Package Insert: Information for the User

LAMBDALINA 40 mg/g Cream

Lidocaine

Read this entire package insert carefully before starting to use the 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 only for you and should not be given 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 or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is LAMBDALINA and what is it used for

2. What you need to know before starting to use LAMBDALINA

3. How to use LAMBDALINA

4. Possible adverse effects

5. Storage of LAMBDALINA

6. Contents of the package and additional information

LAMBDALINA 40 mg/g cream contains lidocaine and is a medication that induces local numbness (local anesthesia) of the skin.

LAMBDALINA is used to desensitize the skin in relation to the insertion of needles (e.g. prior to blood tests).

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 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 auditory canal or inner ear, as there is a risk of damaging the inner ear.
• if you have a serious illness, for example, heart disease or severe liver insufficiency.
• if you take medications for heart rhythm disturbances (see Use of other medicines)
• near the eyes, as lidocaine may cause eye irritation. In addition, with the loss of protective reflexes, corneal irritation or scratches may occur. If LAMBDALINA comes into contact with the eyes, wash them with warm water immediately and protect them until the sensation returns.
• if you are about to receive a live vaccine (for example, the 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 situations mentioned above.

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

Use of LAMBDALINA with other medicines

Inform your doctor or pharmacist if you are taking or have taken recently or may take any other medicine.

It is especially important for your doctor to know if you have 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 anesthetics
• medicines for arrhythmias (heart rhythm disturbances), for example, tocainide, mexiletine, and amiodarone.

Pregnancy and breastfeeding

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

The occasional use of LAMBDALINA during pregnancy is unlikely to cause harm to the fetus.

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

Driving and operating machinery

LAMBDALINA has no known influence on the ability to drive and operate machinery.

Important information about some ingredients of LAMBDALINA

LAMBDALINA contains propylene glycol, which may cause skin irritation.

LAMBDALINA contains hydrogenated soy 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.

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

The usual dose is:

Children aged 6 to 12 years:

The single dose to be applied is 2-3g. The recommended application time, that is, 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 aged 2 to 6 years:

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

Children aged 0 to 2 years:

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

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

If you think 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 medication or too much has been applied to the skin, please contact your doctor or the hospital for an assessment of the risk and advice.

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

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Infrequent (1 to10 per 1000 treated patients):

Local skin reactions (pallor, redness, itching, and stinging) in the treated area. Symptoms are normally transient and mild.

Rare(1 to10 per 10,000 treated patients):

Contact allergic eczema.

Very rare (less than 1 per 10,000 treated patients)

Allergic reactions (in severe cases, anaphylactic shock)

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

• Swelling of the face, tongue, or throat
• Difficulty swallowing
• Urticaria and respiratory problems.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Adverse Effect Reporting

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus.

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

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the box and on the tube after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

After opening the tube, the expiration date is 6 months.

Medicines should not be thrown down the drains or in the trash.Deposit the containers and the medicines you no longer need at the SIGRE collection point of the pharmacy.Ask your pharmacist how to dispose of the containers and the medicines you no longer need. In this way, you will help protect the environment.

Composition of LAMBDALINA

• The active ingredient is lidocaine.1 gram of cream contains 40 mg of lidocaine.
• The other components are purified water, propylene glycol, hydrogenated soy lecithin, benzyl alcohol, polysorbate 80, carbomer 940, triethanolamine, cholesterol.

Appearance of the product and content of the container

LAMBDALINA is a white to yellowish cream.

Presentation:5 g,10 g,20 g,30 g,40 g,50 gin aluminum tubes.Some container sizes may only be marketed.

Holder of the marketing authorization and responsible manufacturer

Holder:

ISDIN, SA

Provençals 33

08019 Barcelona

Spain

Manufacturer:

Medinfar Manufacturing S.A.

Armando Martins Tavares Industrial Park

Rua Outeiro da Armada, 5

Condeixa-a-Nova

3150-194 Sebal

Portugal

Last review date of this leaflet: March 2019