Tobrex

Patient information leaflet

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 other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. 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 species of microorganisms that may infect the eye.
Tobrex is intended for the treatment of external bacterial infections of the eye and its 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 to use Tobrex, discuss this with your doctor or pharmacist:

• if the patient experiences allergic reactions after using Tobrex, treatment should be discontinued and medical advice should be sought immediately (see section 4). Hypersensitivity reactions 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 antibiotics from the same group (aminoglycosides), whether applied locally or systemically.
• 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 the patient develops persistent corneal ulceration during treatment with Tobrex, medical advice should be sought promptly, as this may be a sign of fungal eye infection.

Tobrex with other medicines
Tell 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 eye ointments at the same time, at least a 5-minute interval should be maintained between the administration of each medicine. Eye ointments should be used last.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine.
Pregnancy
Tobrex may be used during pregnancy only if absolutely necessary.
Breastfeeding
The 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 using machines
Tobrex eye drops have no or negligible effect on the ability to drive and use machines.
However, 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 eye drops contain benzalkonium chloride
This 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 be waited before reinserting them.
Benzalkonium chloride may also cause eye irritation, particularly in individuals with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If abnormal sensations in the eye occur, such as stinging or pain after using the medicine, contact your doctor.

3. How to use Tobrex

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
In mild to moderate infections, 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. Thereafter, gradually reduce the frequency of administration until treatment is completed.
This medicine is usually used for 7 to 10 days. Continue using the medicine for as long as your doctor recommends.
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 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 may 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 no data are 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 dysfunction have not been established.

Method of administration
Tobrex is intended exclusively for 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 safety collar is loose after removing the cap, discard it before using the medicine.
4. Hold the bottle with the bottom facing upwards, using 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, into which the drop should be placed (Figure 2).
6. Bring the tip of the dropper 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 drops. 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 does not enter 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 entering the systemic circulation.
10. If using drops in both eyes, repeat the above steps to instill the drops into 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 more than the 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. Administer the next dose at the usual time.
Missed dose of Tobrex eye drops
If the patient forgets to use Tobrex eye drops, they should continue treatment by administering the next dose according to the prescribed schedule. If it is almost time for the next dose, 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, at least a 5-minute interval should be maintained between administration of each product. Ophthalmic 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 may 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 in breathing or swallowing, or other serious adverse reactions occur,
tobrex treatment must be discontinued and immediate contact must be made with a doctor or the
Emergency Department of the nearest hospital.
During the use of Tobrex eye drops, the following adverse reactions have been observed:
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 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, reduced 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 not listed in this leaflet, please inform your doctor,
pharmacist or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of
Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C,
02-222 Warsaw, Tel.: +48 22 4921301, Fax: +48 22 4921309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions enables the collection of further information on the safety of the medicine.

5. How to store Tobrex

To prevent infection, the drops should not be used 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 the sight and reach of children.
Store below 25°C.
Keep the bottle tightly closed.
Do not use this medicine 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. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Tobrex contains

• The active substance is tobramycin 3 mg/ml.
• The other ingredients are: boric acid, anhydrous sodium sulphate, sodium chloride, tyloxapol, benzalkonium chloride, purified water. Minimal amounts of sodium hydroxide and (or) sulphuric acid are added to adjust the appropriate pH.

What Tobrex looks like and contents of the pack
1 polyethylene (LDPE) bottle with a capacity of 5 ml, with a dropper and a cap made of polypropylene (PP), packed in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Croatia, the country of export:
Novartis Hrvatska d.o.o.
Radnička cesta 37b
10 000 Zagreb
Croatia
Manufacturer:
Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona, Spain
S.A. Alcon-Couvreur N.V.
Rijksweg 14
B-2870 Puurs, Belgium
Siegfried El Masnou, S.A.
Camil Fabra 58
El Masnou, 08320 Barcelona, Spain
Novartis Pharma GmbH
Roonstrasse 25
D-90429 Nuremberg, Germany
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorisation number in Croatia, the country of export: HR-H-904981713-01
Parallel import authorisation number: 68/23