AMETOP

Posology Adults (including the elderly):

A maximum of 5 tubes (approximately 5g) can be applied at separate sites at a single time. Application of Ametop gel can be repeated after a minimum of 5 hours if necessary. The maximum cumulative dose in a 24-hour period should not exceed 7 tubes.

3).

Infants over 1 month and children under 5 years of age:

A maximum of 1 tube (approximately 1 g) can be applied at separate sites at a single time. Application of Ametop gel can be repeated after a minimum of 5 hours if necessary. The maximum cumulative dose in a 24-hour period should not exceed 2 tubes.

Children over 5 years of age:

A maximum of 5 tubes (approximately 5 g) can be applied at separate sites at a single time. Application of Ametop gel can be repeated after a minimum of 5 hours if necessary. The maximum cumulative dose in a 24-hour period should not exceed 7 tubes.

Method of administration Cutaneous route. Precautions to be taken before handling or administering the medicinal product It may be advisable to use a finger cot or rubber glove during application and removal of Ametop gel. 6). Apply the contents of the tube to the centre of the area to be anaesthetised and cover with an occlusive dressing.

cm. (6x5cm). Smaller areas of anaesthetised skin may be adequate in infants and small children. Each tube is intended for use on a single occasion only. Adequate anaesthesia can usually be achieved following a thirty minute application time for venepuncture, and a forty-five minute application time for venous cannulation, after which the gel should be removed with a gauze swab and the site prepared with an antiseptic wipe in the normal manner.

It is not necessary to apply Ametop gel for longer than 30-45 minutes and anaesthesia remains for 4-6 hours in most patients after a single application.

Tabulated list of adverse reactions The following listing of adverse reactions is based on clinical trial experience and/or post- marketing use. The frequency of adverse reactions reported during post-marketing use cannot be determined as they are derived from spontaneous reports.

Consequently, the frequency of these adverse events is qualified as "not known". Undesirable effects are listed by MedDRA System Organ Classes.

Assessment of undesirable effects is based on the following frequency groupings:

Very common: ≥1/10 Common: ≥1/100 to <1/10 Uncommon: ≥1/1,000 to <1/100 Rare: ≥1/10,000 to <1/1,000 Very rare: <1/10,000 Not known: cannot be estimated from the available data System Organ Class Adverse drug reactions Common Application site erythema Uncommon Application site oedema Application site pruritus General disorders and administration site conditions Very rare Application site vesicles 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 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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.

Ametop contains Sodium methyl-p-hydroxybenzoate (E219) and Sodium propyl-p- hydroxybenzoate (E217) which may cause allergic reactions (possibly delayed).

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').

1. Do not apply Ametop gel to broken skin, mucous membranes or to the eyes or ears.