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, cream
Lidocaine + Prilocaine
Please read this leaflet carefully before using this medicine, as it contains
important information for the patient.

• 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. This medicine may harm others, even if their symptoms are the same.
• If any adverse reactions occur in the patient, including any adverse reactions 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.
EMLA acts by temporarily numbing the sensation in the superficial layers of the skin. The cream is applied to the skin before certain medical procedures and interventions. This helps to relieve skin pain; 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: injection, 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, other similar local anaesthetics, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before using 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 condition involving blood pigment 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 causing itchy skin called atopic dermatitis, shorter application time of the cream 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 (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, 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 physiological saline solution (0.9% NaCl solution).
Take care to prevent anything from entering the eye until sensation returns.
Carefully supervise children during application of EMLA to any part of the body to prevent transfer of EMLA into the eye(s).
Do not apply EMLA to diseased eardrum membranes.
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 methemoglobin blood 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 mucous membranes of genital organs (e.g. vagina) in children (under 12 years of age) due to insufficient data on absorption of active substances.
EMLA should not be used in children under 12 months of age who are being treated simultaneously with other medicines affecting blood pigment and which 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 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 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-adrenolytic agents, which may increase lidocaine blood levels. This interaction is not clinically significant when EMLA is used short-term 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 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 motor vehicles 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 according to the instructions given by the doctor, pharmacist, or nurse.
If in doubt, consult your doctor, pharmacist, or nurse.

How to use EMLA cream

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

Do not apply EMLA cream to the following areas:

• Broken, abraded, or wounded skin, except for leg ulcers.
• Areas with skin rash or eczema.
• Into or near the eyes.
• Inside the nose, ears, or mouth.
• Into 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 the cream in a thick layer 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 is removed immediately before the procedure begins. If the patient applies the cream themselves, 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 how much cream to use and when to apply it.

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

1. Squeeze a portion 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 made). Half 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 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. 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., before 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 applied 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 prior to hospital procedures requiring deeper skin anaesthesia (e.g., prior to 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 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 in patients with atopic dermatitis). The doctor, nurse, or pharmacist will inform the patient how much 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 in males and for 60 minutes in females.

Application to genital skin prior to 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. No dressing is used. The procedure should begin immediately after removal of the cream.

Application to leg ulcers prior to 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 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 begin immediately.
• EMLA may be used up to 15 times within a 1-2 month period for leg ulcer debridement.
• When EMLA is used on leg ulcers, the tube should be treated as a single-use product: after each 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 the patient feels no discomfort.

The following problems may occur after using too much EMLA. These symptoms should not occur when EMLA is used as directed:

• A "spaced-out" feeling or dizziness.
• Tingling around the mouth and numbness or loss of sensation of the tongue.
• Disturbed taste sensation.
• Blurred vision.
• Ringing in the ears.
• There is also a risk of methaemoglobinaemia (a condition affecting the blood pigment). This is more likely if the patient is taking certain other medicines at the same time. In this condition, 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 may be life-threatening.

If you have any further doubts about the use of this medicine, consult your 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.
All symptoms causing the patient discomfort during treatment with EMLA should be reported to the doctor.

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 within 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 applied to the skin, genital mucous membranes, or leg ulcers.
• Initial mild sensation of burning, itching, or warmth at the site of application when applied to 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 applied to the skin.
• Loss of sensation (numbness) at the site of application when applied to genital mucous membranes.
• 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 mucous membranes, or leg ulcers.
• Methemoglobinemia (a blood disorder) when applied to the skin.
• Small 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 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 effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 4921301, fax: +48 22 4921309, 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 the medicine out of the 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 the sewage system or in 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 are: lidocaine and prilocaine. 1 g of cream contains 25 mg of lidocaine and 25 mg of prilocaine.
• Other ingredients: glyceryl monoleate, carbomers, sodium hydroxide (to adjust pH), 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 a protective epoxy-phenolic lacquer, and fitted with a polypropylene cap with a piercing device, in a cardboard box.
EMLA is available in the following pack:
1 tube containing 5 g of cream and 2 plasters in a cardboard box.
For further information, contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in Belgium, 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
AstraZeneca AB
Astraallén, Gärtunaporten (B 674:5), SE-151 85 Södertälje, Sweden
Recipharm Karlskoga AB
Bjorkbornsvagen 5, SE-691 33 Karlskoga, Sweden
AstraZeneca UK Limited
Silk Road Business Park, Macclesfield, Cheshire, SK10 2NA, United Kingdom
AstraZeneca GmbH
Tinsdaler Weg 183, DE-22880, Germany
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 Belgium, country of export: BE177055
Parallel Import Authorisation Number: 125/24
This medicinal product is authorised 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