Tobrex

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, information on the immediate packaging 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 doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including those not listed in this leaflet, inform a doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What is Tobrex and for what purpose is it used
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 is Tobrex and for what purpose is it used

Tobrex is an antibiotic effective against many microorganisms that can infect the eye.
Tobrex is indicated for the treatment of external eye infections and 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, discuss this with a 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 skin redness 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 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's symptoms 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, the patient should seek medical advice promptly, 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
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 has no effect or a negligible effect on the ability to drive and operate machinery.
For a short time after administration of Tobrex, vision may be blurred. The patient should not drive or operate machinery until this symptom has resolved.
During treatment of an eye inflammatory condition, wearing contact lenses is not recommended.

3. How to use Tobrex

This medicine should always be used exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

In mild or moderate conditions, a small amount (a thin strip approximately 1.5 cm long) of ointment should be applied into the conjunctival sac of the infected eye(s) two or three times daily.

In severe cases, a small amount (a thin strip approximately 1.5 cm long) of ointment should be applied into the conjunctival sac 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 bedtime in combination with Tobrex eye drops, solution, during the day.

The medicine is usually used for 7 to 10 days. Continue treatment 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 this medicine 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 liver or kidney impairment
The safety and efficacy of Tobrex medicinal product in patients with hepatic or renal impairment have not been established.

Method of administration
Tobrex is intended exclusively for ophthalmic use.

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 your thumb and index finger.
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. Apply the ointment 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 touch the tip of the tube to the eye, eyelid, surrounding area, or any other surface. This could contaminate the ointment. Using contaminated ointment may lead to serious complications, including loss of vision.
8. Gently squeeze the tube to extrude a ribbon of ointment (Figure 2). If the ointment was not successfully delivered 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 treating both eyes, repeat the above steps to apply ointment to the second eye. Immediately after use, replace the cap on the tube.
11. Only one tube of medicine should be used at any one 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 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 continued 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 simultaneously, at least a 5-minute interval should be maintained between the administration of each medicine. 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 all medicines, 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 in breathing or swallowing, or if other serious adverse reactions
occur, Tobrex treatment must be discontinued and immediate contact must be made with a doctor
or the nearest hospital Emergency Department.
The following adverse reactions have been observed during the use of 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: ocular surface inflammation, 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, 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 any adverse reactions 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: Aleje Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions enables further information on the safety of the medicine to be collected.

5. How to store Tobrex

To prevent infection, the tube should be discarded 4 weeks after first opening.
Please enter the date of first opening in the space indicated 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.
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 the sewage system or in 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. 1 g of ointment contains 3 mg of tobramycin.
• The other ingredients 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 entity or the parallel importer.
Marketing authorisation holder in Bulgaria, the country of export:
Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany
Manufacturer:
Alcon-Couvreur NV
Rijksweg 14
2870 Puurs
Belgium
Siegfried El Masnou, S.A.
Camil Fabra, 58
08320 El Masnou
Barcelona
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:
Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
Marketing authorisation number in Bulgaria, the country of export: 9600005
Parallel import licence number: 260/20