• 25 mg lidocaine
• 25 mg prilocaine

• Macrogol glycerol hydroxystearate
• Carbomer 974 P
• Sodium hydroxide for pH adjustment
• Purified water

Lidocaine - prilocaine cream Indication / application

• The medicine contains two active substances called lidocaine and prilocaine. These belong to a group of medicines called local anesthetics.
• The preparation works by briefly numbing the surface of the skin. It is applied to the skin before certain medical procedures. This will help turn off the pain on the skin. Even so, you may still feel pressure or touch.
• Adults, teenagers and children
  • It can be used to numb the skin before:
    • a needle stick (e.g. when you have an injection or to have a blood drawn).
    • minor surgical interventions on the skin.
• Adults and adolescents
  • It can also be used:
    • to numb the genitals before:
      • an injection.
      • medical interventions such as wart removal.
    • A doctor or nurse should monitor the use of the drug on the genitals.
• adult
  • It can also be used to numb the skin before:
    • Cleansing or removing damaged skin from leg ulcers

Lidocaine - prilocaine cream dosage

• Always use this medicine exactly as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.
• Application of the cream
  • Where the cream is applied, how much is used, and how long it stays on the skin depends on what it is needed for.
  • Your doctor, pharmacist or nurse will apply the cream or show you how to do it yourself.
  • If the cream is used on the genitals, use should be supervised by a doctor or nurse.
• Use on the skin before minor procedures (such as needle insertion or minor skin operations):
  • A thick layer of cream is applied to the skin. Your doctor, pharmacist or nurse will tell you where to apply it.
  • The cream is then covered with a plaster (plastic wrap). This is removed shortly before the start of the procedure. If you apply the cream yourself, make sure your doctor, pharmacist or nurse has given you patches.
  • The usual dose for adults and adolescents over 12 years of age is 2 g.
  • For adults and adolescents over 12 years of age, the cream is applied at least 60 minutes before the procedure (unless the cream is used on the genital area). However, do not apply them more than 5 hours before the procedure.
  • In children, the amount and duration of the cream depends on the age of the children. Your doctor, pharmacist or nurse will tell you how much to use and when to apply the cream.
• Use on larger areas of freshly shaved skin for outpatient procedures (such as hair removal techniques):
  • The usual dose is 1 g of cream for each 10 cm ² (ten square centimeter) area of skin, applied under a plaster for 1 to 5 hours. The cream should not be used on a freshly shaved area of ​​skin that is larger than 600 cm ² (600 square centimeters, e.g. 30 cm by 20 cm). The maximum dose is 60 g.
• Use on the skin before inpatient procedures (e.g. split-thickness skin grafts) that require a stronger anesthetic of the skin:
  • The cream can 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 for each area of ​​skin that is 10 cm ² (ten square centimeters) in size .
  • The cream is applied under a plaster for 2 to 5 hours.
• Use on the skin prior to the removal of lesions similar to lesions, called "mollusca"
  • The cream can be used in children and adolescents with a skin condition called "atopic dermatitis".
  • The usual dose depends on the age of the child. It is used for 30 to 60 minutes (30 minutes if the patient has atopic dermatitis). Your doctor, nurse or pharmacist will tell you how much cream to use.
• Use on the genital skin before injections of local anesthetics
  • The cream can only be used in this way in adults and adolescents over 12 years of age.
  • The usual dose is 1 g of cream (1 g to 2 g on female genital skin) for each area of ​​skin that is 10 cm ² (10 square centimeters) in size .
  • The cream is applied and covered with a plaster. This happens for 15 minutes on the male genital skin and for 60 minutes on the female genital skin.
• Use on the genital skin before minor surgical procedures (such as wart removal)
  • The cream can only be used in this way in adults and adolescents over 12 years of age.
  • The usual dose is 5 g to 10 g of cream for 10 minutes. No patch is used. The medical procedure should then begin immediately.
• Use on leg ulcers before cleaning or removing damaged skin
  • The usual dose is 1 g to 2 g of cream for each area of ​​skin that is 10 cm ² in size, up to a total dose of 10 g.
  • The cream is placed under an airtight band-aid, e.g. B. a plastic sheet applied. This is done for 30 to 60 minutes before the ulcer is supposed to be cleaned. Remove the cream with gauze and start cleaning without delay.
  • The cream can be used up to 15 times over a period of 1 to 2 months before cleaning leg ulcers.
  • The cream is intended for single use only for use on leg ulcers. Dispose of the tube with the remaining contents after each treatment.

