Tobrex

Leaflet accompanying the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Tobrex

3 mg/ml, eye drops, solution

Tobramycin

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

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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 packaging 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 to use Tobrex, you should discuss it with your doctor or pharmacist:

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

Tobrex and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
If you are using other eye drops or ointments, you should leave at least a 5-minute interval between administrations of the next medicines. Eye ointments should be used last.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult a 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. You 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. You should remove 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 you experience any abnormal sensations in the eye, stinging, or eye pain after using the medicine, you should consult a doctor.

3. How to use Tobrex

This medicine should always be used as directed by your doctor. If you are unsure, you should consult a doctor or pharmacist.
In mild or moderate disease, one to two drops are instilled into the conjunctival sac (sacs) of the infected eye (eyes) every four hours.
In severe cases, one to two drops are instilled into the conjunctival sac (sacs) of the infected eye (eyes) every hour, until improvement is achieved. 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, it is recommended to gently close the eyelid and press the corner of the eye near the nose. This helps reduce the absorption of the medicinal products administered in the form of eye drops and their systemic action.

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 a day is 14 drops for children from 1 to 2 years old and 46 drops for children from 2 to 12 years old.If you are unsure, you should consult a 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 the elderly

In the elderly, 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 intended exclusivelyfor instillation into the eyes.

Method of administration

• 1. Prepare the Tobrex bottle and a mirror.
• 2. Wash your hands.
• 3. Unscrew 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 turn it upside down, holding it with your thumb and middle finger (drawing 1).
• 5. Tilt your head back. With a clean finger, pull the lower eyelid down to create a "pocket" between the eyeball and the eyelid; the drop should fall into this pocket (drawing 2).
• 6. Bring the tip of the bottle close to the eye. You can use a mirror to help.

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 and even vision loss.

• 8. To release a single drop of Tobrex, gently squeeze the bottom of the bottle (drawing 3). If the drop does not fall into the eye, you should repeat the attempt.
• 9. After administering Tobrex, gently close your eye and press the corner of your eye near your nose (drawing 4). This will help prevent the medicine from entering the entire body.
• 10. If you are using drops in both eyes, you should repeat the above procedure to instill the second eye.
• 11. Immediately after using the medicine, screw the bottle cap back on.
• 12. Use only one bottle at a time.

Using a higher dose of Tobrex than recommended

In case of overdose, excess medicine can be rinsed out of the eye with lukewarm water. You should not expect any side effects. Do not instill additional drops. The next dose should be administered at the usual time.

Missing a dose of Tobrex

If you forget to use Tobrex eye drops, you should continue treatment by administering the next dose according to the dosing schedule. If it is almost time for the next dose, 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 you are using other eye drops or ointments, you should leave at least a 5-minute interval between administrations of the next medicines. Eye ointments should be used last.

In case of further doubts about using this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Tobrex can cause side effects, although not everybody gets them.
If you experience 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, you should stop using Tobrex and contact your doctor or the Emergency Department of the nearest hospital immediately.
During the use of 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 you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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, you can help provide 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. In the space marked below, you should write the date of opening the bottle.
Date of first opening: ………….
The medicine should be stored out of sight and reach of children.
Do not store above 25°C. Do not store in the refrigerator.
Store 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 should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the packaging and other information

What Tobrex contains

• The active substance of the medicine 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. The medicine contains minimal amounts of sulfuric acid and/or sodium hydroxide (to adjust the pH).

What Tobrex looks like and what the pack contains

A white LDPE bottle with an LDPE dropper with a capacity of 5 ml, with a protected cap made of plastic, in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization 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
Siegfried El Masnou, S.A., Camil Fabra 58, 08320 El Masnou, Spain
S.A. Alcon – Couvreur N.V., Rijksweg 14, B-2870 Puurs, Belgium
Novartis Pharma GmbH, Roonstrasse 25, 90429 Nuremberg, Germany

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Hungary, the country of export:OGYI-T-5294/01
Parallel import authorization number:78/21
Date of leaflet approval: 21.09.2022
[Information about the trademark]