25 mg / g + 25 mg / g cream 
lidocaine / prilocaine

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Denela is and what it is used for 
2. What you need to know before using Denela 
3. How to use Denela 
4. Possible side effects 
5. How to store Denela 
6. Contents of the packaging and other information 

1. What Denela is and what it is used for

Denela contains two active substances, lidocaine, and prilocaine. They belong to the group of drugs local anesthetics (local anesthetics).

Denela works by numbing the skin for a short time. The cream one is applied to the skin before certain medical procedures. The pain in the skin decreases but you can still feel pressure and touch.

Adults, adolescents, and children:

Cream one can be used to numb the skin before

  • needle stick (eg an injection or a blood test)
  • minor skin surgeries.

Adults and adolescents:

Cream one can also be used to numb the genitals before

  • injection
  • medical procedures (eg removal of genital warts).

When using Denela on the genitals, a doctor or nurse should monitor the use.

Adults:

Cream one can also be used to numb the skin before

  • cleaning or removing damaged skin on leg ulcers.

When used for purposes other than an application to undamaged skin, the product should only be used as recommended by a doctor, pharmacist, or nurse.

Lidocaine and prilocaine contained in Denela may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before using Denela

Do not use Denela

  • if you are allergic to lidocaine or prilocaine or similar types of local anesthetic or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before using Denela:

  • if you or your child have a rare inherited blood disorder called “glucose-6-phosphate dehydrogenase deficiency”.
  • if you or your child has a problem with the pigment content in the blood, so-called “methemoglobinemia”.
  • Do not use Denela on skin areas with rashes, cuts, abrasions, or other open wounds, except leg ulcers. If you have any of these problems, talk to your doctor, pharmacist, or nurse before using the cream.
  • if you or your child has itchy skin, so-called atopic eczema, it may be enough if the cream is applied to the skin for a shorter time. If the cream is left on the skin for longer than 30 minutes, it may lead to more local skin reactions (see also section 4 “Possible side effects”).
  • if you are taking certain medicines to treat heart rhythm disorders ( class III antiarrhythmics, such as amiodarone ). In that case, your doctor will monitor your heart function.

Because the cream may be absorbed more easily into freshly shaved skin, it is important to follow the recommended dosage skin surface and application time.

Avoid getting Denela in the eyes as it may irritate. If you accidentally get Denela in your eyes, rinse immediately with plenty of lukewarm water or saline (sodium chloride). Be careful not to get anything in your eye until the sensation has returned.

Denela should not be used on a damaged eardrum.

If you are using Denela before being vaccinated with a live vaccine (eg tuberculosis vaccine), make an appointment to see your doctor or nurse check the results of your vaccination.

Children and young people

In infants/newborns under 3 months of age, a temporary increase in the blood pigment methemoglobin is common for up to 12 hours after the application of Denela. However, this temporary increase has no significant effect on the child.

Clinical studies have not been able to confirm that Denela has an effect on sampling on the heel in newborns or that it provides sufficient pain relief during circumcision.

Denela should not be applied to the skin of the genitals (eg penis) or genital mucosa (eg vagina ) in children (under 12 years of age). There are insufficient data on how the active ingredients are absorbed into the body.

Denela should not be used in children under 12 months of age who are being treated concomitantly with other medicines that affect the amount of the blood pigment methemoglobin (eg sulfonamides, see also section 2, “Other medicines and Denela”). 

Denela should not be used on premature babies.

Other drugs and Denela

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. This also applies to over-the-counter medicines and herbal medicines. Namely, Denela may affect the way some other medicines work, and some medicines may affect how Denela works.

You must tell your doctor or pharmacist if you or your child have recently taken or been treated with any of the following medicines:

  • Drugs for treating infections, such as sulfonamides and nitrofurantoin.
  • Drugs for the treatment of epilepsy, such as phenytoin and phenobarbital.
  • Other local anesthetics.
  • Drugs for irregular heartbeats, such as amiodarone.
  • Cimetidine or beta-blockers, like these, can increase the level of lidocaine in the blood. This effect has no practical significance in the recommended dose for short-term treatment with Denela.

Pregnancy, breastfeeding, and fertility

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 taking this medicine.

Occasional use of Denela during pregnancy is unlikely to hurt the fetus.

The active substances in Denela ( lidocaine and prilocaine) are excreted in breast milk, but in such small amounts that it generally does not pose a risk to the baby.

Animal studies have not shown any deterioration in male or female fertility.

Driving and using machines

Denela has no or negligible effect on the ability to drive and use machines when used at recommended doses.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Denela contains excipients

Denela contains macrogol glycerol hydroxy stearate

Macrogolglycerol hydroxy stearate may cause skin reactions.

