Emla

Leaflet accompanying the packaging: information for the user

EMLA, 25 mg/g + 25 mg/g, cream

Lidocaine + Prilocaine

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is the medicine and what is it used for
• 2. Important information before using the medicine
• 3. How to use the medicine
• 4. Possible side effects
• 5. How to store the medicine
• 6. Contents of the packaging and other information

1. What is the medicine and what is it used for

The medicine contains two active substances - lidocaine and prilocaine. They belong to a group of medicines called local anesthetics.
The action of the medicine is to temporarily eliminate the sensation in the superficial layers of the skin. The cream is applied to the skin before performing certain medical procedures and treatments.
This helps to eliminate pain in the skin; however, the patient may still feel pressure and touch.

Adults, adolescents, and children

The medicine can be used to anesthetize the skin before:

• insertion of a needle into the skin (e.g., during injection or blood sampling),
• minor surgical procedures on the skin.

Adults and adolescents

The medicine can also be used:

• to anesthetize the genital area before: performing an injection, performing medical procedures such as removing warts. The application of the cream to the genital area should be performed under the supervision of a doctor or nurse.

Adults

The medicine can also be used to anesthetize the skin before:

• debridement or removal of damaged skin of lower limb ulcers.

2. Important information before using the medicine

When not to use the medicine:

Warnings and precautions

Before starting to use the medicine, you should discuss it with your doctor or pharmacist:

• the medicine should not be used on areas of skin with a rash, scratches, abrasions, or other open wounds, except for lower limb ulcers. If the patient has any of these changes, before using the cream, they should contact their doctor or pharmacist,

Due to the possibility of increased absorption from freshly shaved skin, it is essential to follow the recommended dosage, area of application, and duration of application on the skin.
One should avoid contact of the medicine with the eyes, as it may cause irritation and chemical burns to the eyes. If the cream accidentally gets into the eye, it should be rinsed immediately with lukewarm water or a physiological saline solution (0.9% NaCl solution).
One should be careful not to get anything into the eye until sensation returns.
One should carefully observe children when applying the medicine to any part of the body to prevent the child from transferring the medicine to the eye (eyes).
The medicine should not be used on a diseased eardrum.
When the medicine is used in a patient before administering a live vaccine (e.g., tuberculosis vaccine), one should remember to report to the doctor for a follow-up visit at the designated time to assess the effectiveness of the vaccination.

Children and adolescents

In infants and newborns under 3 months of age, a transient, clinically insignificant increase in methemoglobin concentration in the blood (a form of hemoglobin, or blood pigment) is commonly observed during the first 12 hours after application of the medicine.
The efficacy of the medicine during blood sampling from the heel in newborns or to ensure adequate pain relief during circumcision has not been confirmed in clinical trials.
The medicine should not be used on the mucous membrane of the genital organs (e.g., vagina) in children (under 12 years of age) due to insufficient data on the absorption of active substances.
The medicine should not be used in children under 12 months of age who are being treated with other medicines that affect blood pigment and may cause methemoglobinemia (e.g., sulfonamides; see also section 2 "Medicine and other medicines").
The medicine should not be used in premature newborns.

Medicine and other medicines

You should inform your doctor or pharmacist about any other medicines you are currently taking or have recently taken or may take. This includes medicines that can be bought without a prescription and herbal medicines. This is important because the ingredients of the medicine may affect the action of some other medicines, and some other medicines may affect the action of the medicine.
In particular, the patient should inform their doctor or pharmacist if they have used or taken any of the following medicines:

• Medicines used to treat infections called sulfonamides and nitrofurantoin.
• Medicines used to treat epilepsy: phenytoin and phenobarbital.
• Other local anesthetics.
• Medicines used to treat irregular heart rhythm, such as amiodarone.
• Cimetidine or beta-adrenergic blockers, which may increase the concentration of lidocaine in the blood. This interaction is not clinically significant in short-term use of the medicine in recommended doses.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Occasional use of the medicine during pregnancy is not associated with any risk of adverse effects on the fetus.
The active substances of the medicine (lidocaine and prilocaine) are excreted into breast milk. However, the amount that passes into the milk is so small that there is essentially no risk to the breastfed child.
In animal studies, no fertility disorders were found in males or females treated with the active substances of the medicine.

Driving and using machines

The medicine has no or negligible influence on the ability to drive and use machines when used as recommended.

Medicine contains macrogolglycerol hydroxystearate

Macrogolglycerol hydroxystearate may cause skin reactions.

3. How to use the medicine

The medicine should always be used exactly as directed by your doctor, pharmacist, or nurse.
If you are unsure, you should ask your doctor, pharmacist, or nurse.

Using the medicine

• The site of application, amount of cream, and duration of application depend on the purpose of use.
• The doctor, pharmacist, or nurse will apply the cream to the appropriate area or show the patient how to do it themselves.
• When the medicine is used on the genital area, the doctor or nurse should supervise its use.

