Emla

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep this leaflet, information on the immediate packaging in a foreign language!
EMLA
25 mg/g + 25 mg/g, cream
Lidocaine + Prilocaine
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What EMLA is and what it is used for

EMLA contains two active substances – lidocaine and prilocaine. They belong to a group of medicines known as local anaesthetics.
EMLA works by temporarily numbing the sensation in the superficial layers of the skin. The cream is applied to the skin before certain medical procedures and interventions. This helps relieve skin pain; however, the patient may still feel pressure and touch.

Adults, adolescents and children
EMLA may be used to anaesthetize the skin before:

• inserting a needle into the skin (for example, during an injection or blood sampling),
• minor surgical procedures on the skin.

Adults and adolescents
EMLA may also be used:

• to anaesthetize genital organs before: administering an injection, performing medical procedures such as removal of warts. Application of EMLA to genital organs should be performed under the supervision of a doctor or nurse.

Adults
EMLA may also be used to anaesthetize the skin before:

• debriding or removing damaged skin from leg ulcers.

2. Important information before using EMLA

When not to use EMLA:

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

Warnings and precautions
Before starting to use EMLA, discuss this 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 known as methemoglobinemia,
• do not apply EMLA to areas of skin with rash, cuts, scratches, or other open wounds, except for leg ulcers. If any of these skin conditions are present, contact your doctor or pharmacist before using the cream,
• if the patient has a skin condition with itching known as atopic dermatitis, a shorter application time may be sufficient. Applying the cream for longer than 30 minutes increases the likelihood of local skin reactions (see also section 4, "Possible side effects"),
• if the patient is taking certain medicines used to treat heart rhythm disorders (class III antiarrhythmic drugs, such as amiodarone). In such cases, the doctor will monitor the patient's heart function.

Due to the possibility of increased absorption from freshly shaved skin, it is important to follow the recommended dosage, application area size, and duration of application.
Avoid contact of EMLA with the eyes, as it may cause irritation and chemical eye burns. If EMLA accidentally gets into the eye, immediately rinse the eye with lukewarm water or saline solution (0.9% NaCl solution).
Take care to avoid getting anything into the eye until sensation has returned.
Carefully supervise children when EMLA is applied to any part of the body to prevent the child from transferring EMLA to the eye(s).
Do not apply EMLA to a diseased eardrum membrane.
When EMLA is used before administration of a live vaccine (e.g. tuberculosis vaccine), remember to attend the follow-up visit at the scheduled 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.
The efficacy of EMLA during heel blood sampling in newborns or for adequate pain relief during circumcision has not been confirmed in clinical studies.
EMLA should not be applied to the genital mucous membranes (e.g. vagina) in children (under 12 years of age) due to insufficient data on absorption of the active substances.
EMLA 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 and other medicines").
EMLA should not be used in premature newborns.

EMLA and other medicines
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is important because the components of EMLA may affect the action of certain 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 infection known as sulfonamides and nitrofurantoin.
• Medicines used to treat epilepsy: phenytoin and phenobarbital.
• Other local anaesthetics.
• Medicines used to treat irregular heartbeat, such as amiodarone.
• Cimetidine or beta-blockers, which may increase lidocaine blood levels. This interaction is not clinically significant with short-term use of EMLA at recommended doses.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.
There is no risk of adverse effects on the fetus associated with occasional use of EMLA during pregnancy.
The active substances of EMLA (lidocaine and prilocaine) are excreted in human milk. However, the amount transferred into milk is so small that there is essentially no risk to the breastfed infant.
Animal studies have shown no impairment of fertility in males or females treated with the active components of EMLA.

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

EMLA contains macrogol glycerol hydroxystearate
Macrogol glycerol hydroxystearate may cause skin reactions.

3. How to use EMLA

EMLA must always be used exactly as directed by a doctor, pharmacist, or nurse. If in doubt, consult a doctor, pharmacist, or nurse.

Use of EMLA

• The site of application, amount of cream, and duration of application depend on the intended purpose.
• A doctor, pharmacist, or nurse will apply the cream to the appropriate area or instruct the patient how to do it independently.
• When EMLA is used on genital areas, its use should be supervised by a doctor or nurse.

Do not apply EMLA in the following areas:

• Broken skin, cuts, or wounds, except for leg ulcers.
• Areas with skin rash or eczema.
• Into or near the eyes.
• Inside the nose, ears, or mouth.
• In the anal area.
• On the genital organs of children.

Individuals who frequently apply or remove the cream from a patient's skin should ensure they effectively avoid contact with the cream to prevent the development of hypersensitivity.

The protective seal of the tube is pierced using the cap of the tube.

Application to the skin prior to minor procedures (such as needle puncture or minor skin surgery):

• Apply the cream in a thick layer to the skin. The doctor, pharmacist, or nurse will inform the patient where to apply the cream.
• The cream layer should then be covered with a dressing (plastic film). The dressing is removed immediately before the procedure begins. If the patient applies the cream independently, they should ensure they have received dressings from the doctor, pharmacist, or nurse.
• The usual dose in adults and adolescents over 12 years of age is 2 g (grams).
• In adults and adolescents over 12 years of age, apply the cream at least 60 minutes before the planned procedure (except when applied to genital areas). However, do not apply the cream earlier than 5 hours before the procedure.
• The amount of EMLA and duration of application in children depend on the child's age. The doctor, nurse, or pharmacist will inform the patient about the amount of cream to use and when to apply it.

When applying EMLA, it is very important to strictly follow these instructions:

1. Squeeze the cream from the tube to form a mound at the site on the skin where it is needed (for example, where a needle puncture will be performed). A line of cream approximately 3.5 cm long from a 30 g tube corresponds to 1 g of cream. Half the contents of a 5 g tube corresponds to approximately 2 g of EMLA cream. Do not rub the cream into the skin.

