EMLA

Package leaflet: Information for the user

EMLA 25 mg/g + 25 mg/g cream

lidocaine/prilocaine
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What EMLA is and what it is used for
2. What you need to know 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 called lidocaine and prilocaine. These belong to a group
of medicines known as local anaesthetics.
EMLA works by numbing the surface of the skin for a short period. It is applied to the skin
before certain medical procedures. This helps to block pain in the skin; however, you may
still feel sensations of pressure and touch.

Adults, adolescents and children
It can be used to anaesthetize the skin before:

• needle insertions (e.g. injections or blood sampling).
• minor skin surgeries.

Adults and adolescents
It can also be used:

• to anaesthetize the genital organs before:
  o an injection.
  o medical procedures such as removal of warts.
  A doctor or nurse should supervise the use of EMLA on the genital organs.

Adults
It can also be used to anaesthetize the skin before:

• cleansing or removal of damaged skin from leg ulcers.

2. What you should know before using EMLA

Do not use EMLA

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

Warnings and precautions
Talk to your doctor or pharmacist before using EMLA

• if you or your child has a rare inherited blood disorder called ‘glucose-6-phosphate dehydrogenase deficiency’;
• if you or your child has a blood pigment disorder called ‘methaemoglobinaemia’;
• Do not use EMLA on areas of skin affected by rash, cuts, abrasions, or other open wounds, except for a leg ulcer. If any of these conditions are present, consult your doctor or pharmacist before using the cream;
• if you or your child has a skin condition causing itching called ‘atopic dermatitis’, a shorter application time may be sufficient. Application times longer than 30 minutes may increase the incidence of local skin reactions (see also section 4 “Possible side effects”);
• if you are taking certain medicines for heart rhythm disorders (class III antiarrhythmics, such as amiodarone). In this case, your doctor will monitor your heart function.

Due to the potential for increased absorption on recently shaved skin, it is important to follow the recommended dosage, application area, and duration.
Avoid applying EMLA to the eyes, as it may cause irritation and chemical burns. In case of accidental contact with the eyes, immediately rinse thoroughly with lukewarm water or saline solution (sodium chloride). Be careful to avoid putting anything in the eye until normal vision is restored.
Children should be closely supervised when EMLA is applied to any area of their body to prevent them from transferring EMLA to their eyes.
EMLA must not be applied to a damaged eardrum.
When using EMLA before vaccination with live vaccines (e.g. vaccines against tuberculosis), you must return to your doctor or nurse after the specified time to check the vaccination result.

Children and adolescents
In infants/neonates under 3 months of age, a transient and clinically insignificant increase in “methaemoglobinaemia” levels has commonly been observed up to 12 hours after EMLA application.
The efficacy of EMLA in heel blood sampling in newborns or for providing adequate analgesia for circumcision has not been confirmed in clinical studies.
EMLA must not be applied to the genital mucosa (e.g. in the vagina) of children (under 12 years of age), as data on absorption of the active substances are insufficient.
EMLA must not be used in children under 12 months of age who are being treated concurrently with other medicines that affect blood pigment levels, “methaemoglobinaemia” (e.g. sulfonamides; see also section 2 “Other medicines and EMLA”).
EMLA must not be used in premature infants.

Other medicines and EMLA
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. This includes medicines you can buy without a prescription and herbal products. This is because EMLA may affect how some medicines work, and some medicines may affect how EMLA works.
In particular, inform your doctor or pharmacist if you or your child has recently used or been given any of the following medicines:

• medicines used to treat infections, called ‘sulfonamides’ and nitrofurantoin;
• medicines used to treat epilepsy, called phenytoin and phenobarbital;
• other local anaesthetics;
• medicines used to treat irregular heartbeat, including amiodarone;
• cimetidine or beta-blockers, which may cause increased blood levels of lidocaine. This interaction has no clinical relevance when EMLA is used short-term at recommended doses.

Pregnancy, breast-feeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breast-feeding, consult your doctor or pharmacist before using this medicine.
It is unlikely that occasional use of EMLA during pregnancy could cause adverse effects on the fetus.
The active substances in EMLA (lidocaine and prilocaine) are excreted in breast milk. However, the amounts are very small and generally pose no risk to the infant.
Animal studies have shown no impairment of male or female fertility.

Driving and using machines
EMLA has no or negligible influence on the ability to drive or use machinery when used at recommended doses.

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

3. How to use EMLA

Use EMLA exactly as directed by your doctor, pharmacist, or nurse. If
you have any doubts, consult your doctor, pharmacist, or nurse.
How to use EMLA

• The area where the cream should be applied, the amount to use, and the duration of application will depend on the reason for its use.
• Your doctor, pharmacist, or nurse will apply the cream or show you how to do it yourself.
• When EMLA is used on genital areas, a doctor or nurse must supervise its use.

