Prescribing Information Salofalk Orals UK-IE

Presentation: Salofalk 250mg gastro-resistant tablets: gastro-resistant tablet containing 250mg mesalazine. Salofalk 500mg and 1g gastro-resistant tablet (UK ONLY) containing 500mg and 1g mesalazine respectively. Salofalk 500mg/1000mg/1500mg/3000mg prolonged-release granules: prolonged-release granules containing 500mg,1000mg, 1500mg or 3000mg mesalazine per sachet. Indications: Salofalk 250mg tablets (UK): treatment and maintenance of remission of mild/moderate ulcerative colitis. Salofalk 250mg tablets (Ireland): as an anti-inflammatory in the management of ulcerative colitis and in the treatment of Crohn’s disease. Salofalk 500mg tablets (UK): treatment and maintenance of remission of ulcerative colitis. Salofalk 1g tablets (UK): treatment of acute episodes of mild/moderate ulcerative colitis. Salofalk granules: treatment of acute episodes and the maintenance of remission of mild to moderate ulcerative colitis. Dosage: Salofalk 250mg tablets – Adults and elderly: acute treatment 6 -12 tablets daily in 3 divided doses. Maintenance treatment 6 tablets daily in 3 divided doses. Salofalk 500mg tablets (UK only): 1 or 2 tablets 3 times daily. Maintenance: 1 tablet 3 times daily. Salofalk 1g tablets (UK only): 1 tablet three times daily. Salofalk granules – adults: acute treatment – once daily 1 sachet of 3g granules, 1 or 2 sachets of Salofalk 1.5g granules, 3 sachets of 500mg granules or 3 sachets of 1000mg granules (equivalent to 1.5 – 3.0g mesalazine daily), preferably taken in the morning. Alternatively, the dose can be taken divided in three doses. Maintenance treatment – 1 sachet of 500mg granules 3 times daily (1.5g mesalazine daily). Where needed, 3.0g per day in a single morning dose may be taken. Method of administration: oral. Tablets – taken whole without chewing, with liquid, one hour before meals. Granules – taken on the tongue and swallowed, without chewing, with plenty of liquid. Duration of treatment is usually 8 weeks. To be determined by physician. Children (all formulations): there is only limited documentation for an effect in children (age 6-18 years). Children 6 years and older: active disease – on individual basis starting with 30-50mg/kg/day either once daily (granules) or in divided doses (tablets and granules). Maximum 75mg/kg/day. Total dose should not exceed recommended adult dose. Maintenance – on individual basis starting with 15-30mg/kg/day in divided doses. Total dose should not exceed recommended adult dose. 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. 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 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. 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. 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. Tablets may be excreted undissolved in patients with the ileocecal valve removed. Salofalk granules: contain aspartame, a source of phenylalanine. May be harmful to patients with phenylketonuria. Granules also contain sucrose: 0.04mg, 0.08mg, 0.12mg, 0.24mg (500mg/1g/1.5g and 3g granules respectively). Salofalk tablets: For patients on a sodium-controlled diet: the 250mg and 500mg tablets contain 48mg and 49mg of sodium, equivalent to 2.4% and 2.5% of the recommended maximum daily intake for sodium. Urine may be discoloured red-brown after contact with sodium hypochlorite bleach used in toilets. Interactions: Specific interaction studies have not been performed. 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. Salofalk granules (additionally): lactulose, or similar preparations which lower stool pH: possible reduction of mesalazine release from granules due to decreased pH caused by bacterial metabolism of lactulose. Use in pregnancy and lactation: do not use Salofalk during pregnancy unless the potential benefit outweighs the possible risks. Limited experience in the lactation period. Salofalk should only be used during breast-feeding if the potential benefit outweighs the possible risks; if the breast-fed 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, asthenia, fatigue, oligospermia (reversible), changes in hepatic function parameters, changes in pancreatic enzymes, eosinophil count increased. Legal category: POM. Cost (UK – basic NHS price; Ireland – PtW): Salofalk 250mg tablets (100s) £16.19; €13.48. Salofalk 500mg tablets (100s) £32.38. Salofalk 1g tablets (90s) £58.50. Salofalk 500mg granules (100 sachets) £28.74; €27.93. Salofalk 1000mg granules (50 sachets) £28.74; €32.87. Salofalk 1500mg granules (60 sachets) £48.85; €49.66. Salofalk 3g granules (60 sachets) £97.70; €101.64. Product licence number: Salofalk 250mg tablets: PL10341/0004; PA573/4/3. Salofalk 500mg tablets: PL08637/0019. Salofalk 1g tablets: PL08637/0027. Salofalk 500mg granules: PL08637/0007; PA573/3/1. Salofalk 1000mg granules: PL08637/0008; PA573/3/2. Salofalk 1500mg granules: PL08637/0016; PA573/3/7. Salofalk 3g granules: PL08637/0025; PA573/3/6. Product licence holder: Salofalk 250mg tablets in the UK: Dr Falk Pharma UK Ltd, Bourne End Business Park, Cores End Road, Bourne End, SL8 5AS. Salofalk 500mg and 1g tablets and all granules: 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. In the UK: Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ In Ireland: Reporting forms and information can be found 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.