2. Peel off the paper layer from the center window on the non-adhesive 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 stiffener. Gently smooth the edges of the dressing. Then leave the dressing in place for at least 60 minutes if the skin is intact. The cream should not be left in place longer than 60 minutes in children under 3 months of age or longer than 30 minutes in children with a skin condition called "atopic dermatitis." When applying the cream to genital areas or ulcers, shorter application times may be used as described below.

6. The doctor or nurse will remove the dressing and wipe off the cream immediately before the medical procedure (for example, before needle insertion).

Application of EMLA to larger areas of freshly shaved skin prior to outpatient procedures (such as hair removal):
The usual dose of EMLA 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 applied to a freshly shaved skin area larger than 600 cm² (600 square centimeters, e.g., 30 cm by 20 cm). The maximum dose is 60 g.

Application to the skin prior to hospital procedures (e.g., prior to intermediate-thickness skin grafting) requiring deeper skin anaesthesia:

• EMLA may be used in this way in adults and adolescents over 12 years of age.
• The usual dose 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.

Application to the skin prior to removal of warty lesions such as genital warts:

• EMLA may be used in children and adolescents with a skin condition called "atopic dermatitis."
• The usual dose 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 of the amount of cream to use.

Application to genital skin prior to injection of local anaesthetic agents:

• EMLA may be used in this way only in adults and adolescents over 12 years of age.
• The usual dose 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 in place for 15 minutes in males and 60 minutes in females.

Application to genital skin prior to minor skin surgery (such as removal of warts):

• EMLA may be used in this way only in adults and adolescents over 12 years of age.
• The usual dose is 5 g to 10 g of cream for 10 minutes. A dressing is not used. The procedure should be performed immediately thereafter.

Application to leg ulcers prior to ulcer debridement or removal of damaged skin:

• The usual dose is 1 g to 2 g of cream per 10 cm² (10 square centimeters) of skin surface, not exceeding 10 g total.
• The cream is applied and covered with an occlusive dressing, e.g., plastic film. The cream and dressing are applied 30 to 60 minutes before the ulcer debridement procedure. The cream should be removed with cotton gauze, and debridement should begin immediately.
• EMLA may be used up to 15 times within a period of 1–2 months prior to cleaning leg ulcers.
• When applying the cream to leg ulcers, the EMLA tube should be used as a single-use product: after each patient use, the tube with any remaining cream must be discarded.

Use of a higher than recommended dose of EMLA
If more EMLA has been used than recommended by a doctor, pharmacist, or nurse, contact them immediately, even if the patient feels no discomfort.
Problems and symptoms that may occur after using too much EMLA are listed below. These symptoms should not occur when EMLA is used as directed.

• Feeling of "emptiness in the head" or dizziness.
• Tingling around the mouth and numbness or loss of sensation of the tongue.
• Disturbed taste sensation.
• Blurred vision.
• Ringing in the ears.
• There is also a risk of methemoglobinemia (a condition affecting the pigment level in the blood). This is more likely if the patient is simultaneously taking certain other medicines. In this condition, the skin may turn bluish-grey due to insufficient oxygen in the blood.

In severe cases of overdose, symptoms such as seizures, low blood pressure, reduced breathing rate, respiratory arrest, and abnormal heart rhythm may occur. These problems can 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 everyone will experience them.
If any of the adverse reactions listed below occur or persist in the patient, the patient should contact their doctor or pharmacist.
In such cases, the patient should inform the doctor about everything that causes discomfort during treatment with EMLA.

At the site of application of EMLA, 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 cream 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, use should be discontinued immediately and the patient should contact their 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 when used on the skin, genital mucous membranes, or leg ulcers.
• Initial mild sensation of burning, itching, or warmth at the site of application when used on genital mucous membranes or leg ulcers.

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.
• Loss of sensation (numbness) at the site of application when used on genital mucous membranes.
• Skin irritation at the site of application when used on leg ulcers.

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) when used on the skin, genital mucous membranes, or leg ulcers.
• Methemoglobinemia (a blood disorder) when used on the skin.
• Minor pinpoint bleeding (petechiae) at the site of application (particularly in children with eczema after prolonged exposure to the medicine) when used on the skin.
• Eye irritation if EMLA cream accidentally comes into contact with the eyes during application to the skin.

Frequency unknown (cannot be estimated from available data):

• Chemical eye burns if the eyes accidentally come into contact with EMLA cream during treatment.

Additional adverse reactions in children
Methemoglobinemia, a blood disorder, which 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 or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store EMLA

Keep this medicine out of the 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 freeze. Keep the tube tightly closed.
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 pack and other information

What EMLA contains

• The active substances are: lidocaine and prilocaine.
• 1 g of cream contains: 25 mg lidocaine and 25 mg prilocaine.
• Other ingredients: carbomers, glycol monostearate macrogol, sodium hydroxide, and purified water.

What EMLA looks like and contents of the pack
Aluminium tube with a membrane, internally coated with a protective epoxy resin-based lacquer,
fitted with a polypropylene cap with a puncturing device, in a cardboard box.
For more detailed information, please contact the responsible party or parallel importer.
Marketing Authorisation Holder in Spain, country of export:
Aspen Pharma Trading Limited
3016 Lake Drive
Citywest Business Campus
Dublin 24, Ireland
Manufacturer:
Aspen Bad Oldesloe GmbH
32-36 Industriestrasse
23843 Bad Oldesloe
Germany
Recipharm Karlskoga AB
Björkbornsvägen 5
S-69133 – Karlskoga
Sweden
Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing Authorisation Number in Spain, country of export: 679290.2
Parallel Import Licence Number: 202/22