Tobradex

Package leaflet: Information for the patient

Caution! 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 this leaflet 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, 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 the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the 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 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 eye inflammation. The antibacterial agent contained in the medicine (tobramycin) acts against many species of 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:
• corneal inflammation caused by herpes simplex virus;
• corneal inflammation caused by vaccinia virus, varicella (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 also occur when using other antibiotics, either locally or systemically, from 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 during treatment with Tobradex, including those taken orally, medical advice should be sought.
• If the patient has or is suspected to have myasthenia gravis or Parkinson's disease, they should consult a doctor. 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 the eye[s]),
  • develop cataracts,
  • develop Cushing's syndrome due to systemic absorption of the drug. Patients should consult a doctor if they experience swelling and weight gain, particularly noticeable in the trunk and face, as these are often 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 stopping treatment. This risk is particularly relevant 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 especially important in children, as the risk of corticosteroid-induced ocular hypertension may be higher and develop more rapidly in children than in adults. Medical advice should be particularly 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., diabetic patients).
• 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 the eye tissues, medical or pharmaceutical advice should be sought.
• 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, they should contact a doctor.

Tobradex with 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.

In particular, inform the doctor if the patient is using non-steroidal anti-inflammatory drugs (NSAIDs).

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 simultaneously, at least a 5-minute interval should be maintained between administration of each medicine. Eye ointments should be applied last.

Inform the doctor if the patient is 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 has no or negligible effect on the ability to drive and operate machinery.

Vision may be blurred for a short time after administration of Tobradex. The patient should 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 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 occur in the eye, such as stinging or pain after using the medicine, the patient should contact a doctor.

3. How to use Tobradex

This medicine should always be used exactly as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
The dosage of Tobradex is determined individually for each patient by the physician. The physician will specify
how long the treatment should last. Unless otherwise advised by the physician, 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 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, grasped between your thumb and middle finger (Figure 1).
6. Tilt your head backward. Gently pull the lower eyelid downward with a clean finger to form 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. For convenience, you may use a mirror.

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 potential 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 procedure.
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 required, 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 a higher than 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 administered at the usual scheduled time.

Missed dose of Tobradex
If the patient forgets to use Tobradex, they should continue treatment by administering the next dose according to the prescribed schedule.
If the time until the next dose is short, the missed dose should be skipped, and treatment should continue 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 in breathing or swallowing, or other serious adverse reactions occur,
treatment with Tobradex should be discontinued immediately and the patient should contact a doctor or
the nearest hospital Emergency Department without delay.
The following adverse reactions have been observed during the use of Tobradex.
Not very common ( may occur in fewer than 1 in 100 patients ): increased intraocular pressure, eye pain, eye itching, sensation of 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 lacrimation, blurred vision, severe allergic reactions (hypersensitivity), dizziness, headache, nausea, abdominal discomfort, severe skin reactions (erythema multiforme), itching, facial swelling, excessive growth of body hair (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 adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions 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 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions allows the collection of further information on the safety of this medicine.

5. How to store Tobradex medicine

To avoid contamination of the medicine, discard the bottle 4 weeks after first opening.
Enter the date of first opening in the space provided below.
Date of first opening: …………….
Keep the 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. This will help protect the environment.

6. Contents of the package and other information

What Tobradex contains

• The active substances in Tobradex 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 liquid (a white to off-white suspension) supplied in 5 ml LDPE bottles with a dropper and PP cap, packed in a cardboard box.
For more detailed information, please contact the responsible party or the 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 Farmacéutica S.A., Gran Via de les Corts Catalanes, 764, 08013 Barcelona, Spain
Novartis Pharma GmbH, Ronnestrasse, 25, D-90429 Nuremberg, Germany
Siegfried El Masnou, S.A., Camil Fabra, 58, 08320 El Masnou, Barcelona, Spain
Novartis Manufacturing NV, Rijksweg 14, 2870 Puurs-Sint-Amands, Belgium
Novartis Pharma GmbH, Sophie-Germain-Strasse 10, 90443 Nuremberg, Germany
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing Authorisation Number in Portugal, country of export: 5572383
Parallel Import Licence Number: 162/21