Emla

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

EMLA

25 mg/g + 25 mg/g, cream

Lidocaine + Prilocaine

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is EMLA and what is it used for
• 2. Important information before using EMLA
• 3. How to use EMLA
• 4. Possible side effects
• 5. How to store EMLA
• 6. Package contents and other information

1. What is EMLA and what is it used for

EMLA contains two active substances - lidocaine and prilocaine. They belong to a group of medicines called local anesthetics.
The action of EMLA is to temporarily eliminate the sensation in the superficial layers of the skin. The cream is applied to the skin before performing certain medical procedures and treatments.
This helps to eliminate pain in the skin; however, the patient may still feel pressure and touch.

Adults, adolescents, and children

EMLA can be used to anesthetize the skin before:

• injecting a needle into the skin (e.g., during an injection or blood sampling),
• minor surgical procedures on the skin.

Adults and adolescents

EMLA can also be used:

• to anesthetize the genital area before: performing an injection, performing medical procedures such as removing warts. The application of EMLA to the genital area should be performed under the supervision of a doctor or nurse.

Adults

EMLA can also be used to anesthetize the skin before:

• cleaning or removing damaged skin on lower limb ulcers.

2. Important information before using EMLA

When not to use EMLA:

Warnings and precautions

Before starting to use EMLA, you should discuss it with your doctor or pharmacist:

• EMLA should not be used on areas of skin with a rash, cuts, scratches, or other open wounds, except for lower limb ulcers. If the patient has any of these changes, before using the cream, they should contact their doctor or pharmacist,

Due to the possibility of increased absorption from freshly shaved skin, it is essential to follow the recommended dosage, area of application, and duration of application on the skin.
One should avoid contact of EMLA with the eyes, as it may cause irritation. If EMLA accidentally gets into the eye, it should be rinsed immediately with lukewarm water or a physiological saline solution (0.9% NaCl solution). One should be careful not to get anything into the eye until sensation returns.
EMLA should not be used on diseased eardrums.
When EMLA is used in a patient before administering a live vaccine (e.g., tuberculosis vaccine), one should remember to report to the doctor for a follow-up visit at the designated time to assess the effectiveness of the vaccination.

Children and adolescents

In infants and newborns under 3 months of age, a transient, clinically insignificant increase in methemoglobin concentration in the blood (a form of hemoglobin, i.e., a blood pigment) is commonly observed within 12 hours after applying EMLA.
The efficacy of EMLA during heel prick blood sampling in newborns or to ensure adequate pain relief during circumcision has not been confirmed in clinical trials.
EMLA should not be used on the mucous membrane of the genital area (e.g., vagina) in children (under 12 years of age) due to insufficient data on the absorption of active substances.
EMLA should not be used in children under 12 months of age who are being treated with other medicines that affect the 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

The patient should inform their doctor or pharmacist about any other medicines they are currently taking or have recently taken or may take. This includes medicines that can be bought without a prescription and herbal medicines. This is important because the ingredients of EMLA may affect the action of some 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 called sulfonamides and nitrofurantoin.
• Medicines used to treat epilepsy: phenytoin and phenobarbital.
• Other local anesthetics.
• Medicines used to treat irregular heart rhythm, such as amiodarone.
• Cimetidine or beta-adrenergic blockers, which may increase the concentration of lidocaine in the blood. This interaction is not clinically significant in short-term use of EMLA in recommended doses.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Occasional use of EMLA during pregnancy is not associated with any risk of adverse effects on the fetus.
The active substances of EMLA (lidocaine and prilocaine) are excreted into breast milk. However, the amount that passes into the milk is so small that there is essentially no risk to the breastfed child.
In animal studies, no fertility disorders were found in males or females treated with the active ingredients of EMLA.

Driving and using machines

EMLA has no effect or negligible effect on the ability to drive and use machines when used in recommended doses.

EMLA contains macrogolglycerol hydroxystearate

Macrogolglycerol hydroxystearate may cause skin reactions.

3. How to use EMLA

EMLA should always be used according to the doctor's, pharmacist's, or nurse's instructions. In case of doubts, one should consult a doctor, pharmacist, or nurse.

Using EMLA

• The place of application, amount of cream, and duration of application depend on the purpose of 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 the genital area, the doctor or nurse should supervise its use.