Do not use EMLA on the following areas:

• Cuts, abrasions, or wounds, except leg ulcers.
• Areas with skin rash or eczema.
• Inside or near the eyes.
• Inside the nose, ear, or mouth.
• In the anus.
• On the genital organs of children.

People who frequently apply or remove the cream should avoid contact with it to prevent the development of hypersensitivity.
The protective membrane of the tube is pierced by applying the closure cap.
Use on the skin before minor procedures (such as needle insertion or minor skin surgery):

• A thick layer of cream is applied to the skin. Your doctor, pharmacist, or nurse will tell you where to apply it.
• The cream is then covered with an occlusive dressing (transparent film), which is removed immediately before the procedure begins. If you are applying the cream yourself, make sure your doctor, pharmacist, or nurse has provided you with occlusive dressings.
• The standard dose for adults and adolescents over 12 years of age is 2 g (grams).
• For adults and adolescents over 12 years of age, apply the cream at least 60 minutes before the procedure (unless the cream is used on genital areas). However, do not apply it more than 5 hours before.
• For children, the amount of EMLA used and the application time depend on their age. Your doctor, nurse, or pharmacist will tell you how much cream to use and when it should be applied.

When applying the cream, it is very important to follow these instructions carefully:

1. Squeeze a generous amount of cream onto the area of skin where it needs to be applied (e.g., the site where the needle will be inserted). A strip of cream about 3.5 cm long from the 30 g tube corresponds to 1 g of cream. Half of a 5 g tube corresponds to approximately 2 g of EMLA. Do not rub in the cream.

2. Remove the paper layer from the 'central part' of the non-adhesive side of the occlusive dressing (leaving the paper frame).

3. Remove the protective layers from the adhesive side of the occlusive dressing.

4. Carefully position the dressing over the thick layer of cream. Do not spread the cream under the dressing.

5. Remove the paper layer. Smooth down the edges of the occlusive dressing carefully. Then leave the dressing in place for at least 60 minutes if the skin is undamaged. The cream should not be left in place for more than 60 minutes in infants under 3 months of age or for more than 30 minutes in children with a skin condition called “atopic dermatitis” characterized by itching. If the cream is used on genital areas or ulcers, shorter application times should be used as described below.

6. Your doctor or nurse will remove the occlusive dressing and wipe off the cream immediately before performing the procedure (e.g., immediately before inserting the needle).

Use on larger areas of freshly shaved skin before outpatient procedures (e.g., hair removal techniques):
The usual dose is 1 g of cream per 10 cm² (10 square centimeters) of skin area, applied for 1–5 hours under an occlusive dressing. EMLA must not be used on 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.
Use on the skin before hospital procedures (e.g., split-thickness skin grafts) requiring deeper cutaneous anaesthesia:

• EMLA may be used for this purpose in adults and adolescents over 12 years of age.
• The usual dose is 1.5–2 g of cream per 10 cm² (10 square centimeters) of skin area.
• The cream is applied under an occlusive dressing for 2–5 hours.

Use on the skin before removal of wart-like lesions called “molluscum”

• 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 used for 30–60 minutes (30 minutes if the patient has atopic dermatitis). Your doctor, nurse, or pharmacist will tell you how much cream to use.

Use on genital skin before injecting local anaesthetics

• EMLA may be used for this purpose only in adults and adolescents over 12 years of age.
• The usual dose is 1 g of cream (1–2 g for female genital skin) per 10 cm² (10 square centimeters) of skin area.
• The cream is applied under an occlusive dressing for 15 minutes on male genital skin and for 60 minutes on female genital skin.

Use on genital areas before minor skin surgery (e.g., removal of warts)

• EMLA may be used for this purpose only in adults and adolescents over 12 years of age.
• The usual dose is 5–10 g of cream for 10 minutes. An occlusive dressing is not used. Medical procedure should begin immediately afterwards.

Use on leg ulcers before cleansing or removal of damaged skin

• The usual dose is 1–2 g of cream per 10 cm² of skin area, up to a total of 10 g.
• The cream is applied under an occlusive dressing such as transparent film. This is done for 30–60 minutes before ulcer cleansing. Remove the cream with cotton gauze and begin cleansing immediately.
• EMLA may be used before cleansing leg ulcers up to 15 times over a period of 1–2 months.
• The EMLA tube is for single use when used for leg ulcers: the tube with any remaining contents must be discarded after the patient has been treated.

