Tobrex

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Tobrex
3 mg/ml, eye drops, solution
Tobramycinum
Please read the entire 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.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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 species of microorganisms that may infect the eye.
Tobrex is indicated for the treatment of external eye infections and surrounding areas 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 medical advice should be sought immediately (see section 4). Symptoms of hypersensitivity 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 antibiotics from the same group (aminoglycosides), whether applied locally or systemically;
• 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 symptoms of the disease worsen or recur, medical advice should be sought. Prolonged use of Tobrex may increase susceptibility to eye infections;
• if persistent corneal ulceration occurs during treatment with Tobrex, prompt medical advice should be sought, as this may indicate a fungal eye infection.

Tobrex with 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 5 minutes should be left between the application of each medicine. 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 whether 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 minor effect on the ability to drive and operate machinery. However, vision may be blurred for a short time after instillation of Tobrex eye drops. Driving and operating machinery should be avoided until this symptom resolves.

Tobrex contains benzalkonium chloride
The medicine contains 0.1 mg of benzalkonium chloride in each 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 be waited before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially in individuals with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If abnormal sensations, stinging, or eye pain occur after using the medicine, contact a doctor.

3. How to use Tobrex

This medicine should always be used as directed by your doctor. If in doubt, consult your doctor or pharmacist.
In mild or moderate infections, one to two drops should be administered into the conjunctival sac (sacs) of the infected eye (eyes) every four hours.
In severe cases, one to two drops should be administered into the conjunctival sac (sacs) of the infected eye (eyes) every hour until improvement occurs. After that, 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 your doctor recommends.
After instillation, it is recommended to gently close the eyelid and press the corner of the eye near the nose. This helps reduce absorption of the medicinal product administered as eye drops and its 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 your doctor. The safety and efficacy of Tobrex in children under 1 year of age have not been established, and there are no data available on use in this age group.

Use in elderly patients
The same dose 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 dysfunction have not been established.

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

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 backwards. 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 bottle 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 lead to contamination of the drops. Using contaminated drops may result in serious complications, including 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 the corner of the eye near the nose with your finger (Figure 4). This helps prevent the medicine from spreading throughout the body.
10. If applying drops to both eyes, repeat the above steps for 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
If an overdose occurs, 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
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 soon, the missed dose should be skipped and treatment resumed according to the recommended schedule. Do not use a double dose to make up for a missed dose.

If the patient is using other eye drops or eye ointments simultaneously, at least a 5-minute interval should be maintained between the administration of each product. 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 any medicine, this medicine can cause adverse reactions, although not everyone experiences 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 if other serious adverse reactions occur,
treatment with Tobrex should be discontinued and immediate contact should be made with a doctor or
the nearest hospital Emergency Department.
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 1000)
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, decreased eyelash growth or loss of eyelashes, skin depigmentation, skin itching and dryness.
Frequency not known (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 or pharmacist. 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 enables better collection of information on the safety of the medicine.

5. How to store Tobrex

To prevent infections, the drops should not be used more than 28 days after first opening the bottle.
Enter the date of first opening of the bottle in the space below.
Date of first opening: …………….
Keep the medicine out of the sight and reach of children.
Store below 25°C.
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 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.

6. Contents of the package and other information

What Tobrex contains

• The active substance is tobramycin. 1 ml of solution contains 3 mg of tobramycin.
• The other ingredients are: boric acid, sodium sulfate, sodium chloride, tyloxapol, benzalkonium chloride, sodium hydroxide and/or sulfuric acid (to adjust the appropriate pH), purified water. Minimal amounts of sodium hydroxide and/or sulfuric acid are added to adjust the pH.

What Tobrex looks like and contents of the pack
A transparent or white 5 ml DROPTAINER bottle made of LDPE, with a dropper and cap,
packaged in a cardboard box.
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder 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
Siegfried El Masnou, S.A.
Camil Fabra 58, 08320 El Masnou, Barcelona, Spain
Novartis Pharma GmbH
Roonstrasse 25, 90429 Nuremberg, Germany
Parallel Importer:
InPharm Sp. z o.o., Strumykowa Street 28/11, 03-138 Warsaw, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k., Chełmżyńska Street 249, 04-458 Warsaw, Poland
Marketing Authorisation Number in the Czech Republic, country of export: 64/106/87-C
Parallel Import Licence Number: 214/20