EMLA should not be used in the following areas:

• Areas of cuts, scratches, or open wounds, except for lower limb ulcers.
• Areas with skin rash or eczema.
• Eyes or near the eyes.
• Inside the nose, ears, or mouth.
• In the anus.
• On the genital area in children.

People who frequently apply or remove the cream from the patient's body should make sure to effectively avoid contact with the cream to prevent the development of hypersensitivity.
The protective membrane of the tube is pierced with the tube cap.

Using EMLA on the skin before minor procedures (such as needle insertion or minor surgical procedures on the skin):

• The cream is applied to the skin in a thick layer. The doctor, pharmacist, or nurse will tell the patient where to apply the cream.
• Then, the layer of cream is covered with a dressing (plastic foil). The dressing is removed immediately before the procedure starts. If the patient applies the cream themselves, they should make sure to receive dressings from their doctor, pharmacist, or nurse.
• Usually, the dose used in adults and adolescents over 12 years old is 2 g (grams).
• In adults and adolescents over 12 years old, the cream should be applied at least 60 minutes before the planned procedure time (except when the cream is to be applied to the genital area). However, the cream should not be applied more than 5 hours before the procedure or earlier.
• In children, the amount of EMLA used and the duration of application depend on the child's age. The doctor, nurse, or pharmacist will inform the patient about the amount of cream to be used and when to apply it.

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

• 1. Squeeze out a portion of cream from the tube to form a mound in the place where it is needed on the skin (e.g., where the needle is to be inserted). A line of cream about 3.5 cm long from a 30 g tube corresponds to 1 g of cream. Half of the contents of a 5 g tube corresponds to about 2 g of EMLA. Do not rub the cream into the skin.

• 2. Peel off the paper layer from the middle window of the non-stick side of the dressing (leaving the paper frame).

• 3. Remove the top layer of the adhesive dressing.

• 4. Carefully place the dressing over the mound of cream. Do not spread the cream under the dressing.

• 5. Remove the paper reinforcement. Carefully smooth the edges of the dressing. Then, leave the dressing on for at least 60 minutes if the skin is not damaged. The cream should not be left on for more than 60 minutes in children under 3 months or more than 30 minutes in children with atopic dermatitis. In the case of using the cream on the genital area or ulcers, shorter application times can be used as described below.

• 6. The doctor or nurse will remove the dressing and remove the cream immediately before the medical procedure (e.g., before inserting the needle).

Using EMLA on larger areas of freshly shaved skin before procedures in outpatient settings (such as hair removal):

Usually, the dose of EMLA used is 1 g of cream per 10 cm² (10 square centimeters) of skin surface, applied for 1 to 5 hours under a dressing. EMLA should not be used on an area of freshly shaved skin larger than 600 cm² (600 square centimeters, e.g., 30 cm x 20 cm). The maximum dose is 60 g.

Using EMLA on the skin before procedures performed in hospital settings (e.g., before skin grafting), which require deeper skin anesthesia:

• EMLA can be used in this way in adults and adolescents over 12 years old.
• Usually, the dose used 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 a dressing for 2 to 5 hours.

Using EMLA on the skin before removing warts

• EMLA can be used in children and adolescents with atopic dermatitis.
• Usually, the dose used 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 about the amount of cream to be used.

Using EMLA on the genital skin before injecting local anesthetics

• EMLA can be used in this way only in adults and adolescents over 12 years old.
• Usually, the dose used 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 a dressing. The dressing is left on for 15 minutes in the case of male genital skin and for 60 minutes in the case of female genital skin.

Using EMLA on the genital skin before minor surgical procedures on the skin (such as removing warts)

• EMLA can be used in this way only in adults and adolescents over 12 years old.
• Usually, the dose used is 5 g to 10 g of cream for 10 minutes. No dressing is used. The procedure should be started immediately after.

Using EMLA on ulcers on the lower limbs before cleaning or removing damaged skin

• Usually, the dose used is 1 g to 2 g of cream per 10 cm² (10 square centimeters) of skin surface and no more than 10 g.
• The cream is applied and covered with a tight dressing, e.g., plastic foil. The cream and dressing are applied 30 to 60 minutes before the procedure. The cream should be removed with a cotton swab and the procedure started immediately.
• EMLA can be used before cleaning ulcers on the lower limbs up to 15 times in a period of 1-2 months.
• When using the cream on ulcers on the lower limbs, the EMLA tube should be used as a single-use product: after each use of the cream in the patient, the tube with the remaining amount of cream should be discarded.

