Anesderm

Package leaflet: Information for the user

Anesderm, (25 mg + 25 mg)/g, cream
Prilocainum + Lidocainum
Please read all of this leaflet carefully before using this medicine, as it contains
important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

1. What Anesderm is and what it is used for
2. What you need to know before using Anesderm
3. How to use Anesderm
4. Possible side effects
5. How to store Anesderm
6. Contents of the pack 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 known as local anaesthetics.
Anesderm works by temporarily numbing the sensation in the superficial layers of the skin. The cream is applied to the skin before certain medical procedures.
This helps to relieve pain in the skin; however, the patient may still feel pressure and touch.

Adults, adolescents and children
Anesderm may be used to anaesthetise the skin before:

• inserting a needle into the skin (for example, when giving an injection or taking a blood sample),
• minor surgical procedures on the skin.

Adults and adolescents (aged 12 years and older)
Anesderm may also be used to anaesthetise the genital organs before:

• giving an injection,
• performing medical procedures, such as removal of warts. Application of Anesderm cream to the genital organs should be performed under the supervision of a doctor or nurse.

Adults
Anesderm may also be used to anaesthetise the skin before:

• debriding or removing damaged skin from venous ulcers of the lower limbs.

2. Important information before using Anesderm

When not to use Anesderm:

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

Warnings and precautions

Before starting treatment with Anesderm, discuss this with your doctor or pharmacist.

• If the patient has a rare metabolic disorder affecting the blood, known as glucose-6-phosphate dehydrogenase deficiency.
• If the patient has a blood pigment disorder known as methaemoglobinaemia.
• If the patient has a skin condition causing itching, known as "atopic dermatitis", application of the cream for a shorter period – from 15 to 30 minutes – may be sufficient. Using the cream for longer than 30 minutes may increase the frequency of certain local skin reactions, especially redness at the application site, and in some cases small or larger petechiae (red spots on the skin); see also section 4, "Possible side effects". Prior to removal of warts in children with atopic dermatitis, application of the cream for 30 minutes is recommended.
• If the patient is taking certain medications used for heart rhythm disorders (antiarrhythmic drugs of class III, such as amiodarone). In such cases, the doctor will monitor the patient's heart function.
• Do not apply Anesderm to areas of skin with rashes, cuts, scratches, or other open wounds, except for leg ulcers. If the patient has any of these skin changes, contact a doctor or pharmacist before using the cream.

Due to the possibility of increased absorption of the medicine from freshly shaved skin, it is important to follow the recommended dosage, size of the application area, and duration of application on the skin.

Avoid contact of Anesderm with the eyes, as it may cause irritation or chemical eye burns. However, if a doctor recommends applying Anesderm near the eyes, it should be done with caution.

If Anesderm cream accidentally gets into the eye, immediately rinse the eye with lukewarm water or saline solution (0.9% NaCl solution). Protect the eye until sensation returns, to avoid any contact, and inform the doctor.

If Anesderm is used in children, close supervision of the child is essential regardless of the application site, to prevent transfer of the cream to the eyes.

Do not use Anesderm on a diseased eardrum.

When Anesderm is used before administration of a live vaccine (e.g. tuberculosis vaccine), remember to attend the follow-up visit scheduled by the doctor to assess the effectiveness of vaccination.

Children and adolescents

In infants/newborns under 3 months of age, a transient, clinically insignificant increase in methaemoglobin blood levels (a form of haemoglobin, the blood pigment) is commonly observed within 12 hours after application of Anesderm.

The efficacy of Anesderm for heel blood sampling in newborns or for providing adequate analgesia during circumcision has not been confirmed in clinical studies.

Anesderm should not be applied to the skin of genital organs (e.g. penis) or mucous membranes of genital organs (e.g. vagina) in children (under 12 years of age) due to insufficient data on absorption of the active substances.

Anesderm should not be used in newborns or infants under 12 months of age who are being treated concurrently with other medicines that affect blood pigment and may cause methaemoglobinaemia (e.g. sulfonamides; see also section 2, "Anesderm and other medicines").

Anesderm should not be used in premature infants with a gestational age of less than 37 weeks due to the risk of high methaemoglobin levels.

Anesderm and other medicines

Tell your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take. This includes over-the-counter medicines and herbal remedies. This is important because the components of Anesderm may affect the action of certain 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 recently used or taken any of the following medicines:

• Medicines used to treat infections, particularly sulfonamides and nitrofurantoin;
• Medicines used to treat epilepsy, particularly phenytoin and phenobarbital;
• Other local anaesthetics;
• Medicines used to treat irregular heartbeat (class III antiarrhythmic drugs, such as amiodarone);
• Cimetidine or beta-blockers, which may increase blood levels of lidocaine, potentially enhancing its toxic effects. This interaction is not clinically significant with short-term use of Anesderm at recommended doses.

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Occasional use of Anesderm during pregnancy has not been associated with any adverse effects on the fetus. However, due to insufficient data, Anesderm should not be used during pregnancy unless recommended by a doctor.

