Anesderm

Leaflet attached to the packaging: information for the user

Anesderm, (25 mg + 25 mg)/g, cream
Prilocaine + Lidocaine

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What Anesderm is and what it is used for
• 2. Important information before using Anesderm
• 3. How to use Anesderm
• 4. Possible side effects
• 5. How to store Anesderm
• 6. Contents of the packaging and other information

1. What Anesderm is and what it is used for

Anesderm contains two active substances - lidocaine and prilocaine. They belong to a group of medicines called local anesthetics.
The action of Anesderm is to temporarily eliminate the sensation in the superficial layers of the skin.
The cream is applied to the skin before certain medical procedures. This helps to eliminate pain in the skin; however, the patient may still feel pressure and touch.

Adults, adolescents, and children

Anesderm can be used to anesthetize the skin before:

• injecting a needle into the skin (e.g., during an injection or blood sampling),
• minor surgical procedures on the skin.

Adults and adolescents

Anesderm can also be used:
to anesthetize the genital area before:

• injection,
• medical procedures, such as removal of warts. The application of Anesderm cream to the genital area should be performed under the supervision of a doctor or nurse.

Adults

Anesderm can also be used to anesthetize the skin before:

• debridement or removal of damaged skin of lower limb ulcers.

2. Important information before using Anesderm

When not to use Anesderm:

Warnings and precautions

Before starting to use Anesderm, you should discuss it with your doctor or pharmacist.

• Anesderm should not be used on areas of skin with a rash, scratches, or open wounds, except for lower limb ulcers. If the patient has any of these changes, before using the cream, they should contact their doctor or pharmacist.

Due to the possibility of increased absorption from freshly shaved skin, it is essential to follow the recommended dosage, area of application, and time of application on the skin.
Anesderm should be kept away from the eyes, as it may cause irritation.
If the cream accidentally gets into the eye, it should be rinsed immediately with lukewarm water or a physiological saline solution (0.9% NaCl solution). Caution should be exercised to avoid getting anything into the eye until sensation returns.
Anesderm should not be used on a diseased eardrum.
When Anesderm is used in a patient before administering a live vaccine (e.g., tuberculosis vaccine), it should be remembered to report for a follow-up visit at the time specified by the doctor to assess the effectiveness of the vaccination.

Children and adolescents

In infants/newborns under 3 months of age, a transient, clinically insignificant increase in methemoglobin concentration in the blood is commonly observed within 12 hours after using Anesderm.
The efficacy of Anesderm during blood sampling from the heel in newborns or to ensure adequate pain relief during circumcision has not been confirmed in clinical trials.
Anesderm should not be used on the skin of the genital organs (e.g., penis) and mucous membranes of the genital organs (e.g., vagina) in children (under 12 years of age) due to insufficient data on the absorption of active substances.
Anesderm should not be used in children under 12 months of age who are being treated with other medicines that affect blood pigments and may cause methemoglobinemia (e.g., sulfonamides; see also section 2 "Anesderm and other medicines").
Anesderm should not be used in premature newborns.

Anesderm and other medicines

The patient should inform their doctor or pharmacist about any other medicines they are currently taking or have recently taken or may take. This includes medicines that can be bought without a prescription and herbal medicines. This is important because the ingredients of Anesderm may affect the action of some other medicines, and some other medicines may affect the action of Anesderm.
In particular, the patient should inform their doctor, pharmacist, or nurse if they have used or taken any of the following medicines:

• Medicines used to treat infections called sulfonamides and nitrofurantoin.
• Medicines used to treat epilepsy: phenytoin and phenobarbital.
• Other local anesthetics.
• Medicines used to treat irregular heart rhythm, such as amiodarone.
• Cimetidine or beta-adrenergic blockers, which may increase the concentration of lidocaine in the blood. This interaction is not clinically significant in short-term use of Anesderm in recommended doses.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Occasional use of Anesderm during pregnancy is not associated with any risk of adverse effects on the fetus.
The active substances of Anesderm (lidocaine and prilocaine) pass into breast milk. However, the amount that passes into milk is so small that there is essentially no risk to the breastfed child.
In animal studies, no fertility disorders were found in males or females treated with the active ingredients of Anesderm.

Driving and using machines

Anesderm has no or negligible influence on the ability to drive and use machines when used as recommended.
Anesderm contains macrogolglycerol hydroxystearate 40, which may cause skin reactions.

• 3.

How to use Anesderm

Anesderm should always be used as recommended by the doctor or pharmacist. In case of doubts, the patient should consult their doctor, pharmacist, or nurse.

