Tobrex

Package Leaflet: Information for the Patient

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.

Tobrex, 3 mg/ml, Eye Drops, Solution

Tobramycin

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

• 1. What is Tobrex and what is it used for
• 2. Important information before using Tobrex
• 3. How to use Tobrex
• 4. Possible side effects
• 5. How to store Tobrex
• 6. Contents of the pack and other information

1. What is Tobrex and what is it used for

Tobrex is an antibiotic that works against many species of microorganisms that can infect the eye. Tobrex is intended for the treatment of external eye infections and their surroundings in adults and children over 1 year of age, caused by bacteria sensitive to its active substance - tobramycin.

2. Important information before using Tobrex

When not to use Tobrex:

• If the patient is allergicto tobramycin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to use Tobrex, discuss it with your doctor or pharmacist:

Tobrex and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking, has recently taken, or might take, including medicines for the eyes. If the patient is using other eye drops or ointments, they should wait at least 5 minutes between administrations of the different medicines. Eye ointments should be used last.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor before using this medicine. Pregnancy Tobrex can be used during pregnancy only if it is absolutely necessary. Breastfeeding The use of Tobrex is not recommended during breastfeeding. The doctor will decide whether to continue or stop breastfeeding or continue or stop treatment, considering the benefits of breastfeeding for the baby and the benefits of treatment for the mother.

Driving and using machines

Tobrex eye drops have no or negligible influence on the ability to drive and use machines. After administering Tobrex eye drops, vision may be blurred for a while. Do not drive or operate machines until this effect has stopped.

Tobrex eye drops contain benzalkonium chloride

The medicine contains 0.1 mg of benzalkonium chloride per milliliter (0.1 mg/ml). Benzalkonium chloride may be absorbed by soft contact lenses and change their color. Remove contact lenses before administering the drops and wait at least 15 minutes before putting them back. Benzalkonium chloride can also cause eye irritation, especially in people with dry eye syndrome or corneal disorders. If abnormal sensations in the eye, stinging, or eye pain occur after using the medicine, consult a doctor.

3. How to use Tobrex

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. In mild or moderate disease, use one to two drops into the conjunctival sac of the infected eye(s) every four hours. In severe cases, use one to two drops into the conjunctival sac of the infected eye(s) every hour until improvement is achieved. Then use the medicine less frequently until the end of treatment. The medicine is usually used for 7 to 10 days. Use the medicine for as long as your doctor tells you. After administering the medicine, gently close the eyelid and press the corner of the eye near the nose. This helps reduce the absorption of the medicine into the bloodstream and its systemic effects.

Use in children

Tobrex eye drops can be used in children over 1 year of age at the same dosage as in adults. The maximum number of drops that can be administered in 24 hours is 14 drops for children from 1 to <2 years of age and 46 drops for children from 2 to <12 age.< strong> If you have doubts, consult your doctor. The safety and efficacy of using the medicine in children under 1 year of age have not been established, and no data are available for such use.

Use in the elderly

In the elderly, use the same dose as in adults.

Use in patients with liver or kidney disorders

The safety and efficacy of using Tobrex in patients with liver or kidney disorders have not been established. Method of administration Tobrex is onlyintended for administration into the eye. 1 2 3 4 Method of administration

• 1. Prepare the Tobrex bottle and a mirror.
• 2. Wash your hands.
• 3. Remove the cap. If the protective collar is loose after removing the cap, discard it before using the medicine.
• 4. Hold the bottle in your hand, with the tip pointing upwards, using your thumb and middle finger (drawing 1).
• 5. Tilt your head back. With a clean finger, gently pull the lower eyelid down to create a "pocket" between the eye and the eyelid; the drop should fall into this pocket (drawing 2).
• 6. Bring the tip of the bottle close to the eye. You can use a mirror to help you.
• 7. Do not touch the dropper to the eye, eyelid, or surrounding areas.This can lead to infection of the drops. Using infected drops can lead to serious complications, even vision loss.
• 8. To release a single drop of Tobrex, gently squeeze the bottom of the bottle (drawing 3). If the drop does not fall into the eye, try again.
• 9. After administering Tobrex, gently close the eye and press the corner of the eye near the nose (drawing 4). This helps prevent the medicine from entering the body.
• 10. If using drops in both eyes, repeat the above steps for the second eye.
• 11. Replace the cap immediately after use.
• 12. Use only one bottle at a time.

