25 mg / g + 25 mg / g cream
lidocaine / prilocaine
1. What EMLA is and what it is used for
EMLA contains two active substances, lidocaine and prilocaine. They belong to the group of drugs local anesthetics (local anesthetics).
EMLA works by numbing the skin for a short time. The cream one is applied to the skin before certain medical procedures. The pain in the skin decreases but you can still feel pressure and touch.
Lidocaine and prilocaine contained in EMLA may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
Adults, adolescents, and children
Emla cream can be used to numb the skin before:
- needle stick (eg an injection or a blood test)
- minor skin surgeries
Adults
Under supervision or as directed by a doctor or nurse, EMLA cream can also be used to numb the skin before:
- cleaning or removing damaged skin on leg ulcers.
2. What you need to know before using EMLA
Do not use EMLA
- if you are allergic to lidocaine or prilocaine or similar types of local anesthetics, or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using EMLA:
- if you or your child have a rare inherited blood disorder called “glucose-6-phosphate dehydrogenase deficiency”.
- if you or your child has a problem with the pigment content in the blood, so-called “methemoglobinemia”.
- Do not use EMLA on skin areas with rashes, cuts, abrasions, or other open wounds, except leg ulcers. If you have any of these problems, talk to your doctor, pharmacist, or nurse before using the cream.
- If you or your child has itchy skin called atopic eczema, it may be enough if the cream is applied to the skin for a shorter time. If the cream is left on the skin for longer than 30 minutes, it may lead to more local skin reactions (see also section 4 Possible side effects ).
- if you are taking certain medicines to treat heart rhythm disorders ( class III antiarrhythmics, such as amiodarone ). In that case, your doctor will monitor your heart function.
Because the cream may be absorbed more easily into freshly shaved skin, it is important to follow the recommended dosage skin surface and application time.
Avoid getting EMLA in your eyes as it may irritate. If you accidentally get EMLA in your eyes, rinse immediately with plenty of lukewarm water or saline (sodium chloride). Be careful not to get anything in your eye until the sensation has returned.
EMLA should not be used on a damaged eardrum.
If you are using EMLA before being vaccinated with a live vaccine (eg tuberculosis vaccine), you should make an appointment to see your doctor or nurse check the results of your vaccination.
Children and young people
In infants/newborns under 3 months of age, a temporary increase in the blood pigment methemoglobin is common for up to 12 hours after applying EMLA cream. However, this temporary increase has no significant effect on the child.
Clinical studies have not been able to confirm that EMLA is effective in sampling the heel of newborns or that it provides adequate pain relief during circumcision.
EMLA should not be applied to the genitals (eg on the penis) and the genital mucosa (eg in the vagina ) in children (under 12 years of age). There are insufficient data on how the active ingredients are absorbed into the body.
EMLA should not be used in children under 12 months of age who are being treated concomitantly with other medicinal products that affect the amount of the blood pigment methemoglobin (eg sulphonamides, see also section 2, Other medicinal products and EMLA).
EMLA should not be used in premature infants.
Other medicines and EMLA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This also applies to over-the-counter medicines and herbal medicines. Namely, EMLA can affect the way some other medicines work, and some medicines can affect how EMLA works.
You must tell your doctor or pharmacist if you or your child have recently taken or been treated with any of the following medicines:
- drugs for the treatment of infections, sulfonamides, and nitrofurantoin.
- drugs for the treatment of epilepsy, phenytoin, and phenobarbital.
- other local anesthetics.
- drugs for irregular heartbeats, such as amiodarone.
- cimetidine or beta-blockers, as these may increase the level of lidocaine in the blood. This effect has no practical significance in the recommended doses for short-term treatment with EMLA.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Occasional use of EMLA during pregnancy is unlikely to hurt the fetus.
The active substances in EMLA ( lidocaine and prilocaine) are excreted in breast milk, but in such small amounts that it generally does not pose a risk to the baby.
Animal studies have not shown any deterioration in male or female fertility.
Driving and using machines
EMLA has no or negligible effect on the ability to drive and use machines when used at recommended doses.