• If you use more than you should
  • If you have used more than your doctor, pharmacist or nurse has told you, tell them immediately, even if you don't notice any signs of illness.
  • Symptoms after using too much cream are listed below. The discomfort is unlikely to occur if the cream is used as recommended.
    • Feeling light-headed or dizzy
    • Tingling around the mouth and numbness of the tongue
    • Unusual taste
    • Blurred vision
    • Ringing in the ear
    • There is also a risk of 'acute methaemoglobinaemia' (a problem with levels of blood pigment). This is more likely if certain medicines are taken at the same time. When this occurs, the skin turns blue-gray from lack of oxygen.
  • In severe cases of overdose, signs of illness such as seizures, low blood pressure, slow breathing, stopped breathing and an altered heartbeat may occur. These effects can be life threatening.

• If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Lidocaine - prilocaine cream way

• Always use this medicine exactly as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.
• Application of the cream
  • Where the cream is applied, how much is used, and how long it stays on the skin depends on what it is needed for.
  • Your doctor, pharmacist or nurse will apply the cream or show you how to do it yourself.
  • If the cream is used on the genitals, use should be supervised by a doctor or nurse.
• Do not apply the cream on the following areas of skin:
  • Cuts, abrasions, or wounds, with the exception of leg ulcers.
  • In areas with a rash or eczema.
  • On or near the eyes.
  • In the nose, ear or mouth.
  • In the anus region (anus).
  • On the genitals of children.
• People who frequently apply or remove cream should ensure that contact with the cream is avoided to prevent the development of hypersensitivity.
• The protective membrane on the tube opening can be pierced using the screw cap.
• Use on the skin before minor procedures (such as needle insertion or minor skin operations):
  • A thick layer of cream is applied to the skin. Your doctor, pharmacist or nurse will tell you where to apply it.
  • The cream is then covered with a plaster (plastic wrap). This is removed shortly before the start of the procedure. If you apply the cream yourself, make sure your doctor, pharmacist or nurse has given you patches.
  • The usual dose for adults and adolescents over 12 years of age is 2 g.
  • For adults and adolescents over 12 years of age, the cream is applied at least 60 minutes before the procedure (unless the cream is used on the genital area). However, do not apply them more than 5 hours before the procedure.
  • In children, the amount and duration of the cream depends on the age of the children. Your doctor, pharmacist or nurse will tell you how much to use and when to apply the cream.
• When applying the cream, it is important that you carefully follow the instructions below:
  • 1. Squeeze a pile of cream out of the tube where it is needed (for example, where the needle is to be inserted).
  • 2. Do not massage the cream.
  • 3. Peel off the release liner in the center of the patch.
  • 4. Peel off the paper backing from the patch. Then carefully place the plaster over the pile of cream. Do not spread the cream under the patch.
  • 5. Remove the plastic edge from the patch. Carefully press down on the corners of the patch. Then leave it that way for at least 60 minutes.
  • 6. Your doctor or nurse will take the patch off and remove the cream just before they start the medical procedure (for example, just before the needle is inserted).
• Use on larger areas of freshly shaved skin for outpatient procedures (such as hair removal techniques):
  • The usual dose is 1 g of cream for each 10 cm ² (ten square centimeter) area of skin, applied under a plaster for 1 to 5 hours. The cream should not be used on a freshly shaved area of ​​skin that is larger than 600 cm ² (600 square centimeters, e.g. 30 cm by 20 cm). The maximum dose is 60 g.
• Use on the skin before inpatient procedures (e.g. split-thickness skin grafts) that require a stronger anesthetic of the skin:
  • The cream can 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 for each area of ​​skin that is 10 cm ² (ten square centimeters) in size .
  • The cream is applied under a plaster for 2 to 5 hours.
• Use on the skin prior to the removal of lesions similar to lesions, called "mollusca"
  • The cream can be used in children and adolescents with a skin condition called "atopic dermatitis".
  • The usual dose depends on the age of the child. It is used for 30 to 60 minutes (30 minutes if the patient has atopic dermatitis). Your doctor, nurse or pharmacist will tell you how much cream to use.
• Use on the genital skin before injections of local anesthetics
  • The cream can only be used in this way in adults and adolescents over 12 years of age.
  • The usual dose is 1 g of cream (1 g to 2 g on female genital skin) for each area of ​​skin that is 10 cm ² (10 square centimeters) in size .
  • The cream is applied and covered with a plaster. This happens for 15 minutes on the male genital skin and for 60 minutes on the female genital skin.
• Use on the genital skin before minor surgical procedures (such as wart removal)
  • The cream can only be used in this way in adults and adolescents over 12 years of age.
  • The usual dose is 5 g to 10 g of cream for 10 minutes. No patch is used. The medical procedure should then begin immediately.
• Use on leg ulcers before cleaning or removing damaged skin
  • The usual dose is 1 g to 2 g of cream for each area of ​​skin that is 10 cm ² in size, up to a total dose of 10 g.
  • The cream is placed under an airtight band-aid, e.g. B. a plastic sheet applied. This is done for 30 to 60 minutes before the ulcer is supposed to be cleaned. Remove the cream with gauze and start cleaning without delay.
  • The cream can be used up to 15 times over a period of 1 to 2 months before cleaning leg ulcers.
  • The cream is intended for single use only for use on leg ulcers. Dispose of the tube with the remaining contents after each treatment.

