Emla

Patient Information Leaflet

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
EMLA
25 mg/g + 25 mg/g (5% w/w), cream
Lidocaine + Prilocaine
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• 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 other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell 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. These belong to a group of medicines known as local anaesthetics.
EMLA works by temporarily numbing the sensation in the superficial layers of the skin. The cream is applied to the skin before certain medical procedures and treatments. This helps 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 (e.g. 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. Information before using EMLA

When not to use EMLA:

• if the patient is allergic 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 with your 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,
• do not apply EMLA to areas of skin with rashes, cuts, scratches, or other open wounds, except for leg ulcers. If any of these skin conditions are present, contact your doctor or pharmacist before using the cream,
• if the patient has a skin condition involving itchy skin called atopic dermatitis, a shorter application time may be sufficient. Prolonged application beyond 30 minutes increases the likelihood of local skin reactions (see also section 4. "Possible side effects"),
• if the patient is taking certain medicines used to treat heart rhythm disorders (class III antiarrhythmics 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, it is important to follow the recommended dosage, application area size, and duration of application on the skin.
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 eardrum tissue.
When EMLA is used before administration of a live vaccine (e.g., tuberculosis vaccine), remember to attend the follow-up visit scheduled by the doctor to assess vaccine effectiveness.

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 during heel blood sampling in newborns or for adequate pain relief 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 concurrently being treated 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 purchased without a prescription and herbal medicines. This is important because the ingredients 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 heartbeat, 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 fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.
Occasional use of EMLA during pregnancy has not been associated with any adverse effects on the fetus.
The active substances in EMLA (lidocaine and prilocaine) are excreted into human milk. However, the amount transferred into milk is so small that there is essentially no risk to the breastfed infant.
Animal studies have not shown any 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 macrogolglycerol hydroxystearate
Macrogolglycerol hydroxystearate may cause skin reactions.

3. How to use EMLA

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

Using EMLA cream

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

Do not use EMLA cream in the following areas:

• Broken, abraded, or wounded skin, except for leg ulcers.
• Areas affected by skin rash or eczema.
• Into the eyes 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 the patient's skin should ensure they effectively avoid 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 prior to 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.
• The cream layer should then be covered with an occlusive dressing (plastic film). The dressing should be removed immediately before the procedure begins. If the patient applies the cream independently, they should ensure they have received appropriate dressings from the doctor, pharmacist, or nurse.
• The usual dose 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 procedure (except when applied to genital areas). However, the cream should not be applied more than 5 hours before the procedure.
• The amount of EMLA cream and duration of application in children depend on the child's age. The doctor, nurse, or pharmacist will inform the patient about the appropriate amount and timing of application.

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

1. Squeeze a portion of cream from the tube to form a mound directly on the area of skin where it is needed (e.g., where a needle puncture will be performed). Half of the contents of a 5 g tube corresponds to approximately 2 g of EMLA cream. Do not rub the cream into the skin.

2. Peel off the paper backing from the central 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. The cream should not be left on for longer than 60 minutes in infants under 3 months of age, nor for longer than 30 minutes in children with a skin condition called "atopic dermatitis." For application 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 insertion).

Application to larger areas of freshly shaved skin prior to 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. EMLA should not be used on freshly shaved skin areas larger than 600 cm² (600 square centimeters, e.g., 30 cm by 20 cm). The maximum dose is 60 g.

Application to the skin prior to hospital procedures requiring deeper skin anaesthesia (e.g., split-thickness skin grafting):

• 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.
• The cream is applied and covered with an occlusive dressing for 2 to 5 hours.

Application to the skin prior to removal of 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 in patients with atopic dermatitis). The doctor, nurse, or pharmacist will inform the patient of the appropriate amount of cream to use.

Application to genital skin prior to 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 in the case of female genital skin) per 10 cm² (10 square centimeters) of skin surface.
• The cream is applied and covered with an occlusive dressing. The dressing is left in place for 15 minutes for male genital skin and for 60 minutes for female genital skin.

Application to genital skin prior to minor surgical procedures on the skin (such as removal of genital 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. No dressing is used. The procedure should be performed immediately after cream removal.

Application to leg ulcers prior to 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.
• The cream is applied and covered with an occlusive dressing, e.g., plastic film. The cream and dressing are applied 30 to 60 minutes before the debridement procedure. The cream should be removed with cotton gauze, and debridement should be performed immediately.
• EMLA may be used prior to leg ulcer debridement up to 15 times within a 1-2 month period.
• When EMLA is used on leg ulcers, the tube should be treated as a single-use product: after each patient use, the tube with any remaining cream must be discarded.

Use of more than the recommended dose of EMLA

If more EMLA has been used than recommended by the doctor, pharmacist, or nurse, contact them immediately, even if no symptoms are present.
The following problems may occur after using too much EMLA cream. These symptoms should not occur when EMLA is used as directed.

• A "light-headed" or dizzy feeling.
• 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 pigment in the blood). This is more likely if the patient is taking certain other medications simultaneously. In this condition, the skin may appear 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 the doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can 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.
The doctor should be informed about any symptoms causing discomfort during treatment with EMLA.

At the site of application of EMLA cream, 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 quickly without requiring any medical intervention.

If the patient experiences any disturbing or unusual symptoms or reactions during treatment with EMLA, use should be discontinued immediately 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 applied to the skin, genital mucosa, or leg ulcers.
• Initial mild sensation of burning, itching, or warmth at the site of application when applied to the genital mucosa 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 applied to the skin.
• Loss of sensation (numbness) at the site of application when applied to the genital mucosa.
• Skin irritation at the site of application when applied to 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 applied to the skin, genital mucosa, or leg ulcers.
• Methaemoglobinaemia (a blood disorder) when applied to the skin.
• Minor pinpoint bleeding (petechiae) at the site of application (especially in children with eczema after prolonged exposure to the medicine) when applied to 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 eye burns if EMLA cream accidentally comes into contact with the eyes during treatment.

Additional adverse reactions in children
Methaemoglobinaemia, a blood disorder, observed more frequently in children, often associated with overdose in neonates and infants from 0 to 12 months of age.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What EMLA contains

• The active substances in this medicine are: lidocaine and prilocaine. 1 g of cream contains: 25 mg lidocaine and 25 mg prilocaine.
• Other ingredients include: glyceryl monostearate macrogol ether, carbomers, sodium hydroxide (for pH adjustment), 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 coated internally with a protective lacquer, fitted with a perforating cap, and placed in a cardboard box.
EMLA is available in the following pack sizes:
1 tube containing 5 g of cream and 2 dressings in a cardboard box.
1 tube containing 5 g of cream and 3 dressings in a cardboard box.
5 tubes each containing 5 g of cream and 12 dressings in a cardboard box.
For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in Ireland, country of export:
Aspen Pharma Trading Limited
3016 Lake Drive
Citywest Business Campus
Dublin 24, Ireland
Manufacturer:
Aspen Bad Oldesloe GmbH
32-36 Industriestrasse, 23843 Bad Oldesloe, Germany
Recipharm Karlskoga AB
Björkbornsvägen 5, SE-691 33 Karlskoga, Sweden
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing Authorisation Number in Ireland, country of export: PA 1691/023/001
Parallel Import Licence Number: 391/25
This medicinal product is authorised for sale 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