Tobradex

Package leaflet: Information for the patient

Warning! Keep the leaflet – the 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 the medicine, as it contains
important information for the patient.

• Keep this leaflet, so you can read it again if necessary.
• If you have any questions, please 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 adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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 diseases 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 component 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 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 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 immediately and 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 other antibiotics from the same group (aminoglycosides), whether applied locally or systemically, are used.
• If symptoms worsen or suddenly recur during treatment, medical advice should be sought. During treatment with this medicine, the patient may become 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 there is suspicion of either condition, 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 systemic absorption of the drug. Patients should consult a doctor if swelling or weight gain occurs, 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 long-term or intensive treatment with Tobradex. Medical advice should be sought before stopping treatment. This risk is particularly significant in children and 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 develop more rapidly in children than in adults. Special caution and medical advice are recommended for 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).
• Corticosteroids 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 NSAIDs and corticosteroids may increase the risk of impaired ocular wound 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 indicate a fungal eye infection. If blurred vision or other visual disturbances occur, the patient should contact a doctor.

Tobradex and other medicines
Tell the doctor about all medicines the patient is currently taking or has 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 corticosteroids and NSAIDs may lead to problems with ocular wound healing.

If the patient is using other eye drops or ointments at the same time, at least 5 minutes should be left between the administration of each product. Eye ointments should be applied last.

Inform the doctor if ritonavir or cobicistat is being taken, 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.

For a short time after administration, vision may be blurred. Do not drive or operate machinery until this symptom has resolved.

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 alter their colour. Contact lenses should be removed before instillation and not reinserted for at least 15 minutes.

Benzalkonium chloride may also cause eye irritation, especially 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, the patient should 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. The doctor will specify
how long the treatment should last. Unless otherwise advised by the doctor, instill one to two drops of
Tobradex 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 is no data
available on use in this age group.

Use in patients with hepatic or renal impairment
The effect of Tobradex in these patient populations has not been studied. 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, using your thumb and middle finger (Figure 1).
6. Tilt your head backward. Pull the lower eyelid downward gently with a clean finger to form a "pocket" between the eyelid and the eyeball—this is where the drop should go (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 contaminate the drops. Using contaminated drops may lead to serious complications, including 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 attempt.
10. After instilling Tobradex, release the lower eyelid. Close the eye gently 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 systemic circulation.
11. If treatment of both eyes is necessary, repeat the above steps for the second eye.
12. Immediately after use, close the bottle with the cap.
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 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 time for the next dose is approaching, the
missed dose should be skipped and treatment continued as prescribed. 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 experience 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 if other serious side effects occur,
treatment with Tobradex should be stopped immediately and medical advice should be sought
without delay from a doctor or the nearest hospital Emergency Department.
The following side effects have been observed during use of Tobradex eye drops:
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 not known ( frequency cannot be estimated from the available data ): eyelid swelling, eyelid redness, pupil dilation, excessive tearing, blurred vision, severe allergic reactions (hypersensitivity), dizziness, headache, nausea, abdominal discomfort, severe skin reactions (erythema multiforme), itching, facial swelling, marked increase in body hair growth (particularly in women), muscle weakness and loss of muscle mass, purple stretch marks on the skin, increased blood pressure, irregular menstrual periods or absence of menstruation, changes in protein and calcium levels in the body, growth suppression in children and adolescents, as well as fluid retention and 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, pharmacist or nurse. Side effects can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products at Al. Jerozolimskie 181C, 02-222 Warsaw, telephone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects may also be reported to the Marketing Authorisation Holder or the parallel importer.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Tobradex medicine

To avoid contamination of the medicine, the bottle must be discarded 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.
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. 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. These measures will help protect the environment.

6. Contents of the pack 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, 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 suspension, white to off-white in colour, supplied in a plastic bottle containing 5 ml, with a tamper-evident 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:
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
Novartis Manufacturing NV
Rijksweg 14
2870 Puurs-Sint-Amands
Belgium
Parallel Importer:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw
Repackaged in:
CEFEA Sp. z o.o. Sp. Synoptis Industrial Sp. z o.o. Shiraz Productions Sp. z o.o.
komandytowa ul. Forteczna 35-37 ul. Tymiankowa 24/28
ul. Działkowa 56 87-100 Toruń 95-054 Ksawerów
02-234 Warsaw
Marketing Authorisation Number in France, the country of export:
34009 344 299 7 2
344 299-7
Parallel Import Licence Number: 368/25