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

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including those not listed in this leaflet, inform the 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 can infect the eye.
Tobrex is indicated for the treatment of external eye and ocular adnexal 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 treatment with 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). Allergic symptoms may vary in severity: from local itching or redness of the skin to severe allergic reactions (anaphylactic reaction) or serious skin reactions. Such allergic reactions may occur when using other topical or systemic 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's symptoms worsen or recur, 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 be a sign of fungal eye infection.

Tobrex and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
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 applied 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 or negligible effect on the ability to drive and operate machinery.
However, vision may be blurred for a short time after instillation of Tobrex eye drops. Do not drive or operate machinery until this symptom has resolved.

Tobrex contains 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 discolour them. Contact lenses should be removed before instillation and at least 15 minutes should be waited before reinserting them. 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, stinging, or pain in the eye occur after using the medicine, consult a doctor.

3. How to use Tobrex

This medicine should always be used as directed by a physician. If in doubt, consult a doctor or pharmacist.
In mild or moderate infections, instill one to two drops into the conjunctival sac (sacs) of the infected eye(s) every four hours.
In severe cases, instill one to two drops into the conjunctival sac (sacs) of the infected eye(s) every hour until improvement occurs. Then gradually reduce the frequency of administration until treatment is completed.
The medicine is usually used for 7 to 10 days. Continue using the medicine for as long as directed by your doctor.
After instilling the drops, gently close the eyelid and press on the inner 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 in 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 a doctor. The safety and efficacy of Tobrex in children under 1 year of age have not been established, and no data are available regarding use in this age group.

Use in elderly patients
The same dosage as in adults should be used in elderly patients.

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 ocular instillation.

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 down the lower eyelid with a clean finger to create a "pocket" between the eyeball and the eyelid; the drop should be instilled into this pocket (Figure 2).
6. Bring the tip of the dropper close to the eye. A mirror may be used to assist.
7. Do not touch the dropper tip to the eye, eyelid, surrounding areas, or any other surface. This may contaminate the drops. Using contaminated drops may lead to serious complications, including potential loss of vision.
8. To release a single drop of Tobrex, gently squeeze the bottom 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 with a finger on the inner corner of the eye near the nose (Figure 4). This helps prevent the medicine from draining into the systemic circulation.
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 more than the 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. Administer the next dose at the usual scheduled time.

Missed dose of Tobrex eye drops
If the patient forgets to use Tobrex eye drops, they should continue treatment by administering the next dose according to the prescribed schedule. If the next dose is due soon, 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, wait at least 5 minutes between administering different eye medications. Ophthalmic 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 any medicine, 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,
treatment with Tobrex should be discontinued and immediate contact should be made with a doctor
or the Emergency Department of the nearest hospital.
The following adverse reactions have been observed during treatment with Tobrex:
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 unknown (frequency cannot be estimated from 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 adverse reactions not listed in this leaflet, inform a
doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring of 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 allows further information on the safety of the medicine to be collected.

5. How to store Tobrex medicine

To prevent infection, the drops must not be used more than 28 days after first opening the bottle.
Enter the date of first opening in the space below.
Date of first opening: …………….
Keep the medicine out of the sight and reach of children.
Store below 25°C.
Keep the bottle tightly closed.
Do not use Tobrex 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. Such measures help protect the environment.

6. Contents of the package and other information

What Tobrex contains

• The active substance is tobramycin 3 mg/ml.
• The other components are: boric acid, sodium sulfate, sodium chloride, tyloxapol, benzalkonium chloride, purified water. Minimal amounts of sodium hydroxide and/or sulfuric acid are added to adjust the appropriate pH.

What Tobrex looks like and contents of the pack
Clear or white DROPTAINER bottle made of LDPE, with a dropper and cap, 5 ml in capacity, placed in a cardboard box.
For more detailed information, please contact the responsible party or the parallel importer.
Responsible party in the Czech Republic, country of export:
Novartis s.r.o., Na Pankráci 1724/129, 140 00 Prague 4, Czech Republic
Manufacturer:
Novartis Farmacéutica, S.A., Gran Via de les Corts Catalanes, 764, 08013 Barcelona, Spain
Alcon-Couvreur NV, Rijksweg 14, 2870 Puurs, Belgium
Alcon Cusí S.A., Camil Fabra 58, 08320 El Masnou, Barcelona, Spain
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Czech Republic, country of export, registration number: 64/106/87-C
Parallel import registration number: 81/21