Haemorrhoid Relief Ointment
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Anodesyn Ointment Care Haemorrhoid Relief Ointment Sainsburys Haemorrhoid Relief Ointment Tesco Haemorrhoid Relief Ointment
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Allantoin 0.5% w/w.
Lidocaine Hydrochloride 0.5% w/w.
For excipients, see 6.1
3. PHARMACEUTICAL FORM
A soft white translucent ointment.
4. CLINICAL PARTICULARS
4.1. Therapeutic indications
For the symptomatic relief of pain and irritation associated with external haemorrhoids.
4.2. Posology and method of administration
Route of administration: For external application.
Adults & the elderly.
For external piles, wash the affected area with tepid water, dry and apply the ointment with gauze or lint.
Repeat as required, 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 Ointment / Care Haemorrhoid Relief Ointment/Sainsburys Haemorrhoid Relief Ointment/Tesco Haemorrhoid Relief Ointment is 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.
Avoid contact with the eyes.
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. Pregnancy and lactation
The safety of Anodesyn Ointment / Care Haemorrhoid Relief Ointment/ Sainsburys Haemorrhoid Relief Ointment/Tesco Haemorrhoid Relief Ointment in pregnancy and lactation has not been assessed, 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, especially lidocaine.
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 X - Other antihaemorrhoidals for topical use
Lidocaine has a local anaesthetic action, relieving pain and discomfort in the affected areas.
Allantoin is claimed to promote healing.
5.2 Pharmacokinetic properties
No data available.
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.
PHARMACEUTICAL PARTICULARS
6.
6.1 List of excipients
White Soft Paraffin Wool Fat 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 collapsible 25g aluminium tube, internally lacquered with a latex welt and HPDE screw cap. Supplied with a nozzle and packed in a carton.
6.6 Instructions for use/handling
None stated
7. MARKETING AUTHORISATION HOLDER
Thornton & Ross Limited
Linthwaite
Huddersfield
West Yorkshire
HD75QH
United Kingdom
8. MARKETING AUTHORISATION NUMBER
PL 00240/0072
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
2nd December 2002
10 DATE OF REVISION OF THE TEXT
01/12/2014