Emla Plaster

Leaflet attached to the packaging: information for the user

EMLA PLASTER

25 mg + 25 mg, medicinal plaster
Lidocaine + Prilocaine

You should carefully read the contents of the leaflet 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 your doctor, pharmacist, or nurse.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, you should ask your pharmacist.
• If you experience any side effects, including those not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What the medicine is and what it is used for

The medicine contains two active substances – lidocaine and prilocaine. They belong to a group of medicines called local anesthetics.
The medicine works by temporarily numbing the sensation in the outer layers of the skin. The medicine is applied to the skin before certain medical procedures. This helps to numb the pain in the skin; however, the patient may still feel pressure and touch.

Adults, adolescents, and children

The medicine can be used to numb the skin before:

• injection with a needle (e.g., before giving an injection or taking blood for tests)
• minor surgical procedures on the skin.

2. Important information before using the medicine

When not to use the medicine:

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

Warnings and precautions

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

• if the patient has a rare metabolic disorder that affects the blood and is called "glucose-6-phosphate dehydrogenase deficiency",
• if the patient has a problem related to the concentration of a blood pigment called "methemoglobinemia",
• the medicine should not be applied to areas of skin with a rash, cuts, scratches, or other open wounds. If the patient has any of these changes, they should contact their doctor or pharmacist before using the plaster,
• if the patient has a skin disorder called "atopic dermatitis", it may be sufficient to use the plaster for a shorter time. Using the plaster for more than 30 minutes is associated with a higher risk of a local skin reaction (see also section 4 "Possible side effects").

You should avoid contact between the medicine and the eyes, as it may cause irritation. If the medicine accidentally gets into the eye, it should be rinsed immediately with lukewarm water or a physiological saline solution (0.9% NaCl solution). You should be careful not to get anything into the eye until the sensation returns.
If the medicine is used in a patient before administering a live vaccine (e.g., a vaccine against tuberculosis), you should remember to report to the doctor at the scheduled time for a follow-up visit 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 levels in the blood is commonly observed within 12 hours of using the medicine.
The effectiveness of the medicine during blood sampling from the heel in newborns has not been confirmed in clinical trials.
The medicine 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 "Medicine and other medicines").
The medicine should not be used in premature newborns.

Medicine and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. This includes medicines that can be bought without a prescription and herbal medicines. This is important because the ingredients of the medicine may affect the action of some other medicines or some other medicines may affect the action of the medicine.
In particular, you should inform your doctor, pharmacist, or nurse if you 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
• cimetidine or beta-adrenergic blockers, which may increase the level of lidocaine in the blood. This interaction is not clinically significant in short-term use of the medicine in recommended doses.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should ask your doctor or pharmacist for advice before using this medicine.
Occasional use of the medicine during pregnancy is not associated with any risk of side effects in the fetus.
The active substances of the medicine (lidocaine and prilocaine) pass into breast milk.
However, the amount that passes into milk is so small that there is essentially no risk to the breastfed baby.
Animal studies have not shown any fertility problems in males or females treated with the active substances of the medicine.

Driving and using machines

The medicine has no or negligible influence on the ability to drive and use machines when used as recommended.

Medicine contains macrogolglycerol hydroxystearate

The medicine may cause skin reactions.

3. How to use the medicine

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor, pharmacist, or nurse. If you are unsure, you should ask your doctor, pharmacist, or nurse.

Using the medicine

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

Do not use the medicine on the following areas:

• Cuts, scratches, or wounds.
• Areas with skin rash or eczema.
• Near the eyes.
• Inside the mouth.

Using on the skin before minor procedures (e.g., needle injection or minor surgical procedures on the skin):

• The plaster is stuck to the skin. Your doctor, pharmacist, or nurse will tell you where to stick the plaster.
• The plaster is removed immediately before starting the procedure.
• Usually, the recommended dose for adults and adolescents over 12 years is one or more plasters.
• For adults and adolescents over 12 years, the plaster should be applied at least 60 minutes before the planned procedure time. However, the plaster should not be applied 5 hours before the procedure or earlier.
• For children, the number of 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.

Using in children:

Using on the skin before minor procedures (e.g., needle injection or minor surgical procedures on the skin): Duration of application: approximately 1 hour.