EMLA contains macrogol glycerol hydroxy stearate
Macrogolglycerol hydroxy stearate may cause skin reactions.
3. How to use EMLA
Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. If you are not sure, talk to your doctor, pharmacist, or nurse.
How to use EMLA
– Which cream to use, how much to use, and how long it should last depends on what it is to be used for. A half 5-gram tube corresponds to about 2 g of EMLA. 1 g of EMLA squeezed from a tube is about 3.5 cm.
– EMLA should be used on the genitals only by a doctor or nurse.
– If EMLA is to be used on leg ulcers, a doctor or nurse should monitor its use.
Do not use EMLA in the following areas:
cuts, abrasions, or wounds, other than leg ulcers
– on the skin with rash or eczema
– in or near the eyes
– inside the nose, ears, or mouth
– in the anal opening
– on the genitals of children.
People who frequently apply or remove cream should avoid contact with cream one to prevent the development of hypersensitivity.
Make a hole in the tube’s protective membrane by pressing the lid against the membrane.
Use on the skin before small procedures (eg needle sticks or simple skin operations):
- Apply cream one on the skin in a thick layer. Follow the instructions on the package leaflet or from healthcare professionals. In some cases, healthcare professionals apply cream one.
- Then cover the cream with a bandage (plastic wrap). This is removed just before the procedure. If you are going to apply a cream yourself, check that you have been bandaged by your doctor, pharmacist, or nurse.
- The usual dose for adults and adolescents over 12 years of age is 2 g (grams).
- For adults and adolescents over the age of 12, the cream is applied at least 60 minutes before the procedure. However, do not apply cream one earlier than 5 hours before the procedure.
- In the case of children, the amount of EMLA and how long it should be used depends on the age of the child. If your doctor or nurse has not told you how much cream to take and when to apply it, follow the dosing instructions for children below.
Children
Use on the skin before small procedures (eg needle sticks or simple skin operations).
Newborns and infants 0-2 months: up to 1 g of cream on a total area of skin no larger than 2×5 cm. Not more than once a day for 1 hour.
Infants aged 3-11 months: up to 2 g of cream on a total area of skin no larger than 4×5 cm for 1 hour. A maximum of 2 doses at intervals of at least 12 hours can be given over a 24 hour period.
Children aged 1-5 years: up to 10 g of cream on a total skin area not larger than 10×10 cm for 1 hour, but not more than 5 hours. A maximum of 2 doses at intervals of at least 12 hours can be given over a 24 hour period.
Children aged 6-11 years: up to 20 g of cream on a total skin area not larger than 20×10 cm for 1 hour, but not more than 5 hours. A maximum of 2 doses at intervals of at least 12 hours can be given over a 24 hour period.
Children and adolescents with atopic dermatitis:
Emla can be used on children and adolescents with atopic dermatitis ( atopic eczema), but then the application time is a maximum of 30 minutes
Instructions for use
You must follow the instructions below when applying the cream.
- Apply a dollop of cream to the area to be anesthetized (eg where the needle is to be inserted). A string of cream of about 3.5 cm corresponds to 1 g of cream. A half 5-gram tube corresponds to about 2 g of EMLA. Do not rub in cream one.
- Remove the paper layer from the center of the non-adhesive side of the dressing (so that a paper frame remains).
- Remove the adhesive protection from the adhesive side of the dressing.
- Carefully place the dressing over the click with cream. Do not apply cream under the dressing.
- Remove the paper layer. Carefully apply the edges of the dressing to the skin. Then let it sit for as long as described above for each age group. For information on which areas EMLA should not be used in, see section 3 “Do not use EMLA in the following areas”. For information on Children and adolescents with atopic dermatitis, see section 3 “Children and adolescents with atopic dermatitis”.
- The doctor or nurse removes the dressing and creams it just before the procedure (for example, just before the needle stick).
If you use more EMLA then you should
If you have used more EMLA than you should or more than what your doctor, pharmacist, or nurse has told you to do, talk to one of them immediately, even if you have no symptoms.
The symptoms when you have used too much EMLA are listed below. If EMLA is used according to the recommendations, it is unlikely that you will get these symptoms.
