Prescribing Information Salofalk Rectals UK

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® Suppositories 500mg – suppositories containing 500mg mesalazine. Salofalk® 1g Suppositories – suppositories containing 1g mesalazine. Indications: 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 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 enema – adults and elderly: 1 enema a day at bedtime. 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. 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. Monitor patients with pulmonary disease especially asthma. 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. Cases of nephrolithiasis reported; ensure good hydration. 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. Urine may be discoloured red-brown after contact with sodium hypochlorite bleach used in toilets. 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 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: altered blood counts (aplastic anaemia, agranulocytosis, pancytopenia, neutropenia, leukopenia, thrombocytopenia), headache, dizziness, peripheral neuropathy, peri- and myocarditis, allergic and fibrotic lung reactions (including dyspnoea, cough, bronchospasm, alveolitis, pulmonary eosinophilia, lung infiltration, pneumonitis), abdominal pain, diarrhoea, flatulence, nausea, vomiting, constipation (except foam), acute pancreatitis, impairment of renal function including acute and chronic interstitial nephritis and renal insufficiency, nephrolithiasis, 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), myalgia, arthralgia, hypersensitivity reactions such as allergic exanthema, drug fever, lupus erythematosus syndrome, pancolitis, changes in hepatic function parameters, hepatitis, cholestatic hepatitis and oligospermia (reversible). Salofalk rectal foam may also cause abdominal distension, anal discomfort, application site irritation and painful rectal tenesmus. Legal category: POM. Basic UK NHS cost: Salofalk 1g/actuation rectal foam, 14 administrations per container – £30.17. Salofalk enema 2g, 7 enemas – £29.92. Salofalk suppositories 500mg, 30 suppositories – £14.81. Salofalk 1g suppositories, 30 suppositories – £29.62. Product licence number: Salofalk 1g/actuation rectal foam – PL08637/0003. Salofalk enema 2g – PL10341/0008. Salofalk suppositories 500mg – PL10341/0009. Salofalk 1g Suppositories – PL08637/0018. Product licence holder: Salofalk 1g rectal foam 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: January 2023.

Further information is available on request.

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