Tobrex

Package leaflet: Information for the user

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

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet 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 infections and infections of the surrounding areas 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, consult a doctor or pharmacist:

• if the patient experiences allergic reactions after using Tobrex, discontinue use immediately and consult a doctor (see section 4). Hypersensitivity symptoms 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 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 the patient experiences worsening or recurrence of symptoms, consult a doctor. Prolonged use of Tobrex may increase susceptibility to eye infections;
• if persistent corneal ulceration occurs during treatment with Tobrex, the patient should seek immediate medical advice, as this may indicate a fungal eye infection.

Tobrex and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken by the patient, as well as any medicines the patient plans to use.
If the patient is using other eye drops or ointments simultaneously, at least a 5-minute interval should be maintained between administration of each product. 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 a 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 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 eye drops have no effect or have a minor effect on the ability to drive and operate machinery. Vision may be blurred for a short time after instillation of Tobrex eye drops. 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 alter their colour. Contact lenses should be removed before instillation and at least 15 minutes should be waited 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 pain in the eye occur after using the medicine, consult a doctor.

3. How to use Tobrex

This medicine should always be used as directed by the physician. If in doubt, consult your
doctor or pharmacist.
In mild or moderate conditions, one to two drops should be administered into the
conjunctival sac(s) of the infected eye(s) every four hours.
In severe cases, one to two drops should be administered into the conjunctival sac(s) of the
infected eye(s) every hour until improvement occurs. After that, the frequency of administration
should be gradually reduced until treatment is completed.
The medicine is usually used for 7 to 10 days. Tobrex should be used for as long as directed by
the physician.
After instillation, it is recommended to gently close the eyelid and press the inner corner of the
eye near the nose. This helps reduce systemic absorption of ophthalmic drops and minimizes
systemic effects.

Use in children
Tobrex eye drops 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. Safety and efficacy of Tobrex in children under 1 year of age have
not been established, and no data are available regarding 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.

Method of administration
Tobrex is intended exclusively for ocular instillation.

Method of administration

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, it should be discarded before using the medicine.
4. Hold the bottle in your hand with the bottom facing upwards, using your thumb and middle finger (Figure 1).
5. Tilt your head backward. With a clean finger, gently pull the lower eyelid downward to form a "pocket" between the eyeball and the eyelid; the drop should be instilled into this pocket (Figure 2).
6. Bring the dropper tip close to the eye. A mirror may be used to assist.
7. Do not touch the dropper tip to the eye, eyelid, surrounding area, or any other surface. This may lead to contamination of the drops. Using contaminated drops may result in serious complications, including loss of vision.
8. To release a single drop of Tobrex, gently squeeze the base of the bottle (Figure 3). If the drop does not enter the eye, repeat the instillation.
9. After instilling Tobrex, gently close the eye and press the inner corner of the eye near the nose with a finger (Figure 4). This helps prevent the medicine from draining into the systemic circulation.
10. If drops are to be administered to 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.

Use of a higher than recommended dose of Tobrex
In case of overdose, excess medicine can be rinsed from the eye with lukewarm water. No adverse
effects are expected. Do not administer additional drops. The next dose should be given at the
regularly scheduled time.

Missed dose of Tobrex
If the patient forgets to use 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 directed. Do not use a double dose to make up for
a missed dose.

If the patient is using other eye drops or ointments simultaneously, at least a 5-minute interval
should be maintained between administration of each product. 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 side effects

Like all medicines, this medicine 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 in breathing or swallowing, or if other serious
side effects occur, treatment with Tobrex should be discontinued and immediate contact must be made
with a doctor or the Emergency Department of the nearest hospital.
The following side effects have been observed during the use of Tobrex eye drops:
Common side effects (may occur in 1 to 10 patients out of 100)
Ocular symptoms: eye discomfort, eye redness.
Uncommon side effects (may occur in 1 to 10 patients out of 1,000)
Ocular symptoms: inflammation of the eye surface, 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 growth or loss of eyelashes, loss of skin pigmentation, skin itching and dryness.
Frequency not known (frequency cannot be estimated from the 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 side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects 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 side effects helps to provide more information on the safety of the medicine.

5. How to store Tobrex

To prevent infection, do not use the drops more than 4 weeks after first opening the bottle.
Enter the date of first opening in the space below.
Date of first opening: …………….
Keep the medicine out of sight and reach of children.
Do not store above 25°C. Do not store in the refrigerator.
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 3 mg/ml.
• 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
A clear, colourless to slightly yellow, sterile solution. Tobrex is available in a white or colourless LDPE bottle with an LDPE dropper and cap, packed in a cardboard box.

For further information, please contact the Marketing Authorisation Holder or Parallel Importer.
Marketing Authorisation Holder in Hungary, the country of export:
Novartis Hungária Kft.
Bartók Béla út 43-47., 1114 Budapest, Hungary
Manufacturer:
S.A. Alcon – Couvreur N.V., Rijksweg 14, B-2870 Puurs, Belgium
Siegfried El Masnou, S.A., Camil Fabra 58, 08320 El Masnou, Spain
Novartis Farmacéutica, S.A., Gran Via de les Corts Catalanes, 764, 08013 Barcelona, Spain
Novartis Pharma GmbH, Roonstrasse 25, 90429 Nuremberg, Germany
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11, 03-138 Warsaw, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249, 04-458 Warsaw, Poland
Marketing Authorisation Number in Hungary, the country of export: OGYI-T-5294/01
Parallel Import Licence Number: 78/21