Product Information for the User

EMLA 25 mg/g + 25 mg/g cream

lidocaine/prilocaine

Read this entire product information carefully before starting to use this medication, as it containsimportant information for you.

• Keep this product information, as you may need to refer to it again.
• 1. If you have any questions, consult yourdoctor or pharmacist.

-This medication has been prescribedonlyto you, and you should not give it to other people even if they havethe same symptomsas you, as it may harm them.

• If you experience any adverse effects,consult your doctor or pharmacist, evenif they are not listed in this product information. See section 4.

1.What is EMLA and for what it is used

2.What you need to know before starting to use EMLA

3.How to use EMLA

4.Possible adverse effects

5. Storage of EMLA

6. Contents of the package and additional information

EMLA contains two active ingredients called lidocaine and prilocaine. They belong to a group of medications called local anesthetics.

EMLA acts by temporarily numbing the surface of the skin. It is applied to the skin before certain medical procedures. It helps to stop pain in the skin; however, you may still feel sensations such as pressure and contact.

Adults, adolescents, and children

It can be used to numb the skin before:

• Needle puncture (e.g., if you are going to receive an injection or have a blood test).
• Minor surgery on the skin.

Adults and adolescents

It can also be used:

• To numb the genitals before:
• • Receiving an injection.
  • Medical procedures such as wart removal.

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:

• Cleaning or removing damaged skin from leg ulcers.

No use EMLA

• if you are allergic to lidocaine or prilocaine,or other local anesthetics similar to these or any of the other ingredients in this medication (listed in section6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use EMLA

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

-if you or your child have a condition that affects the levels of a pigment in the blood called “methemoglobinemia”.

• do not use EMLA on areas with skin eruptions, cuts, abrasions, or open wounds, except for ulcers on the legs. If any of these problems 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 of more than 30minutes may increase the incidence of local skin reactions (see also section4. “Possible side effects”).

-if you are being treated with medications for heart rhythm disorders (class III antiarrhythmics, such as amiodarone). In this case, your doctor will monitor your heart function.

Due to the potential greater absorption on recently shaved skin, it is essential to respect the recommended dose, skin surface, and application time..

Avoid contact of EMLA with the eyes, as it may cause irritation and chemical burns in the eyes. If it accidentally enters your eye, you must rinse it immediately with warm water or saline solution (sodium chloride solution). Be careful not to apply anything to your eye until you regain sensitivity.

Children should be closely monitored when using EMLA on any part of their body to prevent EMLA from coming into contact with the eyes.

EMLA should not be applied to a damaged eardrum.

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

Children and adolescents

In infants and newborns under 3months, methemoglobinemia is often observed, a transient and clinically insignificant increase in the levels of a pigment in the blood, up to 12hours after EMLA application.

Clinical studies could not confirm the efficacy of EMLAwhen drawing blood from the heel of newborns or providing adequate analgesia for circumcision.

EMLA should not be applied to the genital mucosa (e.g., vagina) of children (under 12years old) due to insufficient data on the absorption of the active ingredients.

EMLA should not be used in children under 12months of age who are receiving simultaneous treatment with other medications that affect the concentrations of the blood pigment“methemoglobin” (e.g., sulfonamides, see also section2. “Use of EMLA with other medications”).

EMLA should not be used in premature newborns.

Use of EMLA with other medications

Inform your doctor or pharmacist if you are using or taking, have used or taken recently, or may need to use or take any other medication, including those purchased without a prescription and herbal medications.This is because EMLA may affect the action of other medications and other medications may have an effect on EMLA.

Particularly, inform your doctor or pharmacist if you or your child have recently used or received treatment with any of the following medications:

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

The occasional use of EMLA during pregnancy is unlikely to have any adverse effects on the fetus.

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

Studies in animals have shown that there are no alterations in male or female fertility.

Driving and operating machinery

EMLA does not affect the ability to drive and use machines, or the effect is insignificant, when used at the recommended doses.

EMLA contains macrogolglycerol hydroxystearate

This medication may cause skin reactions because it contains macrogolglycerol hydroxystearate.

Follow exactly the administration instructions of this medication, indicated by your doctor, pharmacist or nurse. In case of doubt, consultyour doctor, pharmacist or nurse again.

