Prospecto: information for the patient

Anestderma 25 mg/g + 25 mg/gcream

Lidocaína/Prilocaína

Read this prospect carefully before starting to use this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you need advice or more information, consult your doctor, pharmacist, or nurse.

-This medication has been prescribed to you alone, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

• If you experience adverse effects, consult your doctor or pharmacist,even if they do not appear in this prospect. See section 4.

1.What Anestderma is and for what it is used

2.What you need to know before starting to use Anestderma

3.How to use Anestderma

4.Possible adverse effects

5Storage of Anestderma

6.Contents of the package and additional information

Anestdermacontains two active principles called lidocaína and prilocaína. They belong to a group of medications called local anesthetics.

Anestdermaacts by temporarily insensitizing the skin surface. It is applied to the skin before certain medical interventions. It helps to stop pain in the skin; however, you may still perceive sensations such as pressure and contact.

Adults, adolescents, and children

It can be used to insensitize the skin before:

• Needle puncture (e.g., if you are going to receive an injection or have a blood test).
• Minor skin surgery.

Adults and adolescents

It can also be used:

• To insensitize 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 insensitize the skin before:

• Cleaning or removing damaged skin from leg ulcers

No use Anestderma:

• if you are allergic to lidocaine or prilocaine,other local anesthetics similar or to any of the other components of this medication (listed in section6).

Warnings and precautions

Consult your doctor or pharmacist before starting to useAnestderma:

• if you or your child have a rare inherited metabolic disorder that affects the blood called“glucose-6-phosphate dehydrogenase deficiency”.
• if you or your child have a disorder of the levels of a pigment in the blood called“methemoglobinemia”.
• do not useAnestdermaon areas with skin eruption, cuts, abrasions, or open wounds, except for ulcers on the legs. If any of these problems occur, consult your doctor or pharmacist before using the cream.
• if you or your child have a skin disorder with itching called“atopic dermatitis”,a shorter application time may be sufficient. Application times of more than 30minutes may increase the incidence of local skin reactions (see also section4“Possible side effects”).
• if you are being treated with medications for heart rhythm disorders (class III antiarrhythmics, such as amiodarone). In this case, your doctor will monitor your heart function.

Due to the potentially greater absorption on recently shaved skin, it is essential to respect the recommended dose, skin surface, and application time.

Avoid contact ofAnestdermawith the eyes, as it may cause irritation. If it accidentally enters your eye, you must rinse it immediately with warm water or saline solution (sodium chloride solution). Be careful not to apply anything to your eye until you regain sensitivity.

Anestdermashould not be appliedto a damaged eardrum.

When usingAnestdermabefore being vaccinated with live vaccines (e.g., tuberculosis vaccine), return to your doctor or nurse after the required follow-up period for the vaccination result.

Children and adolescents

In infants and newborns under 3months, methemoglobinemiais frequently observedwith a transient and clinically insignificant increase in the levels of a pigment in the blood up to 12hours after application ofAnestderma.

Clinical studies were unable to confirm the efficacy ofAnestdermawhen blood is drawn from the heel of newborns or to provide adequate analgesia for circumcision.

Anestdermashould not be applied to the genital skin (e.g., penis) or mucous membranes (e.g., vagina) of children (under 12years old) due to insufficient data on the absorption of active ingredients.

Anestdermashould not be used in children under 12months of age who are simultaneously receiving treatmentwith other medications that affect the concentrations of the blood pigment“metahemoglobin” (e.g., sulfonamides, see also section2,Use ofAnestdermawith other medications).

Anestdermashould not be used in premature newborns.

Use of Anestderma with other medications

Inform your doctor or pharmacist if you are using or taking, have used or taken recently, or may need to use or take any other medication, including those purchased without a prescription and herbal medications.This is becauseAnestdermamay affect the action of other medications and other medications may have an effect onAnestderma.

In particular, inform your doctor or pharmacist if you or your child have recently used or received treatment with any of the following medications:

• Medications used to treat infections called“sulfonamides”and nitrofurantoin.
• Medications used to treat epilepsy, called phenytoin and phenobarbital.
• Other local anesthetics.
• Medications for treating heart rhythm disorders, such as amiodarone.
• Cimetidine or beta-blockers, which may increase lidocaine levels in the blood. This interaction is not clinically significant in short-term treatment withAnestdermaat the recommended doses.

Pregnancy, breastfeeding, and fertility

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

The occasional use ofAnestdermaduring pregnancy is unlikely to have any adverse effects on the fetus.

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

Studies in animals have shown that there are no alterations in male or female fertility.

Driving and operating machinery

Anestdermadoes not affect the ability to drive and use machines, or the effect is insignificant, when used at the recommended doses.

Anestderma containsmacrogolglycerol hydroxystearate.

This medication may cause skin reactions because it contains macrogolglycerol hydroxystearate.

Follow exactly the administration instructions of this medication, indicated by your doctor, pharmacist or nurse. In case of doubt, consultagain with your doctor, pharmacist or nurse.

Use ofAnestderma

• The application site of the cream, the amount you should use and the time it should be applied will depend on what it is used for.
• Your doctor, pharmacist or nurse will apply the cream or teach you how to apply it yourself.
• When Anestderma is used on the genitals, a doctor or nurse must supervise its use.

Do not useAnestdermain the following areas:

• Cuts, abrasions or wounds, except for leg ulcers.
• Areas where there is skin eruption or eczema.
• On the eyes or nearby.
• Inside the nose, ear or mouth.
• On the anus.
• On the genitals of children.