The active substances in Anesderm (lidocaine and prilocaine) pass into human milk. However, they do so in such small amounts that there is essentially no risk to the breastfed infant. Anesderm should not be used during breastfeeding unless recommended by a doctor.

Driving and operating machinery

Anesderm has no effect or negligible effect on the ability to drive and operate machinery when used at recommended doses.

Anesderm contains polyoxyl 40 hydrogenated castor oil (hydrogenated ricinoleic acid polyethylene glycol ester), which may cause skin reactions.

3. How to use Anesderm

Anesderm should always be used as directed by the doctor or pharmacist. If in doubt, consult a doctor, pharmacist, or nurse.

Use of Anesderm

• The application site, amount of cream, and duration of application depend on the intended use.
• The doctor, pharmacist, or nurse will apply the cream to the appropriate area or show the patient how to do it.
• When Anesderm is applied to genital organs, its use should be supervised by a doctor or nurse.

Do not apply Anesderm to the following areas:

• Areas with cuts, scratches, or wounds, except for leg ulcers;
• Areas with skin rash or eruption;
• Into the eyes or near the eyes;
• Inside the nose, ears, or mouth;
• Into the anus;
• On genital organs in children.

Individuals who frequently apply or remove the cream from the patient's body should ensure they effectively avoid contact with the cream to prevent development of hypersensitivity (allergy).

Pierce the protective seal of the tube using the cap of the tube.

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

• Apply the cream in a thick layer to the skin. The doctor, pharmacist, or nurse will inform the patient where to apply the cream.
• Cover the cream layer with a dressing (plastic film). Remove the dressing immediately before the procedure begins. If the patient applies the cream independently, they should ensure they have received dressings from the doctor, pharmacist, or nurse.
• The usual dose in adults and adolescents aged 12 years and older is 2 g (grams).
• In adults and adolescents aged 12 years and older, apply the cream at least 60 minutes before the scheduled procedure (except when applied to genital organs). However, do not apply the cream more than 5 hours before the procedure.
• The amount of Anesderm cream and duration of application in children depend on the child's age. The doctor, nurse, or pharmacist will inform the patient of the appropriate amount and timing.

When applying Anesderm cream, it is very important to strictly follow these instructions:

1. Squeeze a portion of cream from the tube to form a mound

where it is needed on the skin (e.g. where a needle will be inserted). A strip of cream approximately 3.5 cm long squeezed from a 30 g tube corresponds to 1 g of cream. Half the contents of a 5 g tube corresponds to approximately 2 g of Anesderm cream.

2. Do not rub the cream into the skin.

3. Peel off the paper layer from the dressing.

4. Remove the dressing protectors. Then carefully place the dressing over the cream mound. Do not spread the cream under the dressing.

5. Remove the plastic stiffener. Carefully smooth the edges of the dressing. Then leave the dressing in place for at least 60 minutes.
6. The doctor or nurse will remove the dressing and wipe off the cream before the medical procedure (e.g. before needle insertion).

Application of Anesderm to larger areas of freshly shaved skin before outpatient procedures (such as hair removal):
The usual dose of Anesderm is 1 g of cream per every 10 cm² (10 square centimetres) of skin surface, applied for 1 to 5 hours under an occlusive dressing. Do not apply Anesderm to a freshly shaved skin area larger than 600 cm² (600 square centimetres, e.g. 30 cm by 20 cm). The maximum dose is 60 g.

Application to skin (large area) before hospital procedures (e.g. before split-thickness skin grafting) requiring deeper skin anaesthesia:

• Anesderm may be used in this way in adults and adolescents aged 12 years and older.
• The usual dose is 1.5 g to 2 g of cream per every 10 cm² (10 square centimetres) of skin surface.
• Apply the cream and cover with a dressing for 2 to 5 hours.

Application to skin before removal of wart-like lesions (genital warts)

• Anesderm may be used in this way in children and adolescents with 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 in case of atopic dermatitis). The doctor, nurse, or pharmacist will inform the patient of the appropriate amount of cream to use.

Application to genital skin before injection of local anaesthetics

• Anesderm may be used in this way only in adults and adolescents aged 12 years and older.
• The usual dose is 1 g of cream (1 g to 2 g in case of female genital skin) per every 10 cm² (10 square centimetres) of skin surface.
• Apply the cream and cover with a dressing. Leave the dressing in place for 15 minutes in case of male genital skin, and for 60 minutes in case of female genital skin (unless the doctor recommends a longer duration).

Application to genital skin before minor surgical procedures (such as removal of warts)

• Anesderm may be used in this way only in adults and adolescents aged 12 years and older.
• The usual dose is 5 g to 10 g of cream for 10 minutes. In adolescents with body weight less than 20 kg, the doctor will determine the maximum dose of Anesderm to be used. A dressing is not used. Proceed immediately to the procedure.