Use of EMLA

-The application site of the cream, the amount to be used and the time it should be applied will depend on what it is used for.

-Your doctor, pharmacist or nurse will apply the cream or teach you how to apply it yourself.

-When EMLA is used on the genitals, a doctor or nurse must supervise its use.

Do not use EMLA in the following areas:

-Cuts, abrasions or wounds, except for ulcers on the legs.

-Areas with skin eruption or eczema.

-On the eyes or in their vicinity.

-Inside the nose, ear or mouth.

-On the anus.

-On the genitals of children.

People who frequently apply or remove the cream will ensure to avoid contact to prevent the appearance of hypersensitivity.

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

Use on the skin before small interventions (such as needle puncture or minor skin procedures):

-Apply a thick layer of cream on the skin. Your doctor, pharmacist or nurse will indicate where to apply it.

-Cover the cream with a dressing [transparent plastic]. This is removed just before starting the procedure. If you apply the cream yourself, make sure your doctor, pharmacist or nurse provide you with the dressings.

-The usual dose for adults and adolescents over 12 years old is 2 g (grams).

-For adults and adolescents over 12 years old, 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 before.

-For children, the amount of EMLA used and the time of use depend on their age. Your doctor, nurse or pharmacist will indicate the amount to be used and when to apply it.

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

1. Press the tube to apply the necessary amount of cream on the skin where the procedure is to be performed (e.g., where the needle is to be inserted). A line of cream 3.5 cm from the 30 g tube is equivalent to 1 g of cream. Do not spread the cream.

1. Remove the paper layer from the“central cut”of the non-adhesive side of thedressing(leaving a paper frame).

1. Remove thecoverfrom the adhesive side of the dressing.

1. Place thedressingcarefully overthe creamapplied. Do not spread the cream under the dressing.

1. Remove thepaper support.Smooththe edges of thedressingcarefully. Then leave it in place for at least 60 minutes if the skin is not damaged. The cream should not be left in place for more than 60 minutes in children under 3 months or for more than 30 minutes in children with a skin condition called“atopic dermatitis”. If the cream is used on the genitals oroverulcers, shorter application times may be used as described below.

1. Your doctor or nurse will remove the dressing andremove the cream just beforeperforming the medical procedure(e.g., just before inserting the needle).

Use on the skin before 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 between 1 and 5 hours under a dressing. EMLA should not be used on a recently shaved skin surface larger than 600 cm² (e.g., 30 cm by 20 cm) in size. The maximum dose is 60 g.

Use on the skin before hospital procedures (such as skin grafts) that require deeper skin anesthesia:

-EMLA can be used in this way in adults and adolescents over 12 years old.

-The usual dose is 1.5 g to 2 g of cream per 10 cm² (10 square centimeters) of skin surface.

-The cream is applied under an occlusive dressing for 2 to 5 hours.

Use on the skin to remove warts called “molluscum”:

-EMLA can be used in children and adolescents with 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 indicate how much cream to apply.

Use on the genitals before local anesthetic injections:

-EMLA can be used in this way only in adults and adolescents over 12 years old.

-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 surface.

-The cream is applied under an occlusive dressing. This is kept in place for 15 minutes on male genital skin and for 60 minutes on female genital skin.

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

-EMLA can be used in this way only in adults and adolescents over 12 years old.

-The usual dose is 5 g to 10 g of cream for 10 minutes. No occlusive dressing is used. The medical procedure should be started immediately.

Use on ulcers on the legs before cleaning or removing the damaged skin:

-The usual dose is 1 g to 2 g of cream per 10 cm², up to a maximum of 10 g.

-The cream is applied under an occlusive dressing, e.g., a transparent plastic. This is kept in place for 30 to 60 minutes before cleaning the ulcer. Remove the cream with a cotton swab and start cleaning without delay.

• EMLA can be used before cleaning ulcers on the legs up to 15 times in a period of 1-2 months.
• The EMLA tube is for single use when used on ulcers on the legs: The tube with any remaining content should be discarded after treating each patient.

If you use more EMLA than you should:

If you use more EMLA than your doctor, pharmacist or nurse has indicated, contact them immediately, even if you do not have symptoms.

