Tobrex

Package leaflet: Information for the patient

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

• Keep this leaflet for future reference.
• If you have any questions, 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 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 packaging and other information

1. What Tobrex is and what it is used for

Tobrex is an antibiotic effective against many microorganisms that may infect the eye.
Tobrex is intended for the treatment of external eye infections and surrounding areas 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 to any of the other ingredients of this medicine (listed in section 6).

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

• if the patient experiences allergic reactions after using Tobrex, treatment should be discontinued and medical advice should be sought immediately (see section 4). Hypersensitivity reactions may vary in severity: from local itching or redness of the skin 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 receiving other antibiotic therapy during treatment with Tobrex eye ointment, medical advice should be sought;
• 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 the patient develops persistent corneal ulceration 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 a 5-minute interval should be maintained between administration of each product. Eye ointments should be applied 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 her doctor before using this medicine.

Pregnancy
Tobrex may be used during pregnancy only if absolutely necessary.

Breastfeeding
The use of Tobrex is not recommended during breastfeeding. The doctor will decide whether to continue or discontinue breastfeeding or 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. Do not drive or operate machinery until this symptom has resolved.
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. If in doubt, consult a 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. 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 the medicine in children under 1 year of age have not been established, and there are no data available on its 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 dysfunction have not been established.

Method of administration
Tobrex is intended exclusively for ophthalmic use.

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 pointing downwards, between the thumb and index finger.
5. Tilt the head backwards. With a clean finger, gently pull down the lower eyelid to create a "pocket" between the eyeball and the eyelid. Insert 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 could lead to contamination of the ointment. Using contaminated ointment may result in dangerous complications and even loss of vision.
8. To express 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 helps minimize the amount of medicine passing into the systemic circulation.
10. If applying the ointment to both eyes, repeat the above steps to administer the ointment into the second eye. Immediately after use, replace the cap on the tube.
11. Only one tube of medicine should be used at a 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. Adverse effects are not expected. Do not administer additional ophthalmic ointment. The next dose should be given at the usual time.

Missed dose of Tobrex
If the patient forgets to use Tobrex, treatment should be continued by administering 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 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 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: ocular surface inflammation, 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 eyelash 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 adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Aleje Jerozolimskie 181C, 02-222 Warsaw, telephone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions enables better assessment of medicine safety and helps to gather additional information on the safe use of the medicine.

5. How to store Tobrex ointment

To prevent infection, the tube must be discarded 4 weeks 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 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 stated 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 package and other information

What Tobrex contains

• The active substance is tobramycin 3 mg/g.
• The other ingredients are: chlorobutanol, liquid paraffin (mineral oil), white soft paraffin.

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, please contact the responsible entity or parallel importer.
Marketing Authorisation Holder in Bulgaria, the country of export:
Novartis Pharma GmbH, Roonstrasse 25, 90429 Nuremberg, Germany
Manufacturer:
Novartis Farmacéutica, S.A., Gran Via de les Corts Catalanes, 764, 08013 Barcelona, Spain
Novartis Pharma GmbH, Roonstrasse 25, 90429 Nuremberg, Germany
Alcon - Couvreur NV, Rijksweg 14, 2870 Puurs, Belgium
Siegfried El Masnou, S.A., Camil Fabra, 58, El Masnou 08320, Barcelona, Spain
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 Bulgaria, the country of export: 9600005
Parallel Import Authorisation Number: 135/14