Dex Tobrin eye drops 5ml.

What Dex-Tobrin is and what it is used for
Dex-Tobrin eye drops is a combination drug that contains the corticosteroid dexamethasone and the antibiotic tobramycin, which is active against a large number of microorganisms that infect the eye. It is used in adults and children 2 years of age and older to prevent and treat inflammation and to prevent infection after cataract surgery.

2. What you need to know before you use Dex-Tobrin
Do not use Dex-Tobrin:
• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
• if you have herpes simplex of the cornea, after vaccination against smallpox; in chickenpox and other viral diseases of the cornea and conjunctiva;
• in eye infections caused by mycobacteria (ocular tuberculosis);
• in eye infections caused by fungi.

Warnings and precautions
Talk to your doctor or pharmacist before using Dex-Tobrin if:
• you suffer from a disease that can thin the cornea or sclera of the eyes - e.g. rheumatoid arthritis, Fuchs' dystrophy, or a retinal transplant. Corticosteroids can further thin the cornea or sclera and lead to perforation;
• you have sticky secretions from your eyes. In acute purulent processes of the eye dexamethasone masks or activates the existing infection;
• your eyes have been red for a long time and you have not consulted a doctor;
• take other antibiotics by mouth or by injection, especially if aminoglycosides (eg amikacin, gentamicin);
• you have increased intraocular pressure;
• you will apply the drops to children under 6 years of age, especially if they use dexamethasone ~ containing products. They require more frequent monitoring of intraocular pressure;
• Wear soft lenses. The use of soft lenses is not recommended in the presence of infection and during treatment with Dex-Tobrin.

If you experience swelling, redness and itching after using the eye drops, you should stop using Dex-Tobrin immediately.

Contact your doctor if you have blurred vision or other visual disturbances.

If your symptoms worsen or suddenly return, please contact your doctor.

If you use Dex-Tobrin for a long time:
• You may become more susceptible to infection;
• Your intraocular pressure may rise and cause damage to the optic nerve, defects in visual acuity and visual field, as well as lead to the appearance of a curtain on the eye;
• there is a risk of developing resistant microorganisms, including fungi. In case of secondary infection, appropriate therapy should be prescribed;
• If you have a thin cornea or eclair, perforation may occur.

Talk to your doctor if you experience swelling of the face and weight gain around the abdomen and waist, as these are usually the first signs of a syndrome called Cushing's syndrome. Decreased adrenal function may develop after discontinuation of long-term or intensive treatment with Dex-Tobrin. Talk to your doctor before stopping treatment on your own. These risks are particularly important in children and in patients treated with ritonavir or cobicistat.

If you use the drops for a long time, your doctor will prescribe regular monitoring of your intraocular pressure.

Due to the risk of contamination of the contents, the tip of the vial should not touch any surfaces.

Children
Safety and efficacy in children under 2 years of age have not been established and therefore use is not recommended. Dex-Tobrin eye drops suspension can be used in children 2 years and older in the same dosage as in adults.

Other drugs and Dex-Tobrin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Concomitant use with anticholinergic agents (affecting the size of the pupil) may lead to an increase in intraocular pressure.

Tell your doctor if you are being given antibiotics from the aminoglycoside group (gentamicin, amikacin). In this case, your doctor will order a test to monitor their serum concentration.

Tell your doctor if you are taking ritonavir or cobicistat, as this may increase the amount of dexamethasone in your blood.

When co-administered with another ophthalmic medicinal product, the interval between the administration of the two medicinal products should be at least 10 minutes.
Dex-Tobrin with food, drinks and alcohol

No interactions found.

Pregnancy, breastfeeding her fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

It is recommended to prescribe the product only when absolutely necessary and after careful consideration of the benefit / risk ratio.

Due to the potential risk of passing the active substances into breast milk, it is recommended or to discontinue breast-feeding.
Driving and using machines
Drivers of motor vehicles and machine operators must be especially careful immediately after application, as visual acuity may temporarily change. If your eyesight becomes blurred after applying the eye drops, you must wait until your vision is clear before driving or operating machinery.

Dex-Tobrin contains benzalkonium chloride and edetate disodium.

Benzalkonium chloride may cause eye irritation.

Avoid contact with soft contact lenses.

Remove contact lenses before use and wait at least 15 minutes before putting them back on.