Using Anesderm

• The place of application, amount of cream, and time of application depend on the purpose of use.
• The doctor, pharmacist, or nurse will apply the cream to the appropriate area or show the patient how to do it themselves.
• When Anesderm is used on the genital organs, the doctor or nurse should supervise its use.

Anesderm should not be used in the following areas:

• Areas of scratches, abrasions, or wounds, except for lower limb ulcers.
• Areas with skin rash or eczema.
• Eyes or near the eyes.
• Inside the nose, ears, or mouth.
• In the anus.
• On the genital organs in children.

People who frequently apply or remove the cream from the patient's body should ensure that they effectively avoid contact with the cream to prevent the development of hypersensitivity.
The protective membrane of the tube is pierced using the tube cap.

Application to the skin before minor procedures (such as needle insertion or minor surgical procedures on the skin):

• The cream is applied to the skin in a thick layer. The doctor, pharmacist, or nurse will tell the patient where to apply the cream.
• Then, the layer of cream is covered with a dressing (plastic foil). The dressing is removed immediately before the procedure. If the patient applies the cream themselves, they should ensure that they have received dressings from their doctor, pharmacist, or nurse.
• Usually, the dose used in adults and adolescents over 12 years old is 2 g (grams).
• In adults and adolescents over 12 years old, the cream should be applied at least 60 minutes before the planned procedure time (except when the cream is to be applied to the genital organs). However, the cream should not be applied 5 hours before the procedure or earlier.
• In children, the amount of Anesderm cream used and the time of application depend on the child's age. The doctor, nurse, or pharmacist will inform the patient about the amount of cream to be used and when to apply it.

When applying the Anesderm cream, it is essential to follow the instructions carefully:
Squeeze out a portion of cream from the tube to form a mound
in the place where it is needed on the skin
(e.g., where the injection will be made).
A line of cream about 3.5 cm long from the 30 g tube
corresponds to 1 g of cream. Half of the contents of the 5 g tube
corresponds to about 2 g of Anesderm cream.
Do not rub the cream into the skin.
Remove the paper layer from the dressing.
Remove the dressing covers. Then, carefully place
the dressing over the cream mound.
Do not spread the cream under the dressing.
Remove the plastic stiffener.
Carefully smooth the edges of the dressing.
Then, leave the dressing on for at least 60 minutes.

The doctor or nurse will remove the dressing and remove the cream before performing the medical procedure (e.g., before injecting a needle).

Using Anesderm on larger areas of freshly shaved skin before procedures in outpatient settings (such as hair removal):

Usually, the dose of Anesderm used is 1 g of cream per 10 cm² (10 square centimeters) of skin surface, applied for 1 to 5 hours under a dressing. Anesderm should not be used on an area of freshly shaved skin larger than 600 cm² (600 square centimeters, e.g., 30 cm x 20 cm). The maximum dose is 60 g.

Using Anesderm on the skin before procedures performed in hospital settings (e.g., before skin grafting), which require deeper skin anesthesia:

• Anesderm may be used in this way in adults and adolescents over 12 years old.
• Usually, the dose used is 1.5 g to 2 g of cream per 10 cm² (10 square centimeters) of skin surface.
• The cream is applied and covered with a dressing for 2 to 5 hours.

Using Anesderm on the skin before removing warty lesions

• Anesderm may be used in children and adolescents with a skin condition called atopic dermatitis.
• Usually, the dose used depends on the child's age and is applied for 30 to 60 minutes (30 minutes in the case of atopic dermatitis). The doctor, nurse, or pharmacist will tell the patient how much cream to use.

Using Anesderm on the genital skin before injecting local anesthetics

• Anesderm may be used in this way only in adults and adolescents over 12 years old.
• Usually, the dose used is 1 g of cream (1 g to 2 g in the case of genital skin) per 10 cm² (10 square centimeters) of skin surface.
• The cream is applied and covered with a dressing. The dressing is left on for 15 minutes in the case of female genital skin and 60 minutes in the case of male genital skin.

on the genital skin before minor surgical procedures on the skin (such as removal of warts)

• Anesderm may be used in this way only in adults and adolescents over 12 years old.
• Usually, the dose used is 5 g to 10 g of cream for 10 minutes. No dressing is used. The procedure should be performed immediately after.