Using a larger dose of EMLA than recommended

In case of using a larger amount of EMLA than recommended by the doctor, pharmacist, or nurse, one should contact them immediately, even if the patient does not feel any discomfort.
Problems and discomfort that may occur after using too much EMLA are listed below. These discomforts should not occur when using EMLA according to the instructions.

• Feeling of "emptiness" in the head or dizziness.
• Numbness or tingling of the skin around the mouth and tongue.
• Disturbed sense of taste.
• Blurred vision.
• Ringing in the ears.
• There is also a risk of methemoglobinemia (a problem with the concentration of a blood pigment). This is more likely if the patient is taking certain other medicines. In case of this condition, the skin becomes blue-gray due to insufficient oxygen in the blood. In severe cases of overdose, symptoms such as seizures, decreased blood pressure, decreased breathing rate, respiratory arrest, and abnormal heart rhythm may occur. These problems can be life-threatening. In case of any further doubts about the use of this medicine, one should consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, EMLA can cause side effects, although not everybody gets them.
In case of experiencing or persisting any of the following side effects, the patient should contact their doctor or pharmacist. The patient should then tell the doctor about everything that causes discomfort during the use of EMLA.
In the area where EMLA was applied, a mild reaction may occur (pallor or redness of the skin, slight swelling, initial burning or itching sensation). These are common reactions to the cream and anesthetics, which disappear after a short time without the need for any medical intervention.
In case of experiencing any worrying or unusual effects or reactions during the use of EMLA, one should stop using it and 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 during use on the skin, mucous membrane of the genital area, or on ulcers on the lower limbs.
• Initial mild sensation of burning, itching, or warmth at the site of application during use on the mucous membrane of the genital area or on ulcers on the lower limbs.

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 the skin.
• Numbness (tingling) at the site of application during use on the mucous membrane of the genital area.
• Irritation of the skin at the site of application during use on ulcers on the lower limbs.

Rare(may affect up to 1 in 1000 people)

• Allergic reactions, which in rare cases can lead to anaphylactic shock (skin rash, swelling, fever, difficulty breathing, and fainting) during use on the skin, mucous membrane of the genital area, or on ulcers on the lower limbs.
• Methemoglobinemia (a blood disorder) during use on the skin.
• Minor pinpoint bleeding (petechiae) at the site of application (especially in children with eczema after longer application time) during use on the skin.
• Irritation of the eyes if they accidentally come into contact with EMLA during its use on the skin.

Additional side effects in children

Methemoglobinemia, a blood disorder, which is more common in children, often in connection with overdose in newborns and infants from 0 to 12 months.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 side effects can help gather more information on the safety of the medicine.

5. How to store EMLA

The medicine should be stored 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 month.
Do not freeze. Store the tube tightly closed.
Medicines should not be disposed of via wastewater or household waste. One should ask the pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What EMLA contains

• The active substances of EMLA are: lidocaine and prilocaine.
• 1 g of cream contains: 25 mg of lidocaine and 25 mg of prilocaine.
• EMLA also contains: carbomers, macrogolglycerol hydroxystearate, sodium hydroxide, and purified water.

What EMLA looks like and what the package contains

An aluminum tube with a membrane, coated internally with a protective varnish based on epoxy resin with a polypropylene cap with a piercer, in a cardboard box.
For more detailed information, one should contact the marketing authorization holder or parallel importer.

Marketing authorization 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
AstraZeneca AB
Global External Sourcing (GES), Astraallen, Gärtunaporten (B 674:5)

• 15185 - Södertälje Sweden

AstraZeneca UK Limited
Silk Road Business Park, Macclesfield, Cheshire, SK10 2NA
United Kingdom
AstraZeneca GmbH
Tinsdaler Weg 183, DE-22880
Germany
Aspen Bad Oldesloe GmbH,
32-36 Industriestrasse,
23843 Bad Oldesloe,
Germany

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing authorization number in Spain, the country of export: 679290.2
Parallel import authorization number 202/22
Date of leaflet approval: 11.05.2022
[Information about the trademark]