Benzalkonium chloride is known to discolor soft contact lenses.

Allergic reactions to edetate disodium are also possible.

3. How to use Dex-Tobrin
Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, talk to your doctor or pharmacist.

For topical ocular application.

The dose and duration of treatment are determined by your doctor.

The usual daily dose is 1-2 drops in the conjunctival sac of the affected eye (s) every 4-6 hours.

During the first 24 to 48 hours, the dose may be increased to 1-2 drops every 2 hours and gradually, as the clinical symptoms improve, the intervals between drips are extended until treatment is stopped. Treatment should not be stopped prematurely.

As a prophylactic measure - 1-2 drops 4 times a day in the conjunctival sac of the eye to be operated on, 1-2 days before surgery. One drop can be applied after the operation and from the day after the operation 1-2 drops are applied 4 times a day in the operated eye up to 24 days after the operation.

It is necessary to monitor the intraocular pressure.
It is important to observe hygiene when applying the drops. Do not allow the tip of the vial to touch the eye or surrounding objects, as this may contaminate and lead to the development of an eye infection with serious consequences for the eye, even, loss of vision. Always wash your hands before using the vial!

If you think your vial is dirty, talk to your doctor before continuing to use these drops.

Instructions for use
1. Before using the vial for the first time, make sure that the protective tape between the cap and the vial is not torn. Shake the vial vigorously. Wash your hands and unscrew the cap.
2. Tilt your head back and pull your lower eyelid down. This forms a pocket between the eyelid and the eye. The drop will fall exactly in this place.
3. Hold the vial facing down. Bring the tip close to the eye. Use a mirror if it will make it easier for you.
4. Be careful not to touch the eye, eyelids or other surfaces with the tip of the vial. Gently press the base of the vial to release one drop of Dex-Tobrin. All you need is a little pressure on the bottom.
5. After inserting Dex-Tobrin, close the eyelid and press your finger into the corner of the nose. This will prevent Dex-Tobrin from passing into the nose or leaking.
6. If you need to use the drops for both eyes, repeat all the previous steps for the other eye.

If the drop does not get into the eye, try again.

Use this bottle of Dex-Tobrin only for your eyes.

If you use more Dex-Tobrin than you should
In strict compliance with the instructions for use of the product, no overdose and toxicity are observed after its topical application.

The symptoms of an overdose of Dex-Tobrin eye drops are similar to the side effects: redness, tearing, swelling and itching of the eyelid.

In case of overdose, the eyes should be rinsed thoroughly with clean water.

If you forget to use Dex-Tobrin
Apply the drops as soon as you remember. If it is time for your next dose, go back to your regular dosing schedule. Do not take a double dose to make up for a forgotten dose.

If you stop using Dex-Tobrin
Even if your symptoms improve, do not stop using the eye drops until your doctor tells you to.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Adverse reactions associated with the action of the Dex-Tobrin combination product may be due to the steroid ingredient (dexamethasone), the antibacterial ingredient (tobramycin) or the action of the combination itself.

Following eye drops, the following side effects may occur, which are listed as uncommon (affecting 1 to 10 in 1,000 users): irritation, pain, itching, redness, watery eyes, discomfort, foreign sensation. body in the eye, blurred vision, dry eyes; increased intraocular pressure, leading to headache and impaired vision; swelling and redness of the eyelids, increased sensitivity to light
How to store Dex-Tobrin
Keep out of reach of children.
Store below 25 ° C.
Store in the original package.

The shelf life after opening the vial is 28 days. Discard the vial 4 weeks after opening to avoid possible infections and contamination.

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste.

Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the package and additional information
What Dex-Tobrin contains:
The active substances are: tobramycin sulphate, equivalent to 3.0 mg tobramycin, and 1.0 mg dexamethasone.
The other ingredients are: benzalkonium chloride; edetate disodium; sodium chloride; potassium dihydrogen phosphate; disodium phosphate dodecahydrate; polysorbate 80; hydroxyethylcellulose; water for injections.

What Dex-Tobrin looks like and contents of the pack:

Eye drops, suspension with white to pale yellow color.

Sterile white plastic vials with a volume of 5 ml, equipped with a dropper applicator and closed with a cap with an opening indicator.

1 vial, together with a patient leaflet, in a cardboard box.

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