Tobrex

Patient Information Leaflet

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any 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 pack and other information

1. What Tobrex is and what it is used for

Tobrex is an antibiotic effective against many species of microorganisms that can infect the eye.
Tobrex is indicated for the treatment of external eye infections and infections of the surrounding areas in adults and children aged 1 year and above, 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 with a doctor or pharmacist:

• if the patient experiences allergic reactions after using Tobrex, treatment must be discontinued and immediate medical advice sought (see section 4). Hypersensitivity reactions may vary in severity: from local itching or redness of the skin 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 receiving other antibiotic therapy during treatment with Tobrex, the ointment should be discussed with a doctor;
• if the patient has or is suspected of having myasthenia gravis or Parkinson's disease, 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, the patient should seek immediate medical advice, as this may indicate a fungal eye infection;
• eye ointments may delay corneal healing.

Tobrex with other medicines
Inform the 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 a 5-minute interval should be maintained between administration of each medicine. Eye ointments should be administered last.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a 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 has a negligible effect on the ability to drive and operate machinery.
For a short time after administration of Tobrex, vision may be blurred. Driving and operating machinery should be avoided until this symptom resolves.
During treatment of eye inflammation, wearing contact lenses is not recommended.

3. How to use Tobrex

This medicine should always be used as directed by the physician. In case of doubt, consult a
physician 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 (sacs) 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 (sacs) 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. The medicine should be used for as long as directed by the physician.
Use in children
Tobrex ophthalmic ointment may be used in children aged 1 year and older at the same doses as in adults. The safety and efficacy of Tobrex in children under 1 year of age have not been established, and no data are available regarding 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 hepatic or renal impairment 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 downward, between the thumb and index finger.
5. Tilt the head backward. With a clean finger, gently pull the lower eyelid downward to form a "pocket." Place the ointment ribbon 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 let the tip of the tube touch the eye, eyelid, surrounding area, or any other surface. This may contaminate the ointment. Using contaminated ointment may lead to dangerous complications and even loss of vision.
8. To extrude the ointment ribbon, gently squeeze the tube (Figure 2). If the ointment was not successfully delivered into the eye, repeat the procedure.
9. After applying the ointment, remove the finger from the lower eyelid. Open and close the eye several times to spread the ointment over the entire surface. Gently close the eyelid for a few seconds. This reduces the amount of medicine passing into the systemic circulation.
10. If treating both eyes, repeat the above steps to apply 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 Tobrex than recommended
In case of overdose, excess medicine can be rinsed from the eye with lukewarm water. No adverse effects are expected. Do not apply additional ophthalmic ointment. Administer the next dose at the usual scheduled time.
Missed dose of Tobrex
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 according to the prescribed schedule. Do not use a double dose to make up for a 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 physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
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,
tobrex treatment must be discontinued immediately and the patient should contact a doctor or the
Emergency Department of the nearest hospital without delay.
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 unknown (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, phone: +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 this medicine.

5. How to store Tobrex

To prevent contamination, the tube should be discarded 4 weeks after first opening.
Please write the date of first opening in the space indicated below.
Date of first opening: …………….
Keep the medicine out of the sight and reach of children.
Store below 25°C, in the original packaging.
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 stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the pack and other information

What Tobrex contains

• The active substance is tobramycin. 1 g of ointment contains 3 mg of tobramycin.
• The other components are: chlorobutanol, liquid paraffin, white soft paraffin.

What Tobrex looks like and contents of the pack
1 tube containing 3.5 g of ointment, packed in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Romania, country of export:
Novartis Pharma GmbH
Roonstrasse 25
D-90429 Nuremberg
Germany
Manufacturer:
S.A. ALCON - COUVREUR N.V.
Rijksweg 14, 2870 Puurs, Belgium
Siegfried El Masnou, S.A.
Camil Fabra 58, 08320 El Masnou, Barcelona, Spain
Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764, 08013 Barcelona, Spain
Novartis Pharma GmbH
Roonstrasse 25, 90429 Nuremberg, Germany
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in Romania, country of export: 11113/2018/01
Parallel import authorisation number: 787/15