Emla

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
EMLA, 25 mg/g + 25 mg/g, cream
Lidocaine + Prilocaine
Please read the following information carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What EMLA is and what it is used for
2. Important information 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 – lidocaine and prilocaine. They belong to a group of medicines known as local anaesthetics.
The action of EMLA is to temporarily numb the sensation in the superficial layers of the skin. The cream is applied to the skin before certain medical procedures.
This helps to relieve pain in the skin; however, the patient may still feel pressure and touch.

Adults, adolescents and children
EMLA may be used to anaesthetize the skin before:

• inserting a needle into the skin (for example, during an injection or blood sampling)
• minor surgical procedures on the skin.

Adults and adolescents
EMLA may also be used:

• to anaesthetize the genital organs before:
• injections
• medical procedures such as removal of warts. Application of EMLA cream to the genital organs should be performed under the supervision of a doctor or nurse.

Adults
EMLA may also be used to anaesthetize the skin before:

• debriding or removing damaged skin from leg ulcers.

2. Important information before using EMLA

When not to use EMLA:

• if the patient has a known allergy to lidocaine, prilocaine, any other similar local anaesthetic, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting to use EMLA, discuss this with a doctor or pharmacist:

• if the patient has a rare metabolic disorder affecting the blood called glucose-6-phosphate dehydrogenase deficiency,
• if the patient has a blood pigment disorder known as methemoglobinemia,
• EMLA should not be applied to skin areas with rashes, cuts, scratches, or other open wounds, except for leg ulcers. If any of these skin conditions are present, contact a doctor or pharmacist before using the cream,
• if the patient has a skin condition with itching known as atopic dermatitis, a shorter application time of the cream may be sufficient. Prolonged application beyond 30 minutes increases the risk of local skin reactions (see also section 4. "Possible side effects"),
• if the patient is taking certain medicines used to treat heart rhythm disorders (antiarrhythmic class III agents such as amiodarone). In such cases, the doctor will monitor the patient's heart function.

Due to the possibility of increased absorption from freshly shaved skin surfaces, it is important to follow the recommended dosage, application area size, and duration of application.

Avoid contact of EMLA with the eyes, as it may cause irritation and chemical eye burns. If EMLA cream accidentally gets into the eye, immediately rinse the eye with lukewarm water or saline solution (0.9% NaCl solution). Exercise caution to prevent anything from entering the eye until sensation returns.

Carefully supervise children when EMLA is applied to any part of the body to prevent the child from transferring EMLA to the eye(s).

Do not apply EMLA to diseased or damaged eardrum.

When EMLA is used before administration of a live vaccine (e.g. tuberculosis vaccine), remember to attend the follow-up appointment scheduled by the doctor to assess the effectiveness of vaccination.

Children and adolescents
In infants and newborns under 3 months of age, a transient, clinically insignificant increase in blood methemoglobin levels (a form of hemoglobin, the blood pigment) is commonly observed within 12 hours after application of EMLA.

The efficacy of EMLA for heel blood sampling in newborns or for providing adequate analgesia during circumcision has not been confirmed in clinical studies.

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

EMLA should not be used in children under 12 months of age who are being treated simultaneously with other medicines that affect blood pigment and may cause methemoglobinemia (e.g. sulfonamides; see also section 2 "EMLA and other medicines").

EMLA should not be used in premature newborns.

EMLA and other medicines
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines. This includes medicines available without a prescription and herbal medicines. This is important because the components of EMLA may affect the action of certain other medicines, and some other medicines may affect the action of EMLA.

In particular, the patient should inform their doctor or pharmacist if they have used or recently taken any of the following medicines:

• Medicines used to treat infection known as sulfonamides and nitrofurantoin.
• Medicines used to treat epilepsy: phenytoin and phenobarbital.
• Other local anaesthetics.
• Medicines used to treat irregular heartbeats, such as amiodarone.
• Cimetidine or beta-blockers, which may increase lidocaine blood levels. This interaction is not clinically significant with short-term use of EMLA at recommended doses.

Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.

There is no known risk of adverse effects on the fetus associated with occasional use of EMLA during pregnancy.

The active substances of EMLA (lidocaine and prilocaine) are excreted in human milk. However, the amount transferred into milk is so small that there is essentially no risk to the breastfed infant.

