Tobrex

Package Leaflet: Information for the Patient

Tobrex, 3 mg/g, Eye Ointment

(Tobramycin)

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

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

Tobrex is an antibiotic that works against many types of bacteria that can infect the eye. Tobrex is used to treat external eye infections and their surroundings in adults and children over 1 year of age, caused by bacteria sensitive to its active substance - tobramycin.

2. Important information before using Tobrex

When not to use Tobrex:

• - If you are allergicto tobramycin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions:

Before starting treatment with Tobrex, discuss it with your doctor or pharmacist:

• -if you experience allergic reactions after using Tobrex, stop using the medicine and consult your doctor immediately (see section 4). Hypersensitivity symptoms can range from local itching or skin redness to severe allergic reactions (anaphylactic reaction) or severe skin reactions. Such allergic reactions can occur when using other topical or systemic antibiotics from the same group (aminoglycosides).
• -if you are using other antibiotic therapy while using Tobrex eye ointment, consult your doctor.
• -if you have or suspect myasthenia or Parkinson's disease, consult your doctor. Antibiotics from this group may exacerbate muscle weakness.
• -if your symptoms worsen or recur, consult your doctor. If you use Tobrex for a longer period, you may become more susceptible to eye infections.
• -If you experience persistent corneal ulceration while using Tobrex, consult your doctor as soon as possible, as this may be a sign of fungal eye infection.
• - Eye ointmentsmay delay corneal healing.

Tobrex and other medicines:

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those you have bought without a prescription. If you are using other eye drops or ointments, wait at least 5 minutes between applications. Apply eye ointments last.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine. Pregnancy Tobrex can be used during pregnancy only if it is absolutely necessary. Breastfeeding The use of Tobrex is not recommended during breastfeeding. Your doctor will decide whether to continue or stop breastfeeding, or continue or stop treatment, taking into account the benefits of breastfeeding for the baby and the benefits of treatment for the mother.

Driving and using machines

Tobrex has no or negligible influence on the ability to drive and use machines. After applying the medicine, your vision may be blurred for a while. Do not drive or operate machinery until this effect wears off. During treatment of eye inflammation, it is not recommended to wear contact lenses.

3. How to use Tobrex

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. In mild or moderate infections, apply a small amount (about 1.5 cm) of ointment to the conjunctival sac of the infected eye(s) two or three times a day. In severe infections, apply a small amount (about 1.5 cm) of ointment to the conjunctival sac of the infected eye(s) every three to four hours for the first two days, then two to three times a day, until the infection is resolved. Tobrex eye ointment can be used before bedtime, in combination with Tobrex eye drops, solution, during the day. The treatment usually lasts from 7 to 10 days. Use the medicine for as long as your doctor tells you to.

Use in children

Tobrex eye ointment can be used in children over 1 year of age at the same doses as in adults. The safety and efficacy of using the medicine in children under 1 year of age have not been established, and no data are available for such use.

Use in the elderly

In the elderly, use the same dose as in adults.

Use in patients with liver or kidney disorders

The safety and efficacy of Tobrex in patients with liver or kidney disorders have not been established. Administration Tobrex is intended exclusivelyfor eye use.

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Administration

• 1. Prepare the Tobrex tube and a mirror.
• 2. Wash your hands.
• 3. Remove the cap.
• 4. Hold the tube with the tip down, between your thumb and index finger.
• 5. Tilt your head back. With a clean finger, pull down the lower eyelid to form a "pocket" between the eyeball and the eyelid. Place the ointment into this pocket (drawing 1).
• 6. Bring the tube tip close to the eye. You can use a mirror to help you.
• 7. Do not touch the tube tip to the eye, eyelid, or surrounding areas.This can cause infection of the ointment. Using infected ointment can lead to serious complications, even vision loss.
• 8. To express the ointment, gently squeeze the tube (drawing 2). If you fail to get the ointment into your eye,try again.
• 9. After using the eye ointment, remove the finger that held the lower eyelid. Blink several times to spread the ointment across the entire eye surface. Gently close your eyelid for a few seconds. This helps reduce the amount of medicine that enters the body.
• 10. If using the ointment in both eyes, repeat the above steps to apply the ointment to the second eye. Replace the cap on the tube immediately after use.
• 11. Use only one tube of medicine at a time.

Overdose of Tobrex

In case of overdose, flush the excess medicine from the eye with lukewarm water. Do not expect any side effects. Do not apply extra ointment to the eye. Continue with the next scheduled dose.

Missing a dose of Tobrex

If you forget to use Tobrex, continue treatment by applying the next dose according to the dosing schedule. If it is almost time for the next dose, skip the missed dose and continue treatment according to the prescribed schedule. Do not use a double doseto make up for the missed dose. If you are using other eye drops or ointments, wait at least 5 minutes between applications. Apply eye ointments last.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Tobrex can cause side effects, although not everybody gets them. If you experience allergic reactions, including rash, swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing, or other serious side effects, stop using Tobrex and contact your doctor or the Emergency Department of your nearest hospital immediately. The following side effects have been reported during treatment with Tobrex: Common side effects (may affect up to 1 in 10 people)Eye symptoms: feeling of discomfort in the eye, eye redness. Uncommon side effects (may affect up to 1 in 100 people)Eye symptoms: inflammation of the eye surface, corneal damage, vision 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, hives, skin inflammation, reduced eyelash growth or loss of eyelashes, skin depigmentation, itching, and dry skin. Frequency not known (cannot be estimated from the available data)Eye symptoms: eye allergy, eye irritation, eyelid itching. General symptoms: severe allergic reactions, severe skin reactions (Stevens-Johnson syndrome, erythema multiforme), rash.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet

tell your doctor or pharmacist.You can also report side effects directly to the Pharmacovigilance Department, 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. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tobrex

To prevent infection of the ointment, discard the tube 4 weeks after first opening.Write the date of opening in the space provided below. Date of first opening: ……………. Keep this medicine out of the sight and reach of children. Store in a temperature below 25°C. Do not store in the refrigerator. Store the tube tightly closed. Do not use this medicine after the expiry date stated on the packaging after: EXP. The expiry date refers to the last day of the month stated. Medicines should 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 pack and other information

What Tobrex contains

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

What Tobrex looks like and contents of the pack

1 tube containing 3.5 g of ointment, in a cardboard box.

Marketing authorization holder

Novartis Poland Sp. z o.o., ul. Marynarska 15, 02-674 Warsaw, tel. +48 22 37 54 888

Manufacturer/Importer

Novartis Farmacéutica, S.A., Gran Via de les Corts Catalanes, 764, 08013 Barcelona, Spain Novartis Manufacturing NV, Rijksweg 14, 2870 Puurs-Sint-Amands, Belgium Siegfried El Masnou, S.A., Camil Fabra, 58, El Masnou, 08320 Barcelona, Spain Novartis Pharma GmbH, Roonstrasse 25, 90429 Nürnberg, Germany Date of last revision of the leaflet:10/2024