Prescribing Information Salofalk IE

Presentation: Salofalk® prolonged-release granules containing 500mg, 1g, 1.5g or 3g mesalazine per sachet. Salofalk gastro-resistant tablets containing 250mg mesalazine. Salofalk 1g/actuation rectal foam containing 1g mesalazine per actuation. Salofalk 4g enema enema containing 4g mesalazine in 60ml of suspension. Salofalk Suppositories containing 250mg or 1g mesalazine. Indications: granules: treatment of acute episodes and maintenance of remission of mild to moderate ulcerative colitis. Tablets: 250mg: management of ulcerative colitis and in the treatment of Crohn’s disease. Enema 4g: management of ulcerative colitis, alone or, particularly in the acute phase, with corticosteroids. 1g rectal foam: treatment of active, mild ulcerative colitis of the sigmoid colon and rectum. 250mg suppositories: management of ulcerative colitis, alone or, particularly in the acute phase, with corticosteroids. 1g suppositories: treatment of mild and moderate attacks of ulcerative colitis in the rectum. Dosage: granules: adults: acute episodes: once daily 1 sachet of 3g granules, 1 or 2 sachets of 1.5g granules, 3 sachets of 1g granules or 3 sachets of 500mg granules (equivalent to 1.5 – 3g mesalazine daily), preferably taken in the morning. Alternatively, take in three divided doses. Maintenance: 1 sachet of 500mg granules 3 times a day (1.5g mesalazine daily). Where needed, 3g per day in a single morning dose. 250mg tablets: adults and elderly: acute treatment 6 -12 tablets daily in 3 divided doses. Maintenance: 6 tablets daily in 3 divided doses. Children (all formulations): there is only limited documentation for an effect in children (age 6-18 years). Dosage in children 6 years and older – oral formulations: 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. 4g enema: adults and elderly: 1 enema a day at bedtime. 1g Rectal Foam: adults: 2 administrations once a day at bedtime. Divided dose is also possible (1 administration night and morning). Suppositories 250mg: 2 suppositories 3 times a day; maintenance – 1 suppository 3 times a day. 1g suppositories: adults and elderly: 1 suppository once daily. Method of administration: Oral: 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. Tablets: taken whole without chewing, one hour before meals with liquid. Rectal: read the SmPC and/or patient information leaflet for administration details. Contra-indications: hypersensitivity to salicylates or any of the excipients. Severe impairment of renal or hepatic function. Warnings/Precautions: blood tests and urinary status should be determined before and during treatment. Caution is recommended in patients with impaired hepatic function. Not to 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 case. 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 very carefully monitored. Patients with a history of reaction to preparations containing sulphasalazine should be kept under close medical surveillance. Discontinue immediately if there are acute intolerance reactions e.g.,abdominal cramps, acute abdominal pain, fever, severe headache and rash. 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. Tablets may (rarely) be excreted undissolved in patients with the ileocecal valve removed. Cases of nephrolithiasis reported; ensure good hydration. Urine may be discoloured red-brown after contact with sodium hypochlorite bleach used in toilets. Salofalk granules: contain aspartame as a source of phenylalanine. May be harmful to patients with phenylketonuria. Also contain sucrose: 0.04mg (500mg granules), 0.08mg (1000mg granules), 0.12mg (1.5g granules) 0.24mg (3g granules). Salofalk tablets: for patients on a sodium-controlled diet: the 250mg tablets contain 48mg of sodium – 2.4% of maximum daily sodium intake. Salofalk enema 4g: sodium benzoate may cause local irritation. Potassium metabisulphite may rarely cause severe hypersensitivity reactions and bronchospasm. Salofalk foam: propylene glycol may cause skin irritation, sodium metabisulphite may rarely cause severe hypersensitivity reactions and bronchospasm, cetostearyl alcohol may cause local skin reactions (e.g., contact dermatitis). 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. Salofalk rectal foam may also cause abdominal distension, anal discomfort, application site irritation and painful rectal tenesmus. Salofalk enema and suppositories may also cause constipation. Legal category: POM. Cost – PtW: granules: 500mg (100 sachets) €27.93. 1g (50 sachets) €32.87. 1.5g (60 sachets) €49.66. 3g (60 sachets) €101.64. Tablets 250mg (100s) €13.48. Enema: (7) €30.36. 1g/actuation rectal foam: 14 administrations per canister, €31.55. Suppositories: 250mg (30) €10.70. 1g (30) €36.49. Product licence number: granules: 500mg: PA573/3/1. 1g: PA573/3/2. 1.5g: PA573/3/7. 3g: PA573/3/6. Tablets: 250mg: PA573/4/3; Enema 4g: PA573/4/1. 1g/actuation rectal foam: PA573/4/5. Suppositories: 250mg: PA573/4/2. 1g: PA573/4/4. 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://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