- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
1. Name of the medicinal product
Anacal Rectal Ointment
2. Qualitative and quantitative composition
Mucopolysaccharide polysulphuric acid ester (Heparinoid) 0.2%w/wOxypolyethoxydodecane (Lauromacrogol 400) 5.0%w/w
3. Pharmaceutical form
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.
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
If condition persists or worsens, seek medical advice.
4.5 Interaction with other medicinal products and other forms of interaction
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
4.8 Undesirable effects
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
6. Pharmaceutical particulars
6.1 List of excipients
Polyethylene highpolymer 1500 HSELiquid paraffin BPSorbitan stearate BPMethylhydroxybenzoate BP
6.3 Shelf life
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
7. Marketing authorisation holder
Genus Pharmaceuticals Limited,Park View House65 London Road,Newbury,Berkshire,RG14 1JN
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
02 February 2006/ 18 March 2009
10. Date of revision of the text
18 March 2009
Park View House, 65 London Road, Newbury, Berkshire, RG14 1JN
+44 (0)1635 568 401
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