Prescribing Information Salofalk Rectals UK-IE

Prescribing Information (Please refer to full SPC before prescribing)

Presentation: Salofalk® 1g/actuation rectal foam – containing 1g mesalazine per actuation. Salofalk® enema 2g – enema containing 2g mesalazine in 59ml of suspension. Salofalk® 4g/60ml enema – enema containing 4g mesalazine in 60ml of suspension. Salofalk® 250mg Suppositories – suppositories containing 250mg mesalazine. Salofalk® Suppositories 500mg – suppositories containing 500mg mesalazine. Salofalk® 1g Suppositories – suppositories containing 1g mesalazine. Indications: Salofalk 1g rectal foam: treatment of active, mild ulcerative colitis of the sigmoid colon and rectum. Salofalk enema 2g: treatment and prophylaxis of acute attacks of mild ulcerative colitis, especially in the rectum and sigmoid colon and also in the descending colon. Salofalk 4g/60ml enema and 250mg suppositories: as an anti-inflammatory in the management of ulcerative colitis, alone, or, particularly in the acute phase, with corticosteroids. Salofalk 500mg and 1g suppositories: treatment of mild and moderate attacks of ulcerative colitis, in the rectum. Dosage: Salofalk 1g Rectal Foam – adults: 2 administrations once a day at bedtime. Use at room temperature. 1 administration twice a day is possible. Salofalk 2g and 4g enema – adults and elderly: 1 enema a day at bedtime. Salofalk 250mg suppositories – adults and elderly: 2 suppositories rectally 3 times daily. In severe cases of the disease, the dosage may be doubled. For long term treatment and prevention of recurrences, one suppository three times daily. Salofalk suppositories 500mg – adults and elderly: 1–2 suppositories, 2–3 times daily; Salofalk 1g suppositories – adults and elderly: 1 suppository once daily preferably at bedtime. Do not discontinue treatment suddenly. Duration of treatment – to be determined by physician. All formulations: children: there is little experience and only limited documentation for an effect in children. Contra-indications: known hypersensitivity to salicylates or any of the excipients. Severe impairment of hepatic or renal function. The sulphite component of Salofalk foam may cause hypersensitivity reactions in patients with asthma. Warnings/precautions: blood tests and urinary status should be determined prior to and during treatment. Caution recommended in patients with impaired hepatic function. Not to be used in patients with impaired renal function. Consider mesalazine-induced renal toxicity if renal function deteriorates during treatment. Discontinue treatment immediately. Cases of nephrolithiasis reported; ensure good hydration. Urine may be discoloured red-brown after contact with sodium hypochlorite bleach used in toilets. 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. Monitor patients with pulmonary disease especially asthma. 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. Keep patients with a history of adverse drug reactions to preparations containing sulphasalazine under close medical surveillance. Discontinue treatment if Salofalk causes acute intolerance reactions such as abdominal cramps, acute abdominal pain, fever, severe headache and rash. Special notes: 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. Salofalk 2g and 4g enemas: potassium metabisulphite may rarely cause severe hypersensitivity reactions and bronchospasm. Sodium benzoate may cause local irritation. Salofalk 500mg suppositories: cetyl alcohol may cause local skin reactions. Interactions: specific interaction studies have not been performed. In patients concomitantly treated with azathioprine, 6-mercaptopurine or thioguanine, an increase in their myelosuppressive effects should be taken into account. There is weak evidence that mesalazine might decrease the anticoagulant effect of warfarin. Use in pregnancy and lactation: there are no adequate data on use in pregnant women. Only use during pregnancy if the potential benefit outweighs the possible risk. Acetylated mesalazine passes into breast milk. Only use during breast-feeding if the potential benefit outweighs the possible risk. If the infant develops diarrhoea breast-feeding should be discontinued. Undesirable effects: rash, pruritus, headache, dizziness, peri- and myocarditis, abdominal pain, diarrhoea, flatulence, nausea, vomiting, constipation (except foam), photosensitivity especially with pre-existing skin conditions, altered blood counts (aplastic anaemia, agranulocytosis, pancytopenia, neutropenia, leukopenia, thrombocytopenia), peripheral neuropathy, allergic and fibrotic lung reactions (including dyspnoea, cough, bronchospasm, alveolitis, pulmonary eosinophilia, lung infiltration, pneumonitis), acute pancreatitis, impairment of renal function including acute and chronic interstitial nephritis and renal insufficiency, alopecia, myalgia, arthralgia, hypersensitivity reactions such as allergic exanthema, drug fever, lupus erythematosus syndrome, pancolitis, changes in hepatic function parameters, hepatitis, cholestatic hepatitis, oligospermia (reversible), nephrolithiasis, severe cutaneous adverse reactions (SCARs) including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN). Salofalk rectal foam may also cause abdominal distension, anal discomfort, application site irritation and painful rectal tenesmus. Legal category: POM. Basic UK NHS cost and Irish price to wholesaler: Salofalk 1g/actuation rectal foam, 14 administrations per container – £30.17; €31.55. Salofalk enema 2g, 7 enemas – £29.92; Salofalk 4g/60ml enema, 7 enemas – €30.36. Salofalk 250mg suppositories, 30 suppositories – €10.70; Salofalk suppositories 500mg, 30 suppositories – £14.81. Salofalk 1g suppositories, 30 suppositories – £29.62; €36.49. Product licence number: Salofalk 1g/actuation rectal foam – PL08637/0003; PA 573/4/5. Salofalk enema 2g – PL10341/0008. Salofalk 4g/6ml enema – PA 573/4/1. Salofalk 250mg suppositories – PA 573/4/2. Salofalk suppositories 500 mg – PL10341/0009. Salofalk 1g Suppositories – PL08637/0018; PA573/4/4. Product licence holder: Salofalk 1g rectal foam, Salofalk 4g/60ml enema, Salofalk 250mg and 1g Suppositories: Dr Falk Pharma GmbH, Leinenweberstr. 5, D-79108 Freiburg, Germany. Salofalk enema 2g, Salofalk suppositories 500mg: Dr Falk Pharma UK Limited, Unit K, Bourne End Business Park, Cores End Road, Bourne End, SL8 5AS, United Kingdom. Date of preparation: September 2023.

Further information is available on request.

Adverse Events should be reported

Ireland:
Reporting forms and information can be found at https://www.hpra.ie/homepage/about-us/report-an-issue/human-adverse-reaction-form

United Kingdom:
Reporting forms and information can be found at www.mhra.gov.uk/yellowcard.co.uk
Adverse events should also be reported to Dr Falk Pharma UK Ltd at PV@drfalkpharma.co.uk