Anamap 25 mg/g + 25 mg/g cream

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the Patient

Anamap 25 mg/g + 25 mg/g cream

lidocaine / prilocaine

Please read this entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if the side effects are not listed in this leaflet. See section 4.

Leaflet Contents

1. What Anamap is and what it is used for
2. What you need to know before using Anamap
3. How to use Anamap
4. Possible side effects
5. How to store Anamap
6. Contents of the pack and other information

1. What Anamap is and what it is used for

Anamap contains two active substances called lidocaine and prilocaine. Both belong to the group of medicines known as local anaesthetics.

Anamap works by numbing the surface of the skin for a short period of time. It is applied to the skin before certain medical procedures. It helps to relieve pain on the skin; however, you may still feel sensations such as pressure and touch.

Adults, adolescents and children:

It can be used to anaesthetize the skin before:

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

Adults and adolescents:

It can also be used:

• To numb the genital area before:

• An injection.

• Medical procedures such as removal of warts.

Application of Anamap to the genital area must be performed by a doctor or nurse.

Adults:

It can also be used to numb the skin before:

• Cleaning or removing damaged skin from leg ulcers.

For any use other than application on intact skin, the medicine should only be used on the advice of a doctor, nurse or pharmacist.

2. What you need to know before using Anamap

Do not use Anamap:

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

Warnings and precautions

Talk to 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 blood pigment disorder called methemoglobinemia.
• Do not use Anamap on areas with skin rash, cuts, scratches, or other open wounds, except for a leg ulcer. If any of these conditions occur, consult your doctor, 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 longer than 30 minutes may increase the incidence of local skin reactions (see also section 4, "Possible side effects").
• If you are being treated with medicines for heart rhythm disorders (class III antiarrhythmics such as amiodarone). In this case, your doctor will monitor your heart function.

Due to potentially increased absorption on freshly shaved skin, it is important to follow the recommended dose, skin surface area, and application time.

Avoid contact of Anamap with the eyes, as it may cause irritation and chemical burns. If Anamap accidentally gets into your eye, rinse immediately with lukewarm water or saline (sodium chloride solution). Be careful not to apply anything else to the eye until sensation returns.

Children should be carefully supervised when Anamap is used anywhere on their body to prevent accidental contact with the eyes.

Anamap must not be applied on a damaged eardrum.

When using Anamap before vaccination 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 of age, "methemoglobinemia"—a transient and clinically insignificant increase in levels of a blood pigment—has frequently been observed up to 12 hours after application of Anamap.

Clinical studies have not been able to confirm the efficacy of Anamap when drawing blood from the heel of newborns or for providing adequate analgesia during circumcision.

Anamap must not be applied to the genital skin (e.g., on the penis) or genital mucosa (e.g., in the vagina) of children (under 12 years) due to insufficient data on absorption of the active substances.

Anamap must not be used in children under 12 months of age who are simultaneously receiving treatment with other medicines affecting blood pigment "methemoglobin" levels (e.g., sulfonamides, see also section 2, "Other medicines and Anamap").

Anamap must not be used in premature newborns.

Other medicines and Anamap

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription and herbal products. This is because some medicines may affect (or be affected by) the mechanism of action of Anamap.

In particular, inform your doctor, pharmacist, or nurse if you or your child have recently taken any of the following medicines:

• Medicines used to treat infections called "sulfonamides" and nitrofurantoin.
• Medicines used to treat epilepsy, called phenytoin and phenobarbital.
• Other local anaesthetics.
• Medicines used to treat cardiac arrhythmias, such as amiodarone.
• Cimetidine or beta-blockers, which may increase blood levels of lidocaine. This interaction is not clinically significant when Anamap is used short-term at the recommended doses.

Pregnancy, breast-feeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor, pharmacist, or nurse before using this medicine.

Occasional use of Anamap during pregnancy is unlikely to have any adverse effect on the fetus.

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

Animal studies have shown no effects on male or female fertility.

Driving and using machines

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

Anamap contains macrogol glyceryl hydroxystearate

Macrogol glyceryl hydroxystearate may cause skin reactions.

3. How to use Anamap

Follow exactly the administration instructions for this medicine given by your doctor, pharmacist, or nurse. If in doubt, consult again with your doctor, pharmacist, or nurse.

Use of Anamap

• Where to apply the cream, how much to use, and for how long depend on the intended use. Your doctor, pharmacist, or nurse will apply the cream or instruct you on how to do it. Half a tube of 5 g corresponds to approximately 2 g of Anamap. One gram of Anamap squeezed from the tube is approximately 3.5 cm in length.
• Anamap must be applied to the genital area only by a doctor or nurse.
• When Anamap is used for leg ulcers, application must be supervised by a doctor or nurse.

Do not use Anamap in the following areas:

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

Individuals who frequently apply or remove the cream should ensure they avoid contact to prevent the development of hypersensitivity.

The protective membrane of the tube is pierced by pressing the cap onto it.

Use on the skin prior to minor procedures (such as needle puncture or minor skin surgery):

• Apply a thick layer of cream to the skin. Follow the instructions in this leaflet or those provided by a healthcare professional regarding where to apply it. In certain cases, the healthcare professional must apply the cream.
• Cover the cream with an occlusive dressing [plastic wrap]. This is removed immediately before starting the procedure. If you apply the cream yourself, ensure your doctor, pharmacist, or nurse provides you with the dressings.
• The usual dose for adults and adolescents over 12 years of age is 2 g (grams).
• In adults and adolescents over 12 years of age, apply the cream at least 60 minutes before the procedure (unless the cream is to be used on the genitals). However, do not apply it more than 5 hours beforehand.
• For children, the amount of Anamap used and the duration of application depend on their age. Your doctor, pharmacist, or nurse will tell you how much to use and when to apply it.

