Tobrex

Leaflet attached to the packaging: patient information

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 packaging 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 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 a doctor immediately (see section 4). Hypersensitivity symptoms can have different 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 other antibiotic therapy while using Tobrex eye ointment, they should consult a doctor;
• if the patient has or is suspected of having myasthenia or Parkinson's disease, they should consult a doctor. Antibiotics from this group may 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 ulceration while using Tobrex, they should consult a 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 plan to take.
If you are using other eye drops or ointments, keep a gap of at least 5 minutes 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, considering 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 administering Tobrex, vision may be blurred.
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

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 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, 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 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 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 form a "pocket" between the eye and the eyelid. Put the ointment into this pocket (drawing 1).
• 6. Bring the tip of the tube close to the eye. You can use a mirror to help you.
• 7. Do not touch the tip of the tube 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 squeeze out the ointment, gently press the tube (drawing 2). If you were unable 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 the eyelid for a few seconds. This will help reduce the amount of medicine that gets into the rest of your 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 prescribed

If you use too much Tobrex, flush your eye with warm water.
You are unlikely to experience side effects. Do not take an extra dose of ointment. Take your next dose at the usual time.

Missing a dose of Tobrex

If you forget to use Tobrex, continue with the next dose as planned. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not use a double doseto make up for a missed dose.
If you are using other eye drops or ointments, keep a gap of at least 5 minutes 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 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 any side effects not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly to the Department for Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
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 after 4 weeks of first opening.
Write the date of first opening in the space below.
Date of first opening: …………….
Keep the medicine out of the sight and reach of children.
Store in a temperature 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 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 packaging and other information

What Tobrex contains

• The active substance is tobramycin 3 mg/g.
• The other ingredients are chlorobutanol, liquid paraffin, 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 the parallel importer.

Marketing authorization holder in Belgium, the country of export:

Novartis Pharma NV
Medialaan 40, B-1800 Vilvoorde, Belgium

Manufacturer:

Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764, 08013 Barcelona, Spain
Alcon-Couvreur NV
Rijksweg 14
2870 Puurs
Belgium

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 Belgium, the country of export:BE125115

Parallel import authorization number: 330/22 Date of leaflet approval: 05.09.2022

[Information about the trademark]