Lubristesic 7.5 mg/g ointment

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Lubristesic 7.5 mg/g urethral ointment

Tetracaine hydrochloride

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

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

Leaflet contents

1. What Lubristesic 7.5 mg/g urethral ointment is and what it is used for
2. What you need to know before using Lubristesic 7.5 mg/g urethral ointment
3. How to use Lubristesic 7.5 mg/g urethral ointment
4. Possible side effects
5. How to store Lubristesic 7.5 mg/g urethral ointment
6. Contents of the pack and other information

1. What Lubristesic 7.5 mg/g Urethral Ointment is and what it is used for

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

Lubristesic is a lubricating and anesthetic urethral ointment for local use, used for catheterizations in general, cystoscopies, urethroscopies, urethral soundings, etc.

2. What you need to know before using Lubristesic 7.5 mg/g urethral ointment

Do not use Lubristesic 7.5 mg/g urethral ointment:

• if you are allergic to tetracaine or to any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to other local anesthetic agents of the ester type.
• on lacerated skin or mucous membranes, or on wounds.
• 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.
• concomitantly with other topical products.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use Lubristesic.

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 result from administration of normal doses as well as from exposure to toxic concentrations of local anesthetics.

Application of this medicine in the middle ear or during procedures that may involve penetration into the middle ear is not recommended.

Repeated application of Lubristesic may increase the risk of allergic reactions to tetracaine.

Children

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

Other medicines and Lubristesic 7.5 mg/g urethral ointment

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

Lubristesic, when administered together with the following medicines, may affect the pharmacokinetics of tetracaine, for example:

• sulfonamide-type antibiotic medicines, which may reduce the activity of these drugs.
• cholinesterase inhibitor medicines such as: demecarium (a medicine used to treat glaucoma), cyclophosphamide (a medicine used to treat cancer), ecotiopate (a medicine used to treat cancer), and thiotepa (a medicine used to treat cancer), 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 you are in doubt, consult your doctor or pharmacist.

Pregnancy, breastfeeding, and fertility

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

If you are pregnant or breastfeeding, your doctor will decide whether or not 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.

Lubristesic contains methyl parahydroxybenzoate

May cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate.

3. How to use Lubristesic 7.5 mg/g urethral ointment

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

Lubristesic 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 Lubristesic 7.5 mg/g urethral ointment than you should

This is unlikely to occur, as your doctor will define the most appropriate dose for you. In the event that an excessive dose is administered, your doctor will take appropriate measures to restore your condition.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, go to a medical center, or call the Toxicology Information Service at 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 can cause adverse effects, although not everyone experiences 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, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lubristesic 7.5 mg/g urethral ointment

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

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.

No special storage conditions are required.

Keep in the original packaging.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to your pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Lubristesic 7.5 mg/g urethral ointment

• The active substance is tetracaine hydrochloride.
• Each gram of urethral ointment contains 7.5 mg of tetracaine hydrochloride.
• The other components (excipients) are: glycerol (E-422), corn starch, tragacanth gum, methyl parahydroxybenzoate (E-219), 96% ethanol, and purified water.

Appearance of the medicinal product and contents of the container

Lubristesic 7.5 mg/g urethral ointment is a white, homogeneous, smooth ointment free from visible impurities.

Lubristesic 7.5 mg/g urethral ointment is supplied in a low-density polyethylene tube containing 8 g or 25 g of urethral ointment.

Lubristesic 7.5 mg/g urethral ointment is available in a single package containing 25 g of ointment, and in a clinical pack containing 200 units, each with 8 g of urethral ointment.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Galenicum Derma S.L.U.

Ctra N-1, Km 36

28750 San Agustin del Guadalix (Madrid)

Spain

Manufacturer

SAG Manufacturing, S.L.U.

Carretera N-I, km 36

28750 San Agustín del Guadalix

Madrid – Spain

Date of the most recent revision of this package leaflet: September 2019

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/