Tobrex

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet; the information on the immediate packaging is in a foreign language!
Tobrex
3 mg/ml, eye drops, solution
Tobramycinum
Please read the following instructions carefully before using this medicine, as they contain
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 the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist immediately. See section 4.

Table of contents:

1. What Tobrex is and what it is used for
2. What you need to know 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 ocular adnexa 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 any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting to use 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 symptoms may vary in severity: from local itching or redness of the skin to severe allergic reactions (anaphylactic reaction) or serious skin reactions. Such allergic reactions may occur when using other locally or systemically acting 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's symptoms 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 immediately, as this may indicate a fungal eye infection.

Tobrex and 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 simultaneously, at least 5 minutes should be left 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 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 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 negligible effect on the ability to drive and operate machinery.
For a short time after administration of Tobrex eye drops, vision may be blurred. Do not drive or operate machinery until this symptom has resolved.

Tobrex eye drops contain benzalkonium chloride
The medicine contains 0.1 mg of benzalkonium chloride in each 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, stinging or eye pain occur 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 conditions, instill one to two drops into the conjunctival sac (sacs) of the infected eye(s) every four hours.
In severe cases, instill one to two drops into the conjunctival sac (sacs) of the infected eye(s) every hour until improvement occurs. Then gradually reduce the frequency of administration until treatment is completed.
The usual duration of treatment is 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 the 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 use in this age group.
Use in elderly patients
The same dosage 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 instillation into the eyes.

1 2 3 4
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 in your hand 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; 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 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 the 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 treating both eyes, repeat the above steps to instill drops into the second eye.
11. Immediately after use, 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 instill additional drops. Administer the next dose at the usual time.
Missing a dose of Tobrex
If the patient forgets to use Tobrex eye drops, treatment should be continued by administering the next dose according to the prescribed schedule. If the next scheduled dose is due shortly, the missed dose should be omitted and treatment resumed according to the recommended dosing schedule. Do not use a double dose to make up for a missed dose.
If the patient is using other eye drops or ointments simultaneously, wait at least 5 minutes between administering different products. 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 other serious side effects occur,
treatment with Tobrex should be stopped immediately and the patient should contact a doctor or
the nearest hospital Emergency Department without delay.
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)
Eye-related symptoms: eye discomfort, eye redness.
Uncommon side effects (may occur in 1 to 10 patients out of 1,000)
Eye-related 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 dry skin.
Frequency not known (frequency cannot be estimated from the available data)
Eye-related 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 a doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 provide more information on the safety of this medicine.

5. How to store Tobrex medicine

To prevent infections, do not use the drops more than 4 weeks after first opening the bottle.
Enter the date of first opening 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. Do not store in a refrigerator.
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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will 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 (E 284), anhydrous sodium sulfate (E 514), 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
An LDPE bottle with a capacity of 5 ml, with an LDPE dropper and a tamper-evident screw cap made of plastic, packed in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Hungary, the country of export:
Novartis Hungária Kft.
Bartók Béla út 43-47.
1114 Budapest
Hungary
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
08320 El Masnou
Spain
Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany
Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorisation number in Hungary, the country of export: OGYI-T-5294/01
Parallel import licence number: 184/21