Tobrex

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging 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 so that you can read it again if necessary.
• 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. The medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. 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 eyelid 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 to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Tobrex, discuss the following with your doctor or pharmacist:

• if the patient experiences allergic reactions after using Tobrex, treatment should be discontinued and immediate medical advice should be sought (see section 4). Hypersensitivity reactions may vary in severity: from local itching or redness of the skin to severe allergic reactions (anaphylactic reaction) or severe skin reactions. Such allergic reactions may occur when using other topical or systemic antibiotics from the same group (aminoglycosides).
• if the patient is receiving other antibiotic therapy during treatment with Tobrex 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 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 with 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 5 minutes should be left between the application 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 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 has a negligible effect on the ability to drive and use machinery.
Vision may be blurred for a short time after administration 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

This medicine should always be used exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

For mild to moderate infections: Apply a small amount (a strip about 1.5 cm long) of ointment into the conjunctival sac (sacs) of the infected eye(s) two or three times daily.

For severe infections: Apply a small amount (a strip about 1.5 cm long) of oint游戏副本 into the conjunctival sac (sacs) of the infected eye(s) every three to four hours during the first two days, then reduce 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.

Treatment usually lasts from 7 to 10 days. Continue using the medicine for as long as your doctor has instructed.

Use in children
Tobrex ophthalmic ointment may be used in children aged 1 year and older at the same dosage 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 dosage 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.

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 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. Insert 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 touch the tip of the tube to the eye, eyelid, surrounding areas, or any other surface. This may contaminate the ointment. Using contaminated ointment may lead to serious complications, including loss of vision.
8. Gently squeeze the tube to extrude a small amount of Tobrex 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 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, recap the tube tightly.
11. Only one tube should be used at any given time.

Overdose of Tobrex
If too much ointment is applied, the excess can be rinsed from the eye with lukewarm water. No adverse effects are expected. Do not apply additional ointment. Apply the next dose at the usual time.

Missed dose of Tobrex
If the patient forgets to apply Tobrex, they should continue treatment by applying the next dose according to the prescribed schedule. If the time until the next scheduled dose is short, 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, wait at least 5 minutes between applications of different eye medications. 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 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 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 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: 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 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 or pharmacist. Adverse reactions 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 adverse reactions enables the collection of additional information on the safety of this medicine.

5. How to store Tobrex ointment

To prevent infection, the tube should be discarded 4 weeks after first opening.
The date of first opening should be entered 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 or 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 package and other information

What Tobrex contains

• The active substance is tobramycin 3 mg/g.
• The other ingredients 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 marketing authorization holder or the parallel importer.
Marketing authorization 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11, 03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249, 04-458 Warsaw
Marketing authorization number in Croatia, the country of export: HR-H-257802614-01
Parallel import authorization number: 207/23