Tobradex

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet. Information on the immediate packaging is in a foreign language!
Tobradex
(3 mg + 1 mg)/ml, eye drops, suspension
Tobramycinum + Dexamethasonum
Please read this 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 pass it on 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 of the leaflet

1. What Tobradex is and what it is used for
2. Important information before using Tobradex
3. How to use Tobradex
4. Possible side effects
5. How to store Tobradex
6. Contents of the pack and other information

1. What Tobradex is and what it is used for

Tobradex is used to treat inflammatory eye conditions that may be associated with
infection. Eye inflammation may result from eye surgery, infection, or may be caused by the presence of a foreign body or eye injury.
Tobradex is a combination medicine containing an antibacterial agent and a
corticosteroid. Corticosteroids (in this case dexamethasone) are used to prevent and reduce ocular inflammation. The antibacterial agent contained in the medicine (tobramycin) acts against many species of pathogenic bacteria causing eye infections.
The indication for the use of Tobradex is the prevention and treatment of inflammation and
prevention of infections associated with surgical cataract treatment in adults and children aged 2 years and older.

2. Important information before using Tobradex

When not to use Tobradex

• if the patient is allergic to dexamethasone, tobramycin, or any of the other ingredients of this medicine (listed in section 6), or if the patient has:
• herpes simplex keratitis;
• keratitis caused by cowpox virus, varicella virus (chickenpox/shingles), or other viral infections of the cornea or conjunctiva;
• ocular tuberculosis;
• fungal eye infection or untreated parasitic eye infections;
• untreated purulent eye infections;
• if a foreign body has been removed from the cornea and there are no signs of complications.

Warnings and precautions

• If allergic reactions occur after using Tobradex, treatment must be discontinued and medical advice must 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 serious skin reactions. Such allergic reactions may occur when using other antibiotics from the same group (aminoglycosides), whether applied locally or systemically.
• If symptoms worsen or suddenly recur during treatment, medical advice must be sought. While using this medicine, the patient may be more susceptible to eye infections.
• If the patient is using other antibiotics during treatment with Tobradex, including those taken orally, medical advice should be sought.
• If the patient has myasthenia gravis or Parkinson’s disease, or if these conditions are suspected, medical advice should be sought. Antibiotics from this group may worsen muscle weakness.
• If Tobradex is used for a prolonged period, the patient may:
• become more susceptible to eye infections,
• develop increased intraocular pressure (in one or both eyes),
• develop cataracts,
• develop Cushing's syndrome due to the drug entering the bloodstream. Seek medical advice if the patient develops swelling and increased body weight, particularly noticeable in the trunk and face, as these are usually the first signs of Cushing's syndrome. Adrenal suppression may occur following discontinuation of prolonged or intensive use of Tobradex. Medical advice should be sought before stopping treatment. This risk is particularly significant in children and in patients treated with ritonavir or cobicistat.
• During treatment with Tobradex, intraocular pressure should be monitored regularly; medical advice should be sought. This is particularly important in children, as the risk of corticosteroid-induced ocular hypertension may be higher and may occur more rapidly in children than in adults. Medical advice should be especially sought in children and adolescents. The risk of corticosteroid-induced ocular hypertension and cataract formation is also higher in patients with other underlying diseases (e.g. patients with diabetes).
• Steroid medicines administered to the eye may delay healing of eye injuries. Topically applied non-steroidal anti-inflammatory drugs (NSAIDs) may slow down and delay the healing process. Concurrent topical use of non-steroidal anti-inflammatory drugs and steroid medicines may increase the risk of eye healing problems.
• If the patient has a condition causing thinning of eye tissues, medical or pharmacist advice should be sought.
• If persistent corneal ulceration occurs during treatment with Tobradex, the patient should seek medical advice immediately, as this may be a sign of fungal eye infection.

If the patient experiences blurred vision or other visual disturbances, contact a doctor.
Tobradex and other medicines
Inform the doctor about all medicines currently used or recently used, as well as any medicines the patient plans to use.
Especially inform the doctor if non-steroidal anti-inflammatory drugs (NSAIDs) are being used.
Concurrent topical use of a steroid medicine and a non-steroidal anti-inflammatory drug may lead to problems with healing of eye injuries.
If the patient is using other eye drops or eye ointments simultaneously, at least a 5-minute interval should be maintained between the applications of each medicine. Eye ointments should be applied last.
Inform the doctor if taking ritonavir or cobicistat, as these medicines may increase blood levels of dexamethasone.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor before using this medicine.
Use of Tobradex is not recommended during pregnancy and breastfeeding.
Driving and operating machinery
Tobradex eye drops, suspension, have no or negligible effect on the ability to drive and operate machinery.
Vision may be blurred for a short time after instillation of Tobradex. Do not drive or operate machinery until this effect has passed.
Tobradex contains benzalkonium chloride
The medicine contains 0.1 mg of benzalkonium chloride per millilitre (0.1 mg/ml).
Benzalkonium chloride may be absorbed by soft contact lenses and may change their colour. Contact lenses should be removed before instillation and at least 15 minutes should be waited before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially in patients with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If abnormal sensations, stinging, or pain in the eye occur after using the medicine, contact a doctor.

3. How to use Tobradex

This medicine should always be used exactly as directed by your doctor. If in doubt, consult your
doctor or pharmacist.
The dosage of Tobradex will be determined individually by your doctor. Your doctor will decide
how long the treatment should continue. Unless otherwise directed by your doctor, instill one to two drops of the medicine
into the conjunctival sac(s) of the infected eye(s) every 4 to 6 hours.

