Tobradex

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Tobradex
(3 mg + 1 mg)/ml, eye drops, suspension
Tobramycin + Dexamethasone
Please read the following leaflet carefully before using this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse effects, 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 diseases that may be associated with
infection. Inflammation of the eye 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 eye 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 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 (chickenpox)/zoster (shingles), or other viral diseases of the cornea or conjunctiva;
• tuberculosis of the eye;
• 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 should be discontinued immediately and medical advice should be 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 also occur with other antibiotics, whether applied locally or systemically, belonging to the same group (aminoglycosides).
• If symptoms worsen or suddenly recur during treatment, medical advice should be sought. While using this medicine, the patient may be 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 myasthenia gravis or Parkinson's disease, or if there is suspicion of either condition, medical advice should be sought. Antibiotics in 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. Patients should consult a doctor 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 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 increased 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 impaired eye healing.
• If the patient has a condition 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 immediate medical advice, as this may be a sign of fungal eye infection.

If blurred vision or other visual disturbances occur, the patient should contact a doctor.
Tobradex and other medicines
Inform the doctor about all medicines currently or recently used, as well as any medicines the patient plans to use.
In particular, 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 impair healing of eye injuries.
If the patient uses other eye drops or ointments simultaneously, at least a 5-minute interval should be maintained 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, 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 during pregnancy and breastfeeding is not recommended.
Driving and operating machinery
Tobradex 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 administration of Tobradex. Patients should 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 alter their colour. Contact lenses should be removed before instillation and at least 15 minutes should elapse before reinsertion.
Benzalkonium chloride 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, 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. Your doctor will specify how long the treatment should last. Unless otherwise instructed 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 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 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 upward, grasping it between your thumb and middle finger (picture 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 (picture 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 (picture 3). If the drop does not enter the eye, repeat the instillation procedure.
10. After instilling the drop, release the lower eyelid. Gently close the eye and press with a finger at the inner corner near the nose (picture 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 second eye.
12. Immediately after use, 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 instilled at the usual scheduled time.

Missed dose of Tobradex
If the patient forgets to use Tobradex, they should continue treatment by instilling the next dose according to the prescribed schedule. If the time until the next scheduled dose is short, the missed dose should be skipped and treatment continued as directed. 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 effects

Like all medicines, this medicine may cause adverse effects, 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 if other serious adverse effects occur,
treatment with Tobradex should be stopped immediately and medical advice should be sought
urgently from a doctor or the nearest hospital Emergency Department.

The following adverse effects have been observed during treatment with Tobradex.

Not common (may occur in fewer than 1 in 100 patients): increased intraocular pressure, eye pain, eye itching, eye 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 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 striae, 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 adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the 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.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Tobradex medicine

To avoid contamination of the medicine, the bottle should be discarded 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.
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the packaging 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; anhydrous sodium sulfate; tyloxapol; hydroxyethylcellulose; purified water. Minimal amounts of sulfuric 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 in colour from white to off-white), available in
5 ml polyethylene bottles with a polyethylene dropper and polypropylene cap, packed in a
cardboard box.
For more detailed 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 Farmaceutica S.A., Gran Via de les Corts Catalanes, 764, 08013 Barcelona, Spain
Novartis Manufacturing NV, Rijksweg 14, 2870 Puurs, Belgium
Siegfried El Masnou, S.A., Camil Fabra, 58, 08320 El Masnou, (Barcelona), Spain
Novartis Pharma GmbH, Roonstrasse 25, 90429 Nuremberg, Germany
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in France, the country of export: 3400934429972
Parallel import authorisation number: 67/21