Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Alliance Pharmaceuticals Limited, Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB, United Kingdom
Use in premature babies or in full term infants less than 1 month of age, where the metabolic pathway for Tetracaine may not be fully developed. For premature babies use of Ametop is not recommended before 1 month after the expected delivery date (44 weeks ‘gestation’);
Known hypersensitivity to any of the ingredients or to local anaesthetics of the ester type.
Do not apply Ametop gel to broken skin, mucous membranes or to the eyes or ears.
Only apply to intact, normal skin.
Not to be taken internally.
Ametop gel, like other local anaesthetics may be ototoxic and should not be instilled into the middle ear or used for procedures which might involve penetration into the middle ear. Repeated exposure to Ametop gel may increase the risk of sensitisation reactions to Tetracaine.
Although the systemic availability of Tetracaine by percutaneous absorption of Ametop gel is low, caution should be exercised in patients with epilepsy.
None known.
There is no specific information as to the safety of Tetracaine in pregnancy, although Tetracaine has been in wide use for many years without apparent illconsequence. The rapid hydrolysis of Tetracaine bv plasma pseudocholinesterase means that it is unlikely to present a significant hazard to the fetus when used as indicated.
It is not known whether Tetracaine or its metabolites are secreted in breast milk. Therefore the product is not recommended for use on breast feeding mothers.
No adverse effects on the ability to drive or to use hazardous machinery are expected following use of Ametop Gel.
Slight erythema is frequently seen at the site of application and is due to the pharmacological action of Tetracaine in dilating capillary vessels. This may help delineating the anaesthetised area.
Slight oedema or itching are less frequently seen at the site of application.
This may be due to the local release of histamine and 5-HT.
More severe erythema, oedema and/or itching confined to the site of application have rarely been reported.
In very rare instances, blistering of the skin at the site of application may be apparent – in these cases, remove the gel immediately and treat the affected area symptomatically.
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
None known.
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