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TETRACAINE LAINCO 7.5 mg/g GEL

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About the medicine

How to use TETRACAINE LAINCO 7.5 mg/g GEL

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Leaflet: information for the user

Tetracaine Lainco 7.5 mg/g gel

Tetracaine hydrochloride

Read the entire leaflet carefully before starting to use this medication, as it contains important information for you.

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

Contents of the leaflet

  1. What is Tetracaine Lainco and what is it used for
  2. What you need to know before starting to use Tetracaine Lainco
  3. How to use Tetracaine Lainco
  4. Possible side effects
  5. Storage of Tetracaine Lainco
  6. Package contents and additional information

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

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

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

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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.

Medicine questions

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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/

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General medicine 11 years exp.

Dr. Tarek Agami is a general practitioner registered in both Portugal and Israel, with broad experience in family and preventive medicine. He offers online consultations for adults and children, providing personalised support for primary care needs, chronic disease management, and everyday health concerns.

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Tomasz Grzelewski

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques.

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Frequently Asked Questions

Is a prescription required for TETRACAINE LAINCO 7.5 mg/g GEL?
TETRACAINE LAINCO 7.5 mg/g GEL requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in TETRACAINE LAINCO 7.5 mg/g GEL?
The active ingredient in TETRACAINE LAINCO 7.5 mg/g GEL is tetracaine. This information helps identify medicines with the same composition but different brand names.
How much does TETRACAINE LAINCO 7.5 mg/g GEL cost in pharmacies?
The average pharmacy price for TETRACAINE LAINCO 7.5 mg/g GEL is around 2.19 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures TETRACAINE LAINCO 7.5 mg/g GEL?
TETRACAINE LAINCO 7.5 mg/g GEL is manufactured by Lainco S.A.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of TETRACAINE LAINCO 7.5 mg/g GEL online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether TETRACAINE LAINCO 7.5 mg/g GEL is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to TETRACAINE LAINCO 7.5 mg/g GEL?
Other medicines with the same active substance (tetracaine) include LUBRISTESIC 7.5 mg/g OINTMENT, AMPRES 10 mg/ml INJECTABLE SOLUTION, AMPRES 20 mg/ml INJECTABLE SOLUTION. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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