1. Name Of The Medicinal Product
Anacal Rectal Ointment
2. Qualitative And Quantitative Composition
Mucopolysaccharide polysulphuric acid ester (Heparinoid) 0.2%w/w Oxypolyethoxydodecane (Lauromacrogol 400) 5.0%w/w
3. Pharmaceutical Form
Rectal Ointment
4. Clinical Particulars
4.1 Therapeutic Indications
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.
4.2 Posology And Method Of Administration
Adults and the elderly:
To be applied one to four times daily.
Children:
Not recommended.
4.3 Contraindications
Known sensitivity to any active or inactive component of the formulation.
Not recommended for use in children.
4.4 Special Warnings And Precautions For Use
Not to be taken orally. If symptoms persist or worsen, seek medical advice.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
None known.
4.6 Pregnancy And Lactation
There is no evidence to suggest that Anacal Rectal Ointment should not be used during pregnancy and lactation.
4.7 Effects On Ability To Drive And Use Machines
None.
4.8 Undesirable Effects
None known.
4.9 Overdose
In the absence of any reports of the accidental ingestion of Anacal, no specific advice is available. General supportive measures may be appropriate.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
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.
5.2 Pharmacokinetic 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.
5.3 Preclinical Safety Data
None stated
6. Pharmaceutical Particulars
6.1 List Of Excipients
Polyethylene high polymer 1500 HSE
Liquid paraffin BP
Sorbitan stearate BP
Methylhydroxybenzoate BP
6.2 Incompatibilities
None
6.3 Shelf Life
3 years
6.4 Special Precautions For Storage
Store below 25ºC.
6.5 Nature And Contents Of Container
Lacquered aluminium tubes containing 30gm.
6.6 Special Precautions For Disposal And Other Handling
Not applicable.
7. Marketing Authorisation Holder
Genus Pharmaceuticals Limited
T/A Genus Pharmaceuticals
Benham Valence
Newbury
Berkshire RG20 8LU
United Kingdom
Distributor
Marlborough Pharmaceuticals Ltd
35A High Street
Marlborough
Wilts
SN8 1LW
8. Marketing Authorisation Number(S)
PL 06831/0172
9. Date Of First Authorisation/Renewal Of The Authorisation
02 February 2006
10. Date Of Revision Of The Text
02 February 2006
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