3. How to use Denela

Always use this medicine exactly as your doctor, pharmacist or nurse has told you. If you are not sure, talk to your doctor, pharmacist, or nurse.

How to use Denela

  • Which cream to use, how much to use and how long it should last depends on what it is to be used for. A half 5-gram tube is equivalent to about 2 grams of Denela. 1 gram Denela corresponds to approximately a 3.5 cm long string that is pressed out of the tube.
  • If Denela is to be used on the genitals, this should only be done by a doctor or nurse.
  • If Denela is to be used on leg ulcers, a doctor or nurse should monitor its use.

Do not use Denela in the following areas:

  • Cuts, abrasions, and wounds, except leg ulcers.
  • On skin with rash or eczema.
  • In or near the eyes.
  • Inside the nose, ears, or mouth.
  • In the anal opening.
  • On the genitals of children.

People who frequently apply or remove cream should avoid contact with the cream to prevent the development of hypersensitivity.

Make a hole in the tube’s protective membrane by pressing the lid against the membrane.

Use on the skin before small procedures (eg needle sticks or simple skin operations):

  • Apply cream one on the skin in a thick layer. Follow the instructions in the package leaflet or from the healthcare professional. In some cases, healthcare professionals have to apply a cream.
  • Then cover the cream with a bandage (plastic wrap). This is removed just before the procedure. If you are going to apply a cream yourself, check that you have been bandaged by your doctor, pharmacist, or nurse.
  • The usual dose for adults and adolescents over 12 years of age is 2 g (grams).
  • For adults and adolescents over 12 years of age, cream one is applied at least 60 minutes before the procedure (unless cream one is used on the genitals). However, do not apply cream one earlier than 5 hours before the procedure.

Children

Use on the skin before small procedures (eg needle sticks or simple skin operations): Application time: about 1 hour.

Newborns and infants 0-2 months:  Up to 1 g of cream on a skin surface no larger than 10 cm 2 (10 square centimeters). Application time: 1 hour, no longer. E only one dose should be applied in a 24-hour period.

Infants 3–11 months: Up to 2 g of cream on a total skin area not larger than 20 cm 2(20 square centimeters). Application time: approximately 1 hour, maximum 4 hours.

Children 1-5 years: Up to 10 g of cream on a total skin area not larger than 100 cm 2(100 square centimeters). Application time: approximately 1 hour, maximum 5 hours.

Children 6-11 years: Up to 20 g of cream on a total skin area not larger than 200 cm2 (200 square centimeters). Application time: approximately 1 hour, maximum 5 hours.

For children aged 3 months and older, a maximum of 2 doses can be given, at least 12 hours apart, over a 24-hour period.

Denela can be used on children with a skin condition called “atopic dermatitis”, but the application time is then 30 minutes, no longer.

When applying the cream, you must follow the instructions below exactly:

  1. Apply a dollop of cream to the area to be anesthetized (eg where the needle is to be inserted). A half 5-gram tube is equivalent to about 2 g of Denela. 1 gram of Denela corresponds to approximately a 3.5 cm long string that is pressed out of the tube. Do not rub in cream one.


  2. Remove the paper layer from the dressing.


  3. Remove the guards from the dressing. Carefully place the dressing over the click with cream. Do not apply cream under the dressing.


  4. Remove the plastic cover. Carefully apply the edges of the dressing to the skin. Then let it sit for at least 60 minutes.


  5. The doctor or nurse removes the dressing and creams it just before the procedure (for example, just before the needle stick).

Use on larger areas of freshly shaved skin before outpatient procedures (eg hair removal):

Follow instructions from healthcare professionals.

The usual dose is 1 g of cream for each area of ​​skin of 10 cm² (10 square centimeters), which is allowed to sit for 1 to 5 hours under a dressing. Denela should not be used on an area with freshly shaved skin that is larger than 600 cm² (600 square centimeters, eg 30 cm x 20 cm). The maximum dose is 60 grams.

Use on the skin, before hospital procedures (eg removal of partial skin for transplantation) which requires more in-depth anesthesia:

  • Denela can be used in this way on adults and adolescents over 12 years of age, but only under the supervision of a doctor or nurse.
  • The usual dose is 1.5 g to 2 g of cream for each skin area of ​​10 cm 2 (10 square centimeters).
  • Cream one can lie on under a bandage for 2 to 5 hours.

Use on the skin before removing wart-like lumps, so-called “mollusks”

  • Denela can be used on children and adolescents with a skin condition called atopic dermatitis ( atopic eczema ).
  • Dose one depends on the age of the child and cream one 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 genital skin before injection of local anesthetics

  • Denela can only be used in this way for an application to adults and adolescents over 12 years of age by healthcare professionals.
  • The usual dose is 1 g of cream (1-2 g for the skin on female genitals) on each skin area that is 10 cm 2 (10 square centimeters).
  • The cream one is applied under a dressing. Cream one may work for 15 minutes on men and 60 minutes on women.

