Leaflet: information for the user

Tetracaine Lainco 7.5 mg/g gel

Tetracaine hydrochloride

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Tetracaine Lainco is and what it is used for

2. What you need to know before using Tetracaine Lainco

3. How to use Tetracaine Lainco

4. Possible side effects

5. Storage of Tetracaine Lainco

6. Contents of the pack and additional information

This medication contains tetracaine, an active ingredient that belongs to the group of local anesthetics.

Tetracaína Lainco is a local anesthetic and lubricating gel used for general catheterization, cystoscopy, urethroscopy, urethral catheterization, etc.

No use Tetracaína Lainco:

• If you are allergic to tetracaine or any of the other components of this medication (listed in section 6).
• If you are allergic to other local anesthetics of the ester type.
• On lacerated or damaged skin or mucous membranes.
• In children under 1 month or premature babies due to the immaturity of the enzymatic system that metabolizes ester-type local anesthetics.
• Concurrently with other topical products.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Tetracaína Lainco.

Do not ingest.

The topical or injectable local administration of anesthetics such as benzocaine and prilocaine is more common or after the administration of lidocaine, procaine, and tetracaine may produce methemoglobinemia. Methemoglobinemia may be the result of administering normal doses as well as exposure to toxic concentrations of local anesthetics.

This medication is not recommended for use in the middle ear or in procedures that may involve penetration of the middle ear.

Repeated application of Tetracaína Lainco may increase the risk of developing allergic reactions to tetracaine.

Children

This medication is not recommended for use in children under 1 month or premature babies.

Use of Tetracaína Lainco with other medications

Inform your doctor, pharmacist, or nurse if you are using, have used recently, or may need to use any other medication.

Tetracaína Lainco administered with the following medications may affect the kinetics of tetracaine, for example:

• Sulfonamide-type antibiotics, which may decrease their activity.
• Cholinesterase inhibitors such as demecarium (a medication used to treat glaucoma), cyclophosphamide (a medication used to treat cancer), ecotiopate (a medication used to treat cancer), and tiotepa (a medication used to treat cancer), which may increase the risk of systemic toxicity.
• Medications known to induce methemoglobinemia such as sulfonamides (antibiotics), nitrates, and nitrites (treatment of angina pectoris), nitrofurantoin (antibiotic), nitroglycerin (preventive treatment of angina pectoris), nitroprusside (medication to reduce blood pressure), pamaquine, and quinine (for the treatment of malaria), and naphthalene.

In case of doubt, consult your doctor, pharmacist, or nurse.

Pregnancy, lactation, and fertility

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

In case of pregnancy or breastfeeding, your doctor will decide whether to use this medication.

Driving and operating machines

The influence of this medication on the ability to drive and operate machines is negligible or insignificant.

Follow exactly the administration instructions for this medication as indicated by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse again.

Tetracaína Lainco is exclusively for urethral use. It must not be ingested.

Adults (including elderly patients) and children over 1 month:

Your doctor will determine the most suitable dose for you and the treatment duration based on the application and medical discretion.

If you use more Tetracaína Lainco than you should

It is unlikely that this will happen since your doctor will define the most suitable dose for you. If you are administered more doses than necessary, your doctor will take the necessary measures to restore your condition.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or nurse immediately or visit a medical center or call the Toxicological Information Service, tel.: 91 562 04 20, indicating the medication and the amount ingested.

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

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

Infrequent adverse effects: may affect up to 1 in 100 people

• Mild redness or itching at the application site.

Rare adverse effects: may affect up to 1 in 1,000 people

• More severe redness or itching at the application site.

Very rare adverse effects: may affect up to 1 in 10,000 people

• Blisters on the skin at the application site.
• Contact dermatitis.
• Systemic contact eczema.

Some allergic or anaphylactoid reactions associated with tetracaine may occur.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, 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 Medicinal Products for Human Use:https://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.

Store below 30°C.

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

Dispose of the medication 2 months after opening the packaging.

Medications should not be thrown down the drain or in the trash. Deposit the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Tetracaína Lainco

• The active principle is tetracaine hydrochloride, 1 gram of gel contains 7.5 mg tetracaine hydrochloride.
• The other components (excipients) are: glycerol (E-422), tragacanth gum, citric acid monohydrate, and sodium citrate.

Appearance of the product and contents of the packaging

Tetracaína Lainco is presented as a translucent gel.

It is presented in the following format:

• Format of 6 g: box with 1 low-density polyethylene tube provided with a low-density polyethylene nozzle and a low-density polyethylene plug.
• Format of 25 g: box with 1 low-density polyethylene/high-density polyethylene tube provided with a high-density polyethylene nozzle and a polypropylene closure capsule.

It is also available in clinical packaging of 200 tubes of 6 or 25 g of gel, according to presentation., according to presentation.

Holder of the marketing authorization and responsible for manufacturing

LAINCO, S.A.

Avda. Bizet, 8-12

08191 Rubí (BARCELONA)

SPAIN

Last review date of this leaflet: April 2024

Other sources of information

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