The medicine should not be used in the following areas:

• Areas of scratches, abrasions, or open wounds, except for lower limb ulcers.
• Areas with skin rash or eczema.
• Eyes or near the eyes.
• Inside the nose, ears, or mouth.
• In the anus.
• On the genital organs of children.

People who frequently apply or remove the cream from the patient's body should ensure that they effectively avoid contact with the cream to prevent the development of hypersensitivity.
The protective membrane of the tube is pierced with the tube cap.

Using the medicine on the skin before minor procedures (such as needle insertion or minor surgical procedures on the skin):

• The cream is applied to the skin in a thick layer. The doctor, pharmacist, or nurse will tell the patient where to apply the cream.
• Then, the layer of cream is covered with a dressing (plastic foil). The dressing is removed immediately before the procedure starts. If the patient applies the cream themselves, they should ensure that they have received dressings from their doctor, pharmacist, or nurse.
• Usually, the dose used in adults and adolescents over 12 years of age is 2 g (grams).
• In adults and adolescents over 12 years of age, the cream should be applied at least 60 minutes before the planned time of the procedure (except when the cream is to be applied to the genital area). However, the cream should not be applied more than 5 hours before the procedure or earlier.
• In children, the amount of cream used and the duration of application depend on the child's age. The doctor, nurse, or pharmacist will inform the patient about the amount of cream to be used and when to apply it.

When applying the cream, it is very important to follow the instructions exactly:

• 1. Squeeze a portion of cream from the tube to form a mound in the area where it is needed on the skin (e.g., where the injection will be performed). A line of cream about 3.5 cm long from a 30 g tube corresponds to 1 g of cream. Half of the contents of a 5 g tube corresponds to about 2 g of cream. Do not rub the cream into the skin.

• 2. Remove the paper layer from the middle window of the non-adhesive side of the dressing (leaving the paper frame).

• 3. Remove the top layer of the adhesive dressing.

• 4. Carefully place the dressing over the cream mound. Do not spread the cream under the dressing.

• 5. Remove the paper stiffener. Carefully smooth the edges of the dressing. Then, leave the dressing on for at least 60 minutes, unless the skin is damaged. The cream should not be left on for more than 60 minutes in children under 3 months of age or for more than 30 minutes in children with atopic dermatitis. When using the cream on the genital area or ulcers, shorter application times may be used as described below.

• 6. The doctor or nurse will remove the dressing and remove the cream immediately before performing the medical procedure (e.g., before inserting the needle).

Using the medicine on larger areas of freshly shaved skin before performing procedures in outpatient settings (such as hair removal):

Usually, the dose of the medicine used is 1 g of cream per 10 cm² (10 square centimeters) of skin surface, applied for 1 to 5 hours under a dressing. The medicine should not be used on an area of freshly shaved skin larger than 600 cm² (600 square centimeters, e.g., 30 cm x 20 cm). The maximum dose is 60 g.

Using the medicine on the skin before procedures performed in hospital settings (e.g., before skin grafting), which require deeper skin anesthesia:

• The medicine may be used in this way in adults and adolescents over 12 years of age.
• Usually, the dose used is 1.5 g to 2 g of cream per 10 cm² (10 square centimeters) of skin surface.
• The cream is applied and covered with a dressing for 2 to 5 hours.

Using the medicine on the skin before removing warty growths

• The medicine may be used in children and adolescents with atopic dermatitis.
• Usually, the dose used depends on the child's age and is applied for 30 to 60 minutes (30 minutes in patients with atopic dermatitis). The doctor, nurse, or pharmacist will inform the patient about the amount of cream to be used.

Using the medicine on the genital skin before injecting local anesthetics

• The medicine may be used in this way only in adults and adolescents over 12 years of age.
• Usually, the dose used is 1 g of cream (1 g to 2 g in the case of female genital skin) per 10 cm² (10 square centimeters) of skin surface.
• The cream is applied and covered with a dressing. The dressing is left on for 15 minutes in the case of male genital skin and for 60 minutes in the case of female genital skin.

Using the medicine on the genital skin before minor surgical procedures on the skin (such as removing warts)

• The medicine may be used in this way only in adults and adolescents over 12 years of age.
• Usually, the dose used is 5 g to 10 g of cream for 10 minutes. No dressing is used. The procedure should be performed immediately after.

Using the medicine on lower limb ulcers before debridement or removal of damaged skin

• Usually, the dose used is 1 g to 2 g of cream per 10 cm² (10 square centimeters) of skin surface and no more than 10 g.
• The cream is applied and covered with a tight dressing, e.g., plastic foil. The cream and dressing are applied 30 to 60 minutes before the debridement procedure. The cream should be removed using a cotton swab and the debridement procedure should be performed immediately.
• The medicine can be used before debridement of lower limb ulcers up to 15 times over a period of 1-2 months.
• When using the medicine on lower limb ulcers, the tube of medicine should be used as a single-use product: after each use of the cream in a patient, the tube with the remaining amount of cream should be discarded.

