Lidocaine + Prilocaine
EMLA PLASTER and EMLA are different trade names for the same medicine.
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor, pharmacist, or nurse.
EMLA PLASTER contains two active substances - lidocaine and prilocaine. They belong to a group of medicines called local anesthetics.
The action of EMLA PLASTER is to temporarily numb the sensation in the superficial layers of the skin. The medicine is applied to the skin before certain medical procedures. This helps to numb the pain in the skin; however, the patient may still feel pressure and touch.
EMLA PLASTER can be used to numb the skin before:
Before starting to use EMLA PLASTER, you should discuss it with your doctor or pharmacist:
which may require a shorter application time. Using the plaster for more than 30 minutes is associated with a higher probability of a local skin reaction (see also section 4 "Possible side effects").
You should avoid contact between EMLA PLASTER and your eyes, as it may cause irritation. If EMLA PLASTER accidentally gets into your eye, you should immediately rinse your eye with lukewarm water or a physiological saline solution (0.9% NaCl solution).
You should be careful not to get anything in your eye until the feeling returns.
If EMLA PLASTER is used before administering a live vaccine (e.g., tuberculosis vaccine), you should remember to return for a follow-up visit at the time specified by your doctor to assess the effectiveness of the vaccination.
In infants and newborns under 3 months of age, a transient, clinically insignificant increase in methemoglobin levels in the blood is commonly observed within 12 hours of applying EMLA PLASTER.
The effectiveness of EMLA PLASTER during blood sampling from the heel in newborns has not been confirmed in clinical trials.
EMLA PLASTER should not be used in children under 12 months of age who are being treated with other medicines that may cause methemoglobinemia (e.g., sulfonamides; see also section 2 "EMLA PLASTER and other medicines").
EMLA PLASTER should not be used in premature newborns.
You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. This includes medicines that can be bought without a prescription and herbal medicines. This is important because the ingredients of EMLA PLASTER may affect the action of some other medicines or other medicines may affect the action of EMLA PLASTER.
In particular, you should inform your doctor, pharmacist, or nurse if you have used or taken any of the following medicines:
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
Occasional use of EMLA PLASTER during pregnancy is not associated with any increased risk of side effects in the fetus.
The active substances of EMLA PLASTER (lidocaine and prilocaine) pass into breast milk.
However, the amount that passes into breast milk is so small that there is essentially no risk to the breastfed child.
Animal studies have not shown any fertility problems in males or females treated with the active substances of EMLA PLASTER.
EMLA PLASTER does not affect or has negligible effects on the ability to drive and use machines when used as recommended.
The medicine may cause skin reactions.
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor, pharmacist, or nurse. If you are unsure, you should speak to your doctor, pharmacist, or nurse.
skin procedures):Application time: approximately 1 hour.
Newborns and infants from 0 to 2 months:One plaster is applied to the selected skin area. Application time: 1 hour, no longer. Only one single dose should be
used in any 24-hour period.The size of the plaster makes it less suitable for use on some parts of the body in newborns and infants.
Infants from 3 to 11 months:Up to 2 plasters are applied to the selected skin area. Application time: approximately 1 hour.
Children from 1 to 5 years:Up to 10 plasters are applied to the selected skin area. Application time: approximately 1 hour, maximum 5 hours.
Children from 6 to 11 years:Up to 20 plasters are applied to the selected skin area. Application time: approximately 1 hour, maximum 5 hours.
In children over 3 months, a maximum of 2 doses (as described above) can be used in any 24-hour period, with an interval of at least 12 hours between doses.
EMLA PLASTER can be used in children with a skin condition called "atopic dermatitis", but the application time should not exceed 30 minutes.
When using the plaster, it is essential to follow the instructions below carefully:
EMLA PLASTER should be applied at least 1 hour before the procedure (except for patients with atopic dermatitis, see "Warnings and precautions"). If necessary, hair should be removed from the skin area before applying the plaster. The plaster should not be cut or divided into smaller pieces.
If you use more EMLA PLASTER than described in the leaflet or recommended by your doctor, pharmacist, or nurse, you should immediately inform them, even if you do not notice any side effects.
Symptoms that may occur after using too much EMLA PLASTER are listed below. These symptoms should not occur when using EMLA PLASTER as recommended.
In severe cases of overdose, the following symptoms may occur: seizures, low blood pressure, slow breathing, respiratory arrest, and abnormal heart rhythm. These symptoms can be life-threatening.
If you have any further questions about using this medicine, you should speak to your doctor, pharmacist, or nurse.
Like all medicines, EMLA PLASTER can cause side effects, although not everybody gets them.
If you experience any of the following side effects, you should contact your doctor or pharmacist immediately. You should tell your doctor about everything that makes you feel unwell when using EMLA PLASTER.
At the site of application of EMLA PLASTER, a mild reaction may occur (pallor or redness of the skin, slight swelling, initial burning or itching sensation). These are normal reactions to the plaster and anesthetics, which disappear after a short time without the need for any medical treatment.
If you experience any worrying or unusual effects or reactions when using EMLA PLASTER, you should stop using it and contact your doctor or pharmacist immediately.
Common(may affect up to 1 in 10 people):
Uncommon(may affect up to 1 in 100 people):
Rare(may affect up to 1 in 1,000 people):
Methemoglobinemia, a blood disorder, which is more commonly observed in children, often in association with overdose in newborns and infants under 12 months of age.
If you experience any side effects, including any not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: + 48 22 49 21 301
fax: + 48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Store in a temperature below 25°C. Do not store in the refrigerator or freeze.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
EMLA PLASTER consists of a part that sticks to the skin and a protective foil. The part that sticks to the skin is light beige in color. In the center of the plaster, there is a round white disk containing the active substances and excipients. The rest of the plaster is covered with an acrylic adhesive.
2 plasters, protected on one side by aluminum foil, in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or parallel importer.
Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland
Recipharm Karlskoga AB, Bjorkbornsvagen 5, 691 33, Karlskoga, Sweden
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in Greece, the country of export: 78818/16/22-03-17
[Information about the trademark]
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