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 in Case it Needs to be Read Again.
• In Case of Any Doubts, Consult a Doctor or Pharmacist.
• This Medication has been Prescribed for a Specific Person. Do not Pass it on to Others. The Medication may Harm Another Person, even if the Symptoms of their Illness are the Same.
• If the Patient Experiences any Undesirable Effects, Including any Undesirable 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 Undesirable 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, Discuss it with your 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). Symptoms of Hypersensitivity may Vary in Severity: from Local Itching or Redness of the Skin 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 they have Myasthenia or Parkinson's Disease, they Should Consult their Doctor. Antibiotics from this Group may Increase 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 be more Susceptible to Eye Infections;
• If the Patient Experiences Persistent Corneal Ulceration 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 Medications

Tell your Doctor or Pharmacist about all Medications the Patient is Currently Taking or has Recently Taken, as well as any Medications they Plan to Use.
If the Patient is Using other Eye Drops or Ointments, they Should Wait at Least 5 Minutes between Administrations of the Next Medications. Eye Ointments Should be Used Last.

Pregnancy and Breastfeeding

If the Patient is Pregnant or Breastfeeding, Thinks they may be Pregnant or are Planning 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, Taking into Account the Benefits of Breastfeeding for the Child and the Benefits of Treatment for the Mother.

Driving and Operating Machines

Tobrex Eye Drops have no or Negligible Influence on the Ability to Drive and Operate Machines. For a Certain Period after Administering Tobrex Eye Drops, Vision may be Blurred. Do not Drive or Operate Machines until this Symptom Subsides.

Tobrex Contains Benzalkonium Chloride

The Medication Contains 0.1 mg of Benzalkonium Chloride in each Milliliter (0.1 mg/ml).
Benzalkonium Chloride may be Absorbed by Soft Contact Lenses and Change their Color. Contact Lenses Should be Removed before Instillation and Wait at Least 15 Minutes before Reinserting.
Benzalkonium Chloride may also Cause Eye Irritation, Especially in People with Dry Eye Syndrome or Corneal Disorders (the Transparent Layer on the Front of the Eye). If Abnormal Sensations in the Eye, Stinging, or Eye Pain Occur after Using the Medication, Consult a Doctor.

3. How to Use Tobrex

This Medication Should Always be Used as Directed by the Doctor. In Case of Doubts, Consult a Doctor or Pharmacist.
In Mild or Moderate Diseases, Use one to two Drops into the Conjunctival Sac (Sacs) of the Infected Eye (Eyes) every Four Hours.
In Severe Cases, Use one to two Drops into the Conjunctival Sac (Sacs) of the Infected Eye (Eyes) every Hour, until Improvement is Achieved. Then, the Medication Should be Used Less Frequently until its Use is Stopped.
Usually, the Medication is Used for 7 to 10 Days. The Medication Should be Used for as Long as the Doctor Recommends.
After Instillation, it is Recommended to Gently Close the Eyelid and Press the Corner of the Eye near the Nose. This can Help Reduce the Absorption of the Medication into the System 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 of Age and 46 Drops for Children from 2 to 12 Years of Age.In Case of Doubts, Consult a 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 Dosage is Used as in Adults.

Use in Patients with Liver or Kidney Impairment

The Safety and Efficacy of Using Tobrex in Patients with Liver or Kidney Impairment 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 (Figure 1).
• 5. Tilt your Head Back. With a Clean Finger, Pull the Lower Eyelid Down to Create a "Pocket"; the Drop Should Fall into it (Figure 2).
• 6. Bring the Tip of the Bottle Close to the Eye. For Ease of Use, you can Use a Mirror.
• 7. Do not Touch the Dropper to the Eye, Eyelid, or Surrounding Areas.This can Lead to Infection of the Drops. Using Infected Drops can Lead to Serious Complications, even Vision Loss.
• 8. To Release a Single Drop of Tobrex, Gently Press the Bottom of the Bottle (Figure 3). If the Drop does not Fall into the Eye, Repeat the Attempt.
• 9. After Instillation, Gently Close the Eye and Press the Corner of the Eye near the Nose with your Finger (Figure 4). This will Help Prevent the Medication from Entering the Entire Body.
• 10. If Using Drops in both Eyes, Repeat the Procedure Described Above to Instill the Second Eye.
• 11. Immediately after Use, Tighten the Bottle.
• 12. Use only one Bottle at a Time.

