Emla plaster

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Emla Plaster (EMLApatch 5%)
25 mg + 25 mg, medicated plaster
Lidocaine + Prilocaine
Emla Plaster and EMLApatch 5% are different brand names for the same medicine.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• This medicine should always be used exactly as described in this patient leaflet or as directed by the doctor, pharmacist, or nurse.
• Keep this leaflet for future reference.
• If you need advice or further information, consult your pharmacist.
• If you experience any side effects, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Emla Plaster is and what it is used for
2. Important information before using Emla Plaster
3. How to use Emla Plaster
4. Possible side effects
5. How to store Emla Plaster
6. Contents of the pack and other information

1. What Emla Plaster is and what it is used for

Emla Plaster contains two active substances – lidocaine and prilocaine. These belong to a group of medicines known as local anaesthetics.
The action of Emla Plaster is to temporarily numb the surface layers of the skin. The plaster is applied to the skin before certain medical procedures and interventions. This helps relieve pain in the skin; however, the patient may still feel pressure and touch.
Adults, adolescents, and children
Emla Plaster may be used to anaesthetize the skin before:

• needle insertion (e.g. before an injection or blood sampling)
• minor skin surgical procedures.

2. Important information before using Emla Plaster

When not to use Emla Plaster:

• if the patient is allergic to lidocaine, prilocaine, any other similar local anaesthetic, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting to use Emla Plaster, discuss this with a 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 called "methemoglobinemia",
• Emla Plaster must not be applied to areas of skin with rash, cuts, scratches, or other open wounds. If the patient has any of these skin conditions, contact a doctor or pharmacist before using the patch,
• if the patient has a skin condition with itching called "atopic dermatitis", a shorter application time may be sufficient. Using the patch for longer than 30 minutes increases the likelihood of local skin reactions (see also section 4 "Possible side effects").

Avoid contact of Emla Plaster with the eyes, as it may cause irritation.
If Emla Plaster accidentally gets into the eye, immediately rinse the eye with lukewarm water or saline solution (0.9% NaCl solution). Exercise caution to prevent anything from entering the eye until sensation returns.
When Emla Plaster 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, transient, clinically insignificant increases in blood methemoglobin levels (a form of hemoglobin, the blood pigment) are commonly observed within 12 hours after application of Emla Plaster.
The efficacy of Emla Plaster for heel blood sampling in newborns has not been confirmed in clinical studies.
Emla Plaster must 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 Plaster and other medicines").
Emla Plaster must not be used in premature newborns.

Emla Plaster and other medicines
Inform the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including medicines obtained without a prescription and herbal medicines. This is important because the active ingredients of Emla Plaster may affect the action of certain other medicines, or certain other medicines may affect the action of Emla Plaster.
In particular, inform the doctor, pharmacist, or nurse if the patient has used or recently 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,
• cimetidine or beta-blockers, which may increase lidocaine blood levels. This interaction is not clinically significant with short-term use of Emla Plaster at recommended doses.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Occasional use of Emla Plaster during pregnancy has not been associated with any risk of adverse effects on the fetus.
The active substances of Emla Plaster (lidocaine and prilocaine) pass into human milk. However, the amount transferred 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 substances of Emla Plaster.

Driving and operating machinery
Emla Plaster has no effect or negligible effect on the ability to drive and operate machinery when used at recommended doses.

Emla Plaster contains macrogolglycerol hydroxystearate
This medicine may cause skin reactions.

3. How to use Emla Plaster

This medicine should always be used exactly as described in this patient information leaflet or as advised by your doctor, pharmacist or nurse. If in doubt, consult your doctor, pharmacist or nurse.
How to use Emla Plaster

• The site of application, number of plasters and duration of use depend on the intended purpose.
• Your doctor, pharmacist or nurse will apply the plaster to the appropriate area or show you how to do it yourself.

Do not use Emla Plaster on the following areas:

• Areas of skin abrasions, scratches or wounds.
• Areas with skin rash or irritation.
• Near the eyes.
• Inside the mouth.

Application to the skin prior to minor procedures (e.g. needle insertion or minor skin
surgical procedures):

• The plaster is applied directly to the skin. Your doctor, pharmacist or nurse will tell you where to apply the plaster.
• The plaster should be removed immediately before the procedure begins.
• The usual dose for adults and adolescents over 12 years of age is one or more plasters.
• For adults and adolescents over 12 years of age, the plaster should be applied at least 60 minutes before the planned procedure. However, the plaster should not be applied more than 5 hours before the procedure.
• For children, the number of Emla Plaster applications and duration of use depend on the child's age. Your doctor, nurse or pharmacist will inform you how many plasters to use and when to apply them.

