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What is it?
Tornaza Dexi 3 mg/ml + 1 mg/ml Eye Drops, SuspensionTobramycin/Dexamethasone is Tornaza Dexi and what is it used for? It is a combination medicine containing dexamethasone and tobramycin for use in the eye. Dexamethasone is a corticosteroid with a strong anti-inflammatory effect (it blocks certain substances that cause inflammation in the body). Tobramycin is an antibiotic from the group of aminoglycosides. It blocks bacterial growth and reduces infections and is active against a large number of microorganisms that cause eye infections. It is used in adults and children over 2 years of age for the prevention and treatment of inflammation and to prevent eye infections after cataract surgery (clouding of the natural lens of the eye, also called a cataract). Active substances are: tobramycin sulfate, equivalent to 3.0 mg tobramycin and 1.0 mg dexamethasone. Excipients are: benzalkonium chloride, disodium edetate, sodium chloride, sodium sulfate anhydrous, tyloxapol, hydroxyethylcellulose, sodium hydroxide and/or sulfuric acid (for pH adjustment), water for injections. Do not use Tornaza Dexi eye drops: • If you are allergic to tobramycin, dexamethasone or any of the other ingredients of this medicine. Talk to your doctor if you think you may be allergic; • If you have herpes simplex keratitis, chickenpox and other viral diseases of the cornea and conjunctiva; • If you have eye infections caused by mycobacteria (tuberculosis of the eye); • If you have fungal infections of the eye or untreated parasitic eye infections. Warnings and precautions: Talk to your doctor or pharmacist before using Tornaza Dexi eye drops: • If you develop allergic reactions to Tornaza Dexi eye drops, you should stop using the medicine and consult your doctor. Allergic reactions can manifest in different ways, such as localized itching or redness of the skin, and also severe allergic reactions (anaphylactic reaction) or severe skin reactions. Such allergic reactions can also occur when using other topical or systemic antibiotics of the same group (aminoglycosides). • If symptoms worsen or suddenly recur, please consult your doctor. You may become more susceptible to eye infections by using this product. • If you are taking other antibiotics, including orally, together with Tornaza Dexi, consult your doctor for advice. • If you have or have had conditions such as myasthenia gravis (a neuromuscular disorder that causes weakness of skeletal muscles) or Parkinson's disease (a progressive disorder of the nervous system that affects movement). These types of antibiotics can worsen muscle weakness. • If you have diabetes, please consult your doctor. Patients with diabetes mellitus have an increased risk of elevated intraocular pressure and/or cataract formation with corticosteroids. • Consult your doctor if you have blurred vision or other visual disturbances. • If you use Tornaza Dexi eye drops for a long time, you may become more susceptible to eye infections, develop increased intraocular pressure or cataracts. • Consult your doctor if you have facial swelling and weight gain in the abdominal and waist area, as these are usually the first signs of Cushing's syndrome. Adrenal insufficiency can develop after stopping long-term or intensive treatment with Tornaza Dexi. Talk to your doctor before stopping treatment. These risks are particularly important in children and in patients treated with ritonavir or cobicistat. • Corticosteroids can thin the cornea or sclera, cause perforation, and slow down the healing of eye injuries. Topical non-steroidal anti-inflammatory drugs (NSAIDs) are also known to slow down healing. If you use topical NSAIDs and corticosteroids together, this may increase the likelihood of problems with the healing process. • Your intraocular pressure should be checked frequently. This is particularly important in pediatric patients, as the risk of increased intraocular pressure due to the use of corticosteroids may be higher in children and may occur earlier than in adults. Consult your doctor for advice, especially when it comes to children. • Consult your doctor before using this medicine if you have conditions that cause thinning of the eye tissues. • Children (over 2 years of age): The safety and efficacy of Tornaza Dexi eye drops in children under 2 years of age have not been established and therefore its use is not recommended. Tornaza Dexi eye drops suspension can be used in children over 2 years of age, at the same dose as in adults. • Elderly patients (over 65 years of age): You can use Tornaza Dexi eye drops, suspension, if you are over 65 years of age, at the same dose as in adults. • If you wear contact lenses. Wearing contact lenses is not recommended during treatment for eye inflammation or eye infection. Other medicines and Tornaza Dexi eye drops: Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Be sure to tell your doctor if you are using topical NSAIDs. The simultaneous use of topical steroids and topical NSAIDs may increase the risk of corneal healing problems. Tell your doctor if you are taking ritonavir or cobicistat, as this may increase the amount of dexamethasone in your blood. Pregnancy, breastfeeding and fertility: If you are pregnant or breastfeeding, or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Tornaza Dexi eye drops are not recommended during pregnancy and breastfeeding, except in extreme cases. Ability