Prospect: information for the patient

ANESTOPIC 25 mg/g + 25 mg/g cream

Lidocaína/Prilocaína

Read this prospect carefully before starting to use this medication, because it containsimportant information for you.

• Keep this prospect, as you may need to read it again.
• 1. If you have any doubts, consult yourdoctor or pharmacist.
• This medication has been prescribedonlyto you, and you must not give it to other people even ifthey havethe same symptomsas you,as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What isANESTOPICand how it is used

2.What you need to know before starting to useANESTOPIC

3.How to useANESTOPIC

4.Adverse effects

1. Storage ofANESTOPIC
2. Contents of the package and additional information

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

ANESTOPICacts 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 be able to feel sensations such as pressure and contact.

Adults, adolescents, and children

It can be used to numb the skin before:

• Puncture with a needle (e.g., if you are going to receive an injection or have a blood test).
• Minor surgery on the skin.

Adults and adolescents

It can also be used:

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

The use ofANESTOPICon 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.

No useANESTOPIC

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

Warnings and precautions

Consult your doctor or pharmacist before starting to useANESTOPIC

-if you or your child have a rare inherited blood disorder called “glucose-6-phosphate dehydrogenase deficiency”.

-if you or your child have a condition that affects the levels of a pigment in the blood called “methemoglobinemia”.

• do not use ANESTOPIC on areas with skin eruptions, 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 condition 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 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 greater absorption through recently 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, 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.

Do not apply ANESTOPIC to a damaged eardrum.

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

Children and adolescents

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

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

ANESTOPIC should not be applied to the genital mucosa (e.g., vagina) of children (under 12 years) due to insufficient data on the absorption of the active ingredients.

ANESTOPIC should not be used in children under 12 months of age who are receiving simultaneous treatment with other medicines that affect the concentrations of the blood pigment “methemoglobin” (e.g., sulfonamides, see also section2. “Use ofANESTOPICwith other medicines”).

ANESTOPIC should not be used in premature newborns.

Use ofANESTOPICwith other medicines

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 medicine, including those obtained without a prescription and herbal medicines.This is becauseANESTOPICmay affect the way other medicines work and other medicines may have an effect onANESTOPIC.

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

• sulfonamide medicines used to treat infections and nitrofurantoin.
• medicines used to treat epilepsy, called phenytoin and phenobarbital.
• other local anesthetics.
• medicines used to treat heart arrhythmias, such as amiodarone.
• cimetidine or beta-blockers, which may increase the levels of lidocaine 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 medicine.

The occasional use of ANESTOPIC during pregnancy is unlikely to have any adverse effects on the fetus.

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

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

Driving and operating machinery

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

ANESTOPIC contains macrogolglycerol hydroxystearate

This medicine 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, consultyour doctor, pharmacist or nurse again.

Use of ANESTOPIC

-The application site of the cream, the amount to be used and the time it should be applied will depend on its use.

-Your doctor, pharmacist or nurse will apply the cream or teach you how to apply it yourself.

-When ANESTOPIC is used on the genitals, a doctor or nurse must supervise its use.

Do not use ANESTOPIC in the following areas:

-Cuts, abrasions or wounds, except for leg ulcers.

-Areas with skin eruption or eczema.

-On the eyes or in their vicinity.

-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 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 ofANESTOPICused and the time of use depend on their age. Your doctor, nurse or pharmacist will indicate the amount to use and when to apply it.

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

1. Press 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.
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 dressing covers and place it carefully over the cream mount. Do not spread the cream under the dressing.
4. Remove the plastic frame. Press the dressing edges lightly and leave it in place for at least 60 minutes.
5. Your doctor or nurse will remove the dressing and cream immediately before performing the procedure (e.g., just before the needle puncture).

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.ANESTOPICshould not be used on recently shaved skin areas larger than 600 cm² (600 square centimeters, e.g., 30 cm x 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:

-ANESTOPICcan 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 area.

-The cream is applied under an occlusive dressing for 2 to 5 hours.

Use on the skin to remove warts called "molluscum"

-ANESTOPICcan 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 anesthesia injections:

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 female genital skin) per 10 cm² (10 square centimeters) of skin area.

-The cream is applied under an occlusive dressing. This is maintained for 15 minutes on male genital skin and for 60 minutes on female genital skin.

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

-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 initiated immediately.

Use on leg ulcers before cleaning or removing the damaged skin:

-The usual dose is 1 g to 2 g 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 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 15times 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 moreANESTOPICthan you should:

If you use moreANESTOPICthan your doctor, pharmacist or nurse has indicated, contact 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 muchANESTOPIC. It is unlikely that these symptoms will occur if you follow the recommended use ofANESTOPIC.

-Dizziness or dizziness.

-Tickling sensation on the skin around the mouth and numbness of the tongue.

-Altered taste.

-Blurred vision.

-Ring 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 altered 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.

Like all medicines, this medicine can 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 usingANESTOPIC.

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

If you experience any annoying or unusual side effects while using ANESTOPIC, 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.

Occasional(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, can lead to anaphylactic shock (skin rash, swelling, fever, respiratory difficulty, and fainting) during treatment on the skin, genital mucosa, or leg ulcers.

-Methemoglobinemia (blood disorder) during skin treatment.

-Small punctate bleeding in the treated area (particularly in children with eczema after long periods of application), during skin treatment.

-Irritation of the eyes if ANESTOPIC accidentally comes into contact with the eyes during skin 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, pharmacist, or nurse, even if it is possible side effects that do not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute toproviding more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe packaging and on the tubeafter “EXP”. The expiration date is the last day of the month indicated.

Do not refrigerate or freeze.

Do not use ANESTOPIC if you observe any sign of deterioration.

Medications should not be disposed of through drains or in the trash. Dispose of containers and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition ofANESTOPIC

• The active principles 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 contents of the packaging

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

Holder of the marketing authorization and responsible for manufacturing

Mesoestetic Pharma Group, S.L.

C/Tecnología, 25

08840 Viladecans- Barcelona- SPAIN

Date of the last review of this leaflet:09/2015.

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