Anestopic 25 mg/g + 25 mg/g cream

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

ANESTOPIC 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.
  1. If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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 adverse reactions
   1. How to store ANESTOPIC
   2. Contents of the pack and other 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 medicines known as local anesthetics.

ANESTOPIC 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., receiving an injection or having a blood test).
• Minor skin surgery.

Adults and adolescents

It can also be used:

• To numb the genital area before:
  • Receiving an injection.
  • Medical procedures such as removal of warts.

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 use ANESTOPIC

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

Warnings and precautions

Talk to your doctor or pharmacist before using ANESTOPIC

• 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 “methaemoglobinaemia”.

  • do not use ANESTOPIC on areas with skin rash, 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 this case, your doctor will monitor your heart function.

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

Avoid contact of ANESTOPIC with the eyes, as it may cause irritation. 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.

ANESTOPIC must not be applied to a damaged eardrum.

When using ANESTOPIC before vaccination 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 3 months of age, “methaemoglobinaemia”—a transient and clinically insignificant increase in levels of a blood pigment—may frequently occur up to 12 hours after application of ANESTOPIC.

Clinical studies were unable to confirm the efficacy of ANESTOPIC when drawing blood from the heel of newborns or for providing adequate analgesia during circumcision.

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

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

ANESTOPIC must not be used in premature newborns.

Use of ANESTOPIC with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including over-the-counter medicines and herbal preparations. This is because ANESTOPIC may affect how other medicines work, and other medicines may affect ANESTOPIC.

In particular, inform your doctor or pharmacist if you or your child have recently used or received treatment 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 blood levels of lidocaine. This interaction is not clinically significant when ANESTOPIC is used short-term at 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.

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

The active substances in ANESTOPIC (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

ANESTOPIC has no effect or an insignificant effect on the ability to drive and use machines when used at the recommended doses.

ANESTOPIC contains macrogolglycerol hydroxystearate

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

3. How to use ANESTOPIC

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

Use of ANESTOPIC

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

Do not use ANESTOPIC 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 membrane of the tube is pierced by pressing the cap against it.

Use on the skin prior to 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 indicate where to apply it.
• Cover the cream afterward with an occlusive dressing [clear plastic]. This dressing is removed just before starting the procedure. If you apply the cream yourself, ensure that your doctor, pharmacist, or nurse provides you with the appropriate 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 in advance.
• In children, the amount of ANESTOPIC used and the duration of application depend on their age. Your doctor, nurse, or pharmacist will advise you on the amount to use and when to apply it.

When applying 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 approximately 3.5 cm long from a 30 g tube corresponds to 1 g of cream.

2. Do not spread the cream.

3. Remove the cut-out center portion of the dressing.

4. Remove the paper wrapping from the dressing.

5. Remove the covers of the dressing and carefully place it over the mound of cream. Do not spread the cream under the dressing.

6. Remove the plastic frame. Gently press the edges of the dressing and leave it in place for at least 60 minutes.

7. Your doctor or nurse will remove the dressing and the cream immediately before performing the procedure (e.g., just before needle puncture).

Use on large areas of freshly shaved skin prior to 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. ANESTOPIC must not be used on a freshly shaved skin surface larger than 600 cm² (600 square centimeters, e.g., 30 cm by 20 cm). The maximum dose is 60 g.

Use on the skin prior to hospital procedures requiring deeper cutaneous anesthesia (such as skin grafts):

• ANESTOPIC may 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 the skin to treat wart-like lesions called "molluscum"

• ANESTOPIC may 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 applied for 30 to 60 minutes (30 minutes if the patient has atopic dermatitis). Your doctor, nurse, or pharmacist will advise you on the amount of cream to apply.

Use on genital skin before local anesthetic injections

ANESTOPIC may 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 for female genital skin) per 10 cm² (10 square centimeters) of skin area.
• The cream is applied under an occlusive dressing. This is left in place 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 may 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. No occlusive dressing is 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 left in place for 30 to 60 minutes before cleaning the ulcer. Remove the cream with a cotton swab and begin cleaning without delay.
  • ANESTOPIC may be used before cleaning leg ulcers up to 15 times within a period of 1–2 months.
  • The ANESTOPIC tube is for single use only when used on leg ulcers: The tube, including any remaining content, must be discarded after treating each patient.

If you use more ANESTOPIC than you should

If you use more ANESTOPIC than prescribed by your doctor, pharmacist, or nurse, contact one of them immediately, even if you do not have symptoms. You may also call the Toxicology Information Service at telephone number 91.562.04.20, stating the medicine and the amount used.

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

• Dizziness or lightheadedness.
• 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 "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 changes in heart rhythm. These effects can be potentially fatal.

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 ANESTOPIC.

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

If you experience any unpleasant or unusual 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 (pallor, redness, swelling) at the application site during treatment on the skin, genital mucosa, or leg ulcers.
• Mild initial sensation of burning, itching, or warmth at the application site during treatment on 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 treated area during treatment on the skin.
• Numbness (tingling) at the application site during treatment on 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 progress to anaphylactic shock (skin rash, swelling, fever, breathing difficulty, and fainting) during treatment on 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 on the skin.
• Eye irritation if ANESTOPIC comes into accidental contact with the eyes during treatment on the skin.

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, pharmacist, or nurse, 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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Anestopic

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

Do not use this medicine after the expiry date stated on the carton and tube following "CAD". The expiry date refers to the last day of the month indicated.

Do not refrigerate or freeze.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and additional information / Additional information

Composition of ANESTOPIC

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

• The other components (excipients) are: carbopol, macrogol glyceryl hydroxystearate, sodium hydroxide (for pH 8.7–9.7), and purified water.

Appearance of ANESTOPIC and contents of the container

This medicine 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 most recent review of this leaflet: 09/2015.

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