Tesco Haemorrhoid Relief Suppositories
SUMMARY OF PRODUCT CHARACTERISTICS
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. Interactions with other medicinal products and other forms of interaction
No clinically significant drug interactions known.
4.6 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 PROPERTIES
List of excipients
6.1.
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 Instructions for use/handling
None stated.
7. MARKETING AUTHORISATION HOLDER
Thornton & Ross Limited
Linthwaite
Huddersfield
West Yorkshire
HD75QH
United Kingdom
MARKETING AUTHORISATION NUMBER
8.
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