ANESTOPIC 25 mg/g + 25 mg/g CREAM

Introduction

Package Leaflet: Information for the Patient

ANESTOPIC 25 mg/g + 25 mg/g cream

Lidocaine/Prilocaine

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• 1. If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What ANESTOPIC is and what it is used for
2. What you need to know before using ANESTOPIC
3. How to use ANESTOPIC
4. Possible side effects
   1. Storage of ANESTOPIC
   2. Package contents and additional information

1. What ANESTOPIC is and what it is used for

ANESTOPIC contains two active substances called lidocaine and prilocaine. They belong to a group of medications called local anesthetics.

ANESTOPIC works by temporarily numbing the surface of the skin. It is applied to the skin before certain medical procedures. It helps to stop pain in 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., if you are going to have an injection or a blood test).
• Minor skin surgery.

Adults and Adolescents

It can also be used:

• To numb the genitals before:
• • Having an injection.
  • Medical procedures such as wart removal.

The use of ANESTOPIC 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 ANESTOPIC

Do not useANESTOPIC

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

Warnings and Precautions

Consult your doctor or pharmacist before starting to use ANESTOPIC

• if you or your child have a rare hereditary 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 use ANESTOPIC on areas with skin rash, cuts, abrasions, or open wounds, except for leg ulcers. If you have any of these problems, 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 30 minutes may increase the incidence of local skin reactions (see also section 4, "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 through freshly shaved skin, it is essential to respect the recommended dose, skin surface, and application time.

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

ANESTOPIC should not be applied to a damaged eardrum.

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

Children and Adolescents

In infants and newborns under 3 months, "methemoglobinemia" is frequently observed, a transient and clinically insignificant increase in blood pigment levels, up to 12 hours after application of ANESTOPIC.

Clinical studies could not confirm the efficacy of ANESTOPIC when blood is drawn from the heel of newborns or to provide adequate analgesia during circumcision.

ANESTOPIC should not be applied to the genital mucosa (e.g., in the vagina) of children (under 12 years) because there is insufficient data on the absorption of the active substances.

ANESTOPIC should not be used in children under 12 months of age who are simultaneously receiving treatment with other medications that affect the levels of the blood pigment "methemoglobin" (e.g., sulfonamides, see also section 2, "Using ANESTOPIC with other medications").

ANESTOPIC should not be used in premature newborns.

Using ANESTOPIC with other medications

Tell your doctor or pharmacist if you are using or have recently used or might use any other medications, including those obtained without a prescription and herbal medications. This is because ANESTOPIC may affect the way other medications work, and other medications may have an effect on ANESTOPIC.

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 with ANESTOPIC at the recommended doses.

Pregnancy, Breastfeeding, and Fertility

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

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

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

Animal studies have shown that there are no alterations in male or female fertility.

Driving and Using Machines

ANESTOPIC does not affect the ability to drive and use machines, or the effect is negligible, when used at the recommended doses.

ANESTOPIC contains macrogolglycerol hydroxystearate

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

3. How to use ANESTOPIC

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

Using ANESTOPIC

• The place of application of the cream, the amount to be used, and the time it should remain applied will depend on its intended use.
• Your doctor, pharmacist, or nurse will apply the cream or teach you how to do it yourself.
• When ANESTOPIC is used on the genitals, a doctor or nurse should supervise its use.

Do not use ANESTOPIC on the following areas:

• Cuts, abrasions, or open wounds, except for leg ulcers.
• Areas with skin rash or eczema.
• The eyes or their surroundings.
• Inside the nose, ear, or mouth.
• The anus.
• The genitals of children.

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

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

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

• Apply a thick layer of cream to the skin. Your doctor, pharmacist, or nurse will indicate where to apply it.
• Cover the cream with a dressing [transparent plastic] afterwards. This is removed just before starting the procedure. 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 is 2 g (grams).

• In adults and adolescents over 12 years, 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 ANESTOPIC used and the application time depend on their age. Your doctor, nurse, or pharmacist will indicate the amount to be used 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 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 from the 30 g tube is equivalent to 1 g of cream.
2. Do not spread the cream.