Lidocaine - prilocaine cream Side effects

• Like all medicines, this medicine can have side effects, although not everybody gets them.
• If any of the listed side effects get on or you think they won't go away, please talk to your doctor or pharmacist. Tell your doctor about anything else that makes you feel uncomfortable while using this product.
• A slight reaction (pale or reddening of the skin, slight swelling, initial burning or itching) may occur on the area where the product is used. These are normal reactions to the cream and the anesthetics that will go away after a short time without any action being taken.
• If you experience any unpleasant or unusual effects while using the medicine, stop using it and tell your doctor or pharmacist as soon as possible.
• Common (may affect up to 1 in 10 people)
  • Temporary local skin reactions (paleness, reddening, swelling) on ​​the treated area during treatment of the skin, genital mucosa or leg ulcers.
  • An initial slight burning, itching or warm feeling on the treated area during treatment of the genital mucosa or leg ulcers.
• Uncommon (may affect up to 1 in 100 people)
  • An initial slight burning, itching or warm feeling on the treated area during the treatment of the skin.
  • Numbness (tingling sensation) on the treated area during treatment of the genital mucosa.
  • Irritation of the treated skin during the treatment of leg ulcers.
• Rare (may affect up to 1 in 1,000 people)
  • Allergic reactions which in rare cases may lead to anaphylactic shock (rash, swelling, fever, difficulty breathing and fainting) during treatment of the skin, genital mucosa or leg ulcers.
  • Methaemoglobinaemia (blood disorder) during skin treatment.
  • Small, punctiform bleeding on the treated area (especially in children with eczema after longer exposure times) during the treatment of the skin.
  • Irritation of the eyes if accidentally comes into contact with the medicine while treating the skin.
• Additional side effects in children
  • Methaemoglobinemia, a blood disorder that is seen more frequently, often related to overdose in newborns and infants 0 to 12 months of age.
• If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not specified.

