Ametop 40 mg/g Gel

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Excipients with known effect:

4.1 Therapeutic indications

Ametop is indicated in adults and infants aged over 1 month.

4.2 Posology and method of administration

Posology

Adults (including the elderly): and children over 5 years: 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.

Paediatric population

Ametop is contraindicated in premature babies or in full term infants less than 1 month of age (see section 4.3).

Children Infants over 1 month of age 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. No more than 1 tube should be applied

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. Always wash hands thoroughly after use (see section 6.6).

Up to five tubes of Ametop Gel can be applied for dermal laser procedures, however no more than one tube should be applied to children under 5 years of age.

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 for adults and 2 tubes for children.

Not recommended for infants under 1 month of age.

4.3 Contraindications

For premature babies use of Ametop Ggel is not recommended before 1 month after the expected delivery date (44 weeks ‘gestation’).

Known h Hypersentivity to any ingredients to the active substance or to local anaesthetics of the ester type, or to any of the excipients listed in section 6.1.

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

4.4 Special warnings and precautions for use

Although the systemic availability of tetracaine by percutaneous absorption of Ametop Ggel 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).

4.6 Fertility, pregnancy and lactation

Pregnancy

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 ill-consequence.There are no animal studies to indicate direct or indirect harmful effects with respect to reproductive toxicity There are no adequate data from the use of tetracaine in pregnant women. There are no animal studies to indicate direct or indirect harmful effects with respect to reproductive toxicity As no animal studies were performed looking at reproductive toxicity, it is unknown if there could be direct or indirect harmful effect with respect to pregnancy (see section 5.3).

As a precautionary measure, it is preferable to avoid the use of Ametop during pregnancy.

Breast-feeding

It is not known whether tetracaine or its metabolites are secreted in breast milk. A risk to the new-borns/infants cannot be excluded. Therefore, the product is not recommended for use in breast feeding mothers.

Fertility

There are no clinical data regarding the potential effect of Ametop gel on fertility.

4.7 Effects on ability to drive and use machines

Ametop gel has no or negligible influence on the ability to drive or use machines.

No adverse effects on the ability to drive or to use hazardous machinery are expected following use of Ametop Gel.

4.8 Undesirable effects

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

¹Slight 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.

²Slight 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.

³More severe erythema, oedema and/or itching confined to the site of application have rarely been reported.

⁴In 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.

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 is 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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Anaesthetics, Local, ATC code: N01BA03

Mechanism of action

Tetracaine is a local anaesthetic and is believed to act by blocking nerve conduction mainly by inhibiting sodium ion flux across the axon membrane. Tetracaine achieves this by acting upon specific receptors that control gating mechanisms responsible for conductance changes in specialised proteinaceous sodium channels.

Blocking sodium ion flux prevents the setting up of an action potential in the nerve axon, thus preventing pain receptors signalling to the central nervous system.

Pharmacodynamic effects

Tetracaine additionally has vasodilatory effects, which commonly results in a localised erythema.

6.2 Incompatibilities

Not applicable In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.6 Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product and other handling

As tetracaine can cause contact sensitisation reactions, particularly with

repeated contact, healthcare professionals are advised to wash their hands thoroughly after use, to avoid contamination of other parts of the body. It may be advisable to use a finger cot or rubber glove during application and removal of Ametop gel.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

No special requirements.

10. DATE OF REVISION OF THE TEXT

April 2019 October 2020

Additions are marked on green and deletions are crossed through and marked in red:

Read all of this entire leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to use AMETOP 40mg/g Gel carefully to get the best results from it. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• If any of the you get any side effects get serious, or if you notice any side effects not listed in the leaflet, please tell talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

In What is in this leaflet

1. What AMETOP 40mg/g Gel is and what it is used for
2. Before What you need to know before you use AMETOP 40mg/g Gel
3. How to use AMETOP 40mg/g Gel  
4. Possible side effects
5. How to store AMETOP 40mg/g Gel
6. Further Contents of the pack and other information

1. What AMETOP Gel is and what it is used for

AMETOP Gel contains the active substance tetracaine. Tetracaine is a local anaesthetic which numbs the skin.

AMETOP Gel is used:

• to relieve the pain when needles are inserted into a vein for giving an injection or taking a blood sample.
• prior to non-ablative skin laser treatment to relieve the pain of the procedure.
• AmetopMETOP Gel is used in adults and infants aged over 1 month.

Warnings and precautions

Talk to your doctor or pharmacist before using this medicine Take special care with AMETOP Gel 

• it may be toxic to the ear, therefore you should not put AMETOP Gel in the ear or use it for any middle ear procedures.

