Tobrex

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Tobrex
3 mg/g, eye ointment
Tobramycin
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Tobrex is and what it is 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 package and other information

1. What Tobrex is and what it is used for

Tobrex is an antibiotic effective against many species of microorganisms that may infect the eye.
Tobrex is indicated for the treatment of external eye and periocular infections in adults and children aged 1 year and older, caused by bacteria sensitive to its active substance - tobramycin.

2. Important information before using Tobrex

When not to use Tobrex:

• if the patient is allergic to tobramycin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Tobrex, discuss the following with your doctor or pharmacist:

• if the patient experiences allergic reactions after using Tobrex, treatment must be discontinued and medical advice must be sought immediately (see section 4). Hypersensitivity symptoms may vary in severity: from local itching or skin redness to severe allergic reactions (anaphylactic reaction) or serious skin reactions. Such allergic reactions may occur when using other topical or systemic antibiotics from the same group (aminoglycosides);
• if the patient is undergoing other antibiotic therapy during treatment with Tobrex eye ointment, consult a doctor;
• if the patient has myasthenia gravis or Parkinson's disease, or is suspected of having either condition, medical advice should be sought. Antibiotics from this group may worsen muscle weakness;
• if symptoms of the disease worsen or recur, medical advice should be sought. Prolonged use of Tobrex may increase susceptibility to eye infections;
• if persistent corneal ulceration occurs during treatment with Tobrex, medical advice should be sought immediately, as this may indicate a fungal eye infection;
• eye ointments may delay corneal healing.

Tobrex and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
If the patient is using other eye drops or eye ointments simultaneously, at least 5 minutes should be left between the administration of each product. Eye ointments should be applied last.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she might be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine.
Pregnancy
Tobrex may be used during pregnancy only if absolutely necessary.
Breastfeeding
Use of Tobrex is not recommended during breastfeeding. The doctor will decide whether to continue or discontinue breastfeeding or whether to continue or discontinue treatment, taking into account the benefits of breastfeeding for the child and the benefits of treatment for the mother.

Driving and operating machinery
Tobrex has no effect or a negligible effect on the ability to drive and operate machinery.
However, vision may be blurred for a short time after application of Tobrex. Do not drive or operate machinery until this symptom has resolved.
During treatment of an eye inflammatory condition, wearing contact lenses is not recommended.

3. How to use Tobrex

This medicine should always be used exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

In mild or moderate conditions, a small amount (a ribbon approximately 1.5 cm long) of ointment should be applied into the conjunctival sac(s) of the infected eye(s) two or three times daily.

In severe cases, a small amount (a ribbon approximately 1.5 cm long) of ointment should be applied into the conjunctival sac(s) of the infected eye(s) every three to four hours during the first two days, then reduced to two or three times daily until the infection resolves.

Tobrex ophthalmic ointment may be used at bedtime in combination with Tobrex eye drops, solution, during the day.

The medicine is usually used for 7 to 10 days. Continue using the medicine for as long as your doctor has instructed.

Use in children
Tobrex ophthalmic ointment may be used in children aged 1 year and older at the same doses as in adults. Safety and efficacy in children under 1 year of age have not been established, and no data are available on use in this age group.

Use in elderly patients
The same dose as in adults should be used in elderly patients.

Use in patients with hepatic or renal impairment
The safety and efficacy of Tobrex in patients with liver or kidney disorders have not been established.

Instructions for use
Tobrex is intended exclusively for ophthalmic use.

1 2
Instructions for use

1. Prepare the Tobrex tube and a mirror.
2. Wash your hands.
3. Unscrew the cap.
4. Hold the tube with the tip pointing downwards, between your thumb and index finger.
5. Tilt your head backward. With a clean finger, gently pull down the lower eyelid to create a "pocket" between the eyeball and the eyelid. Apply the ointment into this pocket (Figure 1).
6. Bring the tip of the tube close to the eye. A mirror may be used to assist.
7. Do not touch the tip of the tube to the eye, eyelid, surrounding areas, or any other surface. This could contaminate the ointment. Using contaminated ointment may lead to serious complications, including loss of vision.
8. To express a ribbon of Tobrex ointment, gently squeeze the tube (Figure 2). If the ointment was not successfully applied into the eye, repeat the attempt.
9. After applying the ointment, remove the finger from the lower eyelid. Open and close the eye several times to spread the ointment evenly over the eye surface. Gently close the eyelid for a few seconds. This helps minimize the amount of medicine absorbed into the systemic circulation.
10. If treating both eyes, repeat the above steps to apply the ointment to the second eye. Immediately after use, recap the tube tightly.
11. Only one tube of medicine should be used at any given time.

Use of more than the recommended dose of Tobrex
In case of overdose, excess medicine can be rinsed from the eye with lukewarm water. No adverse effects are expected. Do not apply additional ointment to the eye. Apply the next dose at the usual scheduled time.

If a dose of Tobrex is missed
If the patient forgets to use Tobrex, they should continue treatment by applying the next dose according to the prescribed schedule. If the next dose is due shortly, the missed dose should be skipped and treatment continued as prescribed. Do not use a double dose to make up for the missed dose.

If the patient is using other eye drops or ointments simultaneously, at least a 5-minute interval should be maintained between the administration of each medicine. Ophthalmic ointments should be used last.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although they do not occur in everyone.
If the patient experiences allergic reactions, including rash, swelling of the face, lips, tongue and/or
throat, which may cause difficulty in breathing or swallowing, or other serious adverse reactions occur,
treatment with Tobrex should be discontinued and immediate contact should be made
with a doctor or the Emergency Department of the nearest hospital.
The following adverse reactions have been observed during treatment with Tobrex:
Common adverse reactions (may occur in 1 to 10 patients out of 100)
Ocular symptoms: eye discomfort, eye redness.
Uncommon adverse reactions (may occur in 1 to 10 patients out of 1,000)
Ocular symptoms: inflammation of the eye surface, corneal damage, visual 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, urticaria, skin inflammation, decreased growth or loss of eyelashes, loss of skin pigmentation, skin itching and dryness.
Frequency not known (frequency cannot be estimated from available data)
Ocular symptoms: eye allergy, eye irritation, eyelid itching.
General symptoms: severe allergic reactions, severe skin reactions (Stevens-Johnson syndrome, erythema multiforme), rash.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Tobrex ointment

To prevent infection, the tube must be discarded 28 days after first opening.
Please enter 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 below 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines must 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. 1 g of ointment contains 3 mg of tobramycin.
• The other ingredients are: chlorobutanol, liquid paraffin, white soft paraffin.

What Tobrex looks like and contents of the pack
An aluminium tube with an applicator made of plastic (HDPE) containing 3.5 g of eye ointment,
packaged in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in the Czech Republic, country of export:
Novartis s.r.o.
Na Pankráci 1724/129, 140 00 Prague 4, Czech Republic
Manufacturer:
Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764, 08013 Barcelona, Spain
Siegfried El Masnou, S.A.
Camil Fabra 58, 08320 El Masnou, Barcelona, Spain
Novartis Pharma GmbH
Roonstrasse 25, 90429 Nuremberg, Germany
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11, 03-138 Warsaw, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249, 04-458 Warsaw, Poland
Marketing authorisation number in the Czech Republic, country of export: 64/128/91-C
Parallel import authorisation number: 213/20