Dr. Falk Pharma UK Ltd

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Summary of Product Characteristics last updated on the eMC: 09/08/2007
SPC Salofalk Enema 2g


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1. NAME OF THE MEDICINAL PRODUCT

Salofalk Enema 2g.


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each enema contains the following active ingredient:

Mesalazine 2g in 59 ml of suspension.


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3. PHARMACEUTICAL FORM

Enema.


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

Therapy and prophylaxis of acute attacks of mild ulcerative colitis, especially in the rectum and sigmoid colon and also in the descending colon.


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4.2 Posology and method of administration

Method of administration: Rectal

Adults and the Elderly: 1 enema once a day at bedtime. The action of Salofalk is enhanced if the patient lies on the left side when introducing the enema. 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.


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4.3 Contraindications

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


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4.4 Special warnings and precautions for use

The drug should not be prescribed for infants.

Serious blood dyscrasias have been reported 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. Sulphite component as excipient in enema preparation may cause hypersensitivity reactions in patients suffering from bronchial asthma.

Reports of interstitial nephritis occurring with mesalazine treatment are uncommon; however, patients on oral forms may require renal monitoring. Use with extreme caution in patients with mild to moderate renal impairment (see section 4.3) and if dehydration develops, normal electrolyte levels and fluid balance should be restored as soon as possible.


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4.5 Interaction with other medicinal products and other forms of interaction

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 sulphonylureas. 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).


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4.6 Pregnancy and lactation

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 during the first trimester. It can be used with caution during pregnancy and only if the potential benefits outweigh the potential risks.


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4.7 Effects on ability to drive and use machines

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


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4.8 Undesirable effects

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 methaemogloblin levels may occur. Headache and digestive disturbances such as nausea and diarrhoea may occur. Isolated cases of hair loss have been reported.


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4.9 Overdose

There have been no reported cases of overdosage.


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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

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


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5.2 Pharmacokinetic properties

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.


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5.3 Preclinical safety data

None stated.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Salofalk Enema 2g contain the following excipients:

Carbomer

Disodium edetate

Potassium acetate

Potassium metabisulphite

Purified water

Sodium benzoate

Xanthan gum


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6.2 Incompatibilities

None known.


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6.3 Shelf life

24 months.


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6.4 Special precautions for storage

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


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6.5 Nature and contents of container

Low density concertina shaped polythene bottle with a low density polythene application nozzle packed in cartons containing seven individually blister packed bottles.


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6.6 Special precautions for disposal and other handling

None


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Administrative Data

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7. MARKETING AUTHORISATION HOLDER

Dr Falk Pharma UK Ltd

Unit k

Bourne End Business Park

Cores End Road

Bourne End

Bucks

SL8 5AS

United Kingdom


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8. MARKETING AUTHORISATION NUMBER(S)

PL 10341/0008


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

31st December 2004


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10. DATE OF REVISION OF THE TEXT

August 2006



More information about this product

Link to this document from your website: http://emc.medicines.org.uk/medicine/16911/SPC/Salofalk Enema 2g/

Active Ingredients/Generics

 
   mesalazine


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