Tobrex

Package Leaflet: Information for the Patient

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Tobrex, 3 mg/g, Eye Ointment

Tobramycin

Before Using the Medication, Read the Leaflet Carefully, as it Contains Important Information for the Patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed for a specific person. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the 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. Package contents and other information

1. What is Tobrex and what is it used for

Tobrex is an antibiotic that acts on many species of microorganisms that can infect the eye. Tobrex is intended for the treatment of 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 the patient is allergicto tobramycin or any of the other ingredients of this medication (listed in section 6).

Warnings and precautions

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

• if the patient experiences allergic reactions after using Tobrex, they should stop using the medication and consult a doctor immediately (see section 4). Symptoms of hypersensitivity can vary in severity: 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 the patient is using other antibiotic therapy while using Tobrex eye ointment, they should consult a doctor.
• if the patient has or suspects myasthenia or Parkinson's disease, they should consult a doctor. Antibiotics from this group can exacerbate muscle weakness.
• if the patient's symptoms worsen or recur, they should consult a doctor. If the patient uses Tobrex for a longer period, they may become more susceptible to eye infections.
• if the patient experiences persistent corneal ulcers while using Tobrex, they should consult a doctor as soon as possible, as this may be a sign of a fungal eye infection.
• eye ointmentsmay delay corneal healing.

Tobrex and other medications

Tell your doctor or pharmacist about all medications the patient is currently taking or has recently taken, as well as any medications they plan to use. If the patient is using other eye drops or ointments, they should wait at least 5 minutes between administrations of consecutive medications. Eye ointments should be used last.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor before using this medication. Pregnancy Tobrex may be used during pregnancy only if it is absolutely necessary. Breastfeeding The use of Tobrex is not recommended during breastfeeding. The doctor will decide whether to continue or stop breastfeeding or continue or stop treatment, considering the benefits of breastfeeding for the child 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 using Tobrex, vision may be blurred for a while. Do not drive or operate machines until this symptom subsides. During the treatment of eye inflammation, wearing contact lenses is not recommended.

3. How to use Tobrex

This medication should always be used as directed by a doctor. In case of doubts, consult a doctor or pharmacist. In mild or moderate diseases, a small amount (a 1.5 cm long ribbon) of ointment is applied to the conjunctival sac of the infected eye two or three times a day. In severe cases, a small amount (a 1.5 cm long ribbon) of ointment is applied to the conjunctival sac of the infected eye every three to four hours for the first two days, and then two to three times a day, until the infection subsides. Tobrex eye ointment can be used before bedtime, in combination with Tobrex eye drops during the day. The medication is usually used for 7 to 10 days. The medication should be used for as long as the doctor recommends.

Use in children

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

Use in the elderly

In the elderly, the same dose is used as in adults.

Use in patients with liver or kidney disorders

The safety and efficacy of using Tobrex in patients with liver and kidney disorders have not been established. Method of administration Tobrex is intended exclusivelyfor use in the eye.

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 down, between the 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. Insert the ointment ribbon into this pocket (Figure 1).
• 6. Bring the tube tip close to the eye. You can use a mirror to help.
• 7. Do not touch the tube tip to the eye, eyelid, or surrounding areas.This can lead to infection of the ointment. Using infected ointment can lead to serious complications, even vision loss.
• 8. To express the ointment ribbon, gently squeeze the tube (Figure 2). If you fail to insert the ointment into the eye,try again.
• 9. After using the eye ointment, remove the finger that held the lower eyelid. Open and close the eye several times to spread the ointment over the entire eye surface. Gently close the eyelid for a few seconds. This will reduce the amount of medication that enters the body.
• 10. If using the ointment in both eyes, repeat the above steps to insert the ointment into the second eye. Immediately after use, screw the cap back on the tube.
• 11. Use only one tube of medication at a time.

Using more than the recommended dose of Tobrex

In case of overdose, excess medication can be rinsed from the eye with warm water. No side effects are expected. Do not administer additional ointment to the eye. The next dose should be given at the usual time.

Missing a dose of Tobrex

If the patient forgets to use Tobrex, they should continue treatment by administering 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 recommended dosing schedule. Do not use a double doseto make up for the missed dose. If the patient is using other eye drops or ointments, they should wait at least 5 minutes between administrations of consecutive medications. Eye ointments should be used last.

In case of further doubts about using this medication, consult a doctor or pharmacist.

4. Possible side effects

Like all medications, Tobrex can cause side effects, 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 breathing or swallowing, or other serious side effects, they should stop using Tobrex and contact a doctor or the Emergency Department of the nearest hospital immediately.During the use of Tobrex, the following side effects have been observed: Common side effects (may affect 1 to 10 patients in 100)Eye symptoms: feeling of discomfort in the eye, eye redness. Uncommon side effects (may affect 1 to 10 patients in 1,000)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 eyelash loss, skin depigmentation, itching, and dry skin. Frequency not known (frequency cannot be estimated from 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 any side effects occur, including those not listed in this leaflet, inform a doctor, pharmacist, or nurse.

Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of 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 By reporting side effects, more information can be collected on the safety of the medication.

5. How to store Tobrex

To prevent infection of the ointment, the tube should be discarded 4 weeks after first opening.In the space marked below, write the date of opening the tube. Date of first opening: ……………. The medication should be stored out of sight and reach of children. Store at a temperature below 25°C. Do not store in the refrigerator. Do not freeze. Store the tube tightly closed. Do not use this medication after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month. Medications should not be disposed of via wastewater or household waste containers. Ask a pharmacist how to dispose of unused medications. This will help protect the environment.

6. Package contents and other information

What Tobrex contains

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

What Tobrex looks like and what the package contains

1 tube containing 3.5 g of ointment, placed in a cardboard box. For more detailed information, consult the marketing authorization holder or 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:

Delfarma Sp. z o.o. ul. Św. Teresy od Dzieciątka Jezus 111 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o. ul. Św. Teresy od Dzieciątka Jezus 111 91-222 Łódź Authorization number in Croatia, the country of export: HR-H-257802614-01

Parallel import authorization number: 67/23 Date of leaflet approval: 05.04.2023

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