Summary of Product Characteristics Updated 07-Jul-2021 | Thornton & Ross Ltd
Anodesyn Ointment
Care Haemorrhoid Relief Ointment
Sainsburys Haemorrhoid Relief Ointment
Allantoin 0.5% w/w.
Lidocaine Hydrochloride Monohydrate 0.5% w/w.
For the full list of excipients, see section 6.1.>
A soft white translucent ointment.
For the symptomatic relief of pain and irritation associated with external haemorrhoids.
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.
Hypersensitivity to any of the ingredients, especially lidocaine.
Anodesyn Ointment / Care Haemorrhoid Relief Ointment / Sainsburys 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.
No clinically significant drug interactions known.
The safety of Anodesyn Ointment / Care Haemorrhoid Relief Ointment / Sainsburys 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.
No or negligible influence.
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.
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.
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.
No data available.
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
White Soft Paraffin
Wool Fat
Purified Water
Not applicable.
Three years.
Store at or below 25° C.
A collapsible 25g aluminium tube, internally lacquered with a latex welt and HPDE screw cap. Supplied with a nozzle and packed in a carton.
None stated
Thornton & Ross Limited
Linthwaite
Huddersfield
West Yorkshire
HD7 5QH
United Kingdom
PL 00240/0072
2nd December 2002
05/07/2021
Linthwaite, Huddersfield, West Yorks, HD7 5QH
+44(0)1484 848200
+44 (0) 1484 848164