Repeated use may increase the risk of experiencing an allergic reaction to AMETOP Gel, and to other medicines containing tetracaine.

Do not use AMETOP Gel on:

• Wounds
• broken skin
• lips, mouth or tongue
• eyes or ears
• anal or genital regions
• mucous membranes
• premiture babies until one month after the expected delivery date (44 weeks gestation)

Children

Do not use this medicine in infants less than 1 month old or in premature babies up until one month after the expected delivery date (44 weeks gestation).

Other medicines and AMETOP Gel

Using other medications

Tell your doctor or pharmacist if you are taking or have recently taken any medicines, including medicines obtained without a prescription. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Using AMETOP Gel with food, drink and alcohol

There are no known effects of food, drink or alcohol with AMETOP Gel.

AMETOP Gel contains sodium methyl parahydroxybenzoate (E219) and sodium propyl parahydroxybenzoate (E217) which may cause allergic reactions (possibly delayed).

3. How to use AMETOP Gel

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Adults including the elderly and children over 5 years of age:

• A maximum of 5 tubes (approximately 5g) can be applied at separate sites at one the same time. Application of AMETOP Gel can be repeated after a minimum of 5 hours if necessary. The maximum dose in a 24-hour period should not exceed 7 tubes.

Use in children:

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

• No more than A maximum of 1 tube should (approximately 1g) can be applied at one separate sites at a single time. Application of AMETOP Gel can be repeated after a minimum of 5 hours if necessary. The maximum dose in a 24-hour period should not exceed 2 tubes.
• Do not use if the patient is less than 1 month old or if the patient is a premature baby up until one month after the expected delivery date (44 weeks gestation).

Children over 5 years of age:

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

Appliaction of AMETOP Gel can be repeated after a maximum of 5 hours if necessary.

• The maximum dose in a 24 hour period should not exceed 7 tubes for adults and 2 tubes for children.

How to apply the plastic film dressing

• AMETOP Gel should not be left on for more than 45 minutes for vein related procedures and 2 hours for laser procedures  1 hour

Take care to minimise contact with AMETOP Gel (except for the area of skin to be numbed) during application and removal. Allergic reactions to this product can occur, especially following repeated contact. It may be advisable to use a finger cot or rubber glove during application and removal of AmetopMETOP Gel. Always wash hands thoroughly after use.

If the product comes into contact with the eyes, ears, mouth, tongue or nose you should immediately rinse the affected area and contact your doctor or pharmacist for further advice.

If you use more AMETOP Gel than you should or if you swallow AMETOP Gel

You may experience intoxication, tingling, numbness in your tongue, ringing in your ears (tinnitus), uncontrolled rapid jerky movement of the eyes, feeling sick or actually being sick, twitching and fitting. You should contact your doctor immediately.

4. Possible side effects

Common: may affect up to 1 in 10 people

• Minor redness of the skin at the numbed site (more severe redness has rarely been reported).

Uncommon: may affect up to 1 in 100 people

• Minor itching and swelling of the skin at the numbed site (more severe itching and swelling have rarely been reported).

Very rare: may affect up to 1 in 10,000 people (less than 1 per 10,000

• redness, itching and swelling of the skin at the number site.
• Very rarely, blistering Blistering of the skin at the numbed site. If blistering occurs remove the AMETOP Gel immediately using a clean tissue and contact your doctor or pharmacist

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via HPRA Pharmacovigilance. Earlsfort Terrace ERL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517 Website: www.hpra.ie; E-Mail: medsafety@hpra.ie. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store AMETOP Gel

• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Further Contents of the pack and other Information

What AMETOP Gel contains

• The active substance tetracaine 4% w/w.

What AMETOP Gel looks like and the contents of the pack

AMETOP Gel is a white semi-transparent gel containing 4%w/w of tetacaine. Each gram of gel contains 40mg of tetracaine. Each tube contains 1.5g of AMETOP Gel from which 1g (40mg tetracaine) can be squeezed. Each tube is presented in a carton.

This medicine is also available in a dispenser multipack of 12 cartons, each carton containing a 1.5g tube, plus 24 dressings in an outer carton.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Irish product Authorisation (PA2325/002/001)

Manufacturer

Date of preperationThis leaflet was last revised: January 2019 April August 2020

Ametop^®, Alliance and associated devices are registered trademarks of the Alliance Pharmaceuticals Limited © Alliance Pharmaceuticals Limited 2019 2020

• Section 4.8 Undersirable effects - Amendment to adverse event reporting information.

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