Use in children
Tobradex may be used in children aged 2 years and older at the same dosage as in adults.
Safety and efficacy in children under 2 years of age have not been established, and there are no data available on use in this age group.

Use in patients with hepatic or renal impairment
The use of Tobradex has not been studied in these patient populations. However, due to the low systemic absorption of tobramycin and dexamethasone following topical administration, dosage adjustment is considered unnecessary.
Tobradex is intended exclusively for ophthalmic instillation.

1 2 3 4

1. Prepare the Tobradex bottle and a mirror.
2. Wash your hands.
3. Shake the bottle.
4. Unscrew the cap. If the safety collar is loose after removing the cap, discard it before using the medicine.
5. Hold the bottle in your hand with the bottom facing upwards, supported between your thumb and middle finger (Figure 1).
6. Tilt your head backward. Gently pull down the lower eyelid with a clean finger to create a "pocket" between the eyelid and the eyeball—this is where the drop should be placed (Figure 2).
7. Bring the dropper tip close to the eye. A mirror may be used to assist.
8. Do not touch the dropper tip to the eye, eyelid, surrounding areas, or any other surface. Failure to follow this instruction may result in contamination of the drops. Using contaminated drops may lead to serious complications, including loss of vision.
9. Gently squeeze the bottom of the bottle to release a single drop of Tobradex (Figure 3). If the drop does not enter the eye, repeat the instillation.
10. After instilling Tobradex, release the lower eyelid. Gently close the eye and press with a finger at the inner corner of the eye near the nose (Figure 4). This helps prevent the medicine from draining into the systemic circulation.
11. If treatment of both eyes is necessary, repeat the above steps for the second eye.
12. Immediately after use, tightly replace the cap on the bottle.
13. Only one bottle of medicine should be used at a time.

Use of more than the recommended dose of Tobradex
In case of overdose, excess medicine can be rinsed from the eye with lukewarm water. Do not administer additional drops. The next dose should be given at the usual time.

Missed dose of Tobradex
If the patient forgets to use Tobradex eye drops, 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 resumed according to the prescribed schedule. Do not use a double dose to make up for a missed dose.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get 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 severe side effects occur,
treatment with Tobradex should be discontinued and immediate contact should be made with a doctor
or the nearest hospital Emergency Department.

The following side effects have been observed during use of Tobradex eye drops:

Not common (may occur in less than 1 in 100 patients): elevated intraocular pressure, eye pain, eye itching, eye discomfort, eye irritation.

Rare (may occur in less than 1 in 1,000 patients): corneal inflammation, eye allergy, blurred vision, dry eye syndrome, redness, taste disturbances.

Frequency unknown (frequency cannot be estimated from available data): eyelid swelling, eyelid redness, pupil dilation, increased tearing, blurred vision, severe allergic reactions (hypersensitivity), dizziness, headache, nausea, abdominal discomfort, severe skin reactions (erythema multiforme), itching, facial swelling, excessive body hair growth (particularly in women), muscle weakness and loss of muscle mass, purple striae on the skin, increased blood pressure, irregular menstruation or absence of menstruation, changes in protein and calcium levels in the body, growth suppression in children and adolescents, and fluid retention with weight gain, particularly noticeable in the trunk and face (a condition known as Cushing's syndrome) (see section 2 "Warnings and precautions").

Reporting of side effects
If any side effects occur, including any side effects not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C
02-222 Warszawa
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects helps to provide more information on the safety of the medicine.

5. How to store Tobradex

To avoid contamination of the medicine, discard the bottle 4 weeks after first opening.
Enter the date of first opening in the space below.
Date of first opening: …………….
Keep this medicine out of sight and reach of children.
Do not store above 25°C. Do not freeze.
Store the bottle in an upright position.
Keep the bottle tightly closed.
Do not use this medicine after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the stated month.
The batch number on the packaging is marked as "Lot".
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the packaging and other information

What Tobradex contains

• The active substances are tobramycin 3 mg/ml and dexamethasone 1 mg/ml.
• The other ingredients are: benzalkonium chloride, solution, disodium edetate, sodium chloride, anhydrous sodium sulphate, tyloxapol, hydroxyethylcellulose, purified water. Minimal amounts of sulphuric acid and/or sodium hydroxide are added to adjust the pH.

What Tobradex looks like and contents of the pack
Tobradex is a liquid (suspension) supplied in a 5 ml polyethylene bottle with a polyethylene dropper and a polypropylene cap, packed in a cardboard box.
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in France, the country of export:
Novartis Pharma S.A.S
8-10, rue Henri Sainte-Claire Deville
92500 Rueil-Malmaison, France
Manufacturer:
Alcon-Couvreur NV
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:
Medezin Sp. z o.o.
Zbąszyńska 3 Street, 91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3 Street, 91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
Działkowa 56 Street
02-234 Warsaw
Pharma Innovations Sp. z o.o.
Jagiellońska 76 Street
03-301 Warsaw
Laboratorium Galenowe Olsztyn Sp. z o.o.
Spółdzielcza 25A Street
11-001 Dywity
Synoptis Industrial Sp. z o.o.
Szosa Bydgoska 58 Street
87-100 Toruń
Marketing Authorisation number in France, the country of export:
34009 344 299 7 2
344 299-7
Parallel Import Licence number: 404/19