Tobrex

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, the information on the immediate packaging is 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 that you can read it again if necessary.
• In case of any doubts, consult a 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 or pharmacist. 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 acts on 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:

• if the patient experiences allergic reactions after using Tobrex, they should stop using the medicine and consult a doctor immediately (see section 4). Hypersensitivity symptoms can have varying severity: from local itching or skin redness to severe allergic reactions (anaphylactic reaction) or severe skin reactions. Such allergic reactions may occur when using other locally or systemically acting antibiotics from the same group (aminoglycosides).
• if the patient is using another antibiotic therapy while using Tobrex, they should consult a doctor.
• if the patient has or suspects myasthenia or Parkinson's disease, they should consult a doctor. Antibiotics from this group may exacerbate muscle weakness.
• if the patient's symptoms worsen or recur, they should consult a doctor. If the patient uses Tobrex for a longer period, they may become more susceptible to eye infections.
• if the patient experiences persistent corneal ulceration while using Tobrex, they should consult a doctor as soon as possible, as this may be a sign of fungal eye infection.

Tobrex and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking or has recently taken, as well as any medicines they plan to use. If the patient is using other eye drops or ointments at the same time, they should leave at least a 5-minute interval between administrations of the 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 may 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, taking into account the benefits of breastfeeding for the child 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 symptom subsides.

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 may also cause eye irritation, especially in people with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). 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(s) of the infected eye(s) every four hours. In severe cases, use one to two drops into the conjunctival sac(s) 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 has prescribed. 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 medicinal products administered in the form of eye drops and their systemic action.

Use in children

Tobrex eye drops may 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 years of age.If you have any doubts, consult a doctor. The safety and efficacy of using the medicine in children under 1 year of age have not been established, and there are no data available on 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 and kidney disorders have not been established. Administration Tobrex is intended exclusivelyfor administration into the eyes.

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Administration

• 1. Prepare the Tobrex bottle and a mirror.
• 2. Wash your hands.
• 3. Unscrew 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 cap facing upwards, holding it between your thumb and middle finger (drawing 1).
• 5. Tilt your head back. With a clean finger, 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, repeat the attempt.
• 9. After administering Tobrex, gently close your eye and press the corner of your eye near your nose (drawing 4). This will help prevent the medicine from entering the entire body.
• 10. If using drops in both eyes, repeat the above procedure to administer the drop to the other eye.
• 11. Immediately after use, screw the cap back on the bottle.
• 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 the missed dose. If the patient is using other eye drops or ointments at the same time, they should leave at least a 5-minute interval between administrations of the medicines. Eye ointments should be used last.

In case of further doubts about using this medicine, consult a 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 disorders, 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 eyelash loss, skin depigmentation, itching, and dry skin. Frequency not known (frequency 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 side effects occur, including any side effects not listed in the leaflet

tell your doctor or pharmacist.Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +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 from the first opening of the bottle. Write the date of opening in the space below. Date of first opening: …………. Store the medicine 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 that are no longer needed. This will help protect the environment.

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

What Tobrex looks like and contents of the pack

5 ml LDPE bottle with an LDPE dropper, with a protected cap made of plastic, in a cardboard box. For more detailed information, 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:

Medezin Sp. z o.o. ul. Zbąszyńska 3 91-342 Łódź

Repackaged by:

CEFEA Sp. z o.o. Sp. komandytowa ul. Działkowa 56 02-234 Warsaw Pharma Innovations Sp. z o.o. ul. Jagiellońska 76 03-301 Warsaw Synoptis Industrial Sp. z o.o. ul. Szosa Bydgoska 58 87-100 Toruń CANPOLAND SPÓŁKA AKCYJNA ul. Beskidzka 190 91-610 Łódź Medezin Sp. z o.o. ul. Zbąszyńska 3 91-342 Łódź Marketing authorization number in Hungary, the country of export: OGYI-T-5294/01 Parallel import authorization number: 184/21 Date of leaflet approval: 10.10.2022[Information about the trademark]