TOBREX

Patient Information Leaflet

Warning! Please keep this leaflet. Information on the immediate packaging is in a foreign language.
Tobrex, 3 mg/g, eye ointment
Tobramycinum
Please read this leaflet carefully before using the 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 pass it on to others. It may harm someone else even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform 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 microorganisms that may infect the eye.
Tobrex is indicated for the treatment of external eye and periocular 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 treatment with Tobrex, discuss this with a doctor or pharmacist:

• if the patient experiences allergic reactions after using Tobrex, treatment should be discontinued and immediate medical advice sought (see section 4). Hypersensitivity symptoms 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 antibiotics from the same group (aminoglycosides), whether administered locally or systemically.
• if the patient is undergoing other antibiotic therapy while using Tobrex eye ointment, 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, 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.
• eye ointments may delay corneal healing.

Tobrex and other medicines
Inform the doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient plans to use.
If the patient is using other eye drops or eye ointments simultaneously, at least a 5-minute interval should be maintained between the administration of each product. 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 a 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 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 has a negligible effect on the ability to drive and operate machinery.
For a short period after administration of Tobrex, vision may be blurred. Driving and operating machinery should be avoided until this symptom resolves.
During treatment of eye inflammation, wearing contact lenses is not recommended.

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, a small amount (a strip about 1.5 cm long) of ointment should be applied into the conjunctival sac (sacs) of the infected eye(s) two or three times daily.

In severe cases, a small amount (a strip about 1.5 cm long) of ointment should be applied into the conjunctival sac (sacs) of the infected eye(s) every three to four hours during the first two days, then two to three times daily until the infection resolves.

Tobrex ophthalmic ointment may be used at bedtime, in combination with Tobrex eye drops, solution, during the day.

Treatment usually lasts from 7 to 10 days. The medicine should be used for as long as directed by your doctor.

Use in children
Tobrex ophthalmic ointment may be used in children aged 1 year and older at the same doses as in adults. The safety and efficacy of Tobrex have not been established in children under 1 year of age, and there is no data available on 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 liver or kidney impairment
The safety and efficacy of Tobrex in patients with hepatic or renal impairment have not been established.

Method of administration
Tobrex is intended exclusively for ophthalmic use.

Method of use

1. Prepare the Tobrex tube and a mirror.
2. Wash your hands.
3. Unscrew the cap.
4. Hold the tube with the tip pointing downwards, between your thumb and index finger.
5. Tilt your head backward. With a clean finger, gently pull down the lower eyelid to form a "pocket" between the eyeball and the eyelid. Place the ointment strip into this pocket (Figure 1).
6. Bring the tip of the tube close to the eye. A mirror may be used to assist.
7. Do not let the tip of the tube touch the eye, eyelid, surrounding areas, or any other surface. This could lead to contamination of the ointment. Using contaminated ointment may result in serious complications, including loss of vision.
8. To express a strip of Tobrex ointment, gently squeeze the tube (Figure 2). If the ointment was not successfully delivered into the eye, repeat the attempt.
9. After applying the ointment, remove the finger from the lower eyelid. Open and close the eye several times to spread the ointment over the entire surface. Gently close the eyelid for a few seconds. This helps minimize the amount of medicine passing into the systemic circulation.
10. If treating both eyes, repeat the above steps to apply ointment to the second eye. Immediately after use, recap the tube tightly.
11. Only one tube of medicine should be used at any given time.

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

Missed dose of Tobrex
If the patient forgets to use Tobrex, they should continue treatment by applying the next dose as scheduled. If it is almost time for the next dose, the missed dose should be skipped and treatment should continue according to the prescribed schedule. 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 5 minutes should be allowed between the application of each medicine. Ointments should be used last.

If there are any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone 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 if other serious adverse reactions occur,
tobramycin use must be discontinued immediately and medical advice must be sought immediately
from a doctor or the nearest hospital Emergency Department.
The following adverse reactions have been observed during treatment with 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 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 eyelash growth or loss of eyelashes, loss of skin pigmentation, skin itching and dryness.
Frequency not known (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, pharmacist or nurse.
Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions allows additional information on the safety of the medicine to be collected.

5. How to store Tobrex ointment

To prevent infection, discard the tube 4 weeks after first opening.
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. Do not store in the refrigerator. Do not freeze.
Keep the tube 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 required. This will help protect the environment.

6. Contents of the packaging and other information

What Tobrex contains

• The active substance is tobramycin 3 mg/g.
• The other components are: chlorobutanol, liquid paraffin (mineral oil), white soft paraffin.

What Tobrex looks like and contents of the pack
1 tube containing 3.5 g of ointment, placed in a cardboard box.
For more detailed information, please contact the responsible party or 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-257802614-01
Parallel Import Licence Number: 67/23