Prescribing Information (refer to full SPC before prescribing): 

Presentation: Salofalk 500mg and 1g gastro-resistant tablet (UK ONLY) containing 500mg and  1g mesalazine respectively. 

Salofalk 500mg/1000mg/1500mg/3000mg prolonged-release  granules: prolonged-release granules containing 500mg,1000mg, 1500mg or 3000mg mesalazine  per sachet. 

Indications: Salofalk 500mg tablets (UK): treatment and maintenance of remission of  ulcerative colitis. 

Salofalk 1g tablets (UK): treatment of acute episodes of mild/moderate ulcerative  colitis. 

Salofalk granules: treatment of acute episodes and the maintenance of remission of mild to  moderate ulcerative colitis. 

Dosage: Salofalk 500mg tablets (UK only): 1 or 2 tablets 3 times daily.  Maintenance: 1 tablet 3 times daily. 

Salofalk 1g tablets (UK only): 1 tablet three times daily.  Salofalk granules – adults: acute treatment – once daily 1 sachet of 3g granules, 1 or 2 sachets of  Salofalk 1.5g granules, 3 sachets of 500mg granules or 3 sachets of 1000mg granules (equivalent to  1.5 – 3.0g mesalazine daily), preferably taken in the morning. Alternatively, the dose can be taken  divided in three doses. Maintenance treatment – 1 sachet of 500mg granules 3 times daily (1.5g  mesalazine daily). Where needed, 3.0g per day in a single morning dose may be taken. 

Method of  administration: oral. Tablets - taken whole without chewing, with liquid, one hour before meals.  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. 

Children (all formulations): there is  only limited documentation for an effect in children (age 6-18 years). 

Children 6 years and older:  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. 

Contra-indications: Hypersensitivity to salicylates or any of the excipients. Severe impairment of renal or hepatic function. 

Warnings/Precautions: blood tests and urinary  status (dip sticks) should be determined prior to and during treatment. Caution is recommended in  patients with impaired hepatic function. Should not 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 cases. 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 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 carefully monitored.  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. Consider  discontinuation of mesalazine on signs and symptoms of idiopathic intracranial hypertension  (pseudotumor cerebri), patients should be warned of these, which include severe or recurrent  headache, visual disturbances or tinnitus. Patients with a history of adverse drug reactions to  preparations containing sulphasalazine should be kept under close medical surveillance. If acute  intolerance reactions e.g., abdominal cramps, acute abdominal pain, fever, severe headache and  rash occur, stop treatment immediately. Tablets may be excreted undissolved in patients with the ileocecal valve removed. 

Salofalk granules: contain aspartame, a source of phenylalanine. May be  harmful to patients with phenylketonuria. Granules also contain sucrose: 0.04mg, 0.08mg, 0.12mg, 0.24mg (500mg/1g/1.5g and 3g granules respectively). 

Salofalk tablets: for patients on a sodium controlled diet: the 500mg tablets contain 49mg of sodium, equivalent to 2.5% of the recommended  maximum daily intake for sodium. 

All: urine may be discoloured red-brown after contact with sodium  hypochlorite bleach used in toilets. 

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, visual disturbance, tinnitus, idiopathic intracranial hypertension, 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. 

Legal category: POM. 

Cost (UK - basic NHS price; Ireland - PtW): Salofalk  500mg tablets (100s) £32.38. Salofalk 1g tablets (90s) £58.50. Salofalk 500mg granules (100  sachets) £28.74; €27.93. Salofalk 1000mg granules (50 sachets) £28.74; €32.87. Salofalk 1500mg  granules (60 sachets) £48.85; €49.66. Salofalk 3g granules (60 sachets) £97.70; €99.56. 

Product  licence number: Salofalk 500mg tablets: PL08637/0019. Salofalk 1g tablets: PL08637/0027.  Salofalk 500mg granules: PL08637/0007; PA573/3/1. Salofalk 1000mg granules: PL08637/0008;  PA573/3/2. Salofalk 1500mg granules: PL08637/0016; PA573/3/7. Salofalk 3g granules:  PL08637/0025; PA573/3/6. 

Product licence holder: Salofalk 500mg and 1g tablets and all  granules: Dr Falk Pharma GmbH, Leinenweberstr.5, D-79108 Freiburg, Germany. 

Date of  preparation: March 2025 

Further information is available on request.

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.  Consider discontinuation of mesalazine on signs and symptoms of idiopathic intracranial hypertension  (pseudotumor cerebri), patients should be warned of these, which include severe or recurrent headache, visual  disturbances or tinnitus. 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, visual disturbance, tinnitus, idiopathic intracranial hypertension, peri- and myo-carditis, 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: December 2024. 

Further information is available on request. 

Adverse Events should be reported 

Ireland: 

Reporting forms and information can be found at 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.  

Adverse events should also be reported to Dr Falk Pharma UK Ltd at PV@drfalkpharma.co.uk