SUMMARY OF PRODUCT CHARACTERISTICS

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. Contra-indications

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. Interactions with other Medicaments 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.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

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.

5.1 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 highpolymer 1500 HSE Liquid paraffin BP Sorbitan stearate    BP

Methylhydroxybenzoate (E218) BP

Incompatibilities

None

6.3.    Shelf Life

3 years.

6.4.    Special Precautions for Storage

Store below 25 °C.

6.5.    Nature and Contents of Container

Laquered aluminium tubes containing 30 gm.

6.6.    Instruction for Use/Handling Not applicable.

7    MARKETING AUTHORISATION HOLDER

Genus Pharmaceuticals Limited T/A Genus Pharmaceuticals Linthwaite,

Huddersfield,

HD7 5QH, UK

8    MARKETING AUTHORISATION NUMBER(S)

PL 06831/0172

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 18/03/2009

10 DATE OF REVISION OF THE TEXT

04/12/2014