Important Warnings and Precautions for Ametop Gel 1.5g
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Do not use Ametop Gel 1.5g:
- If you are allergic (hypersensitive) to tetracaine or any of the other ingredients of AMETOP Gel (see Section 6 of PIL).
- 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 1.5g in the ear or use it for any middle ear procedures.
- If you suffer from epilepsy.
Do not swallow AMETOP Gel 1.5g.
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 1.5g:
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 breast-feeding. Ask your doctor or pharmacist before taking or using any medicines.
Driving and using machines:
AMETOP Gel 1.5g is unlikely to affect driving or the use of machines.
AMETOP Gel 1.5g contains Sodium methyl parahydroxybenzoate (E219) and Sodium propyl parahydroxybenzoate (E217) which may cause allergic reactions (possibly delayed).
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 1.5g than you should or if you swallow Ametop Gel 1.5g, 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.
Possible side effects:
Like all medicines AMETOP Gel 1.5g 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 1.5g 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 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 Ametop Gel 1.5g:
- 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 1.5g must be used within 1 month.
- 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.