Anethaine Cream
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Anethaine Cream
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Tetracaine Hydrochloride BP 1% w/w.
3. PHARMACEUTICAL FORM
25 g of a smooth white oil in water cream for topical application.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Anethaine Cream gives prompt temporary relief from itching and stinging in insect bites, stings and nettle rash.
4.2 Posology and method of administration
Route of administration:
Anethaine is applied topically to the affected area.
Smooth Anethaine onto affected area. Repeat as needed. Two or three times daily
4.3 Contraindications
Not suitable for infants under three years of age. Do not apply to broken skin.
Do not get Anethaine into the eyes.
For external use only.
The packaging will contain the following warnings:
If irritation or inflammation persists, stop using Anethaine and seek medical advice. Keep Anethaine out of the reach of children. Not for prolonged use. Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis). Bergamot Oil may increase sensitivity to UV light (natural and artificial sunlight).
4.5 Interactions with other medicinal products and other forms of interaction
None known.
4.6 Pregnancy and lactation
No restrictions necessary.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
None known.
4.9 Overdose
Not applicable.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Tetracaine is a potent local anaesthetic of the ester type which is used for surface and spinal anaesthesia.
5.2 Pharmacokinetic properties
Tetracaine is absorbed through mucous membranes and damaged skin. It is hydrolysed by plasma esterases to p-aminobenzoic acid and other metabolites, which are excreted mainly by the kidney.
5.3 Preclinical safety data
Not applicable.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Macrogol cetostearyl ether Ph. Eur.
Cetostearyl Alcohol BP Diethylene Glycol Monostearate HSE Liquid Paraffin BP Glycerol BP
Bergamot Oil 34869 HSE Purified Water BP
6.2 Incompatibilities
None known.
6.3 Shelf life
Two years.
6.4. Special precautions for storage
Do not store above 25°C
6.5
Nature and contents of container
Internally lacquered aluminium, blind end tubes closed with a polyolefin cap in a cardboard outer. Pack size 25g.
6.6 Instruction for use and handling
None.
7. MARKETING AUTHORISATION HOLDER
Torbet Laboratories Limited
14D Wendover Road
Rackheath Industrial Estate
Norwich
Norfolk
NR13 6LH
8. MARKETING AUTHORISATION NUMBER
PL 00287/0017
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
5th April 2002
10 DATE OF REVISION OF THE TEXT
02/08/2006