Tetracaine Lainco 7.5 mg/g gel

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tetracaine Lainco 7.5 mg/g gel

Tetracaine hydrochloride

Read the entire 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 should not give it 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

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. How to store Tetracaine Lainco
6. Contents of the pack and other information

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

This medicine contains tetracaine, an active substance belonging to the group of local anesthetics.

Tetracaine Lainco is a lubricating and local anesthetic gel used for catheterizations in general, cystoscopies, urethrocystoscopies, urethral catheterizations, etc.

2. What you need to know before using Tetracaine Lainco

Do not use Tetracaine Lainco:

• If you are allergic to tetracaine or to any of the other components of this medicine (listed in section 6).
• If you are allergic to other ester-type local anesthetics.
• On lacerated skin or mucous membranes, or on wounded areas.
• In children under 1 month of age or in premature infants due to the immaturity of the enzymatic system responsible for metabolizing ester-type local anesthetics.
• Concurrently with other topically applied products.

Warnings and precautions

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

This medicine must not be ingested.

Topical or local injectable administration of anesthetics such as benzocaine and prilocaine—more commonly—or following administration of lidocaine, procaine, and tetracaine may cause methemoglobinemia. Methemoglobinemia may occur after administration of normal doses as well as after exposure to toxic concentrations of local anesthetics.

The use of this medicine in the middle ear or in procedures that could involve penetration into the middle ear is not recommended.

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

Children

The use of this medicine is not recommended in children under 1 month of age or in premature infants.

Use of Tetracaine Lainco with other medicines

Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might need to take any other medicines.

Tetracaine Lainco administered concomitantly with the following medicines may affect tetracaine kinetics, for example:

• sulfonamide-type antibiotics, which may reduce their activity;
• cholinesterase inhibitor medicines such as: demecarium (a medicine used in the treatment of glaucoma), cyclophosphamide (a medicine used in cancer treatment), ecotiopate (a medicine used in cancer treatment), and thiotepa (a medicine used in cancer treatment), which may increase the risk of systemic toxicity (in the body);
• medicines known to induce methemoglobinemia such as: sulfonamides (antibiotics), nitrates and nitrites (used to treat angina pectoris), nitrofurantoin (an antibiotic), nitroglycerin (used for preventive treatment of angina pectoris), sodium nitroprusside (a medicine to reduce blood pressure), primaquine and quinine (used to treat malaria), and naphthalene.

If in doubt, consult your doctor, pharmacist, or nurse.

Pregnancy, breastfeeding, and fertility

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

If you are pregnant or breastfeeding, your doctor will decide whether it is appropriate to use this medicine.

Driving and using machines

The effect of this medicine on the ability to drive and use machines is none or negligible.

3. How to use Tetracaine Lainco

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

Tetracaine Lainco is for urethral use only. It must not be ingested.

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

Your doctor will determine the most appropriate dose for you and the duration of treatment according to the indication and at their clinical discretion.

If you use more Tetracaine Lainco than you should

It is unlikely that this will occur, as your doctor will be responsible for determining the most appropriate dose for you. If you are administered more than the recommended dose, your doctor will take appropriate measures to restore your condition.

In case of overdose or accidental ingestion, immediately contact your doctor, pharmacist, or nurse, go to a medical center, or call the Toxicology Information Service at phone number 91 562 04 20, indicating the medicine and the amount ingested.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everybody gets them.

Uncommon 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.
• Allergic contact dermatitis.
• Systemic contact eczema.

Some allergic or anaphylactoid reactions associated with tetracaine may occur.

Reporting of 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 leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tetracaine Lainco

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

Store below 30°C.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Dispose of the medicine 2 months after opening the container.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Tetracaine Lainco

• The active substance 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 contents of the pack

Tetracaine Lainco is presented as a translucent gel.

Available pack sizes:

• 6 g pack: carton containing 1 tube made of low-density polyethylene, equipped with a low-density polyethylene cannula and a low-density polyethylene cap.
• 25 g pack: carton containing 1 tube made of low-density polyethylene/high-density polyethylene, equipped with a high-density polyethylene cannula and a polypropylene closure cap.

Clinical packs containing 200 tubes of 6 g or 25 g 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 most recent review of this leaflet: April 2024

Other sources of information

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