Using a larger dose of the medicine than recommended

If a larger amount of the medicine than recommended by the doctor, pharmacist, or nurse is used, one should immediately contact them, even if the patient does not feel any discomfort.
Problems and discomfort that may occur after using too much of the medicine are listed below. These discomforts should not occur when using the medicine as recommended.

• Feeling of "emptiness in the head" or dizziness.
• Numbness or tingling of the skin around the mouth and tongue.
• Disturbed sense of taste.
• Blurred vision.
• Ringing in the ears.
• There is also a risk of methemoglobinemia (a problem with the concentration of a blood pigment). This is more likely if the patient is taking certain other medicines. In the event of this condition, the skin becomes blue-gray due to insufficient oxygen in the blood.

In severe cases of overdose, symptoms such as seizures, decreased blood pressure, decreased breathing rate, respiratory arrest, and abnormal heart rhythm may occur. These problems can be life-threatening.
If you have any further questions about using this medicine, you should ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following side effects, or if any of the side effects get serious, you should tell your doctor or pharmacist. You should then tell your doctor about everything that makes you feel unwell when using the medicine.
At the site of application, a mild reaction may occur (pallor or redness of the skin, slight swelling, initial burning or itching sensation). These are common reactions to the cream 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 the medicine, you should stop using it and contact your doctor or pharmacist as soon as possible.
Common(may affect up to 1 in 10 people)

• Transient local skin reactions (pallor, redness, swelling) at the site of application during use on the skin, mucous membrane of the genital organs, or on lower limb ulcers.
• Initial mild sensation of burning, itching, or warmth at the site of application during use on the mucous membrane of the genital organs or on lower limb ulcers.

Uncommon(may affect up to 1 in 100 people)

• Initial mild sensation of burning, itching, or warmth at the site of application during use on the skin.
• Numbness (tingling) at the site of application during use on the mucous membrane of the genital organs.
• Skin irritation at the site of application during use on lower limb ulcers.

Rare(may affect up to 1 in 1000 people)

• Allergic reactions, which in rare cases can lead to anaphylactic shock (skin rash, swelling, fever, difficulty breathing, and fainting) during use on the skin, mucous membrane of the genital organs, or on lower limb ulcers.
• Methemoglobinemia (a blood disorder) during use on the skin.
• Minor pinpoint bleeding (petechiae) at the site of application (especially in children with eczema after longer application of the cream) during use on the skin.
• Eyelid irritation if the cream accidentally comes into contact with the eyes during use on the skin.

Frequency not known(cannot be estimated from the available data):

• Chemical burns to the eyes if the cream accidentally comes into contact with the eyes during treatment.

Additional side effects in children

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.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store the medicine

The medicine should be stored out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Expiry Date (EXP)". The expiry date refers to the last day of the month.
Do not freeze.
Store the tube tightly closed.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What the medicine contains

• The active substances of the medicine are: lidocaine and prilocaine.
• 1 g of cream contains: 25 mg of lidocaine and 25 mg of prilocaine.
• The medicine also contains: carbomers, macrogolglycerol hydroxystearate, sodium hydroxide (to adjust pH), and purified water.

What the medicine looks like and contents of the packaging

White, homogeneous cream.
The medicine is packaged in an aluminum tube with a polypropylene cap with a piercing function.
The medicine is available in the following packaging:
1 tube containing 5 g of cream
1 tube containing 5 g of cream and 2 dressings
1 tube containing 5 g of cream and 3 dressings
3 tubes containing 5 g of cream and 8 dressings
5 tubes containing 5 g of cream
5 tubes containing 5 g of cream and 10 dressings
5 tubes containing 5 g of cream and 12 dressings
1 tube containing 30 g of cream
Not all pack sizes may be marketed.

Marketing authorization holder

Aspen Pharma Trading Limited
3016 Lake Drive
Citywest Business Campus
Dublin 24, Ireland
Tel: 0048 22 104 2100

Manufacturer

Recipharm Karlskoga AB
Bjorkbornsvagen 5
SE-691 33 Karlskoga
Sweden
Aspen Bad Oldesloe GmbH
32-36 Industriestrasse
23843 Bad Oldesloe
Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria
Emla 5% - Creme
Belgium
Emla 25mg/25mg crème
Cyprus
Emla Cream 5%
Finland
EMLA
France
EMLA 5 POUR CENT, crème
Greece
EMLA
Iceland
Emla
Ireland
EMLA 5% w/w Cream
Italy
EMLA
Luxembourg
Emla 25mg/25mg crème
Malta
EMLA 5% w/w Cream
Norway
Emla
Poland
EMLA
Spain
EMLA 25 mg/g + 25 mg/g crema
Sweden
EMLA
Netherlands
Emla

Date of last revision of the leaflet: 03/2024