LAMBDALINA 40 mg/g CREAM

2. What you need to know before you use LAMBDALINA

Do not use LAMBDALINA

• if you are allergic to lidocaine or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic (hypersensitive) to local anesthetics, soy or peanuts.
• in premature children (born before the 37th week of gestation).

Warnings and precautions

Consult your doctor or pharmacist before starting to use LAMBDALINA:

• in case of surgical interventions in the ear canal or inner ear, as there is a risk of damaging the inner ear.
• if you have a serious illness, e.g. heart disease or severe liver failure.
• if you are taking medicines for heart rhythm disorders (see Use of other medicines)
• near the eyes, as lidocaine can cause eye irritation. Additionally, with the loss of protective reflexes, corneal irritation or scratches can occur. If LAMBDALINA comes into contact with the eyes, rinse them with warm water immediately and protect them until sensation returns.
• if you are about to receive a vaccination with a live vaccine (e.g. tuberculosis vaccine). Vaccines should not be administered in areas where LAMBDALINA has been applied, as the effect of the vaccine may be affected.

Please inform your doctor if you are affected by any of the above-mentioned situations.

LAMBDALINA should only be used on undamaged skin (not on mucous membranes, wounds, or eczema).

Other medicines and LAMBDALINA

Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.

It is especially important for your doctor to know if you have been treated with any of the following medicines, as the risk of side effects may be increased:

• lidocaine at high doses for other reasons.
• other local anesthetics
• medicines for arrhythmias (heart rhythm disorders), e.g. tocainide, mexiletine, and amiodarone.

Pregnancy and breastfeeding

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

Occasional use of LAMBDALINA during pregnancy is unlikely to cause harmful effects on the fetus.

LAMBDALINA passes into breast milk but is unlikely to affect the baby during breastfeeding.

Driving and using machines

LAMBDALINA has no known influence on the ability to drive and use machines.

LAMBDALINA contains propylene glycol, benzyl alcohol, hydrogenated soybean lecithin, and polysorbate 80.This medicine contains 75 mg of propylene glycol per gram of cream. Propylene glycol may cause skin irritation.

Lambdalina contains hydrogenated soybean lecithin. If you are allergic to peanuts or soy, do not use this medicine.

This medicine contains 15 mg of benzyl alcohol per gram of cream. Benzyl alcohol may cause allergic reactions and may cause moderate local irritation.

This medicine contains polysorbate 80, which may cause allergic reactions.

3. How to use LAMBDALINA

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

The recommended dose is:

Children from6 to12 years:

The single dose to be applied is 2-3g. The recommended application time, i.e. the time the cream should be on the skin, is 60 minutes, but never more than two hours.

Adolescents over 12 years and adults:

The single dose to be applied is 2-3g. The maximum daily dose is 5 grams. The recommended application time is 60 minutes, but never more than two hours.

Children from2 to6 years:

Since there is not enough experience, LAMBDALINA is not recommended for this age group.

Children from0 to2 years:

Since there is no experience, LAMBDALINA should not be used for this age group.

1 gram of cream corresponds to approximately 2.5 cm in length.

If you think that the effect of LAMBDALINA is too strong or too weak, please consult your doctor or pharmacist.

If you use more LAMBDALINA than you should

Overdose is unlikely with normal use on undamaged skin.

If you have used more LAMBDALINA than you should, or if a child has accidentally ingested the medicine or too much has been applied to the skin, please contact your doctor or hospital for a risk assessment and advice.

In case of overdose or accidental ingestion, consult the Toxicology Information Service, phone 91562 04 20.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Uncommon (1 to 10 in 1000 people treated):

Local skin reactions (pallor, redness, itching, and burning) in the treated area. The symptoms are usually transient and mild.

Rare (1 to 10 in 10,000 people treated):

Allergic contact eczema.

Very rare (less than 1 in 10,000 people treated)

Allergic reactions (in severe cases, anaphylactic shock)

Stop using LAMBDALINA and contact your doctor immediately if you have any of the following symptoms (anaphylactic shock)

• Swelling of the face, tongue, or throat
• Difficulty swallowing
• Hives and breathing problems.

If you think any of the side effects you are experiencing are serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing LAMBDALINA

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 expiry date is the last day of the month stated.

Do not store above 30°C.

After opening the tube, the shelf life is 6 months.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of LAMBDALINA

• The active substance is lidocaine. 1 gram of cream contains 40 mg of lidocaine.
• The other ingredients are purified water, propylene glycol, hydrogenated soybean lecithin, benzyl alcohol, polysorbate 80, carbomer 940, tromethamine, cholesterol.

Appearance and packaging

LAMBDALINA is a white to yellowish cream.

Presentation: 5 g, 10 g, 20 g, 30 g, 40 g, and 50 g in aluminum tubes. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

ISDIN, SA

Provençals 33

08019 Barcelona

Spain

Manufacturer:

Medinfar Manufacturing S.A.

Parque Industrial Armando Martins Tavares

Rua Outeiro da Armada, 5

Condeixa-a-Nova

3150-194 Sebal

Portugal

Date of last revision of this leaflet: May 2025