URSITAN 3 MG/ML EYE DROPS IN SINGLE-DOSE CONTAINERS

Introduction

Package Leaflet: Information for the User

Ursitan 3 mg/ml Eye Drops Solution in Single-Dose Container

tobramycin

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 or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Ursitan and what is it used for
2. What you need to know before you use Ursitan
3. How to use Ursitan
4. Possible side effects
5. Storage of Ursitan
6. Contents of the pack and further information

1. What is Ursitan and what is it used for

Ursitan is an eye drop that contains an antibiotic (tobramycin) that acts against microorganisms that cause bacterial infections of the eye surface.

This medication is used for the treatment of bacterial infections of the eye surface and other parts of the eye, such as conjunctivitis, in adults, adolescents, and children over 1 year of age. Eye infections can cause symptoms of irritation such as redness and discharge.

2. What you need to know before you use Ursitan

Do not use Ursitan:

If you are allergic to tobramycin or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Ursitan.

• Use this medication only in your eye(s).
• If you experience symptoms of an allergic reaction with this medication, discontinue treatment and consult your doctor. Allergic reactions can range from localized itching or skin redness to severe allergic reactions (anaphylactic reaction) or severe skin reactions. These allergic reactions can occur with other topical or systemic antibiotics of the same family (aminoglycosides).
• If you are using another antibiotic treatment with this medication, consult your doctor.
• If you have or have had conditions such as myasthenia gravis (a neuromuscular disorder that causes muscle weakness) or Parkinson's disease (a progressive nervous system disorder that affects movement), consult your doctor. Antibiotics of this type can worsen muscle weakness.
• If your symptoms worsen or return suddenly, contact your doctor. If you use this medication for a long period, you may become more sensitive to eye infections.
• If you wear contact lenses
• • Wearing contact lenses is not recommended during the treatment of an eye infection.

• If you or members of your maternal family have a disease caused by a mitochondrial mutation (a genetic disease) or hearing loss due to antibiotics, it is recommended that you inform your doctor or pharmacist before taking this medication. Certain mitochondrial mutations can increase your risk of hearing loss with this product. Your doctor may recommend genetic testing before administering tobramycin.

Other medications and Ursitan

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

Pregnancy and breastfeeding

Ursitan should only be used during pregnancy if your doctor considers it clearly necessary. If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant or start breastfeeding, consult your doctor or pharmacist before using this medication.

Driving and using machines

You may notice that your vision becomes blurry for a while after applying the eye drops. Do not drive or use machines until this effect has disappeared.

Ursitan contains boron

This medication should not be administered to children under 12 years of age without medical advice, as it contains boron and may affect future fertility.

3. How to use Ursitan

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

Do not exceed the recommended dose prescribed by your doctor or pharmacist.

The recommended dose is:

Use in adults

In mild or moderate infections, instill 1 or 2 drops in the affected eye(s) every four hours. In severe infections, instill 2 drops in the affected eye(s) every hour until improvement is noted, then increase the administration interval to complete the total treatment period.

Use in children and adolescents:

This medication can be used in adolescents and children over 1 year of age at the same dose as in adults. The maximum dose that can be administered in a day is 14 drops in children from 1 to 2 years and 45 drops in children from 2 to 12 years of age. In case of doubt, ask your doctor. The safety and efficacy of this medication have not been established in children under 1 year of age. No data are available.

Remember to apply your medication when it is due.

Your doctor will indicate the duration of your treatment with this medication. Do not stop treatment unless your doctor tells you to.

This medication should only be used as eye drops.

Recommendations for use:

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

If you apply drops to both eyes, repeat all the previous steps with the other eye.

If the drop does not fall into the eye, try again.

If you are using other eye medications,wait at least 5 minutes between the administration of this medication and the other eye medications. Eye ointments should be administered last.

If you use more Ursitan than you should,you can eliminate it by rinsing your eyes with warm water. Although side effects are not expected, do not apply more drops until it is time to do so again.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Ursitan, apply a single dose as soon as you remember and continue with the next dose that was scheduled. However, if it is almost time for the next dose, do not apply the missed dose and continue with the next dose of your regular regimen. Do not apply a double dose to make up for missed doses.

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

4. Possible side effects

Like all medications, Ursitan can cause side effects, although not everyone gets them.

If these side effects become severe, consult your doctor or pharmacist.

The following side effects have been reported:

Common side effects (may affect up to 1 in 10 people)

• Eye effects: eye discomfort, eye redness.

Uncommon side effects (may affect up to 1 in 100 people)

• Eye effects: inflammation of the eye surface, corneal damage, visual impairment, blurred vision, eye and eyelid swelling, eyelid redness, dry eye, increased tear production, eye pain, eye itching, eye discharge.
• General effects: allergy (hypersensitivity), headache, hives, skin inflammation, decreased growth or number of eyelashes, skin depigmentation, itching, and dry skin.

Frequency not known (cannot be estimated from the available data)

• Eye effects: eye allergy, eye irritation, eyelid itching.
• General effects: severe allergic reaction, severe skin reactions (Stevens-Johnson syndrome and erythema multiforme), rash

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects that are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Ursitan

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

Do not use this medication after the expiration date (EXP) printed on the box and container. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

• The expiration date after opening the pouch is 90 days.
• After the first opening, store the containers in the pouch and in the box.
• Expiration date after opening the container: the medication must be used immediately. Any unused contents should be discarded.

Medications should not be thrown away down the drain or in the trash. Deposit the containers and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. This way, you will help protect the environment.

6. Contents of the pack and further information

Composition of Ursitan

• The active ingredient is tobramycin 3mg/ml.
• 1 ml of solution contains 3 mg of tobramycin.
• Each single-dose container contains approximately 0.75mg of tobramycin.
• The other components are tiloxapol, boric acid, sodium sulfate anhydrous, sodium chloride, and purified water.

Appearance of the product and contents of the pack

Ursitan is a clear eye drop solution packaged in single-dose plastic containers containing 0.25ml.

The single-dose containers are inside an aluminum pouch within a cardboard box. Each single-dose container contains approximately 0.75mg of tobramycin.

It is presented in commercial formats of 10, 20, or 45 single-dose containers. Not all formats may be marketed.

Marketing authorization holder and manufacturer

Laboratorios Salvat, S.A.

C/ Gall, 30-36 - 08950

Esplugues de Llobregat

Barcelona - Spain

This medication is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Spain Ursitan 3 mg/ml eye drops solution in single-dose container

Portugal Ursitan 0.75 mg/0.25 ml eye drops, solution in single-dose container

Italy Ursitan 3 mg/ml eye drops, solution in single-dose containers

France Ursitan 3 mg/ml eye drops solution

Date of revision of the text: September 2023

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