• When applying the cream, it is important that you follow the instructions below exactly:
  • 1. Squeeze a small amount of cream from the tube onto the area where it is needed (for example, where the needle will be inserted). Do not massage the cream in.
  • 2. Peel the paper layer from the middle cutout of the patch on the non-adhesive side (a paper frame will remain).
  • 3. Peel off the backing on the adhesive side of the plaster.
  • 4. Carefully place the plaster over the mound of cream. Do not spread the cream under the plaster.
  • 5. Remove the paper backing. Press the corners of the patch down firmly. Then leave it in place for at least 60 minutes.
  • 6. Your doctor or medical staff will remove the patch and cream immediately before performing the medical procedure (e.g., just before the needle insertion).

• Always use this medicine exactly as described in the package leaflet or 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 preparation
  • Where the cream is applied, how much is used, and how long it remains on the skin depends on its intended use. Half a 5g tube contains approximately 2g of cream. One gram of cream squeezed from the tube is about 3.5cm long.
  • The cream should only be applied to the genitals by a doctor or medical professional.
  • If the preparation is used on leg ulcers, a doctor or medical professional should supervise the application.
• Do not apply the cream to the following areas of skin:
  • Cuts, abrasions or wounds, except for leg ulcers.
  • in areas with skin rashes or eczema.
  • on or near the eyes.
  • in the nose, ear, or mouth.
  • in the anal 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 at the tube opening can be pierced using the cap.
• Application to the skin before minor procedures (such as needle pricks or minor skin surgeries):
  • Apply a thick layer of cream to the skin. Follow the instructions or those of the medical professional. In certain cases, the medical professional must apply the cream.
  • The cream is then covered with a plaster (plastic film). This is removed shortly before the procedure begins. If you are applying the cream yourself, make sure that your doctor, pharmacist, or healthcare professional has provided you with plasters.
  • 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 should be applied at least 60 minutes before the procedure (unless the cream is being used in the genital area). However, do not apply it more than 5 hours before the procedure.
• Children
  • Application to the skin before minor procedures (such as needle pricks or minor skin surgeries)
    • Exposure time: approx. 1 hour.
  • Newborns and infants from 0 to 2 months:
    • Up to 1 g of cream on a skin area no larger than 10 cm² ⁽ 10 square centimeters).
    • Exposure time: maximum 1 hour.
    • Only one single dose may be used within a 24-hour period.
  • Infants aged 3 to 11 months:
    • Up to 2 g of cream on a skin area that is not larger than 20 cm² ⁽ 20 square centimeters).
    • Exposure time: approx. 1 hour, maximum 4 hours.
  • Children aged 1 to 5 years:
    • Up to 10 g of cream on a skin area that is not larger than 100 cm² ⁽ 100 square centimeters).
    • Exposure time: approx. 1 hour, maximum 5 hours.
  • Children aged 6 to 11 years:
    • Up to 20g of cream on a skin area that is not larger than 200 cm² ⁽ 200 square centimeters).
    • Exposure time: approx. 1 hour, maximum 5 hours.
    • In children over 3 months of age, a maximum of 2 doses may be administered at intervals of 12 hours within a 24-hour period.
    • The cream can be used on children with a skin condition called "atopic dermatitis", however, the application time should not exceed 30 minutes.
• Application on larger areas of freshly shaved skin during outpatient procedures (such as hair removal techniques):
  • Follow the instructions of your medical professional.
    • ^{The usual dose is 1 g of cream for each 10 cm²} (ten square centimeters) area of skin , applied under a plaster for 1 to 5 hours. The cream should not be applied to freshly shaved skin larger than 600 cm² ⁽ 600 square centimeters, e.g., 30 cm by 20 cm).
    • The maximum dose is 60 g.
• Application to the skin prior to inpatient procedures (e.g. split-thickness skin grafts) that require stronger skin anesthesia:
  • The preparation can be used in this way in adults and adolescents over 12 years of age, but only under the supervision of a doctor or medical professional.
  • The usual dose is 1.5 g to 2 g of cream for each area of skin measuring 10 cm² ⁽ ten square centimeters).
  • The cream is applied under a plaster for 2 to 5 hours.
• Application to the skin prior to the removal of molluscum contagiosum-like skin lesions:
  • The preparation can be used in children and adolescents with a skin condition called "atopic dermatitis".
  • The usual dose depends on the child's age. It is applied for 30 to 60 minutes (30 minutes if the patient has atopic dermatitis).
  • Your doctor, medical professional or pharmacist will tell you how much cream to use.
• Application to the genital skin before injections of local anesthetics:
  • The cream can only be applied in this way to adults and adolescents over 12 years of age by medical professionals.
  • The usual dose is 1 g of cream (1 g to 2 g on female genital skin) for each area of skin measuring 10 cm² ⁽ 10 square centimeters).
  • The cream is applied and covered with a plaster. This is done for 15 minutes on male genital skin and for 60 minutes on female genital skin.
• Application to the genital skin before minor surgical procedures (such as wart removal)
  • In this way, the preparation can only be administered to adults and adolescents over 12 years of age by medical professionals.
  • The usual dose is 5 g to 10 g of cream applied for 10 minutes. No plaster is used. The medical procedure should begin immediately afterwards.
• Apply to leg ulcers before cleaning or removing damaged skin:
  • The cream can be used in this way in adults, but only under the supervision of a doctor or medical professional.
  • The usual dose is 1 g to 2 g of cream for each skin area of 10 cm² ^up to a total dose of 10 g.
  • The cream is applied under an airtight dressing, such as plastic wrap. This is done for 30 to 60 minutes before the ulcer is to be cleaned. Remove the cream with gauze and begin cleaning without delay.
  • The preparation 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 on leg ulcers.
  • Dispose of the tube with the remaining contents after each treatment.

• If you have applied a larger amount than you should
  • If you have used a larger amount than indicated in the package leaflet, or a larger amount than your doctor, pharmacist or healthcare professional has told you to, inform them immediately, even if you do not notice any signs of illness.
  • Symptoms that may occur after applying too much cream are listed below. These symptoms are unlikely to occur if the cream is used as directed.
    • A feeling of lightheadedness or dizziness
    • Tingling around the mouth and numbness of the tongue
    • Unusual taste
    • Blurred vision
    • Ringing in the ears
  • There is also a risk of acute methemoglobinemia (a problem with blood pigment concentration). This is more likely if certain medications are taken concurrently. If this occurs, the skin will turn bluish-gray due to a lack of oxygen.
  • In severe cases of overdose, symptoms such as seizures, low blood pressure, slowed breathing, respiratory arrest, and altered heartbeat may occur. These effects can be life-threatening.

• If you have any further questions about the use of this medicine, ask your doctor, pharmacist or healthcare professional.

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