Anacal Rectal Ointment

Mucopolysaccharide polysulphuric acid ester (Heparinoid) 0.2%w/w Oxypolyethoxydodecane (Lauromacrogol 400) 5.0%w/w

Rectal Ointment

Anacal rectal ointment is indicated for the treatment of the following conditions: Relief of symptoms associated with haemorrhoids (including perianal haematomas), perianal eczema, pruritus, anal fissure, proctitis, periproctitis, and aftercare of haemorrhoids treated by surgery or injection.

Adults and the elderly: To be applied one to four times daily. Children: Not recommended.

Known sensitivity to any active or inactive component of the formulation. Not recommended for use in children.

Not to be taken orally. If symptoms persist or worsen, seek medical advice.

None known.

There is no evidence to suggest that Anacal Rectal Ointment should not be used during pregnancy and lactation.

None.

None known.

In the absence of any reports of the accidental ingestion of Anacal, no specific advice is available. General supportive measures may be appropriate.

Mucopolysaccharide polysulphate ester is recognised as having: A weak inhibitory effect on PGE₂ synthesis and an indirect effect on LTB₄ production based on in vitro studies. Anti-coagulant activity: as a heparinoid. Thrombolytic activity: through potentiation of urokinase activity. Anti-exudatory activity: through inhibition of hyaluronidase. Oxypolyethoxydodecane has both topical anaesthetic and anti-pruritic properties.

Radiochemical studies of absorption following cutaneous application of mucopolysaccharide polysulphate have shown that between 0.3 and 4% of the mucopolysaccharide administered is absorbed by various tissues (other than the treated area) within the first 8 hours. Typically between 1.7% and 4.6% will be absorbed within 2 to 4 days. Animal studies have also shown that mucopolysaccharide is bound intracellularly within the subcutis. Peak serum concentrations following cutaneous application are below the threshold of physiological relevance for coagulation. Mucopolysaccharide is excreted in the urine partly unchanged and partly as depolymerized, shorter chain length molecules.

None stated

Polyethylene high polymer 1500 HSE Liquid paraffin BP Sorbitan stearate BP Methylhydroxybenzoate BP

None

3 years

Store below 25ºC.

Lacquered aluminium tubes containing 30gm.

Not applicable.

Genus Pharmaceuticals Limited T/A Genus Pharmaceuticals Benham Valence Newbury Berkshire RG20 8LU United Kingdom

Distributor

Marlborough Pharmaceuticals Ltd35A High StreetMarlboroughWiltsSN8 1LW

PL 06831/0172

02 February 2006

02 February 2006