Using a Higher Dose of Tobrex than Recommended

In Case of Overdose, Excess Medication can be Rinsed out of the Eye with Lukewarm Water. No Undesirable Effects are Expected. Do not Instill Additional Drops. The Next Dose Should be Instilled 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 there is not Much Time Left before 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 Wait at Least 5 Minutes between Administrations of the Next Medications. Eye Ointments Should be Used Last.

In Case of Further Doubts about Using this Medication, Consult a Doctor or Pharmacist.

4. Possible Undesirable Effects

Like all Medications, Tobrex can Cause Undesirable Effects, although not Everybody will Experience 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 Undesirable Effects, they Should Stop Using Tobrex and Immediately Consult a Doctor or the Emergency Department of the Nearest Hospital.
During Treatment with Tobrex Eye Drops, the Following Undesirable Effects have been Observed.
Common Undesirable Effects (may Occur in 1 to 10 Patients out of 100)
Eye Symptoms: Feeling of Discomfort in the Eye, Redness of the Eye.
Uncommon Undesirable Effects (may Occur in 1 to 10 Patients out of 1000)
Eye Symptoms: Inflammation of the Eye Surface, Corneal Damage, Vision Disorders, Blurred Vision, Redness of the Eyelids, Swelling of the Eye and Eyelids, Eye Pain, Dryness of the Eye, Discharge from the Eye, Itching of the Eye, Increased Tear Production.
General Symptoms: Allergy (Hypersensitivity), Headache, Hives, Skin Inflammation, Reduced Eyelash Growth or Loss of Eyelashes, Loss of Skin Pigmentation, Itching, and Dryness of the Skin.
Frequency Not Known (Frequency cannot be Estimated from Available Data)
Eye Symptoms: Eye Allergy, Eye Irritation, Itching of the Eyelids.
General Symptoms: Severe Allergic Reactions, Severe Skin Reactions (Stevens-Johnson Syndrome, Erythema Multiforme), Rash.

Reporting Undesirable Effects

If any Undesirable Effects Occur, Including any Undesirable Effects not Listed in the Leaflet, Inform a Doctor or Pharmacist. Undesirable Effects can be Reported Directly to the Department of Monitoring of Undesirable Effects of Medicinal Products, 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 Undesirable Effects can Help Gather more Information 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 First Opening of the Bottle Should be Written in the Space Below.
Date of First Opening: ………..
The Medication Should be Stored out of Sight and Reach of Children.
Store in a Temperature below 25°C.
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 Sewers or Household Waste Containers. Ask a Pharmacist how to Dispose of Medications 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 Tobrex is Tobramycin. 1 ml of the Solution Contains 3 mg of Tobramycin.
• Other Ingredients are: Boric Acid, Sodium Sulfate, Sodium Chloride, Tyloxapol, Benzalkonium Chloride, Sodium Hydroxide, and/or Sulfuric Acid (to Adjust the pH), Purified Water. The Medication Contains Minimal Amounts of Sodium Hydroxide and/or Sulfuric Acid (to Adjust the pH).

What Tobrex Looks Like and What the Packaging Contains

A Transparent or White DROPTAINER Bottle made of LDPE with a Capacity of 5 ml, with a Dropper and a Cap, in a Cardboard Box.
For more Detailed Information, Contact the Marketing Authorization Holder or the Parallel Importer.

Marketing Authorization Holder in the Czech Republic, the 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., 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 the Czech Republic, the Country of Export:64/106/87-C
Parallel Import Authorization Number:214/20

Date of Approval of the Leaflet: 16.07.2025

[Information about the Registered Trademark]