Tobradex
Poland
Table of Contents
Package leaflet: Information for the patient
Warning! Keep the leaflet. Information on the immediate packaging is in a foreign language.
Tobradex
(3 mg + 1 mg)/ml, eye drops, suspension
Tobramycin + Dexamethasone
Please read the following information carefully before using the medicine, as it contains
important information for the patient.
- Keep this leaflet for future reference.
- 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. It 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:
- What Tobradex is and what it is used for
- Important information before using Tobradex
- How to use Tobradex
- Possible side effects
- How to store Tobradex
- 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 in Tobradex (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:
- corneal inflammation caused by herpes simplex virus;
- corneal inflammation caused by vaccinia virus, varicella zoster virus, or other viral diseases of the cornea or conjunctiva;
- tuberculosis of the eye;
- fungal eye infection or untreated parasitic eye infections;
- 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 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 serious skin reactions. Such allergic reactions may occur when using other topical or systemic 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. If the patient develops swelling and weight gain, particularly noticeable in the trunk and face, medical advice should be sought, as these are usually the first signs of Cushing's syndrome. Adrenal suppression may occur following discontinuation of prolonged or intensive treatment with Tobradex. Medical advice should be sought before deciding to stop 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 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 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 eye tissues, medical or pharmaceutical 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, contact a
doctor.
Tobradex and other medicines
Tell the doctor about all medicines currently or recently used by the patient, as well as any medicines the patient plans to use.
Especially 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 impaired healing of eye injuries.
If the patient is using other eye drops or ointments at the same time, at least a 5-minute interval should be maintained between administration of each medicine. Ointments should be used last.
Inform the doctor if ritonavir or cobicistat is being taken, 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 baby, 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 effect or has a 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 symptom has resolved.
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, 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, 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 will be individually determined by the doctor for each patient. The doctor will
specify how long the treatment should last. Unless otherwise directed by the doctor, instill one to two drops of the medicine 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 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 topical ocular administration, dosage adjustment is considered unnecessary.
Tobradex is intended exclusively for instillation into the eyes.
- Prepare the Tobradex bottle and a mirror.
- Wash your hands.
- Shake the bottle.
- Unscrew the cap. If the safety collar is loose after removing the cap, discard it before using the medicine.
- Hold the bottle in your hand with the bottom facing upwards, using your thumb and middle finger (Figure 1).
- Tilt your head backward. Pull the lower eyelid downward gently with a clean finger to create a "pocket" between the eyelid and the eyeball; the drop should be instilled into this pocket (Figure 2).
- Bring the dropper tip close to the eye. A mirror may be used to assist.
- 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.
- 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.
- After instilling Tobradex, release the lower eyelid. Close the eye gently and press with a 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.
- If treatment of both eyes is necessary, repeat the above steps for the second eye.
- Immediately after use, screw the cap back onto the bottle.
- 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 time.
Missed dose of Tobradex
If the patient forgets to use Tobradex eye drops, suspension, 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 if other serious adverse reactions occur,
treatment with Tobradex should be discontinued immediately and the doctor or the nearest hospital's
Emergency Department should be contacted without delay.
During use of Tobradex eye drops, suspension, the following adverse reactions have been observed:
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): keratitis, eye allergy, blurred vision, dry eye syndrome, redness, taste disturbances.
Frequency unknown (frequency cannot be estimated from the 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 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 and 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 not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can also 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, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of this 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 below.
Date of first opening: …………….
Keep this medicine out of the sight and reach of children.
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 month indicated.
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 components are: benzalkonium chloride solution, disodium edetate, sodium chloride, anhydrous sodium sulphate, 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 in colour from white to off-white), supplied in 5 ml plastic bottles with a dropper and cap, packed in a cardboard box.
For more detailed information, please contact the Marketing Authorisation Holder or the parallel importer.
Marketing Authorisation Holder in Belgium, the country of export:
Novartis Pharma NV, Medialaan 40, B-1800 Vilvoorde, Belgium
Manufacturer:
Alcon-Couvreur NV, Rijksweg 14, B-2870 Puurs, Belgium
Siegfried El Masnou, S.A., Camil Fabra 58, 08320 El Masnou, Barcelona, Spain
Novartis Pharma GmbH, Roonstrasse 25, 90429 Nuremberg, Germany
Novartis Farmaceutica 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, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing Authorisation Number in Belgium, the country of export: BE144873
Parallel Import Licence Number: 33/25