LUBRISTESIC 7.5 mg/g OINTMENT

Introduction

Package Leaflet: Information for the User

Lubristesic 7.5 mg/g Urethral Ointment

Tetracaine Hydrochloride

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Lubristesic 7.5 mg/g Urethral Ointment and what is it used for
2. What you need to know before you start using Lubristesic 7.5 mg/g Urethral Ointment
3. How to use Lubristesic 7.5 mg/g Urethral Ointment
4. Possible side effects
5. Storage of Lubristesic 7.5 mg/g Urethral Ointment
6. Contents of the pack and further information

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

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

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

2. What you need to know before you start 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 any of the other components of this medicine (listed in section 6).
• if you are allergic to other local anesthetics of the ester type.
• on lacerated or wounded skin or mucous membranes.
• in children under 1 month or in premature babies due to the lack of maturity of the enzymatic system that metabolizes local anesthetics of the ester type.
• in conjunction with other topical products.

Warnings and precautions

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

It must 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 be the result of administering normal doses as well as exposure to toxic concentrations of local anesthetics.

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

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

Children

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

Other medicines and Lubristesic 7.5 mg/g Urethral Ointment

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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

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

In case of 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 have a baby, ask your doctor or pharmacist for advice before using this medicine.

In case of pregnancy or breastfeeding, your doctor will decide whether to use this medicine.

Driving and using machines

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

Lubristesic contains methylparaben

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

3. How to use Lubristesic 7.5 mg/g Urethral Ointment

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

Lubristesic is exclusively 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 according to the application and at the doctor's discretion.

If you use more Lubristesic 7.5 mg/g Urethral Ointment than you should

It is unlikely that this will happen since your doctor will be in charge of defining the most suitable dose for you. In case you are administered more doses than due, your doctor will take the necessary measures to restore your state.

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Medicines and Healthcare products Regulatory Agency (MHRA) https://www.mhra.gov.uk/. By reporting side 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 which is stated on the packaging after EXP. The expiry date is the last day of the month shown.

No special storage conditions are required.

Store in the original packaging.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further 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), cornstarch, tragacanth gum, methylparaben (E-219), ethanol 96%, and purified water.

Appearance and packaging of the product

Lubristesic 7.5 mg/g Urethral Ointment is a urethral ointment, white in color, homogeneous, smooth, and free from visible impurities.

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

Lubristesic 7.5 mg/g Urethral Ointment is presented in a single unit pack containing 25 grams of ointment and in a clinical pack containing 200 units, with 8 grams 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 last revision of this leaflet: September 2019

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