Anestderma 25 mg/g + 25 mg/g cream

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Anestderma 25 mg/g + 25 mg/g cream

Lidocaine/Prilocaine

Read this entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you need advice or more information, consult your doctor, pharmacist, or nurse.

• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.

  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What Anestderma is and what it is used for
2. What you need to know before using Anestderma
3. How to use Anestderma
4. Possible side effects
5. Storage of Anestderma
6. Contents of the pack and other information

1. What Anestderma is and what it is used for

Anestderma contains two active substances called lidocaine and prilocaine. They belong to a group of medicines known as local anaesthetics.

Anestderma works by temporarily numbing the surface of the skin. It is applied to the skin before certain medical procedures. It helps prevent pain on the skin; however, you may still feel sensations such as pressure and touch.

Adults, adolescents and children

It can be used to numb the skin before:

• Needle puncture (e.g., when receiving an injection or having a blood test).
• Minor skin surgery.

Adults and adolescents

It can also be used:

• To numb the genitals before:

• Receiving an injection.

• Medical procedures such as wart removal.

The use of Anestderma on the genitals should be supervised by a doctor or nurse.

Adults

It can also be used to numb the skin before:

• Cleaning or removing damaged skin from leg ulcers.

2. What you need to know before using Anestderma

Do not use Anestderma:

• if you are allergic to lidocaine or prilocaine, 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 Anestderma:

• if you or your child have a rare inherited metabolic disorder affecting the blood called “glucose-6-phosphate dehydrogenase deficiency”.
• if you or your child have a blood pigment disorder called “methemoglobinemia”.
• do not use Anestderma on areas of skin with rashes, cuts, abrasions, or open wounds, except for leg ulcers. If any of these conditions are present, consult your doctor or pharmacist before using the cream.
• if you or your child have a skin condition with 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 being treated with medicines for heart rhythm disorders (class III antiarrhythmics such as amiodarone). In such cases, your doctor will monitor your cardiac function.

Due to potentially increased absorption on freshly shaved skin, it is important to strictly follow the recommended dose, skin surface area, and application time.

Avoid contact of Anestderma with the eyes, as it may cause irritation and chemical burns. If it accidentally gets into your eye, rinse immediately with lukewarm water or saline (sodium chloride solution). Be careful not to apply anything else to the eye until sensation returns.

Children must be carefully supervised when Anestderma is used anywhere on their body to prevent contact with the eyes.

Anestderma must not be applied to a damaged eardrum.

When using Anestderma before vaccination with live vaccines (e.g., tuberculosis vaccine), return to your doctor or nurse after the required follow-up period for assessment of the vaccination result.

Children and adolescents

In infants and newborns under 3 months of age, “methemoglobinemia”—a transient and clinically insignificant increase in levels of a blood pigment—has been frequently observed up to 12 hours after application of Anestderma.

Clinical studies have not been able to confirm the effectiveness of Anestderma when used for heel blood sampling in newborns or for providing adequate analgesia during circumcision.

Anestderma must not be applied to the genital skin (e.g., on the penis) or genital mucosa (e.g., in the vagina) of children (under 12 years of age) due to insufficient data on absorption of the active substances.

Anestderma must not be used in children under 12 months of age who are simultaneously receiving treatment with other medicines that affect blood pigment “methemoglobin” levels (e.g., sulfonamides; see also section 2, Use of Anestderma with other medicines).

Anestderma must not be used in premature newborns.

Use of Anestderma with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines, including those obtained without a prescription and herbal medicines. This is because Anestderma may affect how other medicines work, and other medicines may affect Anestderma.

In particular, inform your doctor or pharmacist if you or your child have recently used or have been treated with 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 cardiac arrhythmias, such as amiodarone.
• Cimetidine or beta-blockers, which may increase lidocaine blood levels. This interaction is not clinically significant when Anestderma is used short-term at the recommended doses.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Occasional use of Anestderma during pregnancy is unlikely to have any adverse effect on the fetus.

The active substances in Anestderma (lidocaine and prilocaine) are excreted in breast milk. However, the amount is so small that it generally poses no risk to the infant.

