Emla plaster

Package leaflet: Information for the user

Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
EMLA PLASTER (EMLA), 25 mg + 25 mg, medicated plaster
Lidocaine + Prilocaine
EMLA PLASTER and EMLA 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 a doctor, pharmacist, or nurse.

• Keep this leaflet for future reference.
• If advice or further information is needed, consult a pharmacist.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform a 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 sensation in the superficial layers of the skin. The medicine is applied to the skin before certain medical procedures and interventions. This helps to 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. prior to an injection or blood sampling)
• minor surgical procedures on the skin.

2. Information before using EMLA PLASTER

When not to use EMLA PLASTER:

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

Warnings and precautions
Before using EMLA PLASTER, 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 called "methemoglobinemia",
• do not apply EMLA PLASTER to areas of skin with rashes, cuts, scratches, or other open wounds. If any of these skin conditions are present, consult your doctor or pharmacist before using the patch,
• if the patient has a skin condition involving itching called "atopic dermatitis", a shorter application time may be sufficient. Applying 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 physiological saline (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 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 PLASTER.
The efficacy of EMLA PLASTER during heel blood sampling in newborns has not been confirmed in clinical studies.
EMLA PLASTER 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 PLASTER and other medicines").
EMLA PLASTER should not be used in premature newborns.

EMLA PLASTER and other medicines
Inform your 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 your 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 her 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 in 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 macrogol glycerol hydroxystearate
This medicine may cause skin reactions.

3. How to use EMLA PLASTER

This medicine must always be used exactly as described in this patient leaflet or as directed by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.

Using EMLA PLASTER

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

Do not use EMLA PLASTER on the following areas:

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

Application to the skin before minor procedures (e.g. needle insertion or minor skin surgery):

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

Use in children:
Application to the skin before minor procedures (e.g. needle insertion or minor skin surgery):
Duration of application: approximately 1 hour.

Newborns and infants from 0 to 2 months of age: One patch is applied to the selected area of skin. Duration of application: 1 hour, no longer. Only one single dose should be used within any 24-hour period. The size of the patch may make it less suitable for use on certain parts of the body in newborns and infants.

Infants from 3 to 11 months of age: Up to 2 patches may be applied to the selected area of skin. Duration of application: approximately 1 hour.

Children from 1 to 5 years of age: Up to 10 patches may be applied to the selected area of skin. Duration of application: approximately 1 hour, maximum 5 hours.

Children from 6 to 11 years of age: Up to 20 patches may be applied to the selected area of skin. Duration of application: approximately 1 hour, maximum 5 hours.

In children over 3 months of age, a maximum of 2 doses (as specified above) may be used within any 24-hour period, with at least a 12-hour interval 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 patch, it is essential to follow the instructions below carefully:

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 hair from the area before applying the patch. Do not cut or divide the patch into smaller pieces.

1. Ensure that the skin area to be anaesthetized

is clean and dry.
Take hold of one corner of the aluminium foil protecting the patch and
fold it back.
Then grasp the light beige layer of the patch at the same corner. Before proceeding, ensure that the two layers at the corner of the patch have been properly separated.

2. Pull and separate the two layers apart, 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 patch. Pressing this area may cause the medicine to leak under the adhesive layer and prevent proper adhesion of the patch to the skin. Press firmly on the edges of the patch to ensure good adhesion to the skin.
4. The time of application can be written directly on the edge

of the patch. (A ballpoint pen may be used for this purpose.)

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

Application to the skin before removal of warts (e.g. molluscum contagiosum):

• 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 tell you how many patches 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 by your doctor, pharmacist, or nurse, contact them immediately, even if there are no symptoms.

The following symptoms may occur after using too much EMLA PLASTER. These symptoms should not occur when EMLA PLASTER is used as recommended.

• A "hollow" feeling or dizziness.
• Tingling 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 acute methaemoglobinaemia (a condition affecting the pigment in the blood). The risk is higher if the patient is also taking certain specific medicines. In this condition, 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
If any of the side effects listed below occur or persist in the patient, the patient should immediately contact their doctor or pharmacist.
The doctor should be informed about everything that causes the patient to feel unwell during treatment with EMLA PLASTER.

At the site of application, EMLA PLASTER may cause a mild reaction (pallor or redness of the skin, slight swelling, initial sensation of burning or itching). These are common reactions to the patch and to local anaesthetics, which resolve quickly without requiring any medical intervention.

If the patient experiences any disturbing or unusual effects or reactions 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 when used on the skin.

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

• Initial mild sensation of burning, itching, or warmth at the site of application when used on the skin.

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 difficulties, and fainting).
• Methemoglobinemia (a blood disorder).
• Small pinpoint bleeding (petechiae) at the site of application (particularly in children, especially after prolonged exposure to the medicine).
• Eye irritation if the medicine EMLA PLASTER accidentally comes into contact with the eyes during application to the skin.

Additional side effects in children
Methemoglobinemia, a blood disorder, is more frequently observed in children, often associated with overdose in newborns and infants aged 0 to 12 months.

Reporting of side effects
If any adverse effects occur, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. Side effects 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 side effects 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.
Store below 25°C. Do not store in a refrigerator and 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 package and other information

What EMLA PLASTER contains

• The active substances are lidocaine and prilocaine. One medicinal patch with a surface area of approximately 10 cm² contains 25 mg lidocaine and 25 mg prilocaine.
• Other ingredients: polyglycolised glyceryl hydroxystearate (arlatone 289), carbomer, sodium hydroxide, purified water.

What EMLA PLASTER looks like and contents of the pack
EMLA PLASTER consists of a skin-contacting part and a protective film. The skin-contacting 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 ingredients. The remaining part of the patch is coated with an acrylic adhesive.

Pack size
2 patches, protected on one side with 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 Greece, country of export:
Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland
Manufacturer:
Recipharm Karlskoga AB, Bjorkbornsvagen 5, 691 33, Karlskoga, Sweden
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 Greece, country of export: 78818/16/22-03-17
Parallel import authorisation number: 151/24