Salofalk Suppositories 500mg.

Each suppository contains the following active ingredient:

Mesalazine 500mg.

Suppository.

Management of mild and moderate attacks of ulcerative colitis, especially in the rectum and sigmoid colon and also in the descending colon.

Method of administration: Rectal

Adults and the Elderly: 1 to 2 suppositories, 2 to 3 times daily. The action of Salofalk is enhanced if the patient lies on the left side when introducing the suppository. The dosage should be adjusted to suit the progress of the condition. Do not discontinue treatment suddenly.

Children: There is no recommended dose for children. Mesalazine should not be used in babies and infants.

Severe renal and hepatic function disturbances. Active gastrointestinal ulcers. Hypersensitivity to salicylates.

The drug should not be prescribed for infants.

Serious blood dyscrasias have been reported very rarely with mesalazine. Haematological investigations including methaemogloblin values should be performed regularly during the course of therapy and if the patient develops unexplained bleeding, bruising, purpura, anaemia, fever or sore throat. Treatment should be stopped if there is suspicion or evidence of blood dyscrasia or if renal function deteriorates.

Reports of interstitial nephritis occurring with mesalazine treatment are uncommon; However patients on oral formulations may require renal monitoring.

Use with extreme caution in patients with mild to moderate renal impairment (see section 4.4) and if dehydration develops, normal electrolyte levels and fluid balance should be restored as soon as possible.

Although the following interactions are theoretically possible, owing to the low degree of absorption of the rectally administered mesalazine, the risk of their onset is extremely low: mesalazine may potentiate the actions of sulfonylureas. Interactions with coumarin, methotrexate, probenecid, sulfinpyrazone, spironolactone, furosemide and rifampicin cannot be excluded. Mesalazine can theoretically potentiate the side effects of glucocorticoids on the stomach.

Concurrent use with other known nephrotoxic agents such as NSAID's and azathioprine may increase the risk of renal reactions (see section 4.4).

Animal experiments on mesalazine have produced no evidence of embryonic effects. No untoward effects were seen in a reproductive and fertility study with mesalazine in breast-fed rat pups. Mesalazine is acetylated in the body and passes in this form into breast milk. Limited use of mesalazine in pregnancy has shown no untoward effect on the foetus. However, it should not be used in the first trimester. It can be used with caution during pregnancy and only if the potential benefits outweigh the potential risks.

Salofalk Suppositories are not expected to affect ability to drive and use machines. If dizziness develops, the patient should not drive or operate machinery.

Rectal Salofalk may cause acute intolerance (sensitivity reactions). This is characterised by abdominal pain, bloody diarrhoea, fever, pruritus and rash. These are unrelated to dose.

The most common adverse effects following treatment with rectal mesalazine are:

General symptoms such as dizziness, malaise, paraesthesia, arthralgia and pyrexia may develop following rectal administration of sulphasalazine.

GI effects: abdominal pain, flatulence, nausea, worsening or development of diarrhoea.

CNS effects: Headache, malaise, dizziness and peripheral neuropathy.

Sensitivity reactions: Mesalazine may be associated with an exacerbation of the symptoms of colitis in those patients who have previously had such problems with sulfasalazine. Allergic skin reactions such as rash, bullous skin reactions including erythema multiforme and Stevens-Johnson syndrome.

Other adverse effects: Fever, arthralgia, pericarditis, myocarditis, pancreatitis

Other adverse effects were reported following oral administration of mesalazine. There have been rare reports of leucopenia, neutropenia, agranulocytosis, aplastic anaemia and thrombocytopenia, abnormalities of hepatic function, hepatitis, cholestatic hepatitis, allergic lung reactions, interstitial nephritis and nephrotic syndrome with oral mesalazine treatment, usually reversible on withdrawal. Renal failure has been reported. Mesalazine-induced nephrotoxicity should be suspected in patients developing renal dysfunction during treatment. Increased methaemaglobin levels may occur. Headache and digestive disturbances such as nausea and diarrhoea may occur. Isolated cases of hair loss have been reported.

There have been no reported cases of overdosage.

Mesalazine is the biologically active metabolite of salicylazosulfapyridine that is used in the treatment of certain chronic inflammatory conditions of the intestine.

Following rectal administration the major fraction is recovered from the faeces, a small percentage (approximately 15%) is absorbed; the absorbed mesalazine is excreted mainly in the urine; biliary excretion is secondary. The acetylated and the non-acetylated forms of mesalazine bind slightly to plasma proteins.

None stated.

Salofalk Suppositories 500mg contain the following excipients:

Hard Fat, Docusate sodium, Cetyl alcohol,

None known.

36 months.

Store at room temperature (15-25° C) and protect from light.

Cartons of ten or thirty suppositories in white, opaque PVC/PE moulded strips.

Each strip contains five suppositories

None

Dr Falk Pharma UK Ltd

Unit k

Bourne End Business Park

Cores End Road

Bourne End

Bucks

SL8 5AS

United Kingdom

PL 10341/0009

31^st December 2004

August 2006