If you use more EMLA than you should
If you use more EMLA than directed by your doctor, pharmacist, or nurse, contact one of them immediately, even if you do not have any symptoms.
Symptoms associated with using too much EMLA are listed below. These symptoms are unlikely to occur if EMLA is used according to recommendations.

• Feeling of emptiness in the head or dizziness.
• Tingling sensation on the skin around the mouth and numbness of the tongue.
• Taste disturbances.
• Blurred vision.
• Ringing in the ears.
• There is also a risk of acute 'methaemoglobinaemia' (a condition related to blood pigment levels). This condition is more likely to occur if certain medicines are taken at the same time. If this occurs, the skin turns bluish-grey due to lack of oxygen.

In severe cases of overdose, symptoms may include seizures, low blood pressure, slowed breathing, respiratory arrest, and changes in heart rhythm. These effects can potentially be fatal.
If you have any 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. Contact your doctor or pharmacist if any of the following side effects cause discomfort or do not appear to go away. Inform your doctor of any other symptoms that make you feel unwell while using EMLA.
A mild reaction (pallor or redness of the skin, slight swelling, initial burning or itching) may occur at the site where EMLA is applied. These are normal reactions to the cream and to the anesthetics and will disappear within a short time without requiring any intervention.
If you experience any bothersome or unusual effects while using EMLA, stop using it and consult your doctor or pharmacist as soon as possible.

Common (may affect up to 1 in 10 people)

• Temporary local skin reactions (pallor, redness, swelling) at the application site during treatment of the skin, genital mucosa, or leg ulcers.
• Mild initial sensation of burning, itching, or warmth at the application site during treatment of the genital mucosa or leg ulcers.

Uncommon (may affect up to 1 in 100 people)

• Mild initial sensation of burning, itching, or warmth at the application site during treatment of the skin.
• Numbness (tingling) at the application site during treatment of the genital mucosa.
• Irritation of treated skin during treatment of leg ulcers.

Rare (may affect up to 1 in 1,000 people)

• Allergic reactions which in rare cases may progress to anaphylactic shock (skin rash, swelling, fever, breathing difficulties, and fainting) during treatment of the skin, genital mucosa, or leg ulcers.
• Methemoglobinemia (a blood disorder) during treatment of the skin.
• Appearance of bleeding spots at the application site during treatment of the skin (especially in children with eczema following longer application times).
• Eye irritation in case of accidental contact with EMLA during treatment of the skin.

Frequency not known (cannot be estimated from the available data)

• Chemical burns to the eyes if EMLA accidentally comes into contact with them during treatment.

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this 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 which is stated on the packaging and on the tube after
Exp./EXP. The expiry date refers to the last day of that month.
Do not freeze. Keep the tube tightly closed.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What EMLA contains

• The active substances are: lidocaine and prilocaine
• 1 g of cream contains: 25 mg of lidocaine and 25 mg of prilocaine
• The other components are carbomers, macrogol glycerol hydroxystearate, sodium hydroxide to adjust pH, purified water.

Description of the appearance of EMLA and package contents
White, homogeneous cream.
EMLA is supplied in an aluminium tube with a polypropylene cap equipped with a perforating device.
EMLA is available in the following pack sizes:
1 tube containing 5 g of cream
1 tube containing 5 g of cream + 2 occlusive patches
1 tube containing 5 g of cream + 3 occlusive patches
3 tubes containing 5 g of cream each + 8 occlusive patches
5 tubes containing 5 g of cream each
5 tubes containing 5 g of cream each + 10 occlusive patches
5 tubes containing 5 g of cream each + 12 occlusive patches
1 tube containing 30 g of cream.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Aspen Pharma Trading Limited
3016 Lake Drive, Citywest Business Campus
Dublin 24
Ireland
Tel: +39 0687 502 429

Manufacturer
Meribel Pharma Karlskoga AB, Björkbornsvägen 5, 691 33 Karlskoga, Sweden
Aspen Bad Oldesloe GmbH, 32-36 Industriestrasse, 23843 Bad Oldesloe, Germany

This medicinal product is authorized in the European Economic Area under the
following names:
Austria Emla 5% - Creme
Belgium Emla 25mg/25mg crème
Cyprus Emla Cream 5%
Finland EMLA
France EMLA 5 PER CENT, crème
Greece EMLA
Iceland Emla
Ireland EMLA 5% w/w Cream
Italy EMLA
Luxembourg Emla 25mg/25mg crème
Malta EMLA 5% w/w Cream
Norway Emla
Poland EMLA
Spain EMLA 25 mg/g + 25 mg/g cream
Sweden EMLA
Netherlands Emla

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