to drive and use machines: Temporary blurred vision may occur immediately after using Tornaza Dexi eye drops. If you have temporary blurred vision after using Tornaza Dexi eye drops, you should not drive or operate machinery until your vision is restored. Tornaza Dexi eye drops contain benzalkonium chloride: This medicine contains 0.1 mg of benzalkonium chloride per ml. Benzalkonium chloride, used as a preservative in Tornaza Dexi, can cause eye irritation and discoloration of soft contact lenses. If you wear soft contact lenses, remove them before using Tornaza Dexi and wait at least 15 minutes before reinserting them. Benzalkonium chloride can also cause eye irritation, especially if you have "dry eye" or damage to the cornea (the transparent layer at the front of the eye). If you experience an unusual sensation in your eye, such as burning or pain in your eye after using this medicine, consult your doctor. How to use: Always use this medicine exactly as your doctor or pharmacist has told you. If you are unsure, ask your doctor or pharmacist. Do not exceed the recommended dose prescribed by your doctor. Recommended dose: The recommended daily dose for adults and children over 2 years of age is one or two drops in the affected eye(s) every 4-6 hours. For the first 24-48 hours, your doctor may increase the dose to 1 drop every 2 hours. The frequency of administration and duration of treatment will be determined by the treating physician. The recommended daily dose for severe infections is one or two drops in the affected eye(s) every hour until the inflammation is controlled, and then the dose is gradually reduced to one or two drops every two hours for the next 3 days. If you have planned cataract surgery, contact your doctor for detailed instructions. Instructions for use: Tornaza eye drops are for instillation into the eyes only. 1. Before using the bottle for the first time, make sure the protective tape between the cap and the bottle is not damaged. Shake the bottle vigorously. Wash your hands and open the cap. 2. Tilt your head back and pull down your lower eyelid. This creates a "pocket" between the eyelid and the eye. The drop should fall exactly in this place. 3. Hold the bottle upside down. Bring its tip close to your eye. Use a mirror if it makes the procedure easier for you. 4. Be careful not to touch your eye, eyelids, or other surfaces with the tip of the bottle. Gently press the bottom of the bottle to release a drop of Tornaza Dexi. Slight pressure on the bottom is sufficient. 5. After applying Tornaza Dexi, close your eyelid and press on your eye with your finger at the corner of your nose for at least 1 minute. This will prevent Tornaza Dexi from entering your nose or leaking out. 6. If you need to use drops in both eyes, repeat all the previous steps for the other eye. If the drop does not go into your eye, try again. If you are using other eye drops or eye ointments, wait at least 5 minutes between each application. Eye ointments should be applied last. If you use more Tornaza Dexi eye drops than you should: Rinse your eyes thoroughly with warm water. If you have recently had eye surgery, consult your doctor for detailed instructions. Do not instill more drops until it is time for your next regular dose. If you forget to use Tornaza Dexi eye drops: Continue with the next dose according to your usual schedule. However, if your next dose is approaching, skip the missed dose and return to your usual dosing schedule. Do not take a double dose to make up for a missed dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. Possible side effects: Rare: Eye-related effects: increased pressure in the eye(s), eye pain, eye itching, eye discomfort, eye irritation, eyelid itching, inflammation of the surface of the eye (with nodules), eye allergy, blurred vision, dry eye, redness. General effects: decreased taste sensitivity. Unknown frequency: Eye effects: eyelid swelling, eyelid redness, pupil dilation, increased tearing. General effects: severe allergic reaction (hypersensitivity), dizziness, headache, nausea, stomach discomfort, rash, severe skin reactions (erythema multiforme), facial swelling, itching. Effects related to hormonal disorders: excessive hair growth on the body (especially in women), muscle weakness and loss of muscle mass, purple stretch marks on the skin, high blood pressure, irregular or missed menstrual cycles, changes in protein and calcium levels in the body, delayed growth in children and adolescents, swelling and weight gain in the trunk and face (Cushing's syndrome). Storage conditions: - Keep out of reach of children. - Store at a temperature not exceeding 25°C. - Store in the original packaging. - Shelf life after opening the bottle is 28 days. The bottle should be discarded 4 weeks after opening to prevent possible infections and contamination. - Do not use this medicine after the expiry date which is stated on the bottle and carton after EXP. The expiry date refers to the last day of that month. - Do not dispose of medicines down the drain or in household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment. Marketing Authorisation Holder Antibiotic Razgrad AD 68 Aprilsko vastanie Blvd, Office 201 7200 Razgrad Bulgaria Manufacturer Balkanpharma-Razgrad AD 68 Aprilsko vastanie Blvd. 7200 Razgrad Bulgaria Local Representative of the Marketing Authorisation Holder: Medexport LLC, Omar Khizanishvili St. #264, Gldani District, 0167, Georgia.