Prescribing Information Rectals Salofalk/Budenofalk UK

Presentations: 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. Budenofalk® 2mg rectal foam – each dose of 1.2g foam contains 2mg of budesonide 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 500mg and 1g suppositories: Treatment of mild and moderate attacks of ulcerative colitis in the rectum. Budenofalk 2mg foam: treatment of active ulcerative colitis limited to the rectum and the sigmoid colon. Dosage: Salofalk 1g Rectal Foam – adults: 2 administrations once a day at bedtime. Use at room temperature. Alternatively, 1 administration twice a day. 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. Budenofalk 2mg foam: adults aged over 18 years, one dose of 2mg daily, either in the morning or evening. Should not be used for longer than 6–8 weeks. Children: not recommended. Contra-indications: Salofalk: 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 and pulmonary disease. Budenofalk 2mg foam: hypersensitivity to budesonide or any of the ingredients, hepatic cirrhosis. Warnings/precautions: Salofalk: prior to and during treatment perform blood tests and urinary status. Caution in patients with impaired hepatic function. Should not be used in patients with impaired renal function. Consider mesalazine-induced renal toxicity if renal function deteriorates during treatment. Carefully monitor patients with pulmonary disease especially asthma. Keep under close medical surveillance patients with a history of adverse drug reactions to preparations containing sulphasalazine. Discontinue treatment immediately if acute intolerance reactions such as abdominal cramps, acute abdominal pain, fever, severe headache and rash occur. 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 (e.g., contact dermatitis). 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. Budenofalk 2mg foam: treatment results in lower systemic steroid levels than oral therapy with systemically acting corticoids. Transfer from systemic corticoids may result in recurrence of symptoms due to differences in pharmacokinetics. Caution in patients with tuberculosis, hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma, cataracts, family history of diabetes and family history of glaucoma. Infection: suppression of the inflammatory response and immune function increases susceptibility to infections and their severity, with risk of deterioration of bacterial, fungal, amoebic and viral infections. The clinical presentation of serious infections e.g., septicaemia and tuberculosis, may be masked. Chickenpox is of particular concern in immunosuppressed patients. Those without a definite medical history should avoid close personal contact with chickenpox or herpes zoster. Passive immunisation is needed by exposed non-immune patients receiving (or those who have received within the previous 3 months) systemic corticosteroids, within 10 days of exposure to chickenpox. Urgent specialist care required if chickenpox is confirmed; corticosteroids should not be stopped and the dosage may need to be increased. Immunosuppressed patients who come into contact with measles should receive normal immunoglobulin as soon as possible after exposure. Live vaccines should not be given to individuals with impaired immune responsiveness and antibody response to other vaccines may be diminished. In severe liver function disorders, elimination of glucocorticoids will be reduced and systemic bioavailability increased. Caution where there is slight/moderate hepatic impairment. Corticosteroids may suppress the HPA axis and reduce the stress response. Supplementary systemic glucocorticoid treatment is recommended in patients subject to surgery or other stresses. Concomitant treatment with ketoconazole or other CYP3A4 inhibitors should be avoided. Special notes: local skin reactions may occur, e.g., contact dermatitis due to cetyl alchohol and cetostearyl alcohol. Propylene glycol may cause skin irritation. Interactions: Salofalk: specific interaction studies have not been performed. A possible increase in the myelosuppressive effects of azathioprine, 6-mercaptopurine or thioguanine when used concomitantly with mesalazine. Weak evidence that mesalazine might decrease the anticoagulant effect of warfarin. Budenofalk 2mg foam: concomitant administration of cardiac glycosides may potentiate the activity of the glycoside (due to increased excretion of potassium); simultaneous treatment with saluretics may also exacerbate the hypokalaemia. Avoid concomitant administration with ketoconazole, grapefruit juice or other CYP3A4 inhibitors (e.g., ritonavir, itraconazole and clarithromycin) because they may markedly increase the plasma concentrations of budesonide. CYP3A4 inducers (e.g., carbamazepine and rifampicin) may reduce systemic and local (gut mucosa) exposure, necessitating dose adjustment of budesonide. CYP3A4 substrates may compete with budesonide leading to possible increases in plasma concentrations of either budesonide or substrate, depending on relative affinities. Elevated plasma concentrations and enhanced effects of corticosteroids have been reported with oestrogens or oral contraceptives, although not with oral low dose contraceptives. Use in pregnancy and lactation: Salofalk: there are no adequate data on use in pregnant women. Use during pregnancy only 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. Budenofalk 2mg foam: avoid during pregnancy unless essential. It is not known if budesonide passes into breastmilk. The risks and benefits of breastfeeding for the infant and therapy for the woman need to be considered. Undesirable effects: Salofalk: 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, oligospermia (reversible). Salofalk rectal foam may also cause abdominal distension, anal discomfort, application site irritation and painful rectal tenesmus. Budenofalk 2mg foam: Cushing’s syndrome, dyspepsia, increased risk of infections, osteoporosis, muscle and join pain, muscle weakness and twitching, headache, depression, irritability, euphoria, allergic exanthema, petechiae, delayed wound healing, contact dermatitis, burning in the rectum and pain, duodenal or gastric ulcer, psychomotor hyperactivity, anxiety, glaucoma, cataract, vision blurred, pancreatitis, osteonecrosis, ecchymoses, aggression, growth retardation in children, constipation, pseudotumor cerebri (including papilloedema) in adolescents, increased risk of thrombosis, vasculitis, fatigue and malaise. Side effects observed during clinical trials: increased appetite, increase in erythrocyte sedimentation rate, leucocytosis, nausea, abdominal pain, flatulence, paraesthesias in the abdominal region, anal fissure, aphthous stomatitis, frequent urge to defecate, rectal bleeding, increase in transaminases (GOT, GPT), increase in parameters of cholestasis (GGT, AP), increase in amylase, change in cortisol, urinary tract infection, dizziness, disturbances of smell, insomnia, increased sweating, asthenia, increase in body weight. Occasionally side effects characteristic of systemic corticosteroid therapy may occur, depending on dosage, duration, concomitant or previous treatment with other glucocorticosteroids and individual sensitivity. Exacerbation or reappearance of extraintestinal manifestations when switching treatment from systemically active glucocorticosteroids to locally acting budesonide may occur. Due to local action, risk is generally lower than with systemically acting glucocorticosteroids.
Legal category: POM. Basic UK NHS cost: Salofalk 1g/actuation rectal foam, 14 administrations per canister – £30.17. Salofalk enema 2g, 7 enemas – £29.92. Salofalk suppositories 500mg, 30 suppositories – £14.81. Salofalk 1g suppositories, 30 suppositories – £29.62. Budenofalk rectal foam – one canister sufficient for 14 doses – £57.11. Product licence number: Salofalk 1g/actuation rectal foam – PL08637/0003. Salofalk enema 2g – PL10341/0008. Salofalk suppositories 500 mg – PL10341/0009. Salofalk 1g Suppositories – PL08637/0018. Budenofalk 2mg foam – PL08637/0011. Product licence holder: Salofalk 1g rectal foam, Salofalk 1g Suppositories and Budenofalk 2mg foam: 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, UK. 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.