Using Anesderm on lower limb ulcers before debridement or removal of damaged skin

• Usually, the dose used is 1 g to 2 g of cream per 10 cm² (10 square centimeters) of skin surface and no more than 10 g.
• The cream is applied and covered with a tight dressing, e.g., plastic foil. The cream and dressing are applied 30 to 60 minutes before the debridement procedure. The cream should be removed using a cotton swab and the debridement procedure should be performed immediately.
• Anesderm can be used before debridement of lower limb ulcers up to 15 times in a period of 1-2 months.
• In the case of using the cream on lower limb ulcers, the Anesderm tube is intended for single use: after each use of the cream in the patient, the tube with the remaining amount of cream should be discarded.

Using a larger dose of Anesderm than recommended

In case of using a larger amount of Anesderm than recommended by the doctor, pharmacist, or nurse, the patient should contact them immediately, even if they do not feel any discomfort.
Symptoms that may occur after using too much Anesderm are listed below. These discomforts should not occur after using Anesderm as recommended.

• Feeling of "emptiness" in the head or dizziness.
• Numbness or tingling of the skin around the mouth and tongue.
• Disturbed sense of taste.
• Blurred vision.
• Ringing in the ears.
• There is also a risk of acute methemoglobinemia (a disorder affecting the concentration of a blood pigment). This is more likely if the patient is taking other medicines. In case of this condition, the skin turns blue-gray due to insufficient oxygen in the blood.

In severe cases of overdose, symptoms such as seizures, decreased blood pressure, decreased breathing rate, respiratory arrest, and abnormal heart rhythm may occur. These symptoms can be life-threatening.
In case of any further doubts about the use of this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Anesderm can cause side effects, although not everybody gets them.
In case of occurrence or persistence of any of the following side effects in the patient, the patient should contact their doctor or pharmacist. The patient should tell their doctor about anything that makes them feel unwell while using Anesderm.
At the site of application of Anesderm, a mild reaction may occur (paling or reddening of the skin, slight swelling, initial burning or itching sensation). These are common reactions to the cream and anesthetics, which disappear after a short time without the need for any medical intervention.
In case of occurrence of any worrying side effects in the patient while using Anesderm, the patient should stop using it and contact their doctor or pharmacist as soon as possible.
Common(may affect up to 1 in 10 people)

• Transient local skin reactions (paling, reddening, swelling) at the site of application of the medicine during application to the skin, mucous membranes of the genital organs, or lower limb ulcers.
• Initial mild burning, itching, or warmth sensation at the site of application of the medicine during application to the mucous membranes of the genital organs or lower limb ulcers.

Uncommon(may affect up to 1 in 100 people)

• Initial mild burning, itching, or warmth sensation at the site of application of the medicine during application to the skin.
• Numbness (tingling) at the site of application of the medicine during application to the mucous membranes of the genital organs.
• Skin irritation at the site of application of the medicine during application to lower limb ulcers.

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

• Allergic reactions, which in rare cases can lead to anaphylactic shock (skin rash, swelling, fever, difficulty breathing, and fainting) during application to the skin, mucous membranes of the genital organs, or lower limb ulcers.
• Methemoglobinemia (a blood disorder) during application to the skin.
• Minor pinpoint bleeding (petechiae) at the site of application of the medicine (especially in children with eczema after longer exposure to the medicine) during application to the skin.
• Eyelid irritation if the eyes accidentally come into contact with Anesderm cream during its application to the skin.

Additional side effects in children

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

Reporting side effects

If side effects occur, including any not listed in the leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Anesderm

The medicine should be stored out of sight and reach of children.
Anesderm should not be used after the expiry date stated on the tube and carton packaging after "Expiry Date (EXP)". The expiry date refers to the last day of the specified month.
There are no special precautions for storage of the medicinal product.
The shelf life after opening the tube is 1 month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Anesderm contains

• The active substances of Anesderm are lidocaine and prilocaine. One gram of cream contains 25 mg of lidocaine and 25 mg of prilocaine.
• The other ingredients are: carbomer 980, macrogolglycerol hydroxystearate 40, sodium hydroxide 10%, purified water.

What Anesderm looks like and what the packaging contains

It is a smooth, white cream.
Packaging size: 1 tube of 5 g + 2 adhesive dressings in a cardboard box
5 tubes of 5 g + 10 adhesive dressings in a cardboard box
1 tube of 30 g in a cardboard box
Not all packaging sizes may be available.

Marketing authorization holder:

Pierre Fabre Medicament
Les Cauquillous
81500 Lavaur
France

Manufacturer:

Pierre Fabre Médicament Production
Établissement Progipharm,
Rue de Lycée
F-45500 Gien,
France

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

Germany: ANESDERM 25 mg/g + 25 mg/g Creme
Italy: ANESDERM 25 mg/g + 25 mg/g Crema
Poland: ANESDERM
Date of last revision of the leaflet:03/2023