Tobradex

Package leaflet: Information for the patient

Warning! Keep this leaflet! Foreign language information on the immediate packaging.
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 doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, 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 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 conditions that may be associated with
infection. Eye inflammation 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 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:
• 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 must 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 antibiotics from the same group (aminoglycosides), whether applied locally or systemically.
• If symptoms worsen or suddenly recur during treatment, medical advice must 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,
• experience increased intraocular pressure,
• 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 a condition called Cushing's syndrome. Adrenal suppression may occur following discontinuation of long-term or intensive use of 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 especially 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).
• Corticosteroids administered to the eye may delay healing of ocular wounds. Topically applied nonsteroidal anti-inflammatory drugs (NSAIDs) may slow 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 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, as well as any medicines the patient plans to use.
Especially inform the doctor if nonsteroidal anti-inflammatory drugs (NSAIDs) are being used.
Concurrent topical use of a corticosteroid and a nonsteroidal anti-inflammatory drug may lead to problems with ocular wound healing.
If the patient is using other eye drops or ointments simultaneously, at least a 5-minute interval should be maintained between administrations. 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 or breastfeeding, suspects she may be pregnant, or plans to become pregnant, 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 or 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 milliliter (0.1 mg/ml).
Benzalkonium chloride may be absorbed by soft contact lenses and may alter their color. Contact lenses must be removed before instillation and at least 15 minutes should elapse before reinsertion.
Benzalkonium chloride may also cause eye irritation, especially 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, medical advice should be sought.

3. How to use Tobradex

This medicine should always be used exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

The dosage of Tobradex is determined individually by the doctor for each patient. Your doctor will specify how long you should use the medicine. Unless otherwise instructed by your doctor, instill one or two drops of Tobradex into the conjunctival sac (sacs) 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 use of Tobradex has not been studied in these patient populations. However, due to the minimal systemic absorption of tobramycin and dexamethasone following local ocular administration, dosage adjustment is considered unnecessary.

Tobradex is intended exclusively for instillation into the eyes.

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 backwards. Pull the lower eyelid downwards gently with a clean finger to form a "pocket" between the eyelid and the eyeball; the drop should be instilled into this pocket (Figure 2).
7. Bring the dropper tip close to the eye. You may use a mirror to assist.
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 potential 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 your finger at the inner 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 second eye.
12. Immediately after use, screw the cap back onto the bottle.
13. Only one bottle of medicine should be used at a time.

Use of more Tobradex than recommended
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 time.

If you miss a dose of Tobradex
If you forget to use Tobradex, continue treatment by instilling the next dose according to the prescribed schedule. If it is almost time for the next dose, skip the missed dose and continue with the regular dosing schedule. Do not use a double dose to make up for a forgotten 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 gets 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 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, 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 (especially 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 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 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 for Monitoring Adverse Drug Reactions of the 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 should be discarded 28 days 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, in the original packaging.
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 package 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, 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 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 dropper, packed in a cardboard box.
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Romania, country of export:
Novartis Pharma GmbH
Roonstrasse 25
D-90429, Nuremberg
Germany
Manufacturer:
S.A. ALCON-COUVREUR N.V.
Rijksweg 14, B-2870 Puurs, Belgium
SIEGFRIED EL MASNOU, S.A.
Camil Fabra 58, 08320 El Masnou
Barcelona, Spain
NOVARTIS FARMACÉUTICA, S.A.
Gran Vía de les Corts Catalanes 764
08013 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 in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation number in Romania, country of export: 8966/2016/01
Parallel Import Authorisation number: 818/15