Emla plaster

Patient Information Leaflet

Warning! Keep this leaflet; the information on the immediate packaging is in a foreign language!
EMLA PLASTER (Emla Penso)
25 mg + 25 mg, medicated plaster
Lidocaine + Prilocaine
EMLA PLASTER and Emla Penso are different brand names for the same medicine.
Please read all of this leaflet carefully before using this medicine, as it contains
important information for you.
Always use this medicine exactly as described in this patient leaflet or as directed by your
doctor, pharmacist, or nurse.

• Keep this leaflet so that you can read it again if necessary.
• 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.

Table of contents

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. They belong to a group of medicines known as local anaesthetics.
EMLA PLASTER works by temporarily numbing the superficial layers of the skin. The medicine is applied to the skin before certain medical procedures and treatments. 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, other similar local anaesthetics, 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 rash, cuts, scratches, or other open wounds. If the patient has any of these skin conditions, consult a doctor or pharmacist before applying 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 eye irritation. If EMLA PLASTER accidentally gets into the eye, immediately rinse the eye with lukewarm water or physiological 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 appointment scheduled by the doctor to assess the effectiveness of vaccination.

Children and adolescents
In infants and newborns under 3 months of age, a transient, clinically insignificant increase in methemoglobin levels in blood (a form of hemoglobin, the blood pigment) is 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 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
Tell 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 baby, 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 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 shown no adverse effect on 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 or operate machinery when used at recommended doses.

EMLA PLASTER contains macrogol glyceryl 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 leaflet or as directed 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 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 puncture or minor skin
surgical procedures):

• The plaster is applied directly to the skin. Your doctor, pharmacist, or nurse will inform you where to apply the plaster.
• The plaster should be removed immediately before the procedure begins.
• The usual dose for adults and adolescents aged 12 years and older is one or more plasters.
• For adults and adolescents aged 12 years and older, apply the plaster at least 60 minutes before the planned procedure. However, do not apply the plaster more than 5 hours before the procedure.
• In children, the number of EMLA PLASTER plasters used and the duration of application 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 before minor procedures (e.g., needle puncture or minor skin
surgical procedures): Duration of use: approximately 1 hour.
Newborns and infants aged 0 to 2 months: One plaster is applied to the selected skin area. Duration of use: 1 hour, no longer. Only one single dose should be used within any 24-hour period. The plaster size makes it less suitable for use on certain body parts of newborns and infants.
Infants aged 3 to 11 months: Up to 2 plasters may be applied to the selected skin area. Duration of use: approximately 1 hour.
Children aged 1 to 5 years: Up to 10 plasters may be applied to the selected skin area. Duration of use: approximately 1 hour, maximum 5 hours.
Children aged 6 to 11 years: Up to 20 plasters may be applied to the selected skin area. Duration of use: approximately 1 hour, maximum 5 hours.
In children older than 3 months, a maximum of 2 doses (as specified 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 use 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. Do not cut or divide the plaster 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 are 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 the central part of the plaster. Pressing this area may force the medicine under the adhesive layer and impair proper adhesion to the skin. Press firmly around 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, do not leave the plaster in place for longer than 1 hour.
6. After the recommended duration of use, remove the plaster from the skin.

Application to the skin before removal of warts (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 inform you 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 high a dose of EMLA PLASTER are listed below. These
symptoms should not occur when EMLA PLASTER is used according to the recommendations.

• A "hollow" feeling or dizziness.
• Tingling sensation around the mouth and numbness or loss of sensation of 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 simultaneously taking certain specific medicines. In such cases, the skin may appear 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 abnormal heart rhythm. These symptoms may be life-threatening.
If you have any further doubts about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience 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 the patient 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 quickly without requiring any medical intervention.

If the patient experiences any worrying or unusual symptoms or reactions during treatment with EMLA PLASTER, treatment should be discontinued immediately and the patient should contact their doctor or pharmacist.

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

• Transient local skin reactions (pallor, redness, swelling) at the site of drug exposure during topical application.

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

• Initial mild sensation of burning, itching, or warmth at the site of drug exposure during topical application.

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).
• Methemoglobinemia (a blood disorder).
• Minor pinpoint bleeding (petechiae) at the site of drug exposure (particularly in children with rash after prolonged exposure to the drug).
• Eye irritation, if accidental contact with eyes occurs during application of EMLA PLASTER to the skin.

Additional adverse reactions in children
Methemoglobinemia, a blood disorder, 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, inform a doctor, pharmacist, or nurse. 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, 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 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. These measures 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 medicinal patch with a surface area of approximately 10 cm² contains 25 mg of lidocaine and 25 mg of prilocaine.
• Other components: polyglycolised glycerol hydroxystearate, carbomer, sodium hydroxide, purified water.

What EMLA PLASTER looks like and contents of the pack
EMLA PLASTER consists of a part to be applied to the skin and a protective film. The part applied to the skin 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 with an aluminium foil, in a cardboard box.
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Portugal, 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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged by:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Portugal Marketing Authorisation Number (country of export): 2426385
Parallel Import Licence Number: 72/24