Animal studies have shown no impairment of fertility in males or females treated with the active ingredients of EMLA.

Driving and operating machinery
EMLA has no effect or negligible effect on the ability to drive and operate machinery when used at recommended doses.

EMLA contains macrogol glycerol hydroxystearate
Macrogol glycerol hydroxystearate may cause skin reactions.

3. How to use EMLA

EMLA must always be used exactly as directed by a doctor, pharmacist, or nurse. If in doubt, consult a doctor, pharmacist, or nurse.

How to use EMLA

• The site of application, amount of cream, and duration of application depend on the intended use.
• A doctor, pharmacist, or nurse will apply the cream to the appropriate area or instruct the patient how to do it.
• When EMLA is used on genital areas, its use should be supervised by a doctor or nurse.

Do not use EMLA on the following areas:

• Broken, scratched, or wounded skin, except for leg ulcers.
• Areas with skin rash or eruptions.
• In or near the eyes.
• Inside the nose, ears, or mouth.
• In the rectum.
• On the genital organs of children.

Individuals who frequently apply or remove the cream from a patient's skin should take care to avoid direct contact with the cream to prevent the development of hypersensitivity.

The protective seal on the tube is pierced using the cap of the tube.

Application to the skin before minor procedures (such as needle puncture or minor skin surgery):

• Apply a thick layer of cream to the skin. The doctor, pharmacist, or nurse will inform the patient where to apply the cream.
• Cover the cream layer with an occlusive dressing (plastic film). Remove the dressing immediately before the procedure. If the patient applies the cream themselves, they must ensure they have received appropriate dressings from the 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 12 years of age, apply the cream at least 60 minutes before the planned procedure (except when applied to genital areas). However, do not apply the cream more than 5 hours before the procedure.
• The amount and duration of EMLA cream application in children depend on the child's age. The doctor, nurse, or pharmacist will inform the patient about the correct amount and timing.

When applying EMLA cream, it is very important to follow these instructions precisely:

1. Squeeze the required amount of cream from the tube to form a mound at the site on the skin where it is needed (e.g., where a needle puncture will be performed). A line of cream approximately 3.5 cm long from a 30 g tube corresponds to 1 g of cream. Do not rub the cream into the skin.

2. Peel off the paper layer from the center window on the non-adhesive side of the dressing (leaving the paper frame intact).

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. Gently smooth the edges of the dressing. Leave the dressing in place for at least 60 minutes if the skin is intact. Do not leave the cream on for longer than 60 minutes in infants under 3 months of age or longer than 30 minutes in children with a skin condition called "atopic dermatitis." When applying the cream to genital areas or ulcers, shorter application times may be used as described below.

6. The doctor or nurse will remove the dressing and wipe off the cream immediately before the medical procedure (e.g., needle puncture).

Application of EMLA to larger areas of freshly shaved skin before outpatient procedures (such as hair removal):

The usual dose of EMLA is 1 g of cream per 10 cm² (10 square centimeters) of skin surface, applied for 1 to 5 hours under an occlusive dressing. Do not apply EMLA to 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.

Application to the skin before hospital procedures (e.g., before medium-thickness 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 surface.
• Apply the cream and cover with an occlusive dressing for 2 to 5 hours.

Application to the skin before removal of warts (genital warts):

• EMLA may be used in children and adolescents with a skin condition called "atopic dermatitis."
• The usual dose depends on the child's age and is applied for 30 to 60 minutes (30 minutes for patients with atopic dermatitis). The doctor, nurse, or pharmacist will inform the patient of the correct amount of cream to use.

Application to genital skin before injection of local anaesthetics:

• 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 for female genital skin) per 10 cm² (10 square centimeters) of skin surface.
• Apply the cream and cover with an occlusive dressing. Leave the dressing in place for 15 minutes for male genital skin and 60 minutes for female genital skin.

Application to genital skin before minor surgical procedures (such as 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 applied for 10 minutes. Do not use a dressing. Proceed immediately with the procedure after removing the cream.

Application to leg ulcers before ulcer debridement or removal of damaged skin:

• The usual dose is 1 g to 2 g of cream per 10 cm² (10 square centimeters) of skin surface, not exceeding 10 g in total.
• Apply the cream and cover with an occlusive dressing, e.g., plastic film. Apply the cream and dressing 30 to 60 minutes before the debridement procedure. Remove the cream with cotton gauze and proceed immediately with ulcer debridement.
• EMLA may be used up to 15 times within 1–2 months for leg ulcer debridement.
• When applying the cream to leg ulcers, the EMLA tube should be treated as a single-use product: after each patient use, discard the tube with any remaining cream.

