Tobradex

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language!
Tobradex
(3 mg + 1 mg)/ml, eye drops, suspension
Tobramycinum + Dexamethasonum
Please read the following information carefully before using the 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 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

1. What is Tobradex and what is it 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 is Tobradex and what is it 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 agent
and a corticosteroid. Corticosteroids (in this case dexamethasone) are used to prevent and reduce eye inflammation. The antibacterial agent contained in the medicine (tobramycin) acts against many species of pathogenic bacteria that can infect the eye.
The indication for Tobradex is the prevention and treatment of inflammation and
prevention of infections associated with cataract surgery 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 vaccinia virus, varicella, herpes zoster, or other viral infections of the cornea or conjunctiva;
• ocular tuberculosis;
• fungal infection of the eye 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 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 antibiotics, either topical or systemic, from the same group (aminoglycosides).
• If symptoms worsen or suddenly recur during treatment, consult a doctor. While using 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 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,
  • develop increased intraocular pressure,
  • develop cataracts,
  • develop Cushing's syndrome due to systemic absorption of the drug. Seek medical advice if the patient develops swelling and weight gain, 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 in patients treated with ritonavir or cobicistat.
• During treatment with Tobradex, intraocular pressure should be monitored regularly; consult a doctor. 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, especially 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).
• Ocular steroid medications 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 NSAIDs and steroid medications may increase the risk of impaired eye healing.
• If the patient has a condition causing thinning of ocular tissues, consult a doctor or pharmacist.
• If persistent corneal ulceration occurs during treatment with Tobradex, the patient should seek medical advice promptly, as this may indicate a 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 the patient is currently using or has recently used,
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 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 ointments at the same time, at least 5 minutes should be left between applications of each medicine. Ointments should be applied last.
Inform the doctor about the use of 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.
Blurred vision may occur for a short time after instillation of Tobradex. 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 change their colour. Contact lenses should be removed before instillation and at least
15 minutes should be waited before reinsertion.
Benzalkonium chloride may also cause eye irritation, particularly 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 is determined individually by the doctor for each patient. Your doctor will
specify how long the treatment should last. Unless otherwise advised by your 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 no data are
available on use in this age group.

Use in patients with hepatic or renal impairment
The effect of Tobradex has not been studied in these patient populations. However, due to the
minimal systemic absorption of tobramycin and dexamethasone following local 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 (picture 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—this is where the drop should go (picture 2).
7. Bring the dropper tip close to the eye. Using a mirror may help.
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 loss of vision.
9. Gently squeeze the bottom of the bottle to release a single drop of Tobradex (picture 3). If the drop does not enter the eye, repeat the instillation attempt.
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 (picture 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 should be used at a time.

Use of a higher than recommended dose of Tobradex
In case of overdose, excess medicine can be rinsed from the eye with lukewarm water. Do not
instill additional drops. Administer the next dose at the usual scheduled time.

Missed dose of Tobradex
If the patient forgets to instill Tobradex eye drops, they should continue treatment by
administering the next dose according to the prescribed schedule. If the next dose is due soon,
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 adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If the patient experiences allergic reactions, including rash, swelling of the face, lips, tongue and (or)
throat, which may cause difficulty breathing or swallowing, or other serious adverse reactions occur,
treatment with Tobradex should be stopped immediately and the patient should contact a doctor or
the nearest hospital Emergency Department without delay.
The following adverse reactions have been observed during use of Tobradex eye drops:
Not common ( may occur in fewer than 1 in 100 patients ): increased intraocular pressure, eye pain, eye itching, sensation of ocular discomfort, eye irritation
Rare ( may occur in 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 stretch marks 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 swelling 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 adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Tobradex medicine

To avoid contamination, discard the bottle 4 weeks after first opening.
Enter the date of first opening in the space provided 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. 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 pack and other information

What Tobradex contains

• The active substances in the medicine are tobramycin 3 mg/ml and dexamethasone 1 mg/ml.
• The other ingredients are: benzalkonium chloride solution, disodium edetate, sodium chloride, anhydrous sodium sulphate (E 514), 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 ranging in colour from white to off-white, supplied in 5 ml bottles with a dropper made of LDPE and a cap made of PP, packed in a cardboard box.
For further information, please contact the responsible party or parallel importer.
Marketing Authorisation Holder in Portugal, country of export:
Novartis Farma - Produtos Farmacêuticos, S.A.
Avenida Professor Doutor Cavaco Silva, nº10 E
Taguspark
2740-255 Porto Salvo
Portugal
Manufacturer:
Novartis Manufacturing NV
Rijksweg 14
2870 Puurs-Sint-Amands
Belgium
Siegfried El Masnou, S.A.
Camil Fabra, 58
El Masnou, 08320
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.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing Authorisation number in Portugal, country of export: 5572383
Parallel import licence number: 113/26