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
Tobramycinum + Dexamethasonum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that 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 pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your 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 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 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:
• viral keratitis caused by herpes simplex virus;
• viral keratitis caused by vaccinia virus, varicella (chickenpox/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 stopped 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 occur when using other locally or systemically administered antibiotics 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 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. Medical advice should be sought if the patient develops swelling and increased body weight, particularly noticeable in the trunk and face, as these are usually the first signs of a condition called Cushing's syndrome. Adrenal suppression may occur following discontinuation of prolonged 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; 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. 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 diseases (e.g. diabetic patients).
• Steroid medicines administered to the eye may delay healing of eye 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 eye healing problems.
• If the patient has a condition causing thinning of eye tissues, medical or pharmacist 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, medical advice should be sought.
Tobradex and other medicines
Inform the doctor about all medicines currently or recently taken by the patient, as well as any medicines the patient intends to take.
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 lead to problems with eye 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 medicine. Ointments should be applied last.
Inform the doctor if ritonavir or cobicistat is being taken, as these medicines may increase the blood levels of dexamethasone.
Pregnancy and breastfeeding
If the patient is pregnant, 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 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. Driving and operating machinery should be avoided until this symptom resolves.
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 reinserting them.
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, medical advice should be sought.

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 the medicine into the conjunctival sac (sacs) of the infected eye(s) every 4–6 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 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, 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—this is where the drop should be placed (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 result in contamination of 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.
10. After instilling Tobradex, release the lower eyelid. Close the eye gently and press with a finger on the 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, close the bottle with the cap.
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 instill additional drops. The next dose should be administered at the usual 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 next dose is due shortly, 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 side effects

Like all medicines, this medicine can cause side effects, 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 side effects 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 side effects have been observed during the use of Tobradex.
Not common ( may occur in less than 1 out of 100 patients ): increased intraocular pressure, eye pain, eye itching, eye discomfort, eye irritation.
Rare ( may occur in less than 1 out of 1,000 patients ): corneal inflammation, eye allergy, blurred vision, dry eye syndrome, redness, taste disturbances.
Frequency not known ( 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 (especially 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 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 side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects 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, 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 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.
Store below 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 in use. This will help protect the environment.

6. Contents of the packaging 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, 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 bottles (LDPE) with a dropper (LDPE) and cap (PP), packed in a cardboard box.
For more detailed information, please contact the responsible party or parallel importer.
Marketing Authorisation Holder in Bulgaria, the country of export:
Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany
Manufacturer:
Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
Alcon-Couvreur NV, Rijksweg 14, 2870 Puurs, Belgium
Siegfried El Masnou, S.A., Camil Fabra, 58, El Masnou, 08320, 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 Bulgaria, the country of export: 9600064
Parallel import licence number: 31/15