It is very important to follow these instructions when applying the cream:

1. Squeeze the tube to apply the required amount of cream onto the skin where the procedure will take place (e.g., where the needle will be inserted). Half a 5 g tube corresponds to approximately 2 g of Anamap. One gram of Anamap squeezed from the tube is approximately 3.5 cm long.

Do not spread the cream.

1. Peel off the paper layer from the occlusive dressing.

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

1. Remove the plastic layer. Gently smooth the edges of the occlusive dressing. Then leave it in place for at least 60 minutes if the skin is undamaged. The cream should not be left on for more than 60 minutes in children under 3 months of age or for more than 30 minutes in children with a skin condition causing itching called "atopic dermatitis." If the cream is used on the genitals or on ulcers, application times may be shorter, as described below.

1. The doctor or nurse will remove the occlusive dressing and wipe off the cream before starting the procedure (e.g., just before inserting the needle).

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

Follow the instructions of your healthcare professional.

The recommended dose is 1 g of cream per 10 cm² (10 square centimeters) of skin surface, applied for 1 to 5 hours under an occlusive dressing. Anamap must not be used on freshly shaved areas larger than 600 cm² (600 square centimeters, e.g., 30 cm x 20 cm). The maximum dose is 60 g.

Before hospital procedures (such as skin grafts) requiring deeper anesthesia

• Anamap may be used in this way in adults and adolescents over 12 years of age, but only under the supervision of a doctor or nurse.
• The recommended dose is 1.5 g to 2 g of cream per 10 cm² (10 square centimeters) of skin surface.
• 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 wart-like lesions called "molluscum"

• Anamap may be used in children and adolescents who have 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 tell you how much cream to apply.

Use on genital skin before injection of local anesthesia

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

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

Anamap may be used in this way only in adults and adolescents over 12 years of age and only when applied by a healthcare professional.

The recommended dose is 5 g to 10 g of cream for 10 minutes. Without an occlusive dressing. The medical procedure must begin immediately.

Use before cleaning or debriding leg ulcers

• Anamap may be used in this way in adults, but only under the supervision of a doctor or nurse.
• The recommended dose is 1 g to 2 g of cream per 10 cm², up to a maximum of 10 g.
• The cream is applied under an occlusive dressing, for example, plastic wrap. This is kept in place for 30 to 60 minutes before cleaning the ulcer. Remove the cream with a cotton swab and begin cleaning without delay.
• Anamap may 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 only when used on leg ulcers: The tube, along with any remaining contents, must be discarded after treating each patient.

If you use more Anamap than indicated:

If you use more Anamap than described in this leaflet or more than prescribed by your doctor, pharmacist, or nurse, contact them immediately, even if you have no symptoms. It is recommended to bring the packaging and the leaflet of the medicine to the healthcare professional. You may also call the Toxicology Information Service at telephone number 91 562 04 20, stating the name of the medicine and the amount administered.

Symptoms caused by using too much Anamap include the following (these symptoms are very unlikely to occur if Anamap is used as recommended):

• Dizziness or lightheadedness.
• Tingling of the skin around the mouth and numbness of the tongue.
• Abnormal taste.
• Blurred vision.
• Ringing in the ears.
• There is also a risk of acute methemoglobinemia (a problem with blood pigment levels). This is more common when certain medications are being taken. In these cases, the skin turns bluish-gray due to lack of oxygen.

In severe cases of overdose, symptoms may include seizures, low blood pressure, slow breathing, cessation of breathing, and pulse disturbances. These effects may be potentially fatal.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Contact your doctor or pharmacist if any of the following adverse effects bother you or do not seem to go away. Inform your doctor of any other symptoms that make you feel unwell while using Anamap.

A mild reaction (pallor or redness of the skin, slight swelling, initial burning or itching) may occur at the site where Anamap is applied. These are normal reactions to the cream and anesthetics and will disappear shortly without requiring any intervention.

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

Common (may affect up to 1 in 10 people):

• Transient local skin reactions (pallor, redness, swelling) at the application site during treatment of the skin, genital mucosa, or leg ulcers
• Mild initial sensation of burning, itching, or warmth at the application site during treatment of the genital mucosa or leg ulcers

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

• Mild initial sensation of burning, itching, or warmth at the treated area during treatment of the skin
• Numbness (tingling) at the application site during treatment of the genital mucosa
• Skin irritation at the application site during treatment of leg ulcers

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

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

Frequency not known (cannot be estimated from available data):

• Chemical burns in the eyes if Anamap accidentally comes into contact with the eyes during treatment

Other adverse effects in children

Methaemoglobinaemia, a blood disorder more frequently observed in newborns and infants from 0 to 12 months of age, often associated with overdose.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Anamap

Store below 30°C. Do not refrigerate or freeze. Use within 6 months after first opening.

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Anamap

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

Appearance of the medicinal product and contents of the pack

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

Pack sizes:

1 x 30 g tube

1 x 5 g tube

1 x 5 g tube with 2 patches

1 x 5 g tube with 3 patches

5 x 5 g tubes

5 x 5 g tubes with 12 patches

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

This medicinal product is authorized in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Denmark: Nulbia

Germany: Emulus® 25mg/g + 25mg/g Creme

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

Date of the most recent review of this leaflet: October 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.