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

Tobramycin

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. 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. 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 species of microorganisms that can infect the eye.
Tobrex is intended for use in 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 medicine (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 medicine and consult their doctor immediately (see section 4). Hypersensitivity symptoms can have varying severity: from local itching or skin redness 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 using another antibiotic therapy while using Tobrex eye ointment, they should consult their doctor;
• if the patient has or is suspected of having myasthenia or Parkinson's disease, they should consult their doctor. Antibiotics from this group may exacerbate muscle weakness;
• if the patient's symptoms worsen or recur, they should consult their doctor. If the patient uses Tobrex for a longer period, they may become more susceptible to eye infections;
• if the patient experiences persistent corneal ulceration while using Tobrex, they should consult their doctor as soon as possible, as this may be a sign of a fungal eye infection;
• Eye ointmentsmay delay corneal healing.

Tobrex and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to use.
If you are using other eye drops or ointments, keep a 5-minute interval between administrations of the next medicines. Eye ointments should be used last.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using this medicine.
Pregnancy
Tobrex may be used during pregnancy only if it is absolutely necessary.
Breastfeeding
Using Tobrex is not recommended during breastfeeding. The 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.
For some time after using Tobrex, vision may be blurred. Do not drive or operate machines until this symptom subsides.
During treatment of eye inflammation, wearing contact lenses is not recommended.

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 disease, 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 cases, apply a small amount (about 1.5 cm) of ointment to the conjunctival sac of the infected eye(s) every 3 to 4 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, solution, during the day.
Usually, the medicine is used for 7 to 10 days. Use the medicine for as long as your doctor tells you.

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 medicine in children under 1 year of age have not been established, and there are no data available on such use.

Use in elderly patients

In elderly patients, use the same dose 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.

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 down, between your thumb and index finger.
• 5. Tilt your head back. With a clean finger, pull down the lower eyelid to create a "pocket" between the eyeball and the eyelid. Insert the ointment into this pocket (drawing 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, 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 holding the lower eyelid. Blink several times to spread the ointment over the entire eye surface. Gently close your eyelid for a few seconds. This will 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 other eye. Immediately after use, replace the cap on the tube.
• 11. Use only one tube of medicine at a time.

Using more Tobrex than recommended

In case of overdose, excess medicine can be rinsed from the eye with lukewarm water. Do not expect any side effects. Do not administer additional ointment to the eye. Administer the next dose at the usual time.

Missing a dose of Tobrex

If you forget to use Tobrex, 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 you are using other eye drops or ointments, keep a 5-minute interval between administrations of the next medicines. Eye ointments should be used last.

If you have any further questions about using this medicine, 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 the use of 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 eyelash loss, 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 any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Aleje Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting side effects will help to gather 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 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 month.
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.
For more detailed information, contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Bulgaria, the country of export:

Novartis Pharma GmbH, Roonstrasse 25, 90429 Nuremberg, Germany

Manufacturer:

Novartis Farmacéutica, S.A., Gran Via de les Corts Catalanes, 764, 08013 Barcelona, Spain
Novartis Pharma GmbH, Roonstrasse 25, 90429 Nuremberg, Germany
Alcon - Couvreur NV, Rijksweg 14, 2870 Puurs, Belgium
Siegfried El Masnou, S.A., Camil Fabra, 58, El Masnou 08320, Barcelona, Spain

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Bulgaria, the country of export:9600005
Parallel import authorization number:135/14

Date of leaflet approval: 26.02.2024

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