Salofalk All Preparations

Salofalk All Preparations

Prescribing Information (Please refer to full SmPC before prescribing):

Presentation: Salofalk® gastro-resistant prolonged-release granules containing 500mg, 1g, 1.5g or 3g mesalazine per sachet. Salofalk gastro-resistant tablets containing 250mg, 500mg (UK only) or 1g (UK only) of mesalazine. Salofalk 1g/actuation rectal foam containing 1g mesalazine per actuation. Salofalk enema 2g (UK only) enema containing 2g mesalazine in 59ml of suspension. Salofalk 4g enema (IE only) enema containing 4g mesalazine in 60ml of suspension. Salofalk Suppositories containing 250mg (IE only), 500mg (UK only) or 1g mesalazine.

Indications: granules: treatment of acute episodes and maintenance of remission of ulcerative colitis. Tablets: 250mg (UK): treatment of mild to moderate acute exacerbations and maintenance of remission of ulcerative colitis. 250mg (IE): management of ulcerative colitis and in the treatment of Crohn’s disease. 500mg: treatment of acute episodes and maintenance of remission of ulcerative colitis 1g: treatment of acute episodes of mild to moderate ulcerative colitis. Enema 2g: treatment and prophylaxis of acute attacks of mild ulcerative colitis, especially in the rectum/sigmoid colon/descending colon. 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 (IE): management of ulcerative colitis, alone or, particularly in the acute phase, with corticosteroids. 500mg (UK only) and 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. 500mg tablets: 1 or 2 tablets 3 times daily. Maintenance: 1 tablet 3 times daily. 1g tablets: 1 tablet three times a day. 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. 2g, 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. 500mg suppositories: adults and elderly: 1–2 suppositories, 2–3 times daily. 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. 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. 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. Tablets may (rarely) be excreted undissolved in patients with the ileocecal valve removed. Salofalk granules: contain aspartame as a source of phenylalanine. May be harmful to patients with phenylketonuria. Also contain sucrose: 0.02mg (500mg granules), 0.04mg (1000mg granules), 0.06mg (1.5g granules) 0.12mg (3g granules). Salofalk tablets: for patients on a sodium-controlled diet: the 250mg/500mg tablets contain 48mg/49mg of sodium – 2.4%/2.5% of maximum daily sodium intake. Salofalk enema 2g/4g: sodium benzoate may cause hypersensitivity reactions e.g., irritation of the skin, eyes and mucous membranes. Salofalk enema 4g: potassium metabisulphite may cause allergic reactions with anaphylactic symptoms and bronchial constriction. Salofalk foam: sulphite content may cause hypersensitivity reaction in all patients; especially those with asthma and pulmonary disease. The propylene glycol content may cause lactic acidosis, hyperosmolality, haemolysis and CNS depression. Slight to mild skin irritation may also occur. The cetostearyl alcohol content 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: headache, dizziness, peri- and myocarditis, abdominal pain, diarrhoea, flatulence, dyspepsia, nausea, vomiting, photosensitivity especially with pre-existing skin conditions, 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, nephrolithiasis, alopecia, myalgia, arthralgia, hypersensitivity reactions such as allergic exanthema, drug fever, lupus erythematosus syndrome, pancolitis, asthenia, fatigue, changes in hepatic function parameters, hepatitis, cholestatic hepatitis, changes in pancreatic enzymes, eosinophil count increased and oligospermia (reversible). 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 UK – basic NHS price; IE – Pt W: Granules: 500mg (100 sachets) £28.74; 31.47€. 1g (50 sachets) £28.74; 32.87€. 1.5g (60 sachets) £48.85; 51.99€. 3g (60 sachets) £97.70; 105.43€. Tablets 250mg (100s) £16.19; 14.11€. 500mg (100s) £32.38. 1g £58.50 (90s). Enema: (7) £29.92; 30.36€. 1g/actuation rectal foam: 14 administrations per container, £30.17; 31.55€. Suppositories: 250mg (30) 11.43€. 500mg (30) £14.81. 1g (30) £29.62; 38.66€.

Product licence number: Granules: 500mg: PL08637/0007; PA573/3/1. 1g: PL08637/0008; PA573/3/2. 1.5g: PL08637/0016; PA573/3/7. 3g: PL08637/0025; PA573/3/6. Tablets: 250mg: PL10341/0004; PA573/4/3; 500mg: PL08637/0019; 1g: PL08637/0027. Enema 2g: PL10341/0008. Enema 4g: PA573/4/1. 1g/actuation rectal foam: PL08637/0003; PA573/4/5. Suppositories: 250mg: PA573/4/2. 500mg: PL10341/0009; 1g: PL08637/0018; PA573/4/4.

Product licence holder: 250mg tablets (UK), 2g enema, 500mg suppositories: Dr Falk Pharma UK Ltd, Bourne End Business Park, Cores End Road, Bourne End, SL8 5AS. 250mg tablets (IE), 500mg and 1g tablets, all granules, 1g foam, 250mg, 1g suppositories, 4g enema: Dr Falk Pharma GmbH, Leinenweberstr.5, D-79108 Freiburg, Germany.

Date of preparation: June 2019


Further information is available on request.


Adverse events should be reported. In the UK: Reporting forms and information can be found at . In Ireland, reporting forms and information can be found at Adverse events should also be reported to Dr Falk Pharma UK Ltd.