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 entire leaflet carefully before using the 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, 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 other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions 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. What you need to know 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. 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:

• an injection,
• medical procedures such as removal of genital 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 tissue from venous leg ulcers.

2. Information before using EMLA

When not to use EMLA:

• if the patient is allergic 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, known as glucose-6-phosphate dehydrogenase deficiency,
• if the patient has a condition involving blood pigment levels 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 your doctor or pharmacist before applying the cream,
• if the patient has a skin condition with itching known as atopic dermatitis, a shorter application time may be sufficient. Prolonged application of the cream 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 (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.
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 contact with the eye until sensation returns.
Carefully supervise children when EMLA is applied to any part of the body to prevent the child from transferring the cream to the eye(s).
Do not apply EMLA to diseased eardrum mucosa.
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 vaccination efficacy.

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 EMLA application.
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 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 components of EMLA may affect the action of certain other medicines, and some other medicines may affect the action of EMLA.
In particular, patients 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 lidocaine 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 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 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 on the following areas:

• Areas with cuts, scratches, or wounds, except for leg ulcers.
• Areas with skin rash or irritation.
• 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 ensure they effectively avoid contact with the cream to prevent the development of hypersensitivity.
The protective seal of 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
surgical procedures):

• Apply the cream in a thick layer to the skin. Your doctor, pharmacist, or nurse will tell you where to apply the cream.
• Cover the cream layer with a dressing (plastic film). Remove the dressing immediately before starting the procedure. If you are applying the cream yourself, ensure you have received dressings from your 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 scheduled procedure (except when applied to genital areas). However, do not apply the cream more than 5 hours before the procedure.
• The amount of EMLA cream and duration of application in children depend on the child's age. Your doctor, nurse, or pharmacist will inform you of the appropriate 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 (for example, 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 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. 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 (for example, 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 the skin prior to hospital procedures (e.g., harvesting of split-thickness skin grafts) 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 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 for patients with atopic dermatitis). Your doctor, nurse, or pharmacist will inform you 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 for 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 for male genital skin and 60 minutes for female genital skin.

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. Proceed immediately with the procedure 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 prior to debridement of leg ulcers up to 15 times within a 1-2 month period.
• When applying EMLA to leg ulcers, the 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 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.

• Sensation 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 blood pigment). 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 can 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 medicine 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 everything that causes 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 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 patient should contact their 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 leg ulcers.
• Initial mild sensation of burning, itching, or warmth at the site of application when applied to the 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 the 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 (particularly 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 neonates 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, 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 enhance the safety information available for 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 packaging. The expiry date refers to the last day of the stated month.
Do not store above 30°C. Do not freeze.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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 include: polyglycolyzed hydrostearate, 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 varnish, and fitted with a cap equipped with a piercing device, all contained in a cardboard box.
EMLA is available in the following pack sizes:
1 tube containing 5 g cream and 2 dressings.
5 tubes of 5 g each and 12 dressings.
For further information, please contact the marketing authorization holder or the parallel importer.
Marketing Authorization Holder in Portugal, the country of export:
Aspen Pharma Trading Limited
3016 Lake Drive
Citywest Business Campus
Dublin 24, Ireland
Manufacturer:
Recipharm Karlskoga AB
Björkbornvägen, 5
SE-691 33 Karlskoga
Sweden
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 Authorization Number in Portugal, the country of export: 2443588
Parallel Import Authorization Number: 51/24
This medicinal product is authorized 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