Using a higher dose of Tobrex than recommended

In case of overdose, excess medicine can be rinsed out of the eye with lukewarm water. Do not expect any side effects. Do not administer additional drops. Administer the next dose at the usual time.

Missing a dose of Tobrex

If the patient forgets to use Tobrex eye drops,they should continue treatment by administering the next dose according to the dosing schedule. If it is almost time for the next dose, skip the missed dose and continue treatment according to the recommended dosing schedule. Do not use a double doseto make up for a missed dose. If the patient is using other eye drops or ointments,wait at least 5 minutes between administrations of the different medicines. Use eye ointments last.

If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If the patient experiences allergic reactions, including rash, swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing, or other serious side effects, they should stop using Tobrex and contact their doctor or the Emergency Department of the nearest hospital immediately.During treatment with Tobrex eye drops, the following side effects have been observed. Common side effects (may affect up to 1 in 10 people)Eye symptoms: feeling of discomfort in the eye, eye redness. Uncommon side effects (may affect up to 1 in 100 people)Eye symptoms: inflammation of the eye surface, corneal damage, vision disturbances, blurred vision, eyelid redness, eye and eyelid swelling, eye pain, dry eye, eye discharge, eye itching, increased tear production. General symptoms: allergy (hypersensitivity), headache, hives, skin inflammation, reduced eyelash growth or loss of eyelashes, skin depigmentation, itching, and dry skin. Frequency not known (cannot be estimated from the available data)Eye symptoms: eye allergy, eye irritation, eyelid itching. General symptoms: severe allergic reactions, severe skin reactions (Stevens-Johnson syndrome, erythema multiforme), rash.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tobrex

To prevent infections, do not use the drops after 4 weeks of opening the bottle. In the space below, write the date of opening the bottle. Date of first opening: ................ The medicine should be stored out of sight and reach of children. Do not store above 25°C. Do not store in the refrigerator. Keep the bottle tightly closed. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

Translation of some inscriptions on the immediate packaging:

Felnyitva:

• Opened:

6. Contents of the pack and other information

What Tobrex contains

• The active substance of Tobrex is tobramycin 3 mg/ml.
• The other ingredients are boric acid (E 284), anhydrous sodium sulfate (E 514), sodium chloride, tyloxapol, benzalkonium chloride, purified water.

The medicine also contains minimal amounts of sulfuric acid and/or sodium hydroxide (to adjust the pH).

What Tobrex looks like and contents of the pack

1 white LDPE bottle with an LDPE dropper, with a protected cap made of plastic, with a capacity of 5 ml, placed in a cardboard box. For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Hungary, the country of export:

Novartis Hungária Kft. Bartók Béla út 43-47 1114 Budapest, Hungary

Manufacturer:

Novartis Farmacéutica S.A. Gran Via de les Corts Catalanes, 764, 08013 Barcelona, Spain S.A. Alcon – Couvreur N.V. Rijksweg 14, B-2870 Puurs, Belgium Siegfried El Masnou, S.A. Camil Fabra 58, 08320 El Masnou, Spain Novartis Pharma GmbH Roonstrasse 25, 90429 Nuremberg, Germany

Parallel importer:

Delfarma Sp. z o.o. ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o. ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź Hungarian marketing authorization number, in the country of export: OGYI-T-5294/01 Parallel import authorization number: 275/20 Date of approval of the leaflet: 21.10.2022

[Information about the trademark]