Tobrex

Package Leaflet: Information for the Patient

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Tobrex

3 mg/ml, eye drops, solution

Tobramycin

The patient should carefully read the leaflet before using the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be read again if necessary.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for this patient. It should not be given to others. The medicine may harm another person, even if the symptoms of their disease are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. 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 package 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 treatment with Tobrex, the patient should discuss it with their doctor or pharmacist:

• if the patient experiences allergic reactions after using Tobrex, they should stop using the medicine and consult their doctor immediately (see section 4). Hypersensitivity symptoms may have different 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 topical or systemic antibiotics from the same group (aminoglycosides).
• if the patient is using other antibiotic therapy while using Tobrex, they should consult their doctor.
• if the patient has or is suspected of having myasthenia or Parkinson's disease, they should consult their doctor. Antibiotics from this group may exacerbate muscle weakness.
• if the patient's symptoms worsen or recur, they should consult their doctor. If the patient uses Tobrex for a longer period, they may become more susceptible to eye infections.
• if the patient experiences persistent corneal ulcers while using Tobrex, they should consult their doctor as soon as possible, as this may be a sign of fungal eye infection.

Tobrex and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
If the patient is using other eye drops or ointments, they should leave at least a 5-minute interval between administrations of the different 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 their doctor before using this medicine.
Pregnancy
Tobrex may be used during pregnancy only if it is absolutely necessary.
Breastfeeding
Using Tobrex is not recommended during breastfeeding.
The doctor will decide whether to continue or stop breastfeeding or continue or stop treatment, considering 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.
For some time after administering Tobrex eye drops, vision may be blurred. The patient should 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. The patient should remove their 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 the patient experiences any abnormal sensations in the eye, stinging, or eye pain after using the medicine, they should consult their doctor.

3. How to use Tobrex

This medicine should always be used as directed by the doctor. In case of doubts, the patient should consult their 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 is seen. Then, the medicine should be used less frequently until the end of treatment.
Usually, the medicine is used for 7 to 10 days. The medicine should be used for as long as the doctor recommends.
After administering the medicine, the patient should gently close their eyelid and press the corner of their eye near the nose.
This helps reduce the absorption of the medicinal product into the bloodstream and its systemic effects.

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.In case of doubts, the patient should consult their 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 elderly patients

In elderly patients, the same dose is used 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.
Method of administration
Tobrex is exclusivelyintended for administration into the eye.

Method of administration

• 1. Prepare the Tobrex bottle and a mirror.
• 2. Wash your hands.
• 3. Remove the cap. If the protective collar is loose after removing the cap, it should be discarded before using the medicine.
• 4. Hold the bottle in your hand and direct it upwards, holding it with your thumb and middle finger (figure 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 (figure 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 contamination of the drops. Using contaminated drops can lead to serious complications, even vision loss.
• 8. To release a single drop of Tobrex, gently squeeze the bottom of the bottle (figure 3). If the drop does not fall into the eye, try again.
• 9. After administering the medicine, gently close your eye and press the corner of your eye near the nose (figure 4). This helps prevent the medicine from entering the entire body.
• 10. If using drops in both eyes, repeat the above steps to administer the drops to the other eye.
• 11. Immediately after use, close the bottle tightly.
• 12. Use only one bottle at a time.

Using more Tobrex than recommended

In case of overdose, excess medicine can be rinsed out of the eye with lukewarm water.
No side effects are expected. Do not administer additional drops.
The next dose should be administered 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, the patient should 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, they should leave at least a 5-minute interval between administrations of the different medicines. Eye ointments should be used last.

In case of further doubts about using this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Tobrex 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 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, hives, skin inflammation, reduced eyelash growth or loss of eyelashes, 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse.

Side effects can be reported directly to the Department of Post-Marketing Surveillance 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, it is possible to gather more information on the safety of the medicine.

5. How to store Tobrex

To prevent infections, the drops should not be used after 4 weeks from the first opening of the bottle.
The date of first opening should be written in the space below.
Date of first opening: …………….
The medicine should be kept out of sight and reach of children.
Store at a temperature 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 month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the package and other information

What Tobrex contains

• The active substance of Tobrex is tobramycin 3 mg/ml.
• The other ingredients are boric acid, anhydrous sodium sulfate, sodium chloride, tyloxapol, benzalkonium chloride, purified water. The medicine also contains small amounts of sodium hydroxide and/or sulfuric acid (to adjust the pH).

What Tobrex looks like and contents of the package

1 polyethylene (LDPE) bottle of 5 ml, with a dropper and a polypropylene (PP) cap, in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization 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:

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

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorization number in Croatia, the country of export: HR-H-904981713-01

Parallel import authorization number: 68/23 Date of approval of the leaflet: 05.04.2023

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