Leaflet: information for the user

Lubristesic 7.5 mg/g urethral cream

Tetracaine hydrochloride

Read this 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, consult your doctor, pharmacist or nurse.
• 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, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

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

Lubristesic is a local lubricating and anesthetic urethral cream that is used for general catheterization, cystoscopies, urethroscopies, urethral soundings, etc.

Do not use Lubristesic 7.5 mg/g urethral cream:

• 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 skin or mucous membranes with wounds.
• 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 Lubristesic.

Do not ingest.

The topical or injectable local administration of anesthetics such as benzocaine and prilocaine more commonly 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 Lubristesic may increase the risk of allergic reactions to tetracaine.

Children

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

Other medications and Lubristesic 7.5 mg/g urethral cream

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

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

• antibiotics of the sulfonamide type, which may decrease their activity.
• colinesterase inhibitors such as demecarium (medication used for glaucoma treatment), cyclophosphamide (medication for cancer treatment), ecotiopate (medication for cancer treatment), and tiotepa (medication for cancer treatment), which may increase the risk of systemic toxicity.
• medications known to induce methemoglobinemia such as: phthalidines (antibiotics), nitrates, and nitrites (angina pectoris treatment), 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 or pharmacist.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or if you think you may be 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.

Lubristesic contains methyl parahydroxybenzoate

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

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

Lubristesic isexclusively 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 duration of treatment based on the application and at their discretion.

If you use more Lubristesic 7.5 mg/g urethral cream than you should

It is unlikely that this will happen, as your doctor will be responsible for defining the most suitable dose for you. If you are given 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 or pharmacist immediately or go to 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 or pharmacist or nurse.

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

Less common 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, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Human Medicines Pharmacovigilance System 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.

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.

No special storage conditions are required.

Store in the original packaging.

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Lubristesic 7.5 mg/g urethral ointment

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

Appearance of the product and content of the packaging

Lubristesic 7.5 mg/g urethral ointment is a white, homogeneous, smooth, and impurity-free urethral ointment.

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

Lubristesic 7.5 mg/g urethral ointment is presented in a single-packaging unit containing 25 g of ointment, and in a clinical packaging unit containing 200 units, with 8 g of urethral ointment.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Galenicum Derma S.L.U.

Ctra N-1, Km 36

28750 San Agustin del Guadalix (Madrid)

Spain

Responsible for manufacturing

SAG Manufacturing, S.L.U.

Carretera N-I, km 36

28750 San Agustín del Guadalix

Madrid – Spain

Last review date of this leaflet: September 2019

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