Package Insert: Information for the Patient

Anamap 25 mg/g + 25 mg/g Cream

Lidocaine + Prilocaine

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you only, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse even if they are not listed in this package insert. See section 4.

Anamap contains two active principles called lidocaine and prilocaine. Both belong to the group of local anesthetic medications.

Anamap works by insensitizing the skin surface for a short time. It is applied to the skin before certain medical interventions. It helps to suppress pain on the skin; however, you may still perceive sensations such as pressure and contact.

Adults, adolescents, and children:

It can be used to anesthetize the skin before:

• Inserting a needle (for example, for an injection or blood test).
• Minor skin operations.

Adults and adolescents

It can also be used:

• To insensitize the genital area before:

• An injection.
• Medical interventions such as wart removal.

Anamap application on the genital area should be performed by a doctor or nurse.

Adults:

It can also be used to insensitize the skin before:

• Cleaning or removing damaged skin from leg ulcers.

The medication should only be used for a purpose other than skin application under the recommendation of a doctor, nurse, or pharmacist.

No use Anamap:

• If you are allergic to lidocaine or prilocaine, other similar local anesthetics, or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before using Anamap:

• If you or your child have a rare inherited blood disorder called glucose-6-phosphate dehydrogenase deficiency.
• If you or your child have a condition affecting blood pigment levels called methemoglobinemia.
• Do not use Anamap on areas with skin eruptions, cuts, scratches, or other open wounds, except for a leg ulcer. If any of these problems occur, consult your doctor or pharmacist or nurse before using the cream.
• If you or your child have a skin condition with itching called atopic dermatitis, a shorter application time may be sufficient. Application times of over 30 minutes may increase the incidence of local skin reactions (see also section 4. "Possible side effects").
• If you are being treated with medications for heart rhythm disorders (class III antiarrhythmics, such as amiodarone). In this case, your doctor will monitor your cardiac function.

Due to the potential greater absorption through recently shaved skin, it is essential to respect the recommended dose, skin surface, and application time.

Avoid contact of Anamap with the eyes, as it may cause irritation. If Anamap Lidocaine/Prilocaine Glenmark accidentally enters your eye, rinse it immediately with warm water or saline solution (sodium chloride solution). Be careful not to apply anything to the eye until you regain sensitivity.

Anamap should not be applied to a damaged eardrum.

When using Anamap before being vaccinated with live vaccines (e.g., tuberculosis vaccine), return to your doctor or nurse after the required follow-up period for the vaccination result.

Children and adolescents

In infants and newborns under 3 months, methemoglobinemia, a transient and clinically insignificant increase in blood pigment levels, is often observed up to 12 hours after Anamap application.

Clinical studies could not confirm the efficacy of Anamap when blood is drawn from the heel of newborns or for providing adequate analgesia in circumcision.

Anamap should not be applied to the genital skin (e.g., penis) or mucous membranes (e.g., vagina) of children (under 12 years) due to insufficient data on the absorption of active ingredients.

Anamap should not be used in children under 12 months of age who are simultaneously receiving treatment with other medications affecting metahemoglobin concentrations (e.g., sulfonamides, see also section 2 "Other medications and Anamap").

Anamap should not be used in premature newborns.

Other medications and Anamap

Inform your doctor, pharmacist, or nurse if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription and herbal products. This is because some medications may affect (or be affected by) the mechanism of action of Anamap.

Especially, inform your doctor, pharmacist, or nurse if you or your child have recently used any of the following medications:

• Medications used to treat infections called sulfonamides and nitrofurantoin.
• Medications used to treat epilepsy, called phenytoin and phenobarbital.
• Other local anesthetics.
• Medications for treating heart arrhythmias, such as amiodarone.
• Cimetidine or beta-blockers, which may increase lidocaine levels in the blood. This interaction is not clinically significant in short-term treatment with Anamap at recommended doses.

Pregnancy, breastfeeding, and fertility

If you are pregnant, or in the breastfeeding period, think you may be pregnant, or intend to become pregnant, consult your doctor, pharmacist, or nurse before using this medication.

The occasional use of Anamap during pregnancy is unlikely to have any adverse effects on the fetus.

The active ingredients of Anamap (lidocaine and prilocaine) are excreted in breast milk. However, the amount is so small that there is generally no risk to the baby.

Studies in animals have shown no alterations in male or female fertility.

Driving and operating machines

Anamap does not affect the ability to drive and operate machines, or the effect is insignificant, when used at recommended doses.

Anamap contains macrogolglycerol hydroxystearate

Macrogolglycerol hydroxystearate may cause skin reactions.

Follow exactly the administration instructions of this medication indicated by your doctor, pharmacist or nurse. In case of doubt, consult your doctor, pharmacist or nurse again.

