EMLA 25 mg/g + 25 mg/g cream + 12 Tegaderm plants, 5X5 g

Instructions for use for EMLA 25 mg/g + 25 mg/g cream + 12 Tegaderm plants, 5X5 g

Application Notes

Application areas

Mode of action

How do the ingredients of the drug work?

The drug consists of a combination of the two active ingredients lidocaine and prilocaine, which belong to the group of local anaesthetics. The active ingredients suppress the transmission of stimuli in the nerves, making them insensitive to pain and itching and leading to a localized anaesthetic.

Composition

Contraindications

What speaks against an application?

Always:
- Hypersensitivity to the ingredients

Under certain circumstances - talk to your doctor or pharmacist about this:
- Hereditary enzyme disorder (glucose-6-phosphate dehydrogenase deficiency)
- Decreased oxygen transport of red blood cells (methaemoglobinaemia)
- Neurodermatitis

What age group do you need to consider?
- Children and adolescents under the age of 18: In this age group, the drug should only be used in certain areas of application. Please ask your doctor or pharmacist, if you have questions regarding this topic.

What about pregnancy and lactation?
- Pregnancy: consult your doctor. Various considerations play a role in whether and how the drug can be used during pregnancy.
- Breast-feeding: According to current knowledge, there are no indications that the drug should not be used during breast-feeding.

If you have been prescribed the drug despite a contraindication, talk to your doctor or pharmacist. The therapeutic benefit can be higher than the risk that the use entails in the event of a contraindication.

Side effects

What adverse effects may occur?

- Pain at the application site
- Itching at the application site
- Skin redness at the application site
- Water retention at the application site
- Feeling of warmth at the application site
- Light skin coloration at the application site
- Irritated application site
- Skin discomfort at the application site
- Decreased oxygen transport of red blood cells (methaemoglobinaemia)
- Hypersensitivity
- Irritation of the cornea
- Small to large patches of skin damage (skin lesion), especially after prolonged treatment of children with neurodermatitis or molluscs

If you notice any discomfort or changes during treatment, contact your doctor or pharmacist.

For the information at this point, side effects are primarily taken into account that occur in at least one in 1,000 patients treated.

Hints

What should you consider?
- Be careful with allergies to local anesthetics (local anesthetics such as articaine, bupivacaine, lidocaine, mepivacaine, prilocaine, ropivacaine)!
- Solubilizers (e.g. poly(oxyethylene) castor oils) can cause skin irritation.
- There may be medicines with which interactions occur. You should therefore generally tell your doctor or pharmacist about any other medicine you are already using before starting treatment with a new medicine. This also applies to medicines that you buy yourself, use only occasionally or have been using for some time.

Detailed instructions for EMLA 25 mg/g + 25 mg/g cream + 12 Tegaderm plants, 5X5 g

Field of use

Emla 25 mg/g + 25 mg/g cream + 12 Tegaderm (pack size: 5X5 g) locally anesthetizes the skin and thus reduces the pain sensation on the treated skin area.

Suitable areas of application include, for example, skin anesthesia in preparation for vaccination or surface anesthesia before tattooing a larger area of skin.

Emla products are dermatologically tested and are of the highest quality.

Emla 25 mg / g + 25 mg / g cream + 12 Tegaderm (pack size: 5X5 g) is a numbing ointment / numbing cream and allows easy and uncomplicated application to the areas to be treated. It is used for local anesthesia of the skin and mucous membranes to reduce the sensation of pain. Emla Creme is dermatologically tested.

Active substances / ingredients / ingredients

25 mg lidocaine
25 mg prilocaine
Carbomer 974P excipient (+)
Macrogol glycerol hydroxystearate excipient (+)
Sodium hydroxide excipient (+)
Water, purified excipient (+)

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.

dosage

Recommended use of Emla 25 mg/g + 25 mg/g cream + 12 Tegaderm (pack size: 5X5 g):

The dosage for adults and adolescents over 12 years of age is 2 g of cream for minor procedures and a maximum of 60 g for larger skin areas. Applying the cream is easy and uncomplicated. The exposure time of the EMLA cream is 1-2 hours. The effect then lasts for at least 2 hours. Please follow the instructions in the leaflet.

Revenue

• When applying the cream it is important that you follow the instructions below exactly:
  • 1. Squeeze out a mound of cream from the tube where it is needed (e.g. where you want the needle to go). Do not massage in the cream.
  • 2. Peel off the paper layer from the center cutout of the patch on the non-stick side (a paper frame will remain).
  • 3. Peel off the liner on the sticky side of the patch.
  • 4. Gently place the patch over the mound of cream. Do not spread the cream under the patch.
  • 5. Remove the paper backing. Carefully press the corners of the patch. Then leave it like that for at least 60 minutes.
  • 6. Your doctor or nurse will take off the patch and remove the cream just before doing the medical procedure (e.g. just before the needle is put in).

Patient notes

• Warnings and Precautions
  • Talk to your doctor, pharmacist or nurse before using the cream,
    • if you or your child have a rare hereditary disease called "glucose-6-phosphate dehydrogenase deficiency" that affects the blood.
    • if you or your child have a problem with the blood levels of the blood pigment methaemoglobin, called "methaemoglobinaemia.
    • Except for leg ulcers, do not apply the cream to areas with a rash, cuts, abrasions, or other open wounds. If any of these problems occur, talk to your doctor, pharmacist or nurse before using the cream.
    • if you or your child have an itchy skin condition called "atopic dermatitis", a shorter exposure time may be sufficient. Exposure longer than 30 minutes may lead to an increased occurrence of local vascular reactions.
    • if you are taking special medicines for heart rhythm problems (class III antiarrhythmics such as amiodarone). In this case, the doctor will monitor your heart function.
  • Due to the possible increased absorption through freshly shaved skin, it is important to adhere to the recommended dosage, skin area and exposure time.
  • Avoid getting the cream in your eyes as this can cause irritation. If the cream accidentally gets into your eye, you should immediately rinse it well with lukewarm water or saline (sodium chloride) solution. Be careful not to get anything in your eye until feeling returns.
  • The preparation should not be used on a damaged eardrum.
  • If you use the cream 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 young people
    • In infants/newborns younger than 3 months, a temporary, clinically insignificant increase in the concentration of the blood pigment methemoglobin in the blood is often observed up to 12 hours after application of the cream (methaemoglobinaemia").
    • Clinical trials have not confirmed the effectiveness of the cream for blood collection from the heel of newborns or for providing adequate analgesia during circumcision.
    • Due to insufficient data on the absorption of the active substance, the cream should not be used on the genital skin (e.g. penis) and genital mucosa (e.g. in the vagina) in children (under 12 years of age).
    • The preparation should not be used in children younger than 12 months who are being treated with other medicines that affect the blood concentration of the blood pigment methemoglobin ("methaemoglobinaemia") (e.g. sulfonamides).
    • The cream should not be used on premature babies.

• Ability to drive and use machines
  • The drug has no or negligible influence on the ability to drive and use machines when used at the recommended doses.

Pregnancy

• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
• Pregnancy
  • Occasional use of the cream during pregnancy is unlikely to have any adverse effects on the unborn child.
• Lactation
  • The active ingredients of the drug (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 have not shown any impairment of male or female fertility.

Hints

Manufacturer: Aspen Germany GmbH, Montgelasstraße 14, 81679 Munich