Tobrex

Patient Information Leaflet

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
Tobrex, 3 mg/ml, eye drops, solution
Tobramycinum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet to be able to read it again if necessary.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Table of contents:

1. What Tobrex is and what it is 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 Tobrex is and what it is used for

Tobrex is an antibiotic effective against many microorganisms that may infect the eye.
Tobrex is indicated for the treatment of external eye and surrounding tissue infections in adults and children aged 1 year and older, caused by bacteria sensitive to its active substance – tobramycin.

2. Important information before using Tobrex

When not to use Tobrex:

• if the patient is allergic to tobramycin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting to use Tobrex, discuss with your doctor or pharmacist:

• if the patient experiences allergic reactions after using Tobrex, treatment should be discontinued and immediate medical advice sought (see section 4). Hypersensitivity reactions may vary in severity: from local itching or redness of the skin to severe allergic reactions (anaphylactic reaction) or severe skin reactions. Such allergic reactions may occur when using other topically or systemically administered antibiotics from the same group (aminoglycosides).
• if the patient is receiving other antibiotic therapy during treatment with Tobrex, medical advice should be sought.
• if the patient has or is suspected of having myasthenia gravis or Parkinson's disease, medical advice should be sought. Antibiotics from this group may worsen muscle weakness.
• if the patient experiences worsening or recurrence of symptoms, medical advice should be sought. Prolonged use of Tobrex may increase susceptibility to eye infections.
• if the patient develops persistent corneal ulceration during treatment with Tobrex, medical advice should be sought immediately, as this may indicate a fungal eye infection.

Tobrex and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
If the patient is using other eye drops or ointments at the same time, at least 5 minutes should be left between the administration of each medicine. Eye ointments should be used last.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
Pregnancy
Tobrex may be used during pregnancy only if absolutely necessary.
Breastfeeding
Use of Tobrex is not recommended during breastfeeding. The doctor will decide whether to continue or discontinue breastfeeding or to continue or discontinue treatment, taking into account the benefits of breastfeeding for the child and the benefits of treatment for the mother.

Driving and operating machinery
Tobrex eye drops have no effect or have a negligible effect on the ability to drive and operate machinery.
For a short period after instillation of Tobrex eye drops, vision may be blurred. Do not drive or operate machinery until this symptom has resolved.

Tobrex eye drops contain benzalkonium chloride
The medicine contains 0.1 mg of benzalkonium chloride per millilitre (0.1 mg/ml).
Benzalkonium chloride may be absorbed by soft contact lenses and may change their colour. Contact lenses should be removed before instillation and at least 15 minutes should elapse before reinsertion.
Benzalkonium chloride may also cause eye irritation, especially in patients with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If abnormal sensations occur in the eye, such as stinging or pain after using the medicine, consult a doctor.

3. How to use Tobrex

This medicine should always be used exactly as directed by your doctor. If in doubt, consult your
doctor or pharmacist.
For mild to moderate conditions, instill one to two drops into the conjunctival sac (sacs) of the
affected eye(s) every four hours.
For severe cases, instill one to two drops into the conjunctival sac (sacs) of the affected eye(s)
every hour until improvement occurs. After improvement, gradually reduce the frequency of dosing
until treatment is completed.
The medicine is usually used for 7 to 10 days. Continue using the medicine for as long as your doctor
has instructed.
After instilling the drops, gently close the eyelid and press on the corner of the eye near the nose.
This helps reduce systemic absorption of ophthalmic medications and their potential systemic
effects.

Use in children
Tobrex eye drops may be used in children aged 1 year and older at the same dosage as adults. The maximum number of drops that can be administered per day is 14 drops for children aged 1 to <2 years and 46 drops for children aged 2 to <12 years. If in doubt, consult your doctor. The safety and efficacy of Tobrex in children under 1 year of age have not been established, and no data are available on its use in this age group.

Use in elderly patients
In elderly patients, the same dose as in adults should be used.