Use on genitals before minor surgery (eg removal of condyloma )

  • Denela can only be used in this way and for application to adults and adolescents over 12 years of age by healthcare professionals.
  • The usual dose is 5-10 g of cream for 10 minutes. Cover bandages are not used. The procedure is then started immediately.

Use on leg ulcers before cleaning or removing damaged skin

  • Denela can be used in this way in adults, but only under the supervision of a doctor or nurse.
  • The usual dose is 1-2 g of cream on each skin area which is 10 cm 2 (10 square centimeters). The maximum dose is 10 grams.
  • The cream is applied under an airtight dressing, e.g. plastic film. This is done 30-60 minutes before the wound is to be cleaned. Wipe off the cream with a gauze bandage and start cleaning immediately.
  • Denela can be used for cleaning leg ulcers up to 15 times over a period of 1-2 months.
  • The Denela tube is intended for single-use when used on leg ulcers. After each time a patient has been treated, the tube with the remaining contents should be discarded.

If you use more Denela than you should 

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you have used more Denela than recommended in this leaflet or more than your doctor, pharmacist or nurse have told you to, talk to one of them immediately, even if you have no symptoms.

The symptoms when you use too much Denela are listed in the list below. If Denela is used according to the recommendations, it is unlikely that you will get these symptoms.

  • You feel dizzy or faint.
  • Tingling in the skin around the mouth and numbness in the tongue.
  • Abnormal taste experience.
  • Tamsyn.
  • Tinnitus.
  • There is also a risk of acute methemoglobinemia (problems with the amount of pigment in the blood). The risk is greater if you have taken certain other medicines at the same time. If this were to happen, the skin would turn blue-gray due to lack of oxygen.

In severe cases of overdose, the symptoms may be seizures, low blood pressure, slow breathing, respiratory arrest, and altered heartbeat. These reactions can be life-threatening.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Contact a doctor or pharmacist if any of the following side effects occur or are not resolved. Tell your doctor if there is anything else that makes you feel unwell while using Denela.

A mild reaction (pale or reddened skin, slight swelling, burning, or itchy sensation at first) may occur on the skin where Denela is used. These are normal reactions to the cream and the anesthetic. They disappear after a short while without you having to do anything.

If you get any annoying or unusual reactions while using Denela, stop using the cream and talk to your doctor or pharmacist as soon as possible.

Common (may affect up to 1 in 10 users:

  • Transient local skin reactions (pallor, redness, swelling) on ​​the treated area in the treatment of skin, mucous membranes of genitals, or leg ulcers.
  • In the beginning a slight burning sensation, itching, or feeling of heat in the treated area when treating mucous membranes on genitals or leg ulcers.

Uncommon (may affect up to 1 in 100 people):

  • A slight burning sensation, itching, or feeling of heat in the treated area when treating skin.
  • Numbness (tingling) in the treated area during treatment of the genital mucosa.
  • Irritated skin in the treated area when treating leg 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) when treating skin, genital mucosa, or leg ulcers.
  • Methemoglobinemia (a blood disease) in the treatment of skin.
  • Small punctate hemorrhages in the treated area (especially in children with eczema if the cream is allowed to sit on the skin for a long time) when treating the skin.
  • Eye irritation if cream accidentally comes in contact with the eyes during skin treatment.

Additional side effects in children

Methemoglobinemia, a blood disorder, is more common in newborns and infants aged 0-12 months, often associated with overdose

5. How to store Denela

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and tube after EXP. The expiration date is the last day of the specified month.

Do not store above 25 ° C. Do not freeze.

This medicine should be discarded 3 months after opening.

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 to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substances are lidocaine and prilocaine. One gram of cream contains 25 mg of lidocaine and 25 mg of prilocaine.
  • The other ingredients are macrogol glycerol hydroxy stearate (hydrogenated polyoxyl castor oil), carbomer (974P), sodium hydroxide, and purified water.

What the medicine looks like and the contents of the pack

Denela 25 mg / g + 25 mg / g cream is a white, soft cream .

Pack sizes:

5 g tub

5 g tube with 2 cover bandages

5 x 5 g tubes with 12 cover bandages

30 g tube with a wooden spatula

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Teva BV

Swensen 5

2031 GA Haarlem

Netherlands

Manufacturer

Biopharma BV

Benjamin Franklin Street 5-10

3261 LW Oud-Beijerland

Netherlands

Muhammad Nadeem

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