People who frequently apply or remove the cream will ensure to avoid contact to prevent the appearance of hypersensitivity.

The protective membrane of the tube is pierced by pressing the cap on it.

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

• Apply a thick layer of cream on the skin. Your doctor, pharmacist or nurse will indicate where to apply it.
• Cover the cream with a dressing [transparent plastic]. This is removed just before starting the procedure. If you apply the cream yourself, make sure your doctor, pharmacist or nurse provide you with the dressings.
• The usual dose for adults and adolescents over 12 years old is 2 g (grams).
• In adults and adolescents over 12 years old, 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 time of use depend on their age. Your doctor, nurse or pharmacist will indicate the amount you should use and when to apply it.

When applying the cream yourself, it is very important to follow the following instructions:

1. Squeeze the tube to apply the necessary amount of cream on the skin where the procedure is to be performed (e.g. where the needle is to be inserted)

A line of cream from the 30 g tube is equivalent to 1 g of cream. Half of the 5 g tube corresponds to approximately 2 g of Anestderma

Do not spread the cream

2.Remove thecoversof the dressing.

3. Place it carefully over the cream mound. Do not spread the cream under the dressing

4.Remove thepaper support. Smooththe edges of thedressingcarefully. Then leave it in place for at least 60 minutes if the skin has not been damaged. The cream should not be left in place for more than 60 minutes in children under 3 months or for more than 30 minutes in children with skin condition that causes itching called atopic dermatitis. If the cream is used on genitals or over ulcers, shorter application times may be used as described below

5.Your doctor or nursewill remove thedressingandremove the cream just beforeperformingthe medical procedure(e.g. just before inserting the needle)

Use on extensive skin areas recently shaved before outpatient procedures (such as hair removal techniques):

The usual dose is 1 g of cream per 10 cm² (10 square centimeters) of skin area, applied between 1 and 5 hours under a dressing. Anestderma should not be used on a skin area recently shaved larger than 600 cm² (600 square centimeters, e.g. 30 cm by 20 cm) in size. The maximum dose is 60 g

Use on the skin before hospital procedures (such as skin grafts) that require deeper skin anesthesia:

• Anestderma can be used in this way in adults and adolescents over 12 years old.
• 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 the skin to remove warts called “molluscum”

• Anestderma can 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 to 60 minutes (30 minutes if the patient has atopic dermatitis). Your doctor, nurse or pharmacist will indicate 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 old.
• The usual dose is 1 g of cream (1 g to 2 g in 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 in male genital skin and for 60 minutes in female genital skin.

Use on genital skin before minor surgical procedures (removal of warts)

Anestderma can be used in this way only in adults and adolescents over 12 years old. The usual dose is 5 g to 10 g of cream for 10 minutes. No occlusive dressing is used. The medical procedure should be started immediately.

Use on leg ulcers before cleaning or removing damaged skin

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

If you use more Anestderma than you should

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

The following symptoms may occur if you use too much Anestderma. It is unlikely that these symptoms will occur if you follow the recommended use of Anestderma.

• Dizziness or dizziness.
• Tickling sensation on the skin around the mouth and numbness of the tongue.
• Altered taste.
• Blurred vision.
• Ringing in the ears.
• There is also a risk of “acute methemoglobinemia” (a problem with blood pigment levels). This risk is higher when taking certain medications at the same time. If this occurs, the skin takes on a bluish-gray color due to lack of oxygen.

In severe cases of overdose, symptoms may include convulsions, low blood pressure, slow breathing, cessation of breathing and alteration of heart rhythm. These effects can be potentially fatal.

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

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Consult your doctor or pharmacist if any of the following side effects cause you discomfort or do not seem to go away. Inform your doctor of anything else that makes you feel unwell while usingAnestderma.

A mild reaction (pale skin or redness, mild swelling, initial burning or itching) may appear in the area whereAnestdermais applied. This is a normal reaction to the cream and anesthetics, and it will disappear in a short time without the need for any action.

If you experience any bothersome or unusual side effects while usingAnestderma, 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 (pale skin, redness, swelling) in the application area during treatment on the skin, genital mucosa, or leg ulcers.
• A mild initial sensation of burning, itching, or heat in the application area during treatment on the genital mucosa or leg ulcers.

Possibly frequent(may affect up to 1 in 100 people)

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

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

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

Unknown frequency(cannot be estimated from available data)

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

Other side effects in children

Methemoglobinemia, a blood disorder that is often observed more frequently in newborns and infants from 0 to 12months, often associated with overdose.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es/. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Use within 6 months after the first opening.

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

Do not use this medication after the expiration date shown on the packaging and on the tube after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE point of the pharmacy.SIGREpoint of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. This will help protect the environment..

Composition ofAnestderma

• The active principles are: lidocaine and prilocaine. Each gram of cream contains 25 mg of lidocaine and 25 mg of prilocaine.
• The other components aremacrogolglycerol hydroxystearate, carbomer 974P,sodium hydroxideand purified water.

Appearance of the product and contents of the packaging

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

Packaging sizes:

1 tube of 30g

1 tube of 5g

1 tube of 5g with 2 dressings

1 tube of 5g with 3 dressings

5 tubes of 5g

5 tubes of 5g with 12 dressings

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

GALENICUM DERMA, S.L.

National Highway 1, Km 36

28750 San Agustín de Guadalix (Madrid)

Spain

Responsible for manufacturing

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 medicine is authorized in the member states of the European Economic Area with the following names:

Estonia: Nulbia

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

Revision date of this leaflet:November 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.