Use in children:
Application to the skin prior to minor procedures (e.g. needle insertion or minor skin
surgical procedures): Duration of application: approximately 1 hour.
Newborns and infants aged 0 to 2 months: One plaster is applied to the selected skin area. Duration of application: 1 hour, no longer. Only one single dose should be used within any 24-hour period. The size of the plaster makes it less suitable for use on certain parts of the body in newborns and infants.
Infants aged 3 to 11 months: Up to 2 plasters are applied to the selected skin area. Duration of application: approximately 1 hour.
Children aged 1 to 5 years: Up to 10 plasters are applied to the selected skin area. Duration of application: approximately 1 hour, maximum 5 hours.
Children aged 6 to 11 years: Up to 20 plasters are applied to the selected skin area. Duration of application: approximately 1 hour, maximum 5 hours.
In children over 3 months of age, a maximum of 2 doses (as stated above) may be used within any 24-hour period, with at least 12 hours between doses.
Emla Plaster may be used in children with a skin condition called "atopic dermatitis", but in such cases the duration of application should not exceed 30 minutes.
When applying the plaster, it is essential to follow the instructions below:
Emla Plaster should be applied at least 1 hour before the procedure (except for patients with atopic dermatitis, see "Warnings and precautions"). If necessary, remove any hair from the skin area before applying the plaster. The plaster must not be cut or divided into smaller pieces.

1. Ensure that the skin surface to be anaesthetized is clean and dry. Grasp one corner of the aluminium foil protecting the plaster and fold it back. Then grasp the light beige layer of the plaster at the same corner. Before proceeding, ensure that the two layers at the corner of the plaster have been properly separated.

2. Pull apart and separate the two layers from each other, thus separating the adhesive surface from the protective foil, as shown in the illustration. Be careful not to touch the round white disc containing the medicine.

3. Do not press on the central part of the plaster. Pressing the centre may cause the medicine to leak under the adhesive layer and prevent the plaster from adhering properly to the skin. Press firmly on the edges of the plaster to ensure good adhesion to the skin.

4. The time of application can be written directly on the edge of the plaster. (A ballpoint pen may be used for this purpose.)

5. Leave the plaster in place for at least one hour (except for patients with atopic dermatitis, see "Warnings and precautions"). In children under 3 months of age, the plaster must not be left on for longer than 1 hour.
6. After the recommended time has elapsed, remove the plaster from the skin.

Application to the skin prior to removal of genital warts

• Emla Plaster may be used in children and adolescents with a skin condition called "atopic dermatitis".
• The recommended dose depends on the child's age and is applied for 30 to 60 minutes (30 minutes if the patient has atopic dermatitis). Your doctor, nurse or pharmacist will advise you on how many plasters to use.

Use of a higher than recommended dose of Emla Plaster
If more Emla Plaster has been used than recommended in this leaflet or advised by your doctor, pharmacist or nurse, inform them immediately, even if no symptoms are present.
Symptoms that may occur after using too much Emla Plaster are listed below. These symptoms should not occur when Emla Plaster is used as recommended.

• Feeling of "emptiness in the head" or dizziness.
• Tingling sensation around the mouth and numbness or loss of sensation in the tongue.
• Taste disturbances.
• Blurred vision.
• Ringing in the ears.
• There is also a risk of developing acute methemoglobinemia (a condition affecting the pigment in the blood). The risk is higher if the patient is taking certain specific medicines at the same time. In such cases, the skin may turn bluish-grey due to insufficient oxygen in the blood.

In severe cases of overdose, the following symptoms may occur: seizures, low blood pressure, slowed breathing, respiratory arrest and irregular heartbeat. These symptoms 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 immediately contact their doctor or pharmacist.
The doctor should be informed about any symptoms causing discomfort during treatment with Emla Plaster.

At the site of application of Emla Plaster, 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 patch and local anaesthetics, which resolve within a short time without requiring any medical intervention.

If any disturbing or unusual symptoms or reactions occur during treatment with Emla Plaster, treatment should be discontinued immediately and the patient should contact their doctor or pharmacist without delay.

Common (may affect up to 1 in 10 people):

• Transient local skin reactions (pallor, redness, swelling) at the site of application during cutaneous use.

Uncommon (may affect up to 1 in 100 people):

• Initial mild sensation of burning, itching, or warmth at the site of application during cutaneous use.

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).
• Methemoglobinemia (a blood disorder).
• Minor pinpoint bleeding (petechiae) at the site of application (especially in children with eczema after prolonged exposure to the drug).
• Eye irritation, if Emla Plaster accidentally comes into contact with the eyes during cutaneous application.

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 those not listed in this leaflet, inform your 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 Plaster

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 25°C. Do not store in the refrigerator. 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. This will help protect the environment.

6. Contents of the packaging and other information

What Emla Plaster contains

• The active substances are lidocaine and prilocaine. One medicated patch with a surface area of approximately 10 cm² contains 25 mg of lidocaine and 25 mg of prilocaine.
• Other components: polyglycolized glyceryl stearate (Arlatone 289), carbomer (Carbopol 974P), sodium hydroxide, purified water.

What Emla Plaster looks like and contents of the pack
Emla Plaster consists of a skin-adhesive part and a protective film. The skin-adhesive part is
light beige in colour. In the centre of the patch there is a round, white disc impregnated with an emulsion
containing the active and excipient substances. The remaining part of the patch is coated with an acrylic adhesive.

Pack sizes
2 patches, protected on one side by an aluminium foil, in a cardboard carton.

For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in France, the country of export:
Aspen Pharma Trading Limited
3016 Lake Drive
Citywest Business Campus
Dublin 24, Ireland

Manufacturer:
Recipharm Karlskoga AB
Björkbornsvägen 5
691 33 Karlskoga
Sweden

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 numbers in France, the country of export: 34009 340 007 1 3
34009 339 110 7 2
34009 302 740 5 7

Parallel Import Licence number: 19/25