Emla

Package leaflet: Information for the user

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 the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• 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. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. 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 works by temporarily numbing the sensation in the superficial layers of the skin.
The cream is applied to the skin before certain medical procedures. It 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 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 venous leg ulcers.

2. Important information before using EMLA

When not to use EMLA:

• if the patient is allergic to lidocaine, prilocaine, any other locally acting anaesthetic medicine of similar type, 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 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 applying the cream,
• if the patient has a skin condition with itching known as atopic dermatitis, shorter application time of the cream may be sufficient. Prolonged application for longer than 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 medicines 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 accidentally gets into the eye, immediately rinse the eye with lukewarm water or physiological saline solution (0.9% NaCl solution).
Take care to avoid getting anything into the eye until sensation returns.
Carefully supervise children when EMLA is applied to any part of the body to prevent transfer of EMLA into the eye(s).
Do not apply EMLA to a diseased eardrum membrane.
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 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 providing 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 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 prescription and herbal medicines. This is important because the ingredients of EMLA may affect the action of certain other medicines, and certain 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 blood levels of lidocaine. 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.

There is no 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 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 according to the instructions given by your doctor, pharmacist or nurse.
If in doubt, consult your doctor, pharmacist or nurse.
How to use EMLA

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

Do not use EMLA in the following areas:

• Damaged skin, cuts, scratches or wounds, except in leg ulcers.
• Areas with skin rash or eruptions.
• In or near the eyes.
• Inside the nose, ears or mouth.
• In the rectum.
• On genital organs in children.

Individuals who frequently apply or remove the cream from a patient's skin should ensure they effectively avoid contact with the cream to prevent development of hypersensitivity.
The protective seal on the tube is pierced using the cap of the tube.
Application to skin prior to minor procedures (such as needle puncture or minor skin
surgical procedures):

• Apply a thick layer of cream to the skin. Your doctor, pharmacist or nurse will tell you where to apply the cream.
• The cream layer should then be covered with a dressing (plastic film). The dressing is removed immediately before the procedure begins. If you are applying the cream yourself, ensure you have received dressings from your 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, 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 of EMLA and duration of application in children depend on the child's age. Your doctor, nurse or pharmacist will inform you how much cream to use and when to apply it.

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

1. Squeeze a portion of cream from the tube to form a mound on the skin where it is needed (e.g., where a needle puncture will be performed). A cream line 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).

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. Then 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., before needle insertion).

Application of EMLA 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 skin prior to hospital procedures (e.g., prior to split-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 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). Your doctor, nurse or pharmacist will inform you 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 case of female genital skin) per 10 cm² (10 square centimeters) of skin surface.
• Apply the cream and cover with a dressing. Leave the dressing in place for 15 minutes in males and 60 minutes in females.

Application to genital skin prior to minor skin 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 for 10 minutes. A dressing is not used. The procedure should be performed immediately after application.

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 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 a 1-2 month period prior to leg ulcer debridement.
• When using EMLA 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 your doctor, pharmacist or nurse, contact them immediately, even if you do not feel unwell.
Problems and symptoms that may occur after using too much EMLA are listed below. 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 of the tongue.
• Altered taste sensation.
• Blurred vision.
• Ringing in the ears.
• There is also a risk of methaemoglobinaemia (a condition affecting the pigment in the blood). This is more likely if you are taking certain other medicines at the same time. 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 may be life-threatening.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist or nurse.

4. Possible adverse reactions

Like all medicines, this product may cause adverse reactions, although not everyone experiences them.
If any of the adverse reactions listed below occur or persist in the patient, the patient should contact their doctor or
pharmacist. The patient should inform the doctor about any 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 within a short time without requiring
any medical intervention.
If the patient experiences any disturbing or unusual reactions or symptoms during treatment with EMLA, use should be discontinued immediately and the patient should contact a
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 site of application when applied to the skin, genital mucous membranes, or lower limb ulcers.
• Initial mild sensation of burning, itching, or warmth at the site of application when applied to genital mucous membranes or lower limb 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 lower limb 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) when applied to the skin, genital mucous membranes, or lower limb 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 drug) when applied to the skin.
• Eye irritation, if EMLA 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 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 adverse effects not listed in this leaflet, inform a doctor, pharmacist, or nurse. 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 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 use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the stated month.
Do not freeze. Store the tube tightly closed.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices 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 are: carbomers, polyoxyglycolised glyceryl hydrogenated stearate, 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, internally coated with a protective epoxy resin-based lacquer, fitted with a polypropylene cap with a piercing device, and placed in a cardboard box.
EMLA is available in the following pack sizes:
1 tube containing 30 g of cream.
For further information, 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:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Marketing Authorisation Number in Spain, the country of export: 679290.2
Parallel Import Authorisation Number: 354/19

This medicinal product is authorised for sale in the European Economic Area under the following names:
Austria Emla 5% - Creme
Belgium Emla 25mg/25mg crème
Cyprus Emla Cream 5%
Finland EMLA
France EMLA 5 PER 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