1. Remove the central cut-out part of the dressing.
2. Remove the paper wrapping from the dressing.
3. Remove the covers from the dressing and carefully place it over the cream mound. Do not spread the cream under the dressing.
4. Remove the plastic frame. Gently press the edges of the dressing and leave it in place for at least 60 minutes.
5. Your doctor or nurse will remove the dressing and the cream immediately before performing the procedure (e.g., just before the needle puncture).

Use on extensive 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 between 1 and 5 hours under a dressing. ANESTOPIC 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 the skin before hospital procedures (such as skin grafts) that require deeper skin anesthesia:

• ANESTOPIC can be used in this way in adults and adolescents over 12 years.
• 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 under an occlusive dressing for 2 to 5 hours.

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

• ANESTOPIC 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 indicate the amount of cream to be applied.

Use on the skin of the genitals before injecting local anesthetics

ANESTOPIC can be used in this way only in adults and adolescents over 12 years.

• The usual dose is 1 g of cream (1 g to 2 g on the female genital skin) per 10 cm² (10 square centimeters) of skin surface.
• The cream is applied under an occlusive dressing. This is maintained for 15 minutes on the male genital skin and for 60 minutes on the female genital skin.

Use on the genitals before minor skin surgery (wart removal)

• ANESTOPIC can be used in this way only in adults and adolescents over 12 years.
• 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 per 10 cm² of skin surface, up to a maximum of 10 g.
• The cream is applied under an occlusive dressing, e.g., a transparent plastic. This is maintained for 30 to 60 minutes before cleaning the ulcer. Remove the cream with a cotton swab and start cleaning without delay.
  • ANESTOPIC can be used before cleaning leg ulcers up to 15 times in a period of 1-2 months.
  • The ANESTOPIC 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 ANESTOPIC than you should

If you use more ANESTOPIC than your doctor, pharmacist, or nurse has indicated, contact one of them immediately, even if you do not have symptoms. You can also call the Toxicology Information Service, phone 91.562.04.20, indicating the medication and the amount used.

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

• Dizziness or lightheadedness.
• Numbness or tingling around the mouth and 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 happens, the skin takes on a bluish-gray color due to lack of oxygen.

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Contact your doctor or pharmacist if any of the following side effects bother you or do not seem to go away. Inform your doctor of anything else that makes you feel unwell while using ANESTOPIC.

A mild reaction (pallor or redness of the skin, slight swelling, burning, or initial itching) may appear in the area where ANESTOPIC is applied. These are normal reactions to the cream and anesthetics and will disappear soon without needing to take any action.

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

Common(may affect up to 1 in 10 people)

• Transient local skin reactions (pallor, redness, swelling) in the application area during treatment on the skin, genital mucosa, or leg ulcers.
• A mild initial sensation of burning, itching, or warmth in the application area during treatment on the genital mucosa or leg ulcers.

Uncommon(may affect up to 1 in 100 people)

• A mild initial sensation of burning, itching, or warmth 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, can 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 treatment on the skin.
• Small pinpoint bleeding in the treated area (particularly in children with eczema after long application periods), during treatment on the skin.
• Irritation of the eyes if ANESTOPIC accidentally comes into contact with the eyes during treatment on the skin.

Other side effects in children

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

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of ANESTOPIC

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

Do not use this medication after the expiration date stated on the carton and tube after "EXP". The expiration date is the last day of the month indicated.

Do not refrigerate or freeze.

Do not use ANESTOPIC if you notice any signs of deterioration.

Medications should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Container Content and Additional Information / Additional Information

Composition ofANESTOPIC

• The active ingredients are: lidocaine and prilocaine. Each gram of cream contains 25 mg of lidocaine and 25 mg of prilocaine.

• The other components (excipients) are: carboxypolymethylene, macrogolglycerol hydroxystearate, sodium hydroxide (for pH 8.7-9.7) and purified water.

AppearanceANESTOPICand container content

This medication is presented in boxes containing 1 tube with 30 g of cream.

Marketing authorization holder and manufacturer

Mesoestetic Pharma Group, S.L.

C/Tecnología, 25

08840 Viladecans- Barcelona- SPAIN

Date of the last revision of this prospectus:09/2015.

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