Use in patients with hepatic or renal impairment
The safety and efficacy of Tobrex in patients with liver or kidney disorders have not been established.

Instructions for use
Tobrex is intended exclusively for instillation into the eyes.

1 2 3 4
Instructions for use

1. Prepare the Tobrex bottle and a mirror.
2. Wash your hands.
3. Unscrew the cap. If the safety collar is loose after removing the cap, discard it before using the medicine.
4. Hold the bottle in your hand with the bottom facing upwards, using your thumb and middle finger (Figure 1).
5. Tilt your head backward. Gently pull the lower eyelid downward with a clean finger to form a "pocket" between the eyeball and eyelid; the drop should be instilled into this pocket (Figure 2).
6. Bring the tip of the bottle close to the eye. A mirror may be used to assist.
7. Do not touch the dropper tip to the eye, eyelid, surrounding area, or any other surface. This may contaminate the drops. Using contaminated drops may lead to serious complications, including loss of vision.
8. To release a single drop of Tobrex, gently squeeze the base of the bottle (Figure 3). If the drop does not enter the eye, repeat the instillation.
9. After instilling Tobrex, gently close the eye and press the corner of the eye near the nose with a finger (Figure 4). This helps prevent the medicine from draining into the rest of the body.
10. If treating both eyes, repeat the above steps to instill drops into the second eye.
11. Immediately after use, tightly replace the cap on the bottle.
12. Only one bottle should be used at a time.

Use of a higher than recommended dose of Tobrex
In case of overdose, excess medicine can be rinsed from the eye with lukewarm water. No adverse effects are expected. Do not administer additional drops. Instill the next dose at the usual time.

If a dose of Tobrex eye drops is missed
If the patient forgets to use Tobrex eye drops, treatment should be continued by administering the next dose according to the prescribed schedule. If the next dose is due shortly, the missed dose should be skipped and treatment resumed according to the recommended dosing schedule. Do not use a double dose to make up for a missed dose.

If the patient is using other eye drops or ointments simultaneously, at least a 5-minute interval should be maintained between the administration of each medicine. Eye ointments should be used last.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If the patient experiences allergic reactions, including rash, swelling of the face, lips, tongue and/or
throat, which may cause difficulty in breathing or swallowing, or other serious adverse reactions occur,
tobrex treatment must be discontinued and immediate contact must be made with a doctor or the
Emergency Department of the nearest hospital.

The following adverse reactions have been observed during the use of Tobrex eye drops.
Common adverse reactions (may occur in 1 to 10 patients out of 100)
Ocular symptoms: eye discomfort, eye redness.
Uncommon adverse reactions (may occur in 1 to 10 patients out of 1,000)
Ocular symptoms: inflammation of the eye surface, corneal damage, visual 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, urticaria, skin inflammation, reduced eyelash growth or loss of eyelashes, loss of skin pigmentation, skin itching and dryness.
Frequency not known (frequency cannot be estimated from the available data)
Ocular symptoms: eye allergy, eye irritation, eyelid itching.
General symptoms: severe allergic reactions, severe skin reactions (Stevens-Johnson syndrome, erythema multiforme), rash.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Tobrex

To prevent infection, do not use the drops more than 4 weeks after first opening the bottle.
Enter the date of first opening in the space provided below.
Date of first opening: ................
Keep the medicine out of the sight and reach of children.
Do not store above 25°C. Do not store in a 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.
Translation of certain inscriptions appearing on the immediate packaging:
Felnyitva: - Opened:

6. Contents of the packaging and other information

What Tobrex contains

• The active substance 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.

Minimal amounts of sulfuric acid and (or) sodium hydroxide are added to the medicine (to adjust the appropriate pH).

What Tobrex looks like and contents of the pack

1 white LDPE bottle with an LDPE dropper and a tamper-evident plastic cap, with a capacity of 5 ml, placed in a cardboard box.

For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation 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, Poland

Repackaged in:

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

Marketing Authorisation Number in Hungary, the country of export: OGYI-T-5294/01
Parallel Import Licence Number: 275/20