25 mg / g + 25 mg / g cream
lidocaine + prilocaine
What Lidocaine / Prilocaine Alternova is and what it is used for
Lidocaine / Prilocaine Alternova contains two active substances, lidocaine and prilocaine. They belong to the drug group local anesthetics (local anesthetics).
Lidocaine / Prilocaine Alternova 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.
Lidocaine and prilocaine contained in Lidocaine / Prilocaine Alternova may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
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 young people
Cream one can also be used to
- numb the genitals before
- injection
- medical procedures, e.g. removal of genital warts.
Only a doctor or nurse should apply Lidocaine / Prilocaine Alternova when used on the genitals.
Adults
Cream one can also be used to numb the skin before
- cleaning or removing damaged skin on leg ulcers.
What you need to know before using Lidocaine / Prilocaine Alternova
Do not use Lidocaine / Prilocaine Alternova
- if you are allergic to lidocaine or prilocaine or similar types of local anesthetics, or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor or pharmacist before using Lidokain / Prilokain Alternova:
- 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 Lidocaine / Prilocaine Alternova on skin areas with rashes, cuts, abrasions or other open wounds, with the exception of leg ulcers. If you have any of these problems, talk to your doctor or pharmacist before using a cream .
- If you or your child has itchy skin 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.
Since 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 contact with Lidocaine / Prilocaine Alternova as it may irritate. In case of contact with Lidocaine / Prilocaine Alternova, 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.
Lidocaine / Prilocaine Alternova should not be used on a damaged eardrum.
If you are using Lidocaine / Prilocaine Alternova before being vaccinated with a live vaccine (eg tuberculosis vaccine), you should 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 Lidocaine / Prilocaine Alternova cream. However, this temporary increase has no significant effect on the child.
Clinical studies have not been able to confirm that Lidocaine / Prilokain Alternova is effective when sampling the heel in newborns or that it provides adequate pain relief during circumcision.
Lidocaine / Prilocaine Alternova should not be applied to the genitals (eg penis) and 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.
Lidocaine / Prilocaine Alternova should not be used in children under 12 months of age treated concomitantly with other medicinal products that affect the amount of the blood pigment methemoglobin (eg sulfonamides, see also section 2, “Other medicinal products and Lidocaine / Prilocaine Alternova”).
Lidocaine / Prilocaine Alternova should not be used in premature infants.
Other medicines and Lidocaine / Prilocaine Alternova
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This also applies to over-the-counter medicines and herbal medicines. Lidocaine / Prilocaine Alternova can affect the way some other medicines work, and certain medicines can affect the way Lidocaine / Prilocaine Alternova 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 the treatment of infections , sulfonamides and nitrofurantoin .
- Drugs for the treatment of epilepsy , phenytoin and phenobarbital.
- Other local anesthetics.
- Drugs for irregular heartbeats, such as amiodarone .
- Cimetidine or beta-blockers , as these can increase the level of lidocaine in the blood. This effect has no practical significance in the recommended doses for short-term treatment with Lidocaine / Prilocaine Alternova.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, 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 Lidocaine / Prilocaine Alternova during pregnancy is unlikely to harm the fetus.
The active substances in Lidocaine / Prilocaine Alternova ( 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
Lidocaine / Prilocaine Alternova has no or negligible effect on the ability to drive and use machines when used in recommended doses.
Lidocaine / Prilocaine Alternova contains macrogolglycerol hydroxystearate
Macrogolglycerol hydroxy stearate may cause skin reactions.
How to use Lidocaine / Prilocaine Alternova
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 Lidocaine / Prilocaine Alternova
- Which cream to use, how much to use and how long it should last depends on what it is to be used for.
- Your doctor, pharmacist or nurse will apply cream or show you how to do it.
- If Lidocaine / Prilocaine Alternova is to be used on the genitals, only a doctor or nurse should apply the cream .
Do not use Lidocaine / Prilocaine Alternova 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 cream one 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. Your doctor, pharmacist or nurse will show you where to apply the 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.
- In the case of children, the amount of Lidocaine / Prilocaine Alternova and how long it should be used depends on the child’s age. Your doctor, nurse or pharmacist will tell you how much cream to take and when to apply it.
You must follow the instructions below exactly when applying the cream.
- Apply a dollop of cream to the area to be anesthetized (eg where the needle is to be inserted). A string of cream about 3.5 cm from a 30-gram tube corresponds to 1 g of cream . A half 5-gram tube corresponds to approximately 2 g of Lidocaine / Prilocaine Alternova. Do not rub in cream one.
- Remove the adhesive protection from the dressing.
- Carefully place the dressing over the click with cream . Do not apply cream under the dressing.
- Remove the paper layer. Carefully apply the edges of the dressing to the skin.Then let it sit for at least 60 minutes if the skin is not damaged. Do not let the cream sit on the skin for more than 60 minutes in children under 3 months or for over 30 minutes in children with the itchy skin disease atopic dermatitis . If a cream is used on genitals or wounds, shorter application times can be applied as described below.
