Lambdalina 40 mg/g cream
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
LAMBDALINA 40 mg/g cream
Lidocaine
Read all of this leaflet carefully before you start using this medicine, because 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 must not be given to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What LAMBDALINA is and what it is used for
- What you need to know before using LAMBDALINA
- How to use LAMBDALINA
- Possible adverse effects
- How to store LAMBDALINA
- Contents of the pack and other information
1. What LAMBDALINA is and what it is used for
LAMBDALINA 40 mg/g cream contains lidocaine and is a medicine that induces local loss of skin sensitivity (local anaesthesia).
LAMBDALINA is used to desensitize the skin prior to needle insertion (e.g. before blood sampling).
2. What you need to know before using LAMBDALINA
Do not use LAMBDALINA
- if you are allergic to lidocaine, or to any of the other ingredients of this medicine (listed in section 6).
- if you are allergic (hypersensitive) to local anaesthetics, soy or peanuts.
- in premature children (born before the 37th week of gestation).
Warnings and precautions
Consult your doctor or pharmacist before using LAMBDALINA:
- if you are undergoing surgical procedures 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 medications for heart rhythm disorders (see Use with other medicines).
- near the eyes, as lidocaine may cause eye irritation. In addition, due to loss of protective reflexes, corneal irritation or scratches may occur. If LAMBDALINA comes into contact with the eyes, rinse immediately with lukewarm water and protect the eyes until sensation returns.
- if you are about to receive vaccination with a live vaccine (e.g. the tuberculosis vaccine). Vaccines must not be administered in areas where LAMBDALINA has been applied, as the vaccine's effectiveness may be affected.
Please inform your doctor if any of the above situations apply to you.
LAMBDALINA should only be used on intact skin (not on mucous membranes, wounds or eczema).
Other medicines and LAMBDALINA
Inform your doctor or pharmacist if you are using or have recently used, or might need to use, any other medicines.
It is especially important for your doctor to know if you have previously been treated with any of the following medicines, as the risk of adverse effects may be increased:
- lidocaine at high doses for other reasons.
- other local anaesthetics.
- 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 for LAMBDALINA provided by your doctor. If in doubt, consult your doctor or pharmacist again.
The recommended dose is:
Children 6 to 12 years:
The single applied dose is 2-3 g. The recommended application time, i.e., the time the cream should remain on the skin, is 60 minutes, but never longer than two hours.
Adolescents over 12 years and adults:
The single applied dose is 2-3 g. The maximum daily dose is 5 grams. The recommended application time is 60 minutes, but never longer than two hours.
Children 2 to 6 years:
Due to insufficient experience, LAMBDALINA is not recommended in this age group.
Children 0 to 2 years:
Due to lack of experience, LAMBDALINA must not be used in this age group.
One gram of cream corresponds approximately to a length of 2.5 cm.
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A dressing is recommended to prevent the cream from accidentally coming off before the application time is complete. |
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Close the tube after use. |
If you feel 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 have, or if a child has accidentally ingested the medicine or received too much applied to the skin, please contact your doctor or hospital for risk assessment and advice.
In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone number 91562 04 20.
If you have any further 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 sensation) at the treated area. Symptoms are usually transient and mild.
Rare (1 to 10 in 10,000 people treated):
Allergic contact dermatitis.
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 experience any of the following symptoms (anaphylactic shock):
- Swelling of the face, tongue, or throat
- Difficulty swallowing
- Hives and breathing difficulties.
If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Reporting of side effects
If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet.
You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of LAMBDALINA
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the tube after EXP. The expiry date refers to the last day of the month indicated.
Do not store above 30°C.
After opening the tube, the product is valid for 6 months.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. 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 components are purified water, propylene glycol, hydrogenated soybean lecithin, benzyl alcohol, polysorbate 80, carbomer 940, triethanolamine, cholesterol.
Appearance of the product and contents of the container
LAMBDALINA is a white to yellowish cream.
Presentations: 5 g, 10 g, 20 g, 30 g, 40 g and 50 g in aluminium tubes. Only some pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 the most recent revision of this leaflet: May 2025