EMLA 25 mg/g + 25 mg/g cream

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

EMLA 25 mg/g + 25 mg/g cream

lidocaine/prilocaine

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

  1. If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you must not give it to other people, even if they have the same symptoms as you, because it could harm them.

  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What EMLA is and what it is used for
2. What you need to know before using EMLA
3. How to use EMLA
4. Possible side effects
5. How to store EMLA
6. Contents of the pack and other information

1. What EMLA is and what it is used for

EMLA contains two active substances called lidocaine and prilocaine. They belong to a group of medicines known as local anesthetics.

EMLA works by temporarily numbing the surface of the skin. It is applied to the skin before certain medical procedures. It helps to prevent pain on the skin; however, you may still feel sensations such as pressure and touch.

Adults, adolescents, and children

It can be used to numb the skin before:

• Needle puncture (e.g., receiving an injection or having a blood test).
• Minor skin surgery.

Adults and adolescents

It can also be used:

• To numb the genital area before:
  • Receiving an injection.
  • Medical procedures such as removal of warts.

The use of EMLA on the genitals should be supervised by a doctor or nurse.

Adults

It can also be used to numb the skin before:

• Debriding or removing damaged skin from leg ulcers.

2. What you need to know before using EMLA

Do not use EMLA

• if you are allergic to lidocaine or prilocaine, other similar local anaesthetics, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before using EMLA

• if you or your child have a rare inherited metabolic disorder affecting the blood called “glucose-6-phosphate dehydrogenase deficiency”.

• if you or your child have a disorder affecting levels of a pigment in the blood called “methemoglobinemia”.

  • do not use EMLA on areas of skin with rashes, cuts, abrasions, or open wounds, except for leg ulcers. If any of these conditions occur, consult your doctor or pharmacist before using the cream.

• if you or your child have a skin condition with itching called “atopic dermatitis”, a shorter application time may be sufficient. Application times longer than 30 minutes may increase the incidence of local skin reactions (see also section 4. “Possible side effects”).

• if you are taking medicines for heart rhythm disorders (class III antiarrhythmics such as amiodarone). In this case, your doctor will monitor your heart function.

Due to potentially increased absorption on freshly shaved skin, it is important to strictly follow the recommended dose, skin surface area, and application time.

Avoid contact of EMLA with the eyes, as it may cause irritation and chemical burns to the eyes. If EMLA accidentally gets into your eye, rinse immediately with lukewarm water or saline (sodium chloride solution). Be careful not to apply anything else to the eye until sensation returns.

Children must be carefully supervised when EMLA is used anywhere on their body to prevent EMLA from coming into contact with the eyes.

EMLA must not be applied to a damaged eardrum.

When using EMLA before vaccination with live vaccines (e.g., tuberculosis vaccine), return to your doctor or nurse after the required follow-up period for the vaccination result.

Children and adolescents

In infants and newborns under 3 months of age, “methemoglobinemia”—a transient and clinically insignificant increase in levels of a blood pigment—has been frequently observed up to 12 hours after EMLA application.

Clinical studies have not been able to confirm the effectiveness of EMLA when drawing blood from the heel of newborns or for providing adequate analgesia during circumcision.

EMLA must not be applied to the genital mucosa (e.g., in the vagina) of children (under 12 years of age) due to insufficient data on absorption of the active substances.

EMLA must not be used in children under 12 months of age who are simultaneously receiving treatment with other medicines that affect levels of the blood pigment “methemoglobin” (e.g., sulfonamides, see also section 2. “Use of EMLA with other medicines”).

EMLA must not be used in premature newborns.

Use of EMLA with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines, including those obtained without a prescription and herbal medicines. This is because EMLA may affect how other medicines work, and other medicines may affect EMLA.

In particular, inform your doctor or pharmacist if you or your child have recently used or are being treated with any of the following medicines:

• Medicines used to treat infections called “sulfonamides” and nitrofurantoin.
• Medicines used to treat epilepsy, called phenytoin and phenobarbital.
• Other local anaesthetics.
• Medicines used to treat heart arrhythmias, such as amiodarone.
• Cimetidine or beta-blockers, which may increase lidocaine levels in the blood. This interaction is not clinically significant during short-term treatment with EMLA at the recommended doses.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Occasional use of EMLA during pregnancy is unlikely to have any adverse effect on the fetus.

The active substances in EMLA (lidocaine and prilocaine) are excreted in breast milk. However, the amount is so small that it generally poses no risk to the infant.

Animal studies have shown no effects on male or female fertility.

