: 75mg/kg/day. The total dose should not exceed the maximum adult dose. Maintenance treatment: To be determined individually, starting with 15-30mg/kg/day in divided doses. The total dose should not exceed the recommended adult dose. It is generally recommended that half the adult dose may be given to children up to a body weight of 40kg; and the normal adult dose to those above 40kg. Method of administration: taken on the tongue and swallowed, without chewing, with plenty of liquid. Duration of treatment is usually 8 weeks. To be determined by physician. Contra-indications: hypersensitivity to salicylates or any of the excipients. Severe impairment of renal or hepatic function. Warnings/Precautions: blood tests and urinary status (dip sticks) should be determined prior to and during treatment. Caution is recommended in patients with impaired hepatic function. Should not be used in patients with impaired renal function. Mesalazine-induced renal toxicity should be considered if renal function deteriorates during treatment – stop treatment immediately in such cases. Cases of nephrolithiasis reported; ensure good hydration. 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. Salofalk granules should be discontinued in case of suspected or confirmed blood dyscrasia. Cardiac hypersensitivity reactions (myocarditis and pericarditis) induced by mesalazine have been rarely reported. Salofalk should then be discontinued immediately. Patients with pulmonary disease, in particular asthma, should be carefully monitored. Patients with a history of adverse drug reactions to preparations containing sulphasalazine should be kept under close medical surveillance. If acute intolerance reactions e.g., abdominal cramps, acute abdominal pain, fever, severe headache and rash, occur, stop treatment immediately. 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. Discontinue treatment at the first appearance of signs and symptoms of severe skin reactions, such as skin rash, mucosal lesions, or any other sign of hypersensitivity. Salofalk granules contain aspartame, a source of phenylalanine that may be harmful for patients with phenylketonuria. Salofalk granules contain sucrose: 0.04mg, 0.08mg, 0.12mg and 0.24mg (500mg/1g/1.5g and 3g granules respectively). Urine may be discoloured red-brown after contact with sodium hypochlorite bleach used in toilets. Interactions: specific interaction studies have not been performed. Lactulose or similar preparations that lower stool pH: possible reduction of mesalazine release from granules due to decreased pH caused by bacterial metabolism of lactulose. With concomitant treatment with azathioprine, 6-mercaptopurine or thioguanine consider a possible increase in their myelosuppressive effects. There is weak evidence that mesalazine might decrease the anticoagulant effect of warfarin. Use in pregnancy and lactation: there are no adequate data. Do not use during pregnancy unless the potential benefit outweighs the possible risks. Limited experience in the lactation period. Use during breast-feeding only if the potential benefit outweighs the possible risks; if the infant develops diarrhoea, breast-feeding should be discontinued. Undesirable effects: altered blood counts (aplastic anaemia, agranulocytosis, pancytopenia, neutropenia, leukopenia, thrombocytopenia), hypersensitivity reactions such as allergic exanthema, drug fever, lupus erythematosus syndrome, pancolitis, headache, dizziness, peripheral neuropathy, peri- and myo-carditis, allergic and fibrotic lung reactions (including dyspnoea, cough, bronchospasm, alveolitis, pulmonary eosinophilia, lung infiltration, pneumonitis), abdominal pain, diarrhoea, dyspepsia, flatulence, nausea, vomiting, acute pancreatitis, cholestatic hepatitis, hepatitis, rash, pruritus, photosensitivity – especially with pre-existing skin conditions, alopecia, severe cutaneous adverse reactions (SCARs) including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), arthralgia, myalgia, impairment of renal function including acute and chronic interstitial nephritis and renal insufficiency, nephrolithiasis, oligospermia (reversible), asthenia, fatigue, changes in hepatic function parameters, changes in pancreatic enzymes, eosinophil count increased. Legal category: POM. Basic cost: Salofalk 500mg granules, pack size 100 sachets – €27.93. Salofalk 1000mg granules, pack size 50 sachets – €32.87. Salofalk 1.5g granules, pack size 60 sachets – €49.66. Salofalk 3g granules pack size 60 sachets – €101.64 (PtW). Product licence number: Salofalk 500mg granules – PA573/3/1. Salofalk 1000mg granules – PA573/3/2. Salofalk 1.5g granules – PA573/3/7. Salofalk 3g granules – PA573/3/6. Product licence holder: Dr Falk Pharma GmbH, Leinenweberstr.5, D-79108 Freiburg, Germany. Date of preparation: January 2023

Further information is available on request.

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ (UK residents) or in Ireland at https://www.hpra.ie/homepage/about-us/report-an-issue/human-adverse-reaction-form Adverse events should also be reported to Dr Falk Pharma UK Ltd at PV@drfalkpharma.co.uk