Tobradex

Patient Information Leaflet

Caution! Please keep this leaflet. Information on the immediate packaging is in a foreign language.
Tobradex
(3 mg + 1 mg)/ml, eye drops, suspension
Tobramycin + Dexamethasone
Please read all of this leaflet carefully before using this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

1. What Tobradex is and what it is used for
2. What you need to know 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 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 this medicine (tobramycin) acts against many species of bacteria that cause 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
• 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 the patient experiences allergic reactions after using Tobradex, treatment should be discontinued and medical advice should be 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 from the same group (aminoglycosides), whether applied locally or systemically.
• if the patient's symptoms worsen or suddenly recur, medical advice should be sought. During treatment with 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, 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. If the patient develops swelling and increased body weight, particularly noticeable in the trunk and face, medical advice should be sought, 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 treatment with Tobradex. Medical advice should be sought 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. 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. in patients with diabetes).
• Steroid medicines 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 nonsteroidal anti-inflammatory drugs and steroid medicines may increase the risk of ocular healing problems.
• If the patient has a condition causing thinning of ocular tissues, medical or pharmaceutical advice should be sought.
• If the patient develops persistent corneal ulceration during treatment with Tobradex, medical advice should be sought immediately, as this may be a sign of 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 currently or recently used,
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 steroid medicine and a nonsteroidal anti-inflammatory drug may lead to problems with healing of the eye.
If the patient is using other eye drops or ointments simultaneously, 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 using machines
Tobradex eye drops, suspension, has no or negligible effect on the ability to drive and use machines.
Vision may be blurred for a short time after administration of Tobradex. Do not drive or operate machinery until this effect subsides.
Tobradex contains benzalkonium chloride, solution
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 be waited before reinsertion.
Benzalkonium chloride may also cause eye irritation, particularly in individuals with dry eye syndrome or corneal disorders (transparent front layer of the eye). If abnormal sensations in the eye, stinging or eye pain occur after using the medicine, contact a doctor.

3. How to use Tobradex

This medicine should always be used exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The dosage of Tobradex is individually determined by the doctor for each patient. Your doctor will specify how long the treatment should last. Unless otherwise directed by your doctor, instill one to two drops of Tobradex into the conjunctival sac(s) 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 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 minimal systemic absorption of tobramycin and dexamethasone following topical administration, dosage adjustment is considered unnecessary.
Tobradex is intended exclusively for ophthalmic instillation.

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 (Figure 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 (Figure 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 areas, or any other surface. Failure to follow this instruction may contaminate the drops. Using contaminated drops may lead to serious complications, including vision loss.
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.
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 rest of the body.
11. If treatment of both eyes is necessary, repeat the above steps for the other eye.
12. Immediately after use, tightly close 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 administer additional drops. The next dose should be instilled at the usual time.

Missed dose of Tobradex eye drops
If the patient forgets to use Tobradex eye drops, they should continue treatment by instilling the next dose according to the prescribed schedule. If the time for the next dose is approaching, 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 breathing or swallowing, or other severe adverse reactions occur,
treatment with Tobradex should be discontinued and immediate contact should be made with a doctor
or the nearest hospital Emergency Department.
The following adverse reactions have been observed during use of Tobradex eye drops:
Not common (may occur in fewer than 1 in 100 patients): elevated 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, eye 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 (especially in women), muscle weakness and loss of muscle mass, purple skin striae, increased blood pressure, irregular menstrual periods or amenorrhea, 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 reactions
If any adverse reactions occur, including those not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions 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, 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 the medicine.

5. How to store Tobradex

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 provided below.
Date of first opening: …………….
Keep the medicine out of the 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 no longer required. These measures will help protect the environment.

6. Contents of the pack 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 sulphate (E 514), tyloxapol, hydroxyethylcellulose, purified water. Minimal amounts of sulphuric 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 from white to off-white in colour), supplied in 5 ml bottles with a dropper made of LDPE and a 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, n° 10 E,
Taguspark, 2740-255 Porto Salvo, Portugal
Manufacturer:
Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing Authorisation number in Portugal, country of export: 5572383
Parallel Import Licence number: 301/20