1. Name Of The Medicinal Product
Anbesol Liquid
2. Qualitative And Quantitative Composition
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3. Pharmaceutical Form
Liquid for oral administration
4. Clinical Particulars
4.1 Therapeutic Indications
For the temporary relief of pain caused by recurrent mouth ulcers, denture irritation and teething.
4.2 Posology And Method Of Administration
Adults, the elderly and children: Apply undiluted to the affected area with the fingertip. Two applications immediately will normally be sufficient to obtain pain relief. Use up to 8 times a day.
Babies teething: One application only. Do not repeat for at least half an hour. Use up to 8 times a day.
4.3 Contraindications
Patients with known history of hypersensitivity or allergic type reactions to any of the constituents of the product.
4.4 Special Warnings And Precautions For Use
If symptoms persist for more than 7 days consult your doctor or dentist. For babies teething, do not repeat for at least half an hour.
Keep all medicines out of the reach of children.
Do not exceed the stated dose.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
None known.
4.6 Pregnancy And Lactation
No special precautions required.
4.7 Effects On Ability To Drive And Use Machines
None known.
4.8 Undesirable Effects
There have been reports of non-specific ulceration following oral cetylpyridinium chloride therapy.
4.9 Overdose
Ingestion of the complete contents of the marketed pack would not be expected to cause any adverse effects.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Lidocaine hydrochloride
Absorption and fate: lidocaine is readily absorbed from mucous membranes and through damaged skin. Lidocaine undergoes first-pass metabolism in the liver and about 90% is dealkylated to form monoethylglycinexylidide and glycinexylidide. Further metabolism occurs and the metabolites are excreted in the urine with less than 10% as unchanged lidocaine.
Chlorocresol
Absorption: there is no significant absorption of chlorocresol through the skin or mucous.
Cetylpyridinium chloride
Absorption: there is no significant absorption of cetylpyridinium chloride through the skin or mucous membranes.
5.2 Pharmacokinetic Properties
Lidocaine hydrochloride
White crystalline powder soluble in water and alcohol.
Mechanism of action/effect: lidocaine is a local anaesthetic of the amide type, which acts by reversible inhibition of nerve impulse generation and transmission.
Chlorocresol
Colourless crystals or a white crystalline powder slightly soluble in water and alcohol.
Chlorocresol has a disinfectant action.
Cetylpyridinium chloride
A white unctuous powder soluble in water and alcohol.
Mechanism of action/effect: cetylpyridinium chloride has a disinfectant action.
5.3 Preclinical Safety Data
None stated
6. Pharmaceutical Particulars
6.1 List Of Excipients
Alcohol 96%, menthol, glycerin, caramel colour*, purified water
*contains colorants E110, E104, E123, E142
6.2 Incompatibilities
None known
6.3 Shelf Life
36 months unopened
6.4 Special Precautions For Storage
Store at a temperature not exceeding 25°C
6.5 Nature And Contents Of Container
6.5ml, 15ml: glass bottles
6.6 Special Precautions For Disposal And Other Handling
Not applicable
7. Marketing Authorisation Holder
Alliance Pharmaceuticals Limited
Avonbridge House
Bath Road
Chippenham
Wiltshire
SN15 2BB
UK
8. Marketing Authorisation Number(S)
PL 16853/0128
9. Date Of First Authorisation/Renewal Of The Authorisation
30/07/1998
10. Date Of Revision Of The Text
21st July 2011
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