Use of Anamap

• The place to apply the cream, the amount and the duration are factors that depend on what it is used for. Your doctor, pharmacist or nurse will apply the cream or indicate how you should apply it yourself. A 5g tube of Anamap corresponds approximately to 2g of Anamap. One gram of Anamap extracted from a tube is approximately 3.5 cm.
• Anamap must be applied to the genitals only by a doctor or nurse.
• When Anamap is used on leg ulcers, the application must be supervised by a doctor or nurse.

Do not use Anamap in the following areas:

• Cuts, abrasions or wounds, except for leg ulcers.
• In areas with eczema or irritation.
• In the eyes or near them.
• Inside the nose, ear or mouth.
• In the anal (anus) opening.
• On the genital mucosa of children.

People who frequently apply or remove the cream will ensure they avoid contact to prevent the appearance of hypersensitivity.

The protective membrane of the tube is pierced by pressing the plug on it.

Use on the skinbefore minor interventions (such as needle puncture or minor skin surgery):

• Apply a thick layer of cream to the skin. Follow the instructions in the leaflet or from a healthcare professional who will indicate where to apply it. In certain cases, the healthcare professional will have to apply the cream.
• Cover the cream with a dressing [plastic wrap]. This is removed just before starting the intervention. If you apply the cream yourself, make sure your doctor, pharmacist or nurse provide you with the dressings.
• The usual dose for adults and adolescents over 12 years is 2g (grams).
• For adults and adolescents over 12 years, apply the cream at least 60 minutes before the intervention (unless the cream is to be used on the genitals). However, do not apply it more than 5 hours before.
• For children, the amount of Anamap used and how long it depends on their age. Your doctor, pharmacist or nurse will tell you how much to use and when to apply it.

It is very important that you follow the instructions below when you are going to apply the cream:

1. Squeeze the tube to apply the necessary amount of cream to the skin where the intervention is going to take place (for example, where the needle is going to be inserted). A 5g tube of Anamap corresponds to approximately 2g of Anamap. One gram of Anamap extracted from a tube is approximately 3.5 cm.

Do not spread the cream.

2. Remove the paper layer from the occlusive dressing.

3. Remove the covers from the occlusive dressing and, then, place it carefully over the cream mound. Do not spread the cream covered by the dressing.

4. Remove the plastic layer. Smooth thebordersof the occlusive dressing carefully.Then leave it on for at least 60 minutes if the skin is not damaged. The cream should not be left on for more than 60 minutes in children under 3 months or for more than 30 minutes in children with a skin condition called "atopic dermatitis". If the cream is used on the genitals or over ulcers, the application times may be shorter as described below.

5. The doctor or nurse will remove the occlusive dressing and clean the cream before starting the intervention (for example, just before inserting the needle).

Use on larger areas of recently shaved skin before outpatient interventions (such as laser hair removal techniques)

Follow the instructions from your healthcare professional.

The recommended dose is 1g of cream per 10 cm2 (10 square centimeters) of extension, applied under an occlusive dressing for 1 to 5 hours. Anamap should not be used on recently shaved areas of more than 600 cm2 (600 square centimeters, for example 30 cm x 20 cm) of extension. The maximum dose is 60g.

Before hospital interventions (such as skin grafts) that require deeper anesthesia

• Anamap can be used in this way in adults and adolescents over 12 years, but only under the supervision of a doctor or nurse.
• The recommended dose is 1.5g to 2g of cream per 10 cm2 (10 square centimeters) of extension.
• After applying the cream, it must be covered with an occlusive dressing for a minimum of 2 hours and a maximum of 5 hours.

Use on the skin to remove warts called "molluscum"

• Anamap can be used in children and adolescents who suffer from a skin condition called "atopic dermatitis".
• The usual dose depends on the child's age and is used for 30 to 60 minutes (30 minutes if the patient has atopic dermatitis). Your doctor, nurse or pharmacist will indicate how much cream to apply.

Use on genital skin before local anesthesia injection

• Anamap can be used in this way only in adults and adolescents over 12 years and only applied by a healthcare professional.
• The recommended dose is 1g of cream (1g to 2g for female genital skin) per 10 cm2 (10 square centimeters) of skin extension.
• The cream is applied under a dressing or occlusive dressing. This is kept for 15 minutes on male genital skin and for 60 minutes on female genital skin.

Use on genitals before minor skin surgery (such as wart removal)

Anamap can be used in this way only in adults and adolescents over 12 years and only applied by a healthcare professional.

The recommended dose is 5g to 10g of cream for 10 minutes. Without occlusive dressing. The medical intervention must start immediately.

Use before cleaning or debridement of leg ulcers

• Anamap can be used in this way in adults, but only under the supervision of a doctor or nurse.

• The recommended dose is 1g to 2g of cream per 10 cm2 (10 square centimeters) up to a maximum of 10g.
• The cream is applied under an occlusive dressing, for example, a plastic wrap. This is kept for 30 to 60 minutes before cleaning the ulcer. Remove the cream with a cotton gauze and start cleaning without delay.
• Anamap can be used before cleaning leg ulcers up to a maximum of 15 times during a period of 1 to 2 months.
• The Anamap tube is for single use when used on leg ulcers: The tube with any remaining content must be discarded each time after treating a patient.

