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
Tobramycinum
Please read carefully the entire leaflet 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 doubts, 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 another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the 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 effective against many species of microorganisms that may infect the eye.
Tobrex is intended for the treatment of external eye infections and surrounding areas in adults and children aged 1 year and above, 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, consult 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). Hypersensitivity symptoms may vary in severity: from local itching or skin redness 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 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 promptly, 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 or has recently taken, as well as any medicines the patient plans to use.
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 product. 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 minor effect on the ability to drive and operate machinery.
For a short period after instillation of Tobrex eye drops, vision may be blurred. Driving and operating machinery should be avoided until this symptom resolves.

Tobrex eye drops contain benzalkonium chloride
This 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 be waited before reinserting them.
Benzalkonium chloride may also cause eye irritation, particularly in patients 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, medical advice should be sought.

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 to moderate conditions, instill one to two drops into the conjunctival sac(s) of the affected eye(s) every four hours.
In severe cases, instill one to two drops into the conjunctival sac(s) of the affected eye(s) every hour until improvement occurs. Then gradually reduce the frequency of administration until treatment is completed.
Treatment usually lasts from 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 inner corner of the eye near the nose. This helps reduce systemic absorption of ophthalmic medications and minimizes 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 your doctor. Safety and efficacy in children under 1 year of age have not been established, and there are no data 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 dysfunction have not been established.

Instructions for use
Tobrex is intended exclusively for ophthalmic 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 with the bottom facing upwards, gripped between 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, into which the drop should be instilled (Figure 2).
6. Bring the dropper tip 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 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 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 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 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 a 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 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 a patient is using other eye drops or ointments simultaneously, wait at least 5 minutes between applications of different medicines. 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 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 other serious adverse reactions occur,
treatment with Tobrex should be discontinued immediately and the doctor or the nearest hospital's
Emergency Department should be contacted immediately.
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, decreased growth or loss of eyelashes, loss of skin pigmentation, 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 Adverse Reactions of Medicinal Products at 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 below.
Date of first opening: …………….
Keep the medicine out of sight and reach of children.
Store below 25°C.
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 will help protect the environment.

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, anhydrous sodium sulfate, sodium chloride, tyloxapol, benzalkonium chloride, purified water. Minimal amounts of sulfuric acid and (or) sodium hydroxide are added to adjust the appropriate pH.

What Tobrex looks like and contents of the pack
A polyethylene (LDPE) bottle with a dropper and a polypropylene (PP) cap, with a capacity of 5 ml,
in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Croatia, the country of export:
Novartis Hrvatska d.o.o.
Radnička cesta 37b
10 000 Zagreb, Croatia
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, El Masnou, 08320 Barcelona, Spain
Novartis Pharma GmbH, Roonstrasse 25, D-90429 Nuremberg, Germany
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing authorisation number in Croatia, the country of export: HR-H-904981713-01
Parallel import authorisation number: 205/23