Driving and using machines

EMLA has no effect or a negligible effect on the ability to drive and use machines when used at the recommended doses.

EMLA contains macrogol glycerol hydroxystearate

This medicine may cause skin reactions because it contains macrogol glycerol hydroxystearate.

3. How to use EMLA

Follow exactly the administration instructions for this medicine as given by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse again.

Use of EMLA

• The site of application, the amount you should use, and the duration of application will depend on the intended use.
• Your doctor, pharmacist, or nurse will apply the cream or will show you how to do it yourself.
• When EMLA is used on the genital area, its use must be supervised by a doctor or nurse.

Do not use EMLA in the following areas:

• Cuts, abrasions, or wounds, except leg ulcers.
• Areas with skin rash or eczema.
• In or near the eyes.
• Inside the nose, ear, or mouth.
• In the anal area.
• On the genitals of children.

Individuals who frequently apply or remove the cream should take care to avoid contact in order to prevent the development of hypersensitivity.

The protective membrane of the tube is pierced by pressing the cap onto it.

Use on skin prior to minor procedures (such as needle puncture or minor skin interventions):

• Apply a thick layer of cream to the skin. Your doctor, pharmacist, or nurse will tell you where to apply it.
• Then cover the cream with an adhesive dressing [transparent plastic]. This dressing is removed just before the procedure begins. If you are applying the cream yourself, make sure your doctor, pharmacist, or nurse provides you with the dressings.
• The usual dose for adults and adolescents over 12 years of age is 2 g (grams).
• In adults and adolescents over 12 years of age, apply the cream at least 60 minutes before the procedure (unless the cream is to be used on the genitals). However, do not apply it more than 5 hours in advance.
• In children, the amount of EMLA used and the duration of application depend on their age. Your doctor, nurse, or pharmacist will tell you how much to use and when to apply it.

When you apply the cream yourself, it is very important to follow these instructions:

1. Squeeze the tube to apply the required amount of cream as a mound onto the skin where the procedure will be performed (e.g., where the needle will be inserted). A line of cream about 3.5 cm long from the 30 g tube equals 1 g of cream. Do not spread the cream.

1. Peel off the paper layer from the "central cut" on the non-adhesive side of the dressing (leaving a paper frame).

1. Remove the cover from the adhesive side of the dressing.

1. Carefully place the dressing over the mound of cream. Do not spread the cream under the dressing.

1. Remove the paper backing. Smooth down the edges of the dressing carefully. Then leave it in place for at least 60 minutes if the skin is not damaged. The cream must not be left on for more than 60 minutes in infants under 3 months of age or for more than 30 minutes in children with a skin condition called "atopic dermatitis." If the cream is used on the genitals or on ulcers, shorter application times may be used, as described below.

1. Your doctor or nurse will remove the dressing and wipe off the cream just before the medical procedure is performed (e.g., just before inserting the needle).

Use on large areas of freshly shaved skin prior to outpatient procedures (such as hair removal techniques):

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

Use on skin prior to hospital procedures (such as skin grafting) requiring deeper skin anaesthesia:

• EMLA may be used in this way in adults and adolescents over 12 years of age.
• The usual dose is 1.5 g to 2 g of cream per 10 cm² (10 square centimeters) of skin area.
• The cream is applied under an occlusive dressing for 2 to 5 hours.

Use on skin to remove wart-like lesions called "molluscum"

• EMLA may be used in children and adolescents who have a skin condition called "atopic dermatitis."
• The usual dose depends on the child's age and is used for 30 to 60 minutes (30 minutes if the patient has atopic dermatitis). Your doctor, nurse, or pharmacist will tell you how much cream to apply.

Use on genital skin before local anaesthetic injections

• EMLA may be used in this way only in adults and adolescents over 12 years of age.
• The usual dose is 1 g of cream (1 g to 2 g on female genital skin) per 10 cm² (10 square centimeters) of skin area.
• The cream is applied under an occlusive dressing. This is left in place for 15 minutes on male genital skin and for 60 minutes on female genital skin.

Use on genitals before minor skin surgery (removal of warts)

• EMLA may be used in this way only in adults and adolescents over 12 years of age.
• The usual dose is 5 g to 10 g of cream for 10 minutes. No occlusive dressing is used. The medical procedure should begin immediately.

