Tobrexan

Leaflet attached to the packaging: patient information

Tobrexan, 3 mg/ml, eye drops, solution

Read the leaflet carefully before using the medicine, as it contains

important information for the patient.

• This leaflet should be kept, so that it can be read again if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed specifically for this patient. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness 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 Tobrexan and what is it used for
• 2. Important information before using Tobrexan
• 3. How to use Tobrexan
• 4. Possible side effects
• 5. How to store Tobrexan
• 6. Contents of the packaging and other information

1. What is Tobrexan and what is it used for

Tobrexan 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.
Bacterial surface eye infections.Certain microorganisms (bacteria) can cause inflammatory reactions, resulting in redness, discharge, and other symptoms of irritation on the surface of the eye.

2. Important information before using Tobrexan

When not to use Tobrexan:

• if the patient is allergicto tobramycin or any of the other ingredients (listed in section 6).

Warnings and precautions:

Before starting to use Tobrexan, the patient should discuss it with their doctor or pharmacist:

• if the patient experiences allergic reactions after using Tobrexan, they should stop using the medicine and consult their doctor immediately (see section 4). Symptoms of hypersensitivity may vary in 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 locally or systemically acting antibiotics from the same group (aminoglycosides).
• if the patient is using other antibiotic therapy while using Tobrexan eye drops, 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 Tobrexan for a longer period, they may become more susceptible to eye infections.
• if the patient experiences persistent corneal ulceration while using Tobrexan, they should consult their doctor as soon as possible, as this may be a sign of fungal eye infection.

Tobrexan and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to use.
If the patient is using other eye drops or ointments, they should leave at least a 5-minute interval between administrations of the different 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 their doctor before using this medicine.
Pregnancy
Tobrexan may be used during pregnancy only if it is absolutely necessary.
Breastfeeding
Using Tobrexan 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:

Tobrexan has no or negligible influence on the ability to drive and use machines.
For a short time after administering Tobrexan eye drops, vision may be blurred. The patient should not drive or use machines until this symptom disappears.

Tobrexan eye drops contain benzalkonium chloride

The preservative contained in Tobrexan (benzalkonium chloride) may cause eye irritation. Additionally, it can change the color of soft contact lenses.
During the treatment of eye inflammation, it is not recommended to wear contact lenses. However, if the patient wears contact lenses, they should remove them before using this medicine and wait 15 minutes before putting the lenses back in.

3. How to use Tobrexan

This medicine should always be used as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.

Usual dose

One drop into each eye twice a day- in the morning and evening.
The patient should follow this treatment schedule unless the doctor has recommended otherwise. Tobrexan should be used in both eyes only if the doctor has recommended it.
The doctor will determine the duration of treatment.

Use in children

Tobrexan eye drops may be used in children over 1 year of age in the same doses as in adults. The safety and efficacy of using Tobrexan in children under 1 year of age have not been established, and there are no data available for this age group.

Use in the elderly

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

Use in patients with liver or kidney function disorders

The safety and efficacy of using Tobrexan in patients with liver and kidney disorders have not been established.
Method of administration
Tobrexan is exclusivelyintended for instillation into the eyes.

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2
3
4

• 1. Prepare the Tobrexan bottle and a mirror.
• 2. Wash your hands.
• 3. Hold the bottle and unscrew the cap. If the protective collar is loose after removing the cap, it should be discarded before using the medicine.
• 4. Hold the bottle upside down with the thumb and middle finger (drawing 1).
• 5. Tilt the head back and pull down the lower eyelid with a clean finger to create a "pocket" between the eyelid and the eyeball; the drop should fall into this pocket (drawing 2).
• 6. Bring the tip of the bottle close to the eye. A mirror can be used to help.
• 7. Do not touch the dropper tip to the eye, eyelid, or surrounding areas.Failing to follow this instruction may cause infection of the drops. Using infected drops can lead to serious complications, even vision loss.
• 8. Gently squeeze the bottom of the bottleto release a single drop of Tobrexan (drawing 3).
• 9. Do not squeeze the bottle; it is designed so that gentle pressure on the bottom is enough to release a drop (drawing 3). If the drop does not fall into the eye,the attempt should be repeated.
• 10. After administering Tobrexan, gently close the eye and press the corner of the eye near the nose with a finger (drawing 4). This will help prevent the medicine from entering the entire body.
• 11. If using drops in both eyes, repeat the above steps for the second eye.
• 12. Immediately after use, the bottle should be tightly closed.
• 13. A new bottle should only be opened after the previous one has been completely used, if therapy requires it.

Using more Tobrexan than recommended

In case of overdose, excess medicine can be rinsed from the eye with lukewarm water. No side effects are expected. The eye should not be re-instilled. The next dose should be administered at the usual time.

Missing a dose of Tobrexan

If the patient forgets to use Tobrexan, they should continue treatment by administering the next dose according to the dosing schedule. If it is almost time for the next dose, the missed dose should be skipped, and treatment should continue according to the recommended dosing schedule. A double dose should not be usedto make up for a missed dose.
If the patient is using other eye drops or ointments, they should leave at least a 5-minute interval between administrations of the different medicines. Eye ointments should be used last.

In case of further doubts about using this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Tobrexan 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 Tobrexan and contact their doctor or the Emergency Department of the nearest hospital immediately.
Side effects may be unpleasant, but most of them disappear quickly.
The following side effects have been observed during the use of Tobrexan.
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, eyelid dysfunction.
General symptoms: allergy (hypersensitivity), headache, hives, skin inflammation, reduced eyelash growth or eyelash loss, skin depigmentation, itching, and skin dryness.
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 side effects occur, including any side effects not listed in the leaflet

the patient should tell their doctor or pharmacist.Side effects can be reported directly to the Department of Post-Marketing Surveillance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Tobrexan

To prevent infections, the drops should not be used after 4 weeks from the first opening of the bottle. The date of opening the bottle should be written on the label, carton, or leaflet, in the space provided below.
Date of first opening:………………………………
The medicine should be kept out of sight and reach of children. Store at a temperature below 25°C.
Keep the bottle tightly closed.
Do not use this medicine after the expiry date stated on the bottle and carton after EXP. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Tobrexan contains

• The active substance of Tobrexan is tobramycin 3 mg/ml.
• The other ingredients are: xanthan gum, benzalkonium chloride (BDAB), mannitol, trometamol, boric acid, polysorbate 80, purified water. The medicine may contain minimal amounts of sulfuric acid or sodium hydroxide (to adjust the pH).

What Tobrexan looks like and contents of the pack

Tobrexan is a clear liquid (solution) supplied in 5 ml plastic containers of the DROPTAINER type.
The packaging consists of a 5 ml DROPTAINER container made of plastic, protected by a cap.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Novartis Poland Sp. z o.o.
ul. Marynarska 15
02-674 Warsaw
phone: +48 22 37 54 888
Manufacturer:
s.a. Alcon-Couvreur n.v.
Rijksweg 14, 2870 Puurs
Belgium
Alcon Cusí SA
Camil Fabra 58
08320 El Masnou, Barcelona
Spain

Date of last revision of the leaflet: