Tobrex

Package leaflet: Information for the patient

Warning! Please 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 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. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including those 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 intended for the treatment of external eye and surrounding area 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 the following 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 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 administered antibiotics from the same group (aminoglycosides).
• if the patient is receiving 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, they should consult a doctor. 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
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 administered 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
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.
Vision may be blurred for a short time after applying Tobrex. Do not drive or operate machinery until this effect has passed.
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 thin strip about 1.5 cm long) of ointment should be applied to the conjunctival sac (sacs) of the infected eye(s) two or three
times daily.
In severe cases, a small amount (a thin strip about 1.5 cm long) of ointment should be applied to 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 at bedtime in combination with Tobrex eye drops, solution, during the day.
The usual duration of treatment is 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 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 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. With a clean finger, gently pull down the lower eyelid to form a "pocket" between the eyeball and the eyelid. Place 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 let the tip of the tube touch 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. 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 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 reduces the amount of medicine passing into the systemic circulation.
10. If treating both eyes, repeat the above steps to apply the 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 ointment can be rinsed from the eye with lukewarm water. Adverse effects are not expected. Do not apply 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 soon, 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 simultaneously, at least 5 minutes should be left between the administration of each medicine. 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 can cause adverse reactions, 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 adverse reactions occur,
tobrex treatment must be discontinued immediately and the patient should contact a doctor or the
Emergency Department of the nearest hospital 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 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, decreased 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 at 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 helps provide more information on the safety of the medicine.

5. How to store Tobrex

To prevent contamination, discard the tube 4 weeks after first opening.
Enter the tube opening date in the space indicated below.
Date of first opening: …………….
Keep this medicine out of sight and reach of children.
Store below 25°C.
Do not store in the refrigerator.
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. These measures will help protect the environment.

6. Contents of the package and other information

What Tobrex contains

• The active substance is tobramycin 3 mg/g.
• The other ingredients are: chlorobutanol, liquid paraffin, white soft paraffin.

What Tobrex looks like and contents of the pack
1 tube containing 3.5 g of ointment, packed in a cardboard box.
For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Belgium, country of export:
Novartis Pharma NV, Medialaan 40, B-1800 Vilvoorde, Belgium
Manufacturer:
ALCON CUSI S.A., Camil Fabra 58, 08320 El Masnou, Barcelona, Spain
SA ALCON-COUVREUR NV, Rijksweg 14, B-2870 Puurs, Belgium
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Belgium, country of export, marketing authorisation number: BE125115
Parallel import licence number: 27/22