Application to leg ulcers before debridement or removal of damaged skin

• The usual dose is 1 g to 2 g of cream per every 10 cm² (10 square centimetres) of skin surface, but not more than 10 g.
• Apply the cream and cover with an occlusive dressing, e.g. plastic film. Apply the cream and dressing 30 to 60 minutes before the debridement procedure. Remove the cream with cotton gauze and proceed immediately to debridement.
• Anesderm may be used before debridement of leg ulcers up to 15 times within a period of 1–2 months.
• When applying the cream to leg ulcers, the Anesderm tube should be treated as a single-use product: after each patient use, the tube with any remaining content should be discarded.

Use of a higher than recommended dose of Anesderm

If more Anesderm has been used than recommended by the doctor, pharmacist, or nurse, contact them immediately, even if the patient does not feel unwell.

Symptoms that may occur after using too much Anesderm include:

• Nervousness, anxiety, euphoria, confusion, dizziness, drowsiness, ringing in the ears, double or blurred vision, taste disturbances, vomiting, sensation of heat, cold or numbness, numbness of the tongue, skin tingling around the mouth, tremors, seizures, loss of consciousness, slowed breathing, slowed heart rate, and low blood pressure.
• There is also a risk of acute methaemoglobinaemia (a disorder affecting the blood pigment). This is more likely if the patient is taking other medicines concurrently. In such cases, the skin may become bluish-grey due to insufficient oxygen in the blood.

These symptoms should not occur when Anesderm is used as directed.

In severe cases of overdose, symptoms such as seizures, low blood pressure, reduced breathing rate, respiratory arrest, and abnormal heart rhythm may occur. These symptoms may be life-threatening. If such symptoms occur, go immediately to the emergency department of a hospital.

If you have any further doubts about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like any medicine, this product may cause adverse reactions, although not everyone will experience them.
At the site of application of Anesderm cream, a mild reaction may occur (pallor or redness of the skin, slight swelling, initial sensation of burning or itching). These are common reactions to the cream and to local anaesthetics, which resolve quickly without requiring any medical intervention.
If any disturbing adverse symptoms occur in a patient during treatment with Anesderm, treatment should be discontinued and medical advice should be sought from a doctor or pharmacist as soon as possible.

Common (may affect up to 1 in 10 people)

• Transient (short-lived) local skin reactions (pallor, redness, swelling) at the site of drug exposure when applied to the skin, genital mucous membranes, or lower limb ulcers.
• Sensation of burning, itching (pruritus), or warmth at the site of drug exposure when applied to genital mucous membranes or lower limb ulcers.

Uncommon (may affect up to 1 in 100 people)

• Sensation of burning, itching, or warmth at the site of drug exposure when applied to the skin.
• Loss of sensation (numbness) at the site of drug exposure when applied to genital mucous membranes.
• Skin irritation at the site of drug exposure when applied to lower limb ulcers.

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

• Allergic reactions, which in rare cases may lead to anaphylactic shock [a sudden, generalized allergic reaction that may be life-threatening if not treated immediately, with symptoms such as skin rash (e.g. urticaria, itching), swelling, breathing difficulties, rapid heartbeat, dizziness, sweating, sudden drop in blood pressure, and/or loss of consciousness or fainting] when applied to the skin, genital mucous membranes, or lower limb ulcers. In such cases, urgent medical intervention is required.
• Methemoglobinemia (a blood disorder) when applied to the skin.
• Minor pinpoint bleeding (skin petechiae) at the site of drug exposure [particularly in children with eczema (atopic dermatitis) or molluscum contagiosum after prolonged exposure] when applied to the skin.
• Eye irritation (corneal irritation) if the Anesderm cream accidentally comes into contact with the eyes during application to the skin.

Frequency not known (frequency cannot be estimated from available data)

• Chemical eye burns if Anesderm cream accidentally comes into contact with the eyes during treatment.

Additional adverse reactions in children
Methemoglobinemia, a blood disorder, which is more frequently observed in neonates and infants aged 0 to 12 months, often associated with overdose.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 4921301, fax: +48 22 4921309,
website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Anesderm

Keep the medicine out of sight and reach of children.
Do not use Anesderm after the expiry date stated on the tube and carton after: EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required.
The shelf life after first opening of the tube is 1 month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Anesderm contains

• The active substances in this medicine are lidocaine and prilocaine. One gram of cream contains 25 mg of lidocaine and 25 mg of prilocaine.
• Other components are: carbomer 980, polyoxyl 40 hydrogenated castor oil (polyoxyl 40 hydrogenated castor oil), sodium hydroxide 10%, purified water.

What Anesderm looks like and contents of the pack
This medicine is a smooth, white cream.
Pack sizes: 1 tube containing 5 g + 2 adhesive dressings in a cardboard carton
5 tubes containing 5 g each + 10 adhesive dressings in a cardboard carton
1 tube containing 30 g in a cardboard carton
Not all pack sizes may be marketed.
Marketing Authorisation 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 authorised in the European Economic Area under the following names:
Germany: ANESDERM 25 mg/g + 25 mg/g Creme
Poland: ANESDERM
For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Pierre Fabre Dermo-Cosmetique Polska Sp. z o.o.
ul. Belwederska 20/22
00-762 Warsaw
tel. 22 559 63 60