Emla

Package leaflet: Information for the user

Warning! Keep the 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 doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed strictly for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms appear identical.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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 consists of temporarily numbing the superficial layers of the skin. The cream is applied to the skin before certain medical procedures and interventions. This helps 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 (for example, during an injection or blood sampling),
• minor surgical procedures on the skin.

Adults and adolescents
EMLA may also be used:
to anaesthetize genital organs before:

• administering an injection,
• performing medical procedures such as removal of genital warts. Application of EMLA to genital organs should be performed under the supervision of a doctor or nurse.

Adults
EMLA may also be used to anaesthetize the skin before:
debridement or removal of damaged skin from venous 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 blood pigment disorder known as methemoglobinemia,
• do not apply EMLA to areas of skin with rashes, cuts, scratches, or other open wounds, except in the case of leg ulcers. If the patient has any of these skin conditions, contact a doctor or pharmacist before using the cream,
• if the patient has a skin condition involving itching known as 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 (antiarrhythmic class III drugs 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 with the eyes, as EMLA may cause eye irritation and chemical 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 the child from transferring EMLA to the eye(s).
Do not apply EMLA to diseased tympanic membranes.
When EMLA is used before administration of a live vaccine (e.g. a vaccine against tuberculosis), remember to attend the follow-up visit at the appointed time 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 during heel blood sampling in newborns or to provide 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 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, the patient should inform their doctor or pharmacist if they have used or taken any of the following medicines:

• Medicines used to treat infections 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 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 or 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 a doctor, pharmacist, or nurse.
If in doubt, consult a doctor, pharmacist, or nurse.

Use of 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 themselves.
• 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:

• Broken, abraded, or wounded skin, except for leg ulcers.
• Areas affected by skin rash or eczema.
• Into 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 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 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.
• Cover the cream layer with a dressing (plastic film). Remove the dressing immediately before the procedure begins. If the patient applies the cream themselves, they must ensure they have received 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 use 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, it is very important to follow these instructions carefully:

1. Squeeze a portion of cream from the tube to form a mound on the area of skin where it is needed (for example, where a needle puncture will be made). A line of cream approximately 3.5 cm long from a 30 g tube corresponds to 1 g of cream. Half the contents of a 5 g tube corresponds to approximately 2 g of EMLA. 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., 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 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). The doctor, nurse, or pharmacist will inform the patient how much cream to use.

Application to genital skin prior to 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 in the 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 for male genital skin and 60 minutes for female genital skin.

Application to genital skin prior to minor skin surgery (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 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 ulcer debridement procedure.

Remove the cream with cotton gauze and proceed immediately with ulcer debridement.

• 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 and symptoms may occur after using too much EMLA. These should not occur when EMLA is used as directed.

• A "hollow" or dizzy feeling in the head.
• Tingling around the mouth and numbness or loss of sensation in the tongue.
• Disturbed 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 also taking certain other medicines. 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 can 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 any medicinal product, this medicine can 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 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 within a short time without requiring any medical intervention.

If the patient experiences any disturbing or unusual effects 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 during use on skin, genital mucosa, or lower limb ulcers.
• Initial mild sensation of burning, itching, or warmth at the site of application during use on genital mucosa 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 during use on skin.
• Loss of sensation (numbness) at the site of application during use on genital mucosa.
• Skin irritation at the site of application during use on lower limb 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) during use on skin, genital mucosa, or lower limb ulcers.
• Methemoglobinemia (a blood disorder) during use on skin.
• Small pinpoint bleeding (petechiae) at the site of application (particularly in children with eczema after prolonged exposure to the drug) during use on skin.
• Eye irritation if accidental contact with EMLA cream occurs during application to skin.

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

• Chemical burns of the eye if accidental contact with the cream occurs during treatment.

Additional adverse reactions in children
Methemoglobinemia, a blood disorder, 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 any 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
Phone: +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 the 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 freeze.
Keep 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. This will help protect the environment.

6. Contents of the package and other information

What EMLA contains

• The active substances in the medicine are: lidocaine and prilocaine. 1 g of cream contains: 25 mg lidocaine and 25 mg prilocaine.
• Other ingredients: macrogol glyceryl 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 a protective lacquer, and fitted with a cap with a piercing device, in a cardboard box.
EMLA is available in the following pack sizes:
1 aluminium tube with a membrane, internally coated with an epoxy protective lacquer, with a polypropylene cap with a piercing device, containing 5 g of cream and 2 occlusive dressings, in a cardboard box.
For further detailed information, please 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, SK 10 2 NA, United Kingdom
AstraZeneca GmbH, Tinsdaler Weg 183, DE-22880, Germany
Parallel Importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing Authorisation Number in Belgium, country of export: BE177055
Parallel Import Authorisation Number: 36/25
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 PER CENT, cream
Greece EMLA
Iceland Emla
Ireland EMLA 5% w/w Cream
Italy EMLA
Luxembourg Emla 25mg/2 mg crème
Malta EMLA 5% w/w Cream
Norway Emla
Poland EMLA
Spain EMLA 25 mg/g + 25 mg/g cream
Sweden EMLA
Netherlands Emla