Tobrex

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Tobrex
3 mg/ml, eye drops, solution
Tobramycinum
Please read the following information carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Tobrex is and what it is 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 Tobrex is and what it is used for

Tobrex is an antibiotic effective against many microorganisms that may infect the eye.
Tobrex is indicated for the treatment of external eye and surrounding area infections in adults and children aged 1 year and older, 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, discuss with your doctor or pharmacist:

• if the patient experiences allergic reactions after using Tobrex, treatment should be discontinued and medical advice sought immediately (see section 4). Hypersensitivity reactions 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 locally or systemically administered 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 symptoms of the disease worsen or recur, medical advice should be sought. Prolonged use of Tobrex may increase susceptibility to eye infections;
• if persistent corneal ulceration occurs during treatment with Tobrex, the patient should seek medical advice promptly, as this may indicate a fungal eye infection.

Tobrex with 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 a 5-minute interval should be maintained between the administration of each medicine. Eye ointments should be applied 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 whether 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 has no effect or a negligible effect on the ability to drive and operate machinery. However, vision may be blurred for a short time after instillation of Tobrex. Do not drive or operate machinery until this symptom has resolved.

Tobrex contains benzalkonium chloride
The 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 elapse before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially in individuals with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If abnormal sensations, stinging, or eye pain occur after using the medicine, consult a doctor.

3. How to use Tobrex

This medicine should always be used exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
In mild or moderate conditions, instill one to two drops into the conjunctival sac(s) of the infected eye(s) every four hours.
In severe cases, instill one to two drops into the conjunctival sac(s) of the infected eye(s) every hour until improvement occurs. Then gradually reduce the frequency of administration until treatment is completed.
The medicine is usually used for 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 their potential systemic effects.

Use in children
Tobrex 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. The safety and efficacy of Tobrex in children under 1 year of age have not been established, and there are no data available on its use in this age group.

Use in elderly patients
The same dose 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 disorders have not been established.

Instructions for use
Tobrex is intended exclusively for ophthalmic use (instillation into the eye).

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 in your hand with the bottom facing upward, grasped 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—this is where the drop should go (Figure 2).
6. Bring the tip of the bottle 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 dropper and the solution. Using contaminated drops may lead to serious complications, including loss of vision.
8. To release a single drop of Tobrex, gently squeeze the bottom of the bottle (Figure 3). If the drop misses 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 using drops in 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.

If you use more Tobrex than you should
In case of overdose, rinse the eye with lukewarm water. No adverse effects are expected. Do not instill additional drops. Use the next dose at the usual time.

If you forget to use Tobrex
If the patient forgets to instill 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 continued as prescribed. Do not use a double dose to make up for a missed dose.

If the patient is using other eye drops or ointments at the same time, wait at least 5 minutes between administering each medication. 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 breathing or swallowing, or other serious adverse reactions occur,
treatment with Tobrex should be discontinued immediately and the patient should contact a doctor or
the nearest hospital Emergency Department without delay.
The following adverse reactions have been observed during the use of Tobrex.
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 1000)
Ocular symptoms: ocular surface inflammation, 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 eyelash growth or loss of eyelashes, loss of skin pigmentation, skin itching and dryness.
Frequency unknown (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 Drug Reactions 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.
Reporting adverse reactions enables continued monitoring of the medicine's safety and helps provide more information on its safe use.

5. How to store Tobrex

To prevent infections, the drops must not be used more than 28 days after first opening the bottle.
Enter the bottle opening date in the space provided below.
Date of first opening: …………….
Keep the medicine out of the sight and reach of children.
Do not store above 25°C. Protect from light.
Keep 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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Tobrex contains

• The active substance is tobramycin. 1 ml of solution contains 3 mg of tobramycin.
• 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
Plastic bottle with a dropper, with a PP cap, in a cardboard box.
Clear, colourless to pale yellow or brown solution.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Portugal, country of export:
Novartis Farma - Produtos Farmacêuticos, S.A.
Av. Professor Doutor Cavaco Silva, 10 E, Taguspark, 2740-255 Porto Salvo, Portugal
Manufacturer:
Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes 764, 08013 Barcelona, Spain
Siegfried El Masnou, S.A.
Camil Fabra 58, El Masnou 08320, Barcelona, Spain
Novartis Manufacturing NV
Rijksweg 14, 2870 Puurs-Sint-Amands, Belgium
Novartis Pharma GmbH
Roonstrasse 25, D-90429 Nuremberg, Germany
Parallel importer:
InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw
Marketing authorisation number in Portugal, country of export: 8740902
Parallel import authorisation number: 173/21