Animal studies have shown no effects on male or female fertility.

Driving and using machines

Anestderma has no effect or only a negligible effect on the ability to drive and use machines when used at the recommended doses.

Anestderma contains macrogol glyceryl hydroxystearate.

This medicine may cause skin reactions because it contains macrogol glyceryl hydroxystearate.

3. How to use Anestderma

Follow exactly the administration instructions for this medicine as given by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse again.

Use of Anestderma

• The site of application, the amount you should use, and how long it should remain applied will depend on the intended use.
• Your doctor, pharmacist, or nurse will apply the cream or will teach you how to do it yourself.
• When Anestderma is used on the genital area, its use must be supervised by a doctor or nurse.

Do not use Anestderma in the following areas:

• Cuts, abrasions, or wounds, except leg ulcers.
• Areas with skin rash or eczema.
• In or around the eyes.
• Inside the nose, ear, or mouth.
• In the anal area.
• On the genitals of children.

Individuals who frequently apply or remove the cream should take care to avoid contact in order to prevent the development of hypersensitivity.

The protective seal of the tube is pierced by pressing the cap against it.

Use on skin before minor procedures (such as needle puncture or minor skin interventions):

• Apply a thick layer of cream to the skin. Your doctor, pharmacist, or nurse will tell you where to apply it.
• Cover the cream with an adhesive dressing [clear plastic]. This dressing is removed just before the procedure begins. If you apply the cream yourself, make sure your doctor, pharmacist, or nurse provides you with the dressings.
• The usual dose for 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 procedure (unless the cream is to be used on the genitals). However, do not apply it more than 5 hours before.
• In children, the amount of Anestderma used and the duration of application depend on their age. Your doctor, nurse, or pharmacist will tell you how much to use and when to apply it.

When you apply the cream yourself, it is very important to follow these instructions:

1. Squeeze the tube to apply the required amount of cream in a mound onto the skin where the procedure will be performed (e.g., where the needle will be inserted).

A line 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 approximately to 2 g of Anestderma.

Do not spread the cream.

1. Remove the covers from the dressing.

1. Carefully place it over the mound of cream. Do not spread the cream under the dressing.

1. Remove the paper backing. Gently smooth the edges of the dressing. Then leave it 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 the itchy skin condition called atopic dermatitis. If the cream is used on the genitals or over ulcers, shorter application times than those described may be used, as described below.

1. Your doctor or nurse will remove the dressing and wipe off the cream just before performing the medical procedure (e.g., just before inserting the needle).

Use on large areas of freshly shaved skin before outpatient procedures (such as hair removal techniques):

The usual dose is 1 g of cream per 10 cm² (10 square centimeters) of skin surface, applied for 1 to 5 hours under an occlusive dressing. Anestderma should 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 skin before hospital procedures (such as skin grafts) requiring deeper skin anesthesia:

• Anestderma can 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 area.
• The cream is applied under an occlusive dressing for 2 to 5 hours.

Use on skin to remove wart-like lesions called "molluscum"

• Anestderma can be used in children and adolescents who have a skin condition called "atopic dermatitis".
• The usual dose depends on the child's age and is used for 30 to 60 minutes (30 minutes if the patient has atopic dermatitis). Your doctor, nurse, or pharmacist will tell you how much cream to apply.

Use on genital skin before local anesthetic injections

• Anestderma can 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 on female genital skin) per 10 cm² (10 square centimeters) of skin area.
• The cream is applied under an occlusive dressing. This is kept in place for 15 minutes on male genital skin and for 60 minutes on female genital skin.

Use on genitals before minor skin surgery (removal of warts)

Anestderma can 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. An occlusive dressing is not used. The medical procedure should begin immediately.

Use on leg ulcers before cleaning or removing damaged skin

• The usual dose is 1 g to 2 g per 10 cm² of skin area, up to a maximum of 10 g.
• The cream is applied under an occlusive dressing, e.g., a clear plastic film. This is kept in place for 30 to 60 minutes before cleaning the ulcer. Remove the cream with a cotton swab and begin cleaning without delay.
• Anestderma may be used before cleaning leg ulcers up to 15 times within a period of 1 to 2 months.
• The Anestderma tube is for single use when used on leg ulcers: The tube, including any remaining content, must be discarded after treating each patient.