The following symptoms may occur if you use too much EMLA. It is unlikely that these symptoms will occur if you follow the recommended use of EMLA.

-Dizziness or dizziness.

-Tickling sensation on the skin around the mouth and numbness of the tongue.

-Alteration of taste.

-Blurred vision.

-Ringing in the ears.

-There is also a risk of “acute methemoglobinemia” (a problem with blood pigment levels). This risk is higher when taking certain medications at the same time. If this occurs, the skin takes on a bluish-gray color due to lack of oxygen.

In severe cases of overdose, symptoms may include convulsions, low blood pressure, slow breathing, cessation of breathing and alteration of heart rhythm. These effects can be potentially fatal.

For accidental ingestion or overdose, contact the Toxicology Information Service. Phone 91 562 04 20.

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

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

Consult your doctor or pharmacist if any of the following side effects cause you discomfort or do not seem to disappear. Inform your doctor of anything else that makes you feel unwell while using EMLA.

A mild reaction (pale skin or redness, mild swelling, initial burning or itching) may appear on the area where EMLA is applied. This is a normal reaction to the cream and anesthetics, and it will disappear in a short time without needing any action.

If you experience any bothersome or unusual side effects while using EMLA, stop using it and consult your doctor or pharmacist as soon as possible.

Frequent(may affect up to 1 in 10 people)

-Transient local skin reactions (pale skin, redness, swelling) in the application area during treatment on the skin, genital mucosa, or leg ulcers.

-A mild initial sensation of burning, itching, or heat in the application area during treatment on the genital mucosa or leg ulcers.

Occasional(may affect up to 1 in 100 people)

-A mild initial sensation of burning, itching, or heat in the treated area during treatment on the skin.

-Numbness (tingling) in the application area during treatment on the genital mucosa.

-Skin irritation in the application area during treatment of leg ulcers.

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

-Allergic reactions that, in rare cases, can lead to anaphylactic shock (skin rash, swelling, fever, respiratory difficulty, and fainting) during treatment on the skin, genital mucosa, or leg ulcers.

-Methemoglobinemia (blood disorder) during skin treatment.

-Small punctate hemorrhage in the treated area (particularly in children with eczema after long periods of application), during skin treatment.

-Irritation of the eyes if EMLA accidentally comes into contact with them during skin treatment.

Unknown frequency(cannot be estimated from available data)

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

Other side effects in children

Methemoglobinemia, a blood disorder that is often observed more frequently in newborns and infants from 0 to 12 months, often associated with overdose.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es/. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe packaging and tubeafter “EXP”. The expiration date is the last day of the month indicated.

Do not freeze.

Store the tube tightly closed.

Medications should not be disposed of through drains or in the trash. Dispose of containers and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of EMLA

• The active principles are: lidocaine and prilocaine.
• 1 g of cream contains 25 mg of lidocaine and 25 mg of prilocaine.
• The other components arecarbomers, macrogolglycerol hydroxystearate, sodium hydroxide and purified water

Appearance of EMLA and contents of the package

Homogeneous cream of white color.

It is presented in an aluminum tube with a polypropylene cap provided with a piercing device.

EMLA is available in packages of:

1 tube containing 5 g of cream

1 tube containing 5 g of cream + 2 dressings

1 tube containing 5 g of cream + 3 dressings

3 tubes containing 5 g of cream + 8 dressings

5 tubes containing 5 g of cream

5 tubes containing 5 g of cream + 10 dressings

5 tubes containing 5 g of cream + 12 dressings

1 tube containing 30 g of cream

Only some package sizes may be marketed

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

Aspen Pharma Trading Limited

3016 Lake Drive,

Citywest Business Campus,

Dublin 24, Ireland

Tel: +34 952 010 137

Manufacturer responsible:

Recipharm Karlskoga AB

Björkbornsvägen 5

S-69133 – Karlskoga

Sweden

Or

Aspen Bad Oldesloe GmbH,

32-36 Industriestrasse,

23843 Bad Oldesloe,

Germany

Local representative:

Aspen Pharmacare España S.L.

Avenida Diagonal, 512,

Ground floor, Office 4,

Barcelona, 08006, Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of thisleaflet:July 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/