Use of more than the recommended dose of EMLA

If more EMLA has been applied than recommended by the doctor, pharmacist, or nurse, contact them immediately, even if no symptoms are present.

The following problems may occur after excessive use of EMLA. These symptoms should not occur when EMLA is used as directed.

• Feeling of "emptiness in the head" or dizziness.
• Tingling around the mouth and numbness or loss of sensation in the tongue.
• Altered taste sensation.
• Blurred vision.
• Ringing in the ears.
• There is also a risk of methemoglobinemia (a condition affecting the oxygen-carrying pigment in the blood). This risk is higher if the patient is taking certain other medications. In such cases, the skin may become bluish-grey due to insufficient oxygen in the blood.

In severe cases of overdose, symptoms such as seizures, low blood pressure, reduced breathing rate, respiratory arrest, and irregular heartbeat may occur. These problems can be life-threatening.

If there are any further doubts about the use of this medicine, consult a doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like any medicine, this medicine may cause adverse reactions, although not everyone will experience them.
If any of the adverse reactions listed below occur or persist in the patient, the patient should contact their doctor or pharmacist.
In such cases, the patient should inform the doctor about all symptoms causing discomfort during treatment with EMLA.

At the site of application of EMLA, a mild reaction may occur (pallor or redness of the skin, slight swelling, initial sensation of burning or itching). These are common reactions to the cream and local anaesthetics, which resolve after a short time without requiring any medical intervention.

If the patient experiences any disturbing or unusual symptoms or reactions during treatment with EMLA, use should be discontinued and the doctor or pharmacist should be contacted 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 when used on the skin, genital mucous membranes, or leg ulcers.
• Initial mild sensation of burning, itching, or warmth at the site of application when used on genital mucous membranes or leg ulcers.

Uncommon (may affect up to 1 in 100 people)

• Initial mild sensation of burning, itching, or warmth at the site of application when used on the skin.
• Loss of sensation (numbness) at the site of application when used on genital mucous membranes.
• Skin irritation at the site of application when used on leg ulcers.

Rare (may affect up to 1 in 1000 people)

• Allergic reactions, which in rare cases may lead to anaphylactic shock (skin rash, swelling, fever, breathing difficulty, and fainting) when used on the skin, genital mucous membranes, or leg ulcers.
• Methemoglobinemia (a blood disorder) when used on the skin.
• Small pinpoint bleeding (petechiae) at the site of application (especially in children with eczema after prolonged exposure to the drug) when used on the skin.
• Eye irritation if EMLA cream accidentally comes into contact with the eyes during application to the skin.

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

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

Additional adverse reactions in children
Methemoglobinemia, a blood disorder, which is more frequently observed in children, often associated with overdose in newborns and infants aged 0 to 12 months.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, they should be reported to a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store EMLA

Keep this medicine out of sight and reach of children.
Do not freeze. Store the tube tightly closed.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What EMLA contains

• The active substances are: lidocaine and prilocaine. 1 g of cream contains: 25 mg lidocaine and 25 mg prilocaine.
• Other ingredients: polyglyceryl hydroxystearate, carbomers, sodium hydroxide, and purified water.

What EMLA looks like and contents of the pack
White, homogeneous cream.
The medicine is packed in an aluminium tube with a membrane, internally coated with an epoxy resin-based protective varnish, and fitted with a polypropylene cap with a piercing device, in a cardboard box.
EMLA is available in the following pack sizes:
1 tube containing 30 g of cream in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Spain, the country of export:
Aspen Pharma Trading Limited
3016 Lake Drive
Citywest Business Campus
Dublin 24, Ireland
Manufacturer:
Recipharm Karlskoga AB
Björkbornsvägen 5
S-69133 – Karlskoga
Sweden
Aspen Bad Oldesloe GmbH
32-36 Industriestrasse
23843 Bad Oldesloe
Germany
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in Spain, the country of export: 679290.2
Parallel import authorisation number: 2/20
This medicinal product is authorised for marketing in the European Economic Area countries 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