Tobradex

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Tobradex
(3 mg + 1 mg)/ml, eye drops, suspension
Tobramycin + Dexamethasone
Please read the entire leaflet carefully before using this 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 share it with others. This 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 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 ophthalmic 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 bacteria causing eye infections.
The indication for Tobradex is the prevention and treatment of inflammation and the 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:
• viral keratitis caused by herpes simplex virus;
• viral keratitis caused by vaccinia virus, varicella zoster virus (chickenpox/shingles) or other viral diseases of the cornea or conjunctiva;
• ocular tuberculosis;
• fungal infection of the eye or untreated parasitic infections of the eye;
• 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 stopped 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 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 become more susceptible to eye infections.
• If the patient is using other antibiotics, including those taken orally, during treatment with Tobradex, 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 Tobradex is used for a prolonged period, the patient may:
• become more susceptible to eye infections,
• experience increased intraocular pressure (in one or both eyes),
• develop cataracts,
• develop Cushing's syndrome due to systemic absorption of the drug. If the patient develops swelling and weight gain, particularly noticeable in the trunk and face, medical advice should be sought, as these are usually the first signs of Cushing's syndrome. Adrenal suppression may occur following discontinuation of prolonged or intensive treatment with Tobradex. Medical advice should be sought before deciding to stop treatment. This risk is particularly relevant 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. Special medical advice should be 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 ocular wounds. 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 impaired ocular healing.
• If the patient has a disease causing thinning of ocular tissues, medical or pharmaceutical 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, they should contact a doctor.
Tobradex and other medicines
Inform the doctor about all medicines currently or recently taken, as well as any medicines the patient plans to use.
Inform the doctor especially if non-steroidal anti-inflammatory drugs (NSAIDs) are being used.
Concurrent topical use of steroid and non-steroidal anti-inflammatory medicines may lead to impaired healing of eye wounds.
If the patient is using other eye drops or ointments simultaneously, at least 5 minutes should be left between applications of each medicine. 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 child, 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 has no effect or has a 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 symptom has resolved.
Tobradex contains benzalkonium chloride, solution
The medicine contains 0.1 mg of benzalkonium chloride, solution in each millilitre (0.1 mg/ml).
Benzalkonium chloride, solution may be absorbed by soft contact lenses and may alter their colour. Contact lenses should be removed before instillation and at least 15 minutes should be waited before reinserting them.
Benzalkonium chloride, solution may also cause eye irritation, particularly in individuals 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 prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
The dosage of Tobradex is determined individually by the doctor for each patient. Your doctor will
specify how long the treatment should last. Unless otherwise directed by your doctor, instill one to two drops of the medicine into the conjunctival sac (sacs) of the affected eye(s) every 4 to 6 hours.

Use in children
Tobradex may be used in children aged 2 years and older at the same doses as in adults.
The 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 minimal 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, using your thumb and middle finger (figure 1).
6. Tilt your head backward. Gently pull down the lower eyelid with a clean finger to form a "pocket" between the eyelid and the eyeball; the drop should be instilled into this pocket (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 area, 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 potential loss of vision.

9. Gently press 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 on the inner corner of the eye near the nose (figure 4). This helps prevent the medicine from draining into the rest of the body.
11. If treatment of both eyes is necessary, repeat the above steps for the other eye.
12. Immediately after use, tightly replace the cap on the bottle.
13. Only one bottle of medicine should be used at any given 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 instilled at the usual time.
Missed dose of Tobradex
If the patient forgets to use Tobradex eye drops, they should continue treatment by instilling the next dose according to the prescribed schedule. If the next dose is due soon, 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 gets 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 side effects occur,
treatment with Tobradex medicine should be stopped immediately and the patient should contact a doctor
or the nearest hospital Emergency Department without delay.
During use of Tobradex eye drops, the following side effects have been observed:
Not common ( may affect fewer than 1 in 100 patients ): increased intraocular pressure, eye pain, eye itching, sensation of eye discomfort, eye irritation.
Rare ( may affect fewer 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 the 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 skin stretch marks, 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 not listed in this leaflet, please inform your doctor or pharmacist. Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions 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 side effects helps provide more information on the safety of this 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 the medicine out of the sight and reach of children.
Store below 25°C. Do not freeze.
Keep the bottle in an upright position.
Keep the bottle tightly closed.
Do not use this medicine after the expiry date stated on the container.
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. Such measures help protect the environment.

6. Contents of the package and other information

What Tobradex contains

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

What Tobradex looks like and contents of the pack
Tobradex is a liquid (a suspension ranging from white to off-white) available in
5 ml DROPTAINER bottles made of LDPE with a dropper and a PP cap, packed in a
cardboard box.
For more detailed information, please contact the responsible entity or the parallel importer.
Marketing Authorisation Holder in the Czech Republic, the country of export:
Novartis s.r.o.
Na Pankráci 1724/129
140 00 Prague 4
Czech Republic
Manufacturer:
Alcon-Couvreur N.V.
Rijksweg 14
B-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 and Obere
Turnstrasse 8-10
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 the Czech Republic, the country of export: 64/706/99-C
Parallel Import Licence Number: 384/19