- The doctor or nurse will remove the dressing and cream one 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):
The usual dose is 1 g of cream for each skin area of 10 cm² (10 square centimeters), which is allowed to sit for 1 to 5 hours under a dressing. Lidocaine / Prilocaine Alternova should not be used on an area of freshly shaved skin larger than 600 cm² (600 square centimeters, eg 30 cm x 20 cm). The maximum dose is 60 grams.
Use on the skin, before surgery in a hospital (eg removal of partial skin for transplantation) which requires more in-depth anesthesia:
- Lidocaine / Prilocaine Alternova 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 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”
- Lidocaine / Prilocaine Alternova can be used in children and adolescents with 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 the genitals before injection of local anesthetics
- Lidocaine / Prilocaine Alternova can only be used in this way in adults and adolescents over 12 years of age.
- The usual dose is 1 g of cream (1-2 g on female genitals) on each skin area that is 10 cm 2 (10 square centimeters).
- Cream one is applied under a dressing. Cream one may work for 15 minutes on men and for 60 minutes on women.
Use on genitals before minor surgery (eg removal of condyloma )
- Lidocaine / Prilocaine Alternova can only be used in this way in adults and adolescents over 12 years of age.
- 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
- The usual dose is 1-2 g of cream on each skin area which is 10 cm 2 (10 square centimeters). Maximum dose is 10 grams.
- Cream is applied under an airtight dressing, e.g. plastic wrap. 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.
- Lidocaine / Prilocaine Alternova can be used for cleaning leg ulcers up to 15 times in 1-2 months.
- The Lidocaine / Prilocaine Alternova tube is for single use when used on leg ulcers. After each occasion a patient has been treated, the tube with the remaining contents should be discarded.
If you take more Lidocaine / Prilokain Alternova than you should
If you have used more Lidocaine / Prilocaine Alternova 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 have used too much Lidocaine / Prilocaine Alternova are listed below. If Lidocaine / Prilocaine Alternova 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.
- Dimsyn.
- 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. Should this happen, the skin becomes bluish 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.
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 become uncomfortable. Tell your doctor if there is anything else that makes you feel unwell while you are using Lidocaine / Prilocaine Alternova.
A mild reaction (pale or reddened skin, slight swelling, burning, or itchy sensation at first) may occur on the skin where Lidocaine / Prilocaine Alternova 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 Lidokain / Prilokain Alternova, stop using the cream and talk to your doctor or pharmacist as soon as possible.
Common side effects are (may affect up to 1 in 10):
- Transient local skin reactions (paleness, redness , swelling) on the treated area during 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.
Less common side effects are (may affect up to 1 in 100):
- In the beginning 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 mucous membranes on genitals.
- Irritated skin in the treated area when treating leg ulcers.
Rare side effects are (may affect up to 1 in 1000 people):
- Allergic reactions, which in rare cases can turn into anaphylactic shock (rash, swelling, fever, difficulty breathing and fainting) when treating skin, genital mucosa on genitals or leg ulcers.
- Methemoglobinemia (blood disease) in the treatment of skin.
- Small punctate haemorrhages 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 Lidocaine / Prilocaine Alternova accidentally comes into 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.
How to store Lidocaine / Prilocaine Alternova
Keep this medicine out of the sight and reach of children.
Do not store above 30 ° C. Store in a cold place. Do not freeze.
Used within 6 months after the first opening.
Do not use this medicine after the expiry date which is stated on the carton and tube after EXP. That. The expiration date is the last day of the specified 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 to protect the environment.
Contents of the package and other information
Content declaration
- The active substances are lidocaine and prilocaine. Each gram of cream contains 25 mg of lidocaine and 25 mg of prilocaine.
- Other ingredients: Macrogolglycerol hydroxystearate, carbomer 974P, sodium hydroxide, purified water.
What the medicine looks like and contents of the pack
Appearance
Lidocaine / Prilocaine Alternova is a white soft cream .
The cream one is available in an aluminum tube of 5 g and 30 g, with epoxy phenol varnish on the inside.
Pack sizes
1 x 30 g tub
1 x 5 g tube (over-the-counter)
1 x 5 g tube with 2 cover bandages (non-prescription)
1 x 5 g tube with 3 cover bandages (over-the-counter)
5 x 5 g tub
5 x 5 g tube with 12 cover bandages
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Alternova A / S, Lodshusvej 11, 4230 Skælskør, Denmark
Manufacturer
Reform SA, These Pousi-Xatzi, Agiou Louka, Paiania, PO Box 37, Attiki-19002, Greece
or
Qualimetrix SA
579 Mesogeion avenue, Agia Paraskevi,
Athens, 15343, Greece This medicine is authorized in the European Economic Area under the names:
Denmark: Nulbia
Bulgaria: ROMLA 25mg / 25mg / g Cream
Germany: Emulus ® 25mg / g + 25mg / g Cream
Poland: MOTTI
Romania: ROMLA 25mg / 25mg / g Cream
United Kingdom: Nulbia 5% Cream
Spain: ANAMAP® 25 mg / g + 25 / g cream
Czech Republic: ROMLA
Slovakia: ROMLA
Estonia: Nulbia