If you use more Anamap than indicated:

If you use more Anamap than described in this leaflet or more than indicated by your doctor, pharmacist or nurse, contact them immediately, even if you do not have any symptoms.

The symptoms produced by using too much Anamap are as follows. The appearance of these symptoms is very unlikely if Anamap is used as recommended.

• Dizziness or drowsiness.
• Itching of the skin around the mouth and numbness of the tongue.
• Unusual taste.
• Blurred vision.
• Tinnitus.
• There is also the risk of acute methemoglobinemia (a problem with blood pigment levels). This is a more frequent problem when certain medications are taken. In these cases, the skin turns blue-gray due to lack of oxygen.

In severe cases of overdose, symptoms may include convulsions, low blood pressure, slow breathing, cessation of breathing and alterations in pulse. These effects can be potentially fatal.

If you have any questions about the use of this medication, consult your doctor, pharmacist or nurse.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Consult your doctor or pharmacist if any of the following side effects cause you discomfort or do not seem to go away. Inform your doctor of anything else that makes you feel unwell while using Anamap.

A mild reaction (pale skin or redness, mild swelling, initial burning or itching) may appear in the area where Anamap is applied. This is a normal reaction to the cream and anesthetics, and it will disappear in no time without needing any further action.

If you experience any bothersome or unusual side effects while using Anamap, stop using it and consult your doctor or pharmacist as soon as possible.

Frequent(may affect 1 in 10 people):

• Transient local skin reactions (pale skin, redness, swelling) in the application area during treatment on the skin, genital mucosa, or leg ulcers
• A mild initial sensation of burning, itching, or heat in the application area during treatment on the genital mucosa or leg ulcers.

Infrequent(may affect 1 in 100 people):

• A mild initial sensation of burning, itching, or heat in the treated area during treatment on the skin.
• Numbness (tingling) in the application area during treatment on the genital mucosa.
• Skin irritation in the application area during treatment of leg ulcers.

Rare(may affect 1 in 1,000 people):

• Allergic reactions, which in rare cases may lead to anaphylactic shock (skin rash, swelling, fever, difficulty breathing, and fainting) during treatment on the skin, genital mucosa, or leg ulcers.
• Methemoglobinemia (blood disorder) during skin treatment.
• Small pinpoint bleeding in the treated area (particularly in children with eczema after long periods of application) during skin treatment.
• Eye irritation if Anamap accidentally comes into contact with the eyes during skin treatment.

Other side effects in children

Methemoglobinemia, a blood disorder that is often observed more frequently in newborns and infants from 0 to 12 months, often associated with overdose.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Store at a temperature below 30°C, do not refrigerate or freeze.

Use within 6 months from the first opening.

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

Do not use this medication after the expiration date indicated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Anamap

• The active principles are lidocaine and prilocaine. Each gram of cream contains 25 mg of lidocaine and 25 mg of prilocaine.
• The other components are macrogolglycerol hydroxystearate (hydrogenated ricin oil polyoxyl), carbomer (974P), sodium hydroxide, and purified water.

Appearance of the product and contents of the package

Anamap is a soft white cream. It is presented in a collapsible aluminum tube of 5 g and 30 g, internally coated with an epoxyphenolic lacquer.

Package sizes:

1 x tube of 30 g

1 x tube of 5 g

1 x tube of 5 g with 2 dressings

1 x tube of 5 g with 3 dressings

5 x tube of 5 g

5 x tube of 5 g with 12 dressings

Not all package sizes may be marketed.

Holder of the marketing authorization and manufacturer

Holder of the marketing authorization:

Glenmark Arzneimittel GmbH

Industriestr. 31,

82194 Gröbenzell,

Germany

Manufacturer:

Rafarm SA,

Thesi Pousi-Xatzi

Agiou Louka,

Paiania, Attiki-19002

P.P. Box 37,

Greece

Qualimetrix SA

579 Mesogeion avenue, Agia Paraskevi,

Athens, 15343,

Greece

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Viso Farmacéutica, S.L.U.

c/ Retama 7, 7th Floor

28045 Madrid

Spain

This medication is authorized in the member states of the European Economic Area with the following names:

Denmark: Nulbia

Bulgaria:ROMLA 25mg/25mg/g ????

Germany:Emulus®25mg/g + 25mg/gCreme

Poland:MOTTI

Romania: ROMLA 25mg/25mg/g Crema

Sweden: Lidokain/Prilokain Alternova

United Kingdom:Nulbia 5% Cream

Spain: Anamap 25mg/g + 25mg/g cream

Czech Republic:ROMLA

Slovakia: ROMLA

Estonia: Nulbia

Last review date of this leaflet: April 2021

Other sources of information

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.