TETRACAINE LAINCO 7.5 mg/g GEL

2. What you need to know before starting to use Tetracaine Lainco

Do not use Tetracaine 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 broken or wounded skin or mucous membranes.
• In children under 1 month or in premature babies due to the lack of maturity of the enzyme system that metabolizes local anesthetics of the ester type.
• In combination with other topical products.

Warnings and precautions

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

It should not be ingested.

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

It is not recommended to apply this medication to the middle ear or in procedures that may involve penetration of the middle ear.

Repeated application of Tetracaine Lainco could increase the risk of allergic reactions to tetracaine.

Children

It is not recommended to use this medication in children under 1 month or in premature babies.

Using Tetracaine Lainco with other medications

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

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

• antibiotic medications of the sulfonamide type, may decrease their activity.
• cholinesterase inhibitor medications such as: demecarium (medication used to treat glaucoma), cyclophosphamide (medication for cancer treatment), echothiophate (medication for cancer treatment), and thiotepa (medication for cancer treatment), may increase the risk of systemic toxicity (in the body).
• medications known to induce methemoglobinemia such as: sulfonamides (antibiotics), nitrates and nitrites (treatment for angina pectoris), nitrofurantoin (antibiotic), nitroglycerin (preventive treatment for angina pectoris), nitroprusside (medication to reduce blood pressure), pamaquine, and quinine (for malaria treatment), and naphthalene.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan 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 using machines

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

3. How to use Tetracaine Lainco

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

Tetracaine Lainco is exclusively for urethral use. It should not be ingested.

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

Your doctor will determine the most suitable dose for you and the duration of treatment according to the application and at their discretion.

If you use more Tetracaine Lainco than you should

It is unlikely that this will happen since your doctor will define the most suitable dose for you. In case 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 go to a medical center or call the Toxicology Information Service, tel.: 91 562 04 20, indicating the medication and the amount ingested.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Uncommon side effects: may affect up to 1 in 100 people

• Mild redness or itching at the application site.

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

• More severe redness or itching at the application site.

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

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

Some allergic or anaphylactoid reactions associated with tetracaine may occur.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Tetracaine Lainco

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

Store below 30°C.

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

Discard the medication 2 months after opening the packaging.

Medications should not be thrown away through the sewage system or in the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Tetracaine Lainco

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

Appearance of the product and package contents

Tetracaine Lainco is presented as a translucent gel.

It is available in the following formats:

• 6g format: box with 1 low-density polyethylene tube with a low-density polyethylene cannula and a low-density polyethylene cap.
• 25g format: box with 1 low-density polyethylene/high-density polyethylene tube with a high-density polyethylene cannula and a polypropylene closure cap.

Clinical packages of 200 tubes of 6 or 25g of gel are also available, depending on the presentation.

Marketing authorization holder and manufacturer

LAINCO, S.A.

Avda. Bizet, 8-12

08191 Rubí (BARCELONA)

SPAIN

Date of the last revision of this leaflet: April 2024

Other sources of information

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