Newborns and infants from 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 in any 24-hour period.The size of the plaster makes it less suitable for use on some parts of the body in newborns and infants.
Infants from 3 to 11 months:Up to 2 plasters are applied to the selected skin area. Duration of application: approximately 1 hour.
Children from 1 to 5 years:Up to 10 plasters are applied to the selected skin area. Duration of application: approximately 1 hour, up to 5 hours.
Children from 6 to 11 years:Up to 20 plasters are applied to the selected skin area. Duration of application: approximately 1 hour, up to 5 hours.
In children over 3 months, a maximum of 2 doses (as specified above) can be used in any 24-hour period, with an interval of at least 12 hours between doses.
The medicine can be used in children with a skin disease called "atopic dermatitis", but the duration of application should not exceed 30 minutes.
When using the plaster, it is essential to follow the instructions below carefully:

• 1. Make sure the skin surface to be anesthetized is clean and dry. Hold one of the corners of the aluminum foil protecting the plaster and bend it back. Then, hold the light beige-colored layer of the plaster at the same corner. Before proceeding, make sure the two layers at the corner of the plaster have been properly separated.

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

• 3. Do not press the central part of the plaster. Pressing this part of the plaster may cause the medicine to leak under the adhesive layer and prevent the plaster from sticking properly to the skin. You should press the edges of the plaster firmly to ensure good adhesion to the skin.

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

• 5. Leave the plaster on for at least one hour (except for patients with atopic dermatitis, see "Warnings and precautions"). In children under 3 months, the plaster should not be left on for more than 1 hour.
• 6. After the application time has passed, remove the plaster from the skin.

Using on the skin before removing warty lesions

• The medicine can be used in children and adolescents with a skin disease 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 plasters to use.

Using more than the recommended dose of the medicine

If you use more of the medicine than described in the leaflet or recommended by your doctor, pharmacist, or nurse, you should inform them immediately, even if you do not notice any symptoms.
Symptoms that may occur after using too much of the medicine are listed below. These symptoms should not occur when using the medicine as recommended.

• A feeling of "emptiness" in the head or dizziness.
• Numbness or tingling of the skin around the mouth and tongue.
• Disturbances of taste.
• Blurred vision.
• Ringing in the ears.
• There is also a risk of acute methemoglobinemia (a problem with the concentration of a blood pigment). The risk of this is higher if the patient is taking certain other medicines. If this condition occurs, the skin becomes blue-gray due to insufficient oxygen in the blood.

In severe cases of overdose, the following symptoms may occur: seizures, decreased blood pressure, slow breathing, respiratory arrest, and abnormal heart rhythm. These symptoms can be life-threatening.
If you have any further questions about using this medicine, you should ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following side effects, you should contact your doctor or pharmacist immediately. You should tell your doctor about everything that makes you feel unwell while using the medicine.
A mild reaction may occur at the site of application of the medicine (pallor or redness of the skin, slight swelling, initial burning or itching sensation). These are normal reactions to the plaster and anesthetics, which disappear after a short time without the need for any medical action.
If you experience any worrying or unusual reactions or effects while using the medicine, you should stop using it and contact your doctor or pharmacist immediately.

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

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

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

• Initial mild sensation of burning, itching, or warmth at the site of application of the medicine.

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).
• Methemoglobinemia (a blood disorder).
• Minor pinpoint bleeding (petechiae) at the site of application of the medicine (especially in children with eczema after longer application times).
• Irritation of the eyes if they accidentally come into contact with the medicine during application to the skin.

Additional side effects in children

Methemoglobinemia, a blood disorder, which is more commonly observed in children, often in association with overdose in newborns and infants under 12 months of age.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products, Office for Registration 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.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store the medicine

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 after "Expiry Date (EXP)". The expiry date refers to the last day of the month stated.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What the medicine contains

• The active substances of the medicine are lidocaine and prilocaine. One medicinal plaster with an area of about 10 cm² contains 25 mg of lidocaine and 25 mg of prilocaine.
• The other ingredients are: macrogolglycerol hydroxystearate, carbopol 974P, sodium hydroxide to adjust the pH to 8.7-9.7, purified water.

What the medicine looks like and contents of the pack

The medicine consists of a part that sticks to the skin and a protective foil. The part that sticks to the skin is light beige in color. In the center of the plaster, there is a round white disc containing the active substances and excipients. The rest of the plaster is covered with an acrylic adhesive.

Pack sizes

2 plasters, protected on one side with aluminum foil, in a cardboard box.

Marketing authorization holder

Aspen Pharma Trading Limited
3016 Lake Drive
Citywest Business Campus
Dublin 24, Ireland
Tel: 0048 221253376

Manufacturer

Recipharm Karlskoga AB
Bjorkbornsvagen 5
SE-691 33 Karlskoga
Sweden

Date of last revision of the leaflet: 03/2024