Lidocaine - prilocaine cream Interactions

• Use with other medicines
  • Tell your doctor or pharmacist if you are taking, have recently used, or are planning to use any other medicines.
  • This includes medicines that are available without a prescription and herbal medicines. This is because this preparation can affect the way other medicines work, and other medicines can have an influence on this preparation.
  • In particular, tell your doctor and pharmacist if you or your child have recently used or been given any of the following medicines:
    • Medicines used to treat infections called "sulfonamides" and nitrofurantoin.
    • Medicines used in epilepsy, such as phenytoin and phenobarbital.
    • Other local anesthetics.
    • Medicines to treat an irregular heartbeat, such as amiodarone.
    • Cimetidine or beta blockers, which may increase the levels of lidocaine in the blood. This interaction is clinically insignificant during short-term treatment with this cream within the recommended dosages.

Lidocaine - prilocaine cream Contraindications

• The drug must not be used
  • if you are allergic to lidocaine or prilocaine, other similar local anesthetics, or any of the other ingredients of this medicine.

Lidocaine - prilocaine cream pregnancy and breast feeding period

• Ask your doctor or pharmacist for advice before using this medicine if you are pregnant or breast-feeding, if you suspect you may be pregnant or planning to become pregnant.
• pregnancy
  • Occasional use of the cream during pregnancy is unlikely to have any adverse effects on the unborn child.
• Breastfeeding
  • The active ingredients in this cream (lidocaine and prilocaine) are excreted in breast milk. However, the amount is so small that there is generally no risk to the child.
• Fertility
  • Animal studies showed no impairment of male or female fertility or childbearing ability.

Lidocaine - prilocaine cream Patient information

• Warnings and Precautions
  • Talk to your doctor or pharmacist before using this medicine:
    • if you or your child have a rare hereditary disease called "glucose-6-phosphate dehydrogenase deficiency" which affects the blood.
    • if you or your child have a problem with the levels of the pigment methaemoglobin in the blood called 'methaemoglobinaemia'.
    • With the exception of leg ulcers, do not apply the medicine to areas with rashes, cuts, abrasions, or other open wounds. If any of these problems apply, talk to your doctor or pharmacist before using the cream.
    • If you or your child has an itchy skin disease called "atopic dermatitis", a shorter exposure time may be sufficient. An exposure time longer than 30 minutes can lead to an increased occurrence of local vascular reactions.
    • if you are taking special medicines for irregular heartbeat (class III antiarrhythmics such as amiodarone). In this case, the doctor will monitor your heart function.
    • Due to the possible increased absorption through the freshly shaved skin, it is important to adhere to the recommended dosage, skin area and exposure time.
    • Avoid getting the medicine in your eyes as it may cause irritation. If the medicine accidentally gets into your eye, you should immediately rinse it well with lukewarm water or sodium chloride 9 mg / ml (0.9%) solution. Be careful not to get anything in your eye until the feeling has returned.
    • The drug should not be used on a damaged eardrum.
    • If you use the preparation before vaccinations with live vaccines (e.g. tuberculosis vaccinations), you should visit your doctor or nurse again within the specified period to check the vaccination result.
• Children and adolescents
  • In infants / newborns under 3 months of age, a transient, clinically insignificant increase in the concentration of the blood pigment methaemoglobin in the blood ("methaemoglobinaemia") is often observed for up to 12 hours after application of lidocaine / prilocaine cream.
  • The effectiveness of lidocaine / prilocaine cream for taking blood from the heel of newborns or for ensuring adequate pain relief during circumcision has not been confirmed in clinical studies.
  • Due to insufficient data on the absorption of the active substance, the preparation should not be used on the genital mucous membrane (e.g. in the vagina) in children (under 12 years of age).
  • The medicine should not be used in children under 12 months of age who are being treated with other medicines that affect the levels of the blood pigment methaemoglobin ("methaemoglobinaemia") in the blood (e.g. sulphonamides).
  • The drug should not be used in premature babies.

• Driving and using machines
  • This medicinal product has no or negligible influence on the ability to drive and use machines when used in the recommended doses.