Tobrex

Patient Information Leaflet

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, 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. 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 surrounding area infections in adults and children aged 1 year and above, 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 the following 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 redness of the skin 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 applied locally or administered systemically;
• if the patient is receiving another antibiotic therapy during treatment with Tobrex eye ointment, consult a doctor;
• 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, prompt medical advice should be sought, as this may indicate a fungal eye infection;
• eye ointments may delay corneal healing.

Tobrex with other medicines
Inform the 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 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.
Vision may be blurred for a short time after application of Tobrex.
Do not drive or operate machinery until this symptom has resolved.
During treatment of eye inflammation, wearing contact lenses is not recommended.

3. How to use Tobrex medicine

This medicine should always be used exactly as directed by the doctor. If in doubt, consult a
physician 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 reduced to two or three times daily until the infection resolves.
Tobrex ophthalmic ointment may be used before going to bed, 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 the physician.
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 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 dysfunction have not been established.
Method of administration
Tobrex is intended exclusively for ophthalmic use.

1 2
Method of administration

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 the thumb and index finger.
5. Tilt the head backwards. With a clean finger, gently pull down the lower eyelid to create a "pocket" between the eyeball and the eyelid. Apply the ointment into this space (Figure 1).
6. Bring the tip of the tube close to the eye. A mirror may be used to assist.
7. Do not touch the tip of the tube to 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. Gently press the tube to extrude a small amount of Tobrex ointment (Figure 2). If the ointment was not successfully applied into the eye, repeat the procedure.
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 applying ointment to both eyes, repeat the above steps to administer the ointment into the second eye. Immediately after use, recap the tube tightly.
11. Only one tube of medicine should be used at a time. If more than the recommended dose of Tobrex is used
    In case of overdose, excess medicine 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 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 the administration of each medicine. Ophthalmic ointments should be applied last.
If you have 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 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 if other serious adverse reactions occur,
treatment with Tobrex should be discontinued immediately and the doctor or the Emergency Department
of the nearest hospital should be contacted without delay.
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 1000)
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, skin depigmentation, 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 those 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, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Tobrex ointment

To prevent infection, the tube should be discarded 4 weeks after first opening.
Please enter the date of first opening in the space below.
Date of first opening: …………….
Keep the medicine out of sight and reach of children.
Store below 25°C. Do not store in the refrigerator.
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 should 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/g.
• The other components are: chlorobutanol, liquid paraffin, white vaseline.

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 the parallel importer.
Marketing Authorisation Holder in Belgium, the country of export:
Novartis Pharma NV
Medialaan 40, B-1800 Vilvoorde, Belgium
Manufacturer:
Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764, 08013 Barcelona, Spain
Alcon-Couvreur NV
Rijksweg 14
2870 Puurs
Belgium
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11, 03-138 Warsaw, Poland
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249, 04-458 Warsaw, Poland
Marketing Authorisation Number in Belgium, the country of export: BE125115
Parallel Import Authorisation Number: 330/22