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

Tobramycin

Before Using the Medication, Carefully Read the Contents of the Leaflet, 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, consult a doctor or pharmacist.
• This medication has been prescribed specifically for one person. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform 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 medication (listed in section 6).

Warnings and precautions

Before starting to use 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 medication and consult their doctor immediately (see section 4). Hypersensitivity symptoms can 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 their doctor;
• if the patient has or suspects 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 a fungal eye infection.

Tobrex and other medications

The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications 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 medications. 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 medication.
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 medication 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 on.
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 medication, they should consult their doctor.

3. How to use Tobrex

This medication 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 disease, one to two drops are instilled into the conjunctival sac of the infected eye(s) every four hours.
In severe cases, one to two drops are instilled into the conjunctival sac of the infected eye(s) every hour until improvement is achieved. Then, the medication should be used less frequently until the end of treatment.
Usually, the medication is used for 7 to 10 days. The patient should use the medication for as long as the doctor recommends.
After administering the medication, the patient should gently close their eyelid and press the corner of their eye near the nose. This helps reduce the absorption of the medication 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 a day is 14 drops for children from 1 to 2 years old and 46 drops for children from 2 to 12 years old.In case of doubts, the patient should consult their doctor. The safety and efficacy of using the medication 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 or 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 medication.
• 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 down the lower eyelid 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, try again.
• 9. After administering the medication, gently close your eye and press the corner of your eye near the nose (drawing 4). This helps prevent the medication from entering the entire body.
• 10. If using drops in both eyes, repeat the above steps to administer the drops to the other eye.

to administer the drops to the other eye.

• 11. Immediately after use, screw the bottle cap back on.
• 12. Use only one bottle at a time.

Using more than the recommended dose of Tobrex

In case of overdose, excess medication 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 dosage schedule. If it is almost time for the next dose, skip the missed dose and continue treatment according to the recommended dosage 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 medications. Eye ointments should be used last.

In case of further doubts about using this medication, consult a doctor or pharmacist.

4. Possible side effects

Like all medications, 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 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 eyelash loss, 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 or pharmacist.Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, more information can be gathered on the safety of the medication.

5. How to store Tobrex

To prevent infections, the drops should not be used after 28 days from the first opening of the bottle. The date of opening the bottle should be written in the space below.
Date of first opening:…………….
The medication should be kept out of sight and reach of children.
Store in a temperature below 25°C, in the original packaging.
Keep the bottle tightly closed.
Do not use Tobrex after the expiration date stated on the packaging.
The expiration date is the last day of the specified month.
Medications should not be disposed of in wastewater or household waste containers. The patient should ask their pharmacist how to dispose of unused medications. This will help protect the environment.

6. Contents of the packaging 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, sodium hydroxide, and sulfuric acid (to adjust the pH), purified water.

What Tobrex looks like and what the pack contains

1 bottle with a dropper and cap, with a capacity of 5 ml, placed in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, the country of export:

Novartis Pharma GmbH
Roonstrasse 25
D-90429 Nuremberg
Germany

Manufacturer:

S.A. ALCON - COUVREUR N.V., Rijksweg 14, B-2870 Puurs, Belgium
Siegfried El Masnou, S.A., Camil Fabra 58, 08320 El Masnou, Barcelona, Spain
Novartis Farmacéutica, S.A., Gran Via de les Corts Catalanes, 764, 08013 Barcelona, Spain

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
Authorization number in Romania, the country of export:8412/2015/01
Parallel import authorization number:163/12
Date of leaflet approval: 30.09.2022
[Information about the trademark]