EMLA PATCH is local anaesthetic which is used for pain relief on the skin prior to procedures such as needle insertion, minor and superficial skin surgery.
1. What EMLA PATCH is and what it is used for
2. What you need to know before you use EMLA PATCH
Do not use EMLA PATCH :
- if you are hypersensitive (allergic) to lidocaine, prilocaine or any other ingredients of EMLA PATCH, or to any local anaesthetics.
- in infants younger than 12 months who are being treated at the same time with other medicines that affect methaemoglobin levels in the blood. Ask your doctor, pharmacist or other healthcare provider.
Warnings and precautions
Take special care with EMLA PATCH:
- If you have had an allergic, unpleasant or unusual reaction to EMLA PATCH or to any other medicine.
- Do not use EMLA PATCH on areas with skin rash, cuts, grazes or other open wounds. If any of these problems are present, check with your doctor or pharmacist before using the patch.
- Avoid getting EMLA PATCH in the eyes, as it may cause irritation. If you accidentally get EMLA PATCH in your eye, you should immediately rinse it well with lukewarm water or sodium chloride solution and protect it until sensation returns.
- If you have one of the rare metabolic conditions, glucose-6-phosphate dehydrogenase deficiencies or congenital or idiopathic methaemoglobinaemia, as this increases the risk of medicine-induced methaemoglobinaemia (see section 4).
3. How to use EMLA PATCH
Always use EMLA PATCH exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.
Your doctor, nurse or other healthcare provider will apply EMLA PATCH or will explain how to use it according to the condition that you are receiving treatment for. The dosage prescribed to you is individualised according to the condition being treated, or for the procedure being done on you. If you develop any allergic reaction you should remove the patch immediately. Do not share medicines prescribed for you with any other person.
Adults and adolescents: One or more patches are applied to the skin areas selected for a minimum of 1 hour, maximum 5 hours.
Children: Newborn infants and infants under the age of 3 months: One patch is applied to the skin area selected for 1 hour, not more. Not more than one EMLA PATCH should be applied at the same time. The size of the patch makes it less suitable for use on certain parts of the body in neonates and infants.
Infants aged 3 to 11 months: The patch is applied to the skin area selected for 1 hour, maximum 4 hours. Not more than two EMLA patches should be applied at the same time.
Toddlers and children aged 1 to 5 years: The patch is applied to the skin area selected for 1 hour, maximum 5 hours. Maximum dose: 10 patches.
Children aged 6 to 11 years: The patch is applied to the skin area selected for 1 hour, maximum 5 hours. Maximum dose: 20 patches.
Special skin problems: If you have skin problems such as atopic dermatitis or mollusca, a shorter application time, 15 to 30 minutes, may be sufficient. When mollusca are removed from the skin in children with atopic dermatitis, a 30 minutes application time of EMLA PATCH is recommended. If you feel that the effect of EMLA PATCH is too strong or too weak, tell your doctor or pharmacist.
DIRECTIONS FOR USE:
EMLA PATCH must be applied at least 1 hour before the start of the procedure. (If necessary, shave the area prior to application).
4. Possible side effects
EMLA PATCH can have side effects. Not all side effects reported for EMLA PATCH are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking EMLA PATCH, please consult your healthcare provider for advice.
If any of the following happens, stop using EMLA PATCH and tell your doctor immediately or go to the casualty department at your nearest hospital:
- swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
- rash or itching,
- fainting,
These are all very serious side effects. If you have them, you may have had a serious reaction to EMLA PATCH. You may need urgent medical attention or hospitalisation.
Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:
- Methaemoglobinaemia (bluish grey discolouration of the skin).
These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following:
Frequent side effects
• Cases of small red dots (petechiae) at the application site, especially in children with skin problems (atopic dermatitis or mollusca).
Less frequent side effects
• Eye irritation when the eyes accidentally have been exposed to EMLA PATCH. A mild reaction (paleness or redness of the skin, slight puffiness, initial burning or itching) may occur on the area on which EMLA PATCH is used. These are normal reactions to the patch and the anaesthetics and will disappear in a short while without any measures being needed.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Reporting of side effects
If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to: SAHPRA: https://www.sahpra.org.za/Publications/Index/8 . Aspen Pharmacare: E-mail: [email protected] Tel: 0800 118 088. By reporting side effects, you can help provide more information on the safety of EMLA PATCH.
5. How to store EMLA PATCH
Store all medicines out of reach of children. Store at or below 25 °C. Do not store in a fridge or freezer. Keep in original packaging until required for use. Do not store in a bathroom. Do not use after the expiry date stated on the label. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).