Package Leaflet: Information for the User

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

tobramycin

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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 1 year of age and older. Eye infections can cause symptoms of irritation like redness and discharge.

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.

• Only use this medication in your eyes.
• 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 weakness in skeletal muscles) or Parkinson's disease (a progressive disorder of the nervous system that affects movement), consult your doctor. This type of antibiotic can worsen muscle weakness.
• If your symptoms worsen or return suddenly, contact your doctor. If you use this medication for a long period of time, you may become more sensitive to eye infections.
• If you wear contact lenses
• • Wearing contact lenses is not recommended during treatment of an eye infection.

•If you or your maternal family members 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 may increase your risk of hearing loss with this product. Your doctor may recommend genetic testing before administration of tobramycin.

Other medications and Ursitan

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

Pregnancy and breastfeeding

This medication should only be used during pregnancy if your doctor considers it clearly necessary. If you are pregnant or breastfeeding, believe you may be pregnant, or intend to become pregnant or start breastfeeding, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

You may notice that your vision becomes blurry for a short time after applying the eye drops. Do not drive or operate machinery 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 harm fertility in the future.

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:

Adult use

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, increasing the administration interval afterwards to complete the total treatment period.

Use in children and adolescents:

This medication can be used in adolescents and children aged 1 year and older at the same dose as in adults. The maximum daily dose is 14 drops in children aged 1 to 2 years and 45 drops in children aged 2 to 12 years. In case of doubt, ask your doctor. The safety and efficacy of this medication have not been established in children under 1 year. 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 discontinue treatment unless your doctor instructs you to do so.

This medication should only be used as eye drops.

Usage recommendations:

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

If drops are applied to both eyes, repeat all previous steps for 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 remove it by washing your eyes with warm water. Although adverse effects are not expected, do not apply more drops until you are instructed to do so.

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

If you forgot to use Ursitan, apply a single dose as soon as you remember and continue with the next dose 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 compensate for the missed doses.

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

Like all medications, Ursitan may produce adverse effects, although not everyone will experience them.

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

The following adverse effects have been reported:

Frequent Adverse Effects (may affect up to 1 in 10 people)

• Eye effects: eye discomfort, eye redness.

Rare Adverse Effects (may affect up to 1 in 100 people)

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

Unknown Frequency (cannot be estimated from 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 Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es.Reporting adverse effects can help provide 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 (EXP) printed on the box and on the packaging. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be thrown down the drain or in the trash. Dispose of the containers and medications you do not need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you do not need. In this way, you will help protect the environment.

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, anhydrous sodium sulfate, sodium chloride, and purified water.

Appearance of the product and contents of the packaging

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

Single-dose containers are found 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. It is possible that not all formats are marketed.

Holder of the marketing authorization and responsible manufacturer

Laboratorios Salvat, S.A.

C/ Gall, 30-36 - 08950

Esplugues de Llobregat

Barcelona - Spain

This medicine 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 drop solution in single-dose container

Portugal Ursitan 0.75 mg/0.25 ml colírio, solução em recipiente unidose

Italy Ursitan 3 mg/ml collirio, soluzione in contenitori monodose

France Ursitan 3 mg/ml collyre en solution

Last review date of the text: September 2023

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