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 medicine, carefully read the contents of the leaflet, as it contains important information for the patient.

• The leaflet should be kept so that it can be read again if necessary.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for one person. 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 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. 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 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 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 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 a fungal eye infection.
• eye ointmentsmay delay the healing of the cornea.

Tobrex and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking, has recently taken, or might take, as well as any medicines they plan to use. If the patient is using other eye drops or ointments, they should keep a 5-minute interval between administrations of consecutive medicines. 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 medicine. 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 some time. 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 medicine should always be used exactly as the doctor has told the patient. In case of doubts, consult a doctor or pharmacist. In mild or moderate diseases, a small amount (about 1.5 cm) of ointment is applied to the conjunctival sac of the infected eye(s) two or three times a day. In severe cases, a small amount (about 1.5 cm) of ointment is applied to the conjunctival sac of the infected eye(s) every 3 to 4 hours for the first two days, 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. The medicine is usually used for 7 to 10 days. The medicine should be used for as long as the doctor has prescribed.

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, the same dose is used as in adults.

Use in patients with liver or kidney impairment

The safety and efficacy of using Tobrex in patients with liver or kidney impairment 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 the lower eyelid down to create a "pocket" between the eyeball and the eyelid. Place the ointment roll (drawing 1) in this pocket.
• 6. Bring the tube tip close to the eye. For convenience, you can use a mirror.
• 7. Do not touch the tube tip to the eye, eyelid, or surrounding areas.This may cause infection of the ointment. Using infected ointment can lead to dangerous complications, even vision loss.
• 8. To squeeze out the ointment roll, gently press the tube (drawing 2). If the ointment does not come out,try again.
• 9. After using the eye ointment, remove the finger holding 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 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. Immediately after use, screw the cap back on the tube.
• 11. Use only one tube of medicine at a time.

Using more Tobrex than prescribed

In case of overdose, excess medicine can be rinsed from the eye with lukewarm 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 prescribed 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 keep a 5-minute interval between administrations of consecutive medicines. Eye ointments should be used last.

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

4. Possible side effects

Like all medicines, 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.The following side effects have been observed 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 (frequency 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 any side effects occur, including any side effects not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse.

Side effects can be reported directly to the Department for 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 this medicine.

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 medicine should be kept out of the sight and reach of children. Store below 25°C. Do not store in the refrigerator. 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 pack 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, placed in a cardboard box. For more detailed information, consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Belgium, the country of export:

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

Manufacturer:

ALCON CUSI S.A., Camil Fabra 58, 08320 El Masnou, Barcelona, Spain SA ALCON-COUVREUR NV, Rijksweg 14, B-2870 Puurs, Belgium

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 Permit number in Belgium, the country of export: BE125115

Parallel import permit number: 27/22 Date of leaflet approval: 13.01.2022

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