If you use more Anestderma than you should

If you use more Anestderma than your doctor, pharmacist, or nurse has instructed, contact one of them immediately, even if you do not have any symptoms.

The following are symptoms that may occur if you use too much Anestderma. These symptoms are unlikely to occur if you follow the recommended use of Anestderma.

• Feeling dizzy or lightheaded.
• Tingling sensation around the mouth and numbness of the tongue.
• Taste disturbances.
• Blurred vision.
• Ringing in the ears.
• There is also a risk of acute "methemoglobinemia" (a problem with levels of a blood pigment). This risk is higher when certain medications are taken at the same time. If this occurs, the skin may turn bluish-gray due to lack of oxygen.

In severe cases of overdose, symptoms may include seizures, low blood pressure, slow breathing, respiratory arrest, and irregular heartbeat. These effects can be potentially fatal.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone 91 562 04 20.

If you have any questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Contact your doctor or pharmacist if any of the following adverse effects bother you or do not seem to go away. Inform your doctor of any other symptoms that make you feel unwell while using Anestderma.

A mild reaction (pallor or redness of the skin, slight swelling, initial burning or itching) may occur at the site where Anestderma is applied. These are normal reactions to the cream and anesthetics and will disappear shortly without requiring any intervention.

If you experience any unpleasant or unusual effects while using Anestderma, stop using it and consult your doctor or pharmacist as soon as possible.

Frequent (may affect up to 1 in 10 people)

• Transient local skin reactions (pallor, redness, swelling) at the application site during treatment of the skin, genital mucosa, or leg ulcers.
• A 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)

• A mild initial sensation of burning, itching, or warmth at the treated area during treatment of the skin.
• Numbness (tingling) at the application site during treatment of the genital mucosa.
• Skin irritation at the application site during treatment of leg ulcers.

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

• Allergic reactions, which in rare cases may lead to anaphylactic shock (skin rash, swelling, fever, breathing difficulty, and fainting) during treatment of the skin, genital mucosa, or leg ulcers.
• Methemoglobinemia (a blood disorder) during treatment of the skin.
• Small punctate bleeding at the treated area (particularly in children with eczema after prolonged application), during treatment of the skin.
• Eye irritation if Anestderma accidentally comes into contact with the eyes during treatment of the skin.

Frequency not known (cannot be estimated from available data)

• Chemical burns in the eyes if Anestderma accidentally comes into contact with them during treatment.

Other adverse effects in children

Methemoglobinemia, a blood disorder more commonly observed in newborns and infants from 0 to 12 months of age, often associated with overdose.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es/. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Anestederma

Store below 30 °C. Do not refrigerate or freeze.

After first opening, use within 6 months.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and on the tube after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Package contents and other information

Composition of Anestderma

• The active substances are: lidocaine and prilocaine. Each gram of cream contains 25 mg of lidocaine and 25 mg of prilocaine.
• The other components are macrogol glycerol hydroxystearate, carbomer 974P, sodium hydroxide, and purified water.

Appearance of the product and package contents

Anestderma is a soft white cream. It is supplied in flexible aluminum tubes of 5 g and 30 g, internally coated with a phenolic epoxy lacquer.

Pack sizes:

1 tube of 30 g

1 tube of 5 g

1 tube of 5 g with 2 patches

1 tube of 5 g with 3 patches

5 tubes of 5 g

5 tubes of 5 g with 12 patches

Only some pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

GALENICUM DERMA, S.L.U.

Ctra. Nacional 1, Km 36

28750 San Agustín del Guadalix (Madrid)

Spain

Manufacturer

Rafarm SA,

Thesi Pousi-Xatzi,

Agiou Louka,

Paiania, Attiki-19002,

P.O. Box 37, Greece.

or

Qualimetrix SA

579 Mesogeion avenue, Agia Paraskevi,

Athens, 15343, Greece

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Estonia: Nulbia

Spain: Anestderma 25mg/g + 25 mg/g cream

Date of the most recent revision of this leaflet: November 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.