- you feel dizzy or faint
- tingling in the skin around the mouth and numbness in the tongue
- abnormal taste experience
- dimsyn
- tinnitus
- there is also a risk of acute methemoglobinemia (problems with the amount of pigment in the blood). The risk is greater if you have taken certain other medicines at the same time. If this were to happen, the skin would turn blue-gray due to lack of oxygen.
In severe cases of overdose, the symptoms may be seizures, low blood pressure, slow breathing, respiratory arrest, and altered heartbeat. These reactions can be life-threatening.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse. If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Contact a doctor or pharmacist if any of the following side effects occur or do not work. Tell your doctor if there is anything else that makes you feel unwell while using EMLA.
A mild reaction (pale or reddened skin, slight swelling, burning, or itchy sensation at first) may occur on the skin where EMLA is used. These are normal reactions to the cream and the anesthetic. They disappear after a short while without you having to do anything.
If you experience any troublesome or unusual reactions when using EMLA, stop using the cream and talk to your doctor or pharmacist as soon as possible.
Common (may affect up to 1 in 10 people)
- transient local skin reactions (paleness, redness, swelling) on the treated area in the treatment of skin, mucous membranes of genitals, or leg ulcers
- initially, a slight burning sensation, itching, or heat sensation in the treated area when treating mucous membranes on genitals or leg ulcers.
Uncommon (may affect up to 1 in 100 people)
- initially a slight burning sensation, itching, or feeling of heat in the treated area when treating skin
- numbness (tingling) in the treated area during treatment of mucous membranes on genitals
- irritated skin in the treated area when treating leg ulcers.
Rare (may affect up to 1 in 1,000 people)
- allergic reactions, which in rare cases can turn into anaphylactic shock (rash, swelling, fever, difficulty breathing, and fainting) in the treatment of skin, genital mucosa on genitals, or leg ulcers
- methemoglobinemia (a blood disease) in the treatment of skin
- small punctate hemorrhages in the treated area (especially in children with eczema if the cream is allowed to sit on the skin for a long time)
- Eye irritation if EMLA accidentally comes into contact with the eyes during skin treatment.
Additional side effects in children
Methemoglobinemia, a blood disorder, is more common in newborns and infants aged 0-12 months, often associated with overdose.
5. How to store EMLA
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and tube after EXP. The expiration date is the last day of the specified month.
Do not freeze.
Keep the tube tightly closed.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substances are lidocaine and prilocaine.
- 1 g of cream contains 25 mg of lidocaine and 25 mg of prilocaine
- The other ingredients are carbomer, macrogol glycerol hydroxy stearate, sodium hydroxide for pH adjustment, and purified water.
What the medicine looks like and the contents of the pack
White, homogeneous cream.
Packed in an aluminum tube with a polypropylene cork fitted with a tip for perforation.
Pack size:
1 tube containing 5 g cream + 3 dressings
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Aspen Pharma Trading Limited
3016 Lake Drive,
Citywest Business Campus,
Dublin 24, Ireland
Tel .: 0046 856642572
Aspen Bad Oldesloe GmbH, 32-36 Industriestrasse, 23843 Bad Oldesloe, Germany
This medicinal product is authorized under the European Economic Area under the names:
| Austria | Emla 5% – Cream |
| Belgium | Emla 25 mg / 25 mg cream |
| Cyprus | Emla Cream 5% |
| Czech Republic | Emla cream 5% |
| Denmark | Emla |
| Finland | EMLA |
| France | EMLA 5 FOR CENT, cream |
| Germany | EMLA |
| Greece | EMLA |
| Iceland | Emla |
| Ireland | EMLA 5% w / w Cream |
| Italy | EMLA |
| Latvia | Emla 5% cream |
| Luxembourg | Emla 25 mg / 25 mg cream |
| Malta | EMLA 5% w / w Cream |
| Norway | Emla |
| Poland | EMLA |
| Portugal | Emla |
| Spain | EMLA 25 mg / g + 25 mg / g cream |
| Netherlands | Emla |
| UK | Emla Cream 5% |