Use on leg ulcers before cleaning or removing damaged skin

• The usual dose is 1 g to 2 g per 10 cm² of skin area, up to a maximum of 10 g.
• The cream is applied under an occlusive dressing, e.g., a transparent plastic. This is left in place for 30 to 60 minutes before cleaning the ulcer. Remove the cream with a cotton swab and begin cleaning without delay.
  • EMLA may be used before cleaning leg ulcers up to 15 times within a period of 1–2 months.
  • The EMLA tube is for single use only when used on leg ulcers: The tube, including any remaining contents, must be discarded after each patient is treated.

If you use more EMLA than you should

If you use more EMLA than your doctor, pharmacist, or nurse has instructed, contact one of them immediately, even if you have no symptoms.

The following symptoms may occur if you use too much EMLA. These symptoms are unlikely to occur if you follow the recommended use of EMLA.

• Feeling dizzy or lightheaded.
• Tingling sensation around the mouth and numbness of the tongue.
• Taste disturbances.
• Blurred vision.
• Ringing in the ears.
• There is also a risk of acute "methaemoglobinaemia" (a problem with levels of a blood pigment). This risk is higher when certain medications are taken at the same time. If this occurs, the skin may turn bluish-grey due to lack of oxygen.

In severe cases of overdose, symptoms may include seizures, low blood pressure, slow breathing, respiratory arrest, and irregular heartbeat. These effects can be potentially fatal.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone 91 562 04 20.

If you have any questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Contact your doctor or pharmacist if any of the following adverse effects bother you or do not seem to go away. Inform your doctor of any other symptoms that make you feel unwell while using EMLA.

A mild reaction (pale skin, redness, slight swelling, initial burning or itching) may occur at the site where EMLA is applied. These are normal reactions to the cream and anesthetics and will disappear shortly without requiring any intervention.

If you experience any unpleasant or unusual effects while using EMLA, stop using it and consult 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 application site during treatment of the skin, genital mucosa, or leg ulcers.
• A mild initial sensation of burning, itching, or warmth at the application site during treatment of the genital mucosa or leg ulcers.

Uncommon (may affect up to 1 in 100 people)

• Mild initial sensation of burning, itching, or warmth at the treated area during treatment of the skin.
• Numbness (tingling) at the application site during treatment of the genital mucosa.
• Skin irritation at the application site during treatment of leg ulcers.

Rare (may affect up to 1 in 1,000 people)

• Allergic reactions, which in rare cases may lead to anaphylactic shock (skin rash, swelling, fever, breathing difficulty, and fainting) during treatment of the skin, genital mucosa, or leg ulcers.
• Methaemoglobinaemia (a blood disorder) during treatment of the skin.
• Small punctate bleeding in the treated area (particularly in children with eczema after prolonged application), during treatment of the skin.
• Eye irritation if EMLA accidentally comes into contact with the eyes during treatment of the skin.

Frequency not known (cannot be estimated from available data)

• Chemical burns in the eyes if EMLA accidentally comes into contact with them during treatment.

Other adverse effects in children

Methaemoglobinaemia, a blood disorder more frequently observed in newborns and infants from 0 to 12 months of age, often associated with overdose.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es/. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of EMLA

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and tube after “EXP”. The expiry date refers to the last day of the month indicated.

Do not freeze.

Keep the tube tightly closed.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of EMLA

• The active substances are: lidocaine and prilocaine.
• 1 g of cream contains 25 mg of lidocaine and 25 mg of prilocaine.
• The other components are carbomers, macrogol glycerol hydroxystearate, sodium hydroxide, and purified water.

Appearance of EMLA and contents of the pack

Homogeneous white cream.

It is presented in an aluminum tube with a polypropylene cap equipped with a perforation device.

EMLA is available in the following pack sizes:

1 tube containing 5 g of cream
1 tube containing 5 g of cream + 2 patches
1 tube containing 5 g of cream + 3 patches
3 tubes containing 5 g of cream + 8 patches
5 tubes containing 5 g of cream
5 tubes containing 5 g of cream + 10 patches
5 tubes containing 5 g of cream + 12 patches
1 tube containing 30 g of cream

Only some pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aspen Pharma Trading Limited
3016 Lake Drive,
Citywest Business Campus,
Dublin 24, Ireland
Tel: +34 952 010 137

Manufacturer:

Meribel Pharma Karlskoga AB
Björkbornsvägen 5
Karlskoga, Örebro Lan,
691 33, Sweden

Or

Aspen Bad Oldesloe GmbH,
32-36 Industriestrasse,
23843 Bad Oldesloe,
Germany

Local Representative:

Aspen Pharmacare España S.L.
Avenida Diagonal, 512,
Planta Interior 1, Oficina 4,
Barcelona, 08006, Spain

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

Date of the last revision of this leaflet: November 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/