This information is intended for use by health professionals

1. Name of the medicinal product

Anodesyn Suppositories

Tesco Haemorrhoid Relief Suppositories

Care Haemorrhoid Relief Suppositories

Sainsburys Haemorrhoid Relief Suppositories

Boots Haemorrhoid Relief Suppositories

2. Qualitative and quantitative composition

Allantoin

10.25mg

Lidocaine Hydrochloride

10.25mg

For excipients, see 6.1

3. Pharmaceutical form

Suppositories

White or nearly white suppositories.

4. Clinical particulars
4.1 Therapeutic indications

For the symptomatic relief of pain and irritation associated with haemorrhoids.

4.2 Posology and method of administration

Route of administration: For rectal administration.

Adults and the elderly.

If necessary empty the bowels before using the suppository. Remove the protective film and insert the suppository as deep as possible into the rectum. One suppository should be inserted night and morning after each bowel movement. Do not use for more than 7 days unless advised by your doctor.

Children.

Not recommended for children.

4.3 Contraindications

Hypersensitivity to any of the ingredients, especially lidocaine.

4.4 Special warnings and precautions for use

Anodesyn Suppositories/Tesco Haemorrhoid Relief Suppositories / Boots Haemorrhoid Suppositories / Care Haemorrhoid Relief Suppositories/Sainsburys Haemorrhoid Relief Suppositories are intended for use for short periods and should not be used for longer than 7 days without medical advice. Patients should be instructed to seek medical advice if they experience persistent pain or bleeding from the anus, especially where associated with a change in bowel habit, if the stomach is distended or if they are losing weight.

The label will state:

Keep all medicines out of the reach and sight of children.

If symptoms persist for more than 7 days consult your doctor.

4.5 Interaction with other medicinal products and other forms of interaction

No clinically significant drug interactions known.

4.6 Fertility, pregnancy and lactation

The safety of Anodesyn Suppositories/Tesco Haemorrhoid Relief Suppositories/Boots Haemorrhoid Suppositories /Care Haemorrhoid Relief Suppositories/Sainsburys Haemorrhoid Relief Suppositories in pregnancy and lactation has not been established, but it is thought unlikely to constitute a hazard, though caution should be exercised during the first trimester.

Lidocaine crosses the placenta and is distributed into breast milk..

4.7 Effects on ability to drive and use machines

No or negligible influence.

4.8 Undesirable effects

Hypersensitivity to any of the ingredients, particularly lidocaine. Occasionally may cause diarrhoea.

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

Accidental ingestion may result in anaesthesia of the upper respiratory tract, nausea, vomiting and abdominal discomfort. Ingestion of very large quantities could result in CNS and cardiovascular toxicity.

Treatment should be symptomatic and supportive.

5. Pharmacological properties
5.1 Pharmacodynamic properties

C05A D0l - Products containing local anaesthetics

Lidocaine has a local anaesthetic action, relieving pain and discomfort in the affected areas. Allantoin is claimed to promote healing.

5.2 Pharmacokinetic properties

Not applicable

5.3 Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical particulars
6.1 List of excipients

Colloidal Anhydrous Silica

Witepsol W35

Purified Water

6.2 Incompatibilities

Not applicable

6.3 Shelf life

Three years.

6.4 Special precautions for storage

Store at or below 25°C.

6.5 Nature and contents of container

A white polythene lined, unplasticised PVC moulded strip, heat sealed and placed into a printed carton, containing 6, 12 or 24 suppositories.

6.6 Special precautions for disposal and other handling

None stated.

7. Marketing authorisation holder

Thornton & Ross Limited

Linthwaite

Huddersfield

West Yorkshire

HD7 5QH

United Kingdom

8. Marketing authorisation number(s)

PL 00240/0071

9. Date of first authorisation/renewal of the authorisation

6th September 2002

10. Date of revision of the text

08.01.2015