Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Ametop
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Tetracaine may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
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.
- to relieve the pain of inserting small plastic tubes (cannulae) into veins for putting up drips. AMETOP Gel is used in adults and infants aged over 1 month.
Ametop PIL UK 003
What you need to know before you take it
e AMETOP Gel Do not use AMETOP Gel:
- if you are allergic (hypersensitive) to tetracaine or any of the other ingredients of AMETOP Gel (see Section 6).
- if you are allergic (hypersensitive) to any other local anaesthetics.
- if you are pregnant or breast-feeding.
- if the patient is less than 1 month old.
- If the patient is a premature baby up until one month after the expected delivery date (44 weeks gestation).
- on wounds
- on broken skin
- on lips, mouth or tongue
- on eyes or ears
- on anal and genital regions. Warnings and precautions Talk to your doctor or pharmacist before using this medicine
- 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.
- if you suffer from epilepsy. Do not swallow AMETOP Gel 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 Tell your doctor or pharmacist if you are taking or have recently taken any medicines, including medicines obtained without a prescription. Pregnancy and breast-feeding Do not use if you are pregnant, thinking of becoming pregnant, or breastfeeding. Ask your doctor or pharmacist before taking or using any medicines. Driving and using machines AMETOP Gel is unlikely to affect driving or the use of machines. AMETOP Gel contains Sodium methyl parahydroxybenzoate (E219) and Sodium propyl parahydroxybenzoate (E217) which may cause allergic reactions (possibly delayed).
Ametop PIL UK 003
How to take it
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: 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. Use in children: Infants over 1 month of age and children under 5 years of age:
- A maximum of 1 tube (approximately 1g) 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 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. Your doctor, nurse or pharmacist will tell you where on the skin you need to apply the medicine. One tube of AMETOP Gel can cover an area of up to 30 sq cm (6cm x 5cm or 21⁄2in. x 2in.). This medicine may be administered by a doctor, nurse or pharmacist. If not, you should carry out the following steps:
Ametop PIL UK 003
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To open the tube, invert the cap and pierce the seal. Apply the contents of the tube on the area of the skin to be numbed. Do not rub the gel into the skin. The mound of gel should then be covered with a plastic film dressing which may be supplied by your doctor or pharmacist. Each tube is intended for use on a single occasion only.
How to apply the plastic film dressing Apply the plastic film dressing as per the manufacturer's instructions. • •
• •
Place the dressing over the mound of gel and down around the edges of the gel. If no plastic dressing is supplied to you, the mound of gel can be covered by clear plastic kitchen wrap. The gel must be covered for it to work. It will not work if you rub it in like an ointment.
After 30-45 minutes, or as recommended by your doctor or pharmacist:
- The dressing should be removed and the gel wiped off the skin with a clean tissue
- Dispose of these carefully out of the reach of children
- AMETOP Gel should not be left on for more than 45 minutes
- The site will remain numb for about 4-6 hours. 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 AMETOP Gel. Always wash hands thoroughly after use.
Ametop PIL UK 003
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. Only apply to intact, healthy skin. 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 Like all medicines AMETOP Gel can cause side effects, although not everyone gets them. The following side effects may happen with this medicine: Common: may affect up to 1 in 10 people
- redness of the skin at the numbed site (more severe redness has rarely been reported). Uncommon: may affect up to 1 in 100 people
- 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
- 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. The risk of these side effects happening may increase with repeated use. 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
Possible side effects
directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
How to store it
AMETOP Gel • • • •
Keep out of the sight and reach of children. Use once, then discard. Store in a refrigerator at 2-8°C. Do not freeze. Protect from heat. If not stored in a refrigerator AMETOP Gel must be used within 1 month.
Ametop PIL UK 003
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•
The expiry date is printed on the base of the tube and on the carton (MM/YYYY). The medicine can be used until the end of the month stated. Do not use your medicine after this date. 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.
Contents of the pack and other information
What AMETOP Gel contains
- The active substance tetracaine 4% w/w.
- AMETOP Gel: the other ingredients are purified water, sodium chloride, potassium dihydrogen phosphate, xanthan gum (E415), sodium hydroxide (E524) and sodium methyl parahydroxybenzoate (E219) and sodium propyl parahydroxybenzoate (E217). What AMETOP Gel looks like and the contents of the pack AMETOP Gel is a white semi-transparent gel. Each gram of gel contains 40mg of tetracaine. Each tube contains 1.5g of AMETOP Gel from which 1g (40mg tetracaine) can be squeezed. Marketing Authorisation Holder Alliance Pharmaceuticals Limited, Avonbridge Chippenham, Wiltshire, SN15 2BB, United Kingdom.
House,
Bath
Road,
Manufacturer Perstorp Specialty Chemicals AB, Perstorp Pharma, SE-284 80 Perstorp, Sweden. This leaflet was last revised: August 2020 Ametop®, Alliance and associated devices are registered trademarks of Alliance Pharmaceuticals Limited © Alliance Pharmaceuticals Limited 2020
Ametop PIL UK 003
Ametop PIL UK 003
Frequently asked questions about Ametop
What is the active substance in Ametop?
The active substance in Ametop is tetracaine.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Ametop, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Ametop without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: tetracaine
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Percutaneous local anaesthetic to produce anaesthesia of the skin prior to venepuncture or venous cannulation.
Ametop is indicated in adults and infants aged over 1 month.
4.2. Posology and method of administration
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.
Paediatric population
Ametop is contraindicated in premature babies or in full term infants less than 1 month of age (see section 4.3).
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. Always wash hands thoroughly after use (see section 6.6).
Apply the contents of the tube to the centre of the area to be anaesthetised and cover with an occlusive dressing. The contents expellable from 1 tube (approximately 1 gram) are sufficient to cover and anaesthetise an area of up to 30 sq.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.
4.3. Contraindications
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').
Hypersensitivity to the active substance, to local anaesthetics of the ester type, or to any of the excipients listed in section 6.1.
Do not apply Ametop gel to broken skin, mucous membranes or to the eyes or ears.
4.4. Special warnings and precautions for use
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).
4.5. Interaction with other medicinal products and other forms of interaction
None known
4.6. Fertility, pregnancy and lactation
Pregnancy
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 (see section 5.3).
The rapid hydrolysis of tetracaine by plasma pseudocholinesterase means that it is unlikely to present a significant hazard to the foetus when used as indicated.
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 on 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.
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
System Organ Class
Adverse drug reactions
General disorders and administration site conditions
Common
Application site erythema
Uncommon
Application site oedema
Application site pruritus
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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Overdosage with Ametop gel is unlikely to result from application to intact skin. If accidentally ingested systemic toxicity may occur, and signs will be similar to those observed after administration of other local anaesthetics. These signs have been described as: signs of inebriation, tingling, numbness of the tongue, tinnitus, nystagmus, nausea or vomiting, twitching and ultimately convulsions. Oxygen is recommended as the first line treatment for systemic toxicity.
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Not the same combination. This medicine contains Tetracaine. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
- Pliaglis partial — not the same combinationLidocainum + Tetracainum
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Ametop. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.