TOBRADEX EYE DROPS
Active substance: TOBRAMYCIN
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Tobradex Eye Drops, Suspension
(Tobramycin and dexamethasone) This product is available using the above name but will be referred to as Tobradex throughout this leaflet. Patient Information Leaflet Read all of this leaflet carefully before you start using this medicine Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or your pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if their symptoms are the same as yours. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1) What Tobradex is and what it is used for 2) Before you use Tobradex 3) How to use Tobradex 4) Possible side effects 5) How to store Tobradex 6) Further information Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. If you are also using other eye drops, wait at least 10 minutes between using each one. Pregnancy and breast-feeding If you are pregnant or might get pregnant, or if you are breast-feeding a baby, talk to your doctor before you use Tobradex. Driving and using machines If you experience temporary blurred vision after using Tobradex you should not drive or operate machinery until your vision is clear. Important information if you wear Contact Lenses Benzalkonium chloride, used as a preservative in Tobradex, may cause eye irritation and discolour soft contact lenses. If you wear soft contact lenses remove them before using Tobradex and wait at least 15 minutes before putting them back in.
1) What Tobradex is and what it is used for
Tobradex contains dexamethasone, a corticosteroid and tobramycin, an antibiotic which is active against a wide range of bacteria that may infect the eye. It is used to reduce inflammation and prevent possible infection of the eye after cataract surgery.
3) How to use Tobradex
The usual dose The usual dose is 1 drop in the affected eye(s) every 4 to 6 hours while you are awake. During the initial 48 hours, your doctor may increase the dose to 1 drop every 2 hours. Do not use for more than 24 days. Not recommended for use in CHILDREN and adolescents under 18 years of age. Remove the loose collar from the cap when the bottle is first opened. Always use Tobradex exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Wash your hands before you start. Shake the bottle well. Twist off the bottle cap. Hold the bottle pointing down, between your thumb and fingers. Tilt your head back. Pull down your lower eyelid with a finger, until there is a 'pocket' between the eyelid and your eye. (picture 1). Bring the bottle tip close to the eye.
2) Before you use Tobradex
Do not use Tobradex If you have or think that you have any type of infection of the eye. Use of corticosteroids may make infections worse. If you have a sticky discharge from your eye. If you have a red eye that has not been seen by a doctor. If you are allergic to tobramycin or dexamethasone or to any of the other ingredients listed in section 6. If any of these apply ask your doctor for advice. Not recommended for use in CHILDREN and adolescents under 18 years of age. Take special care If you have a disorder causing a thinning of the eye tissues, such as rheumatoid arthritis, Fuchs dystrophy or following a corneal transplant. Corticosteroids may cause further thinning and possible perforation. You may still be able to use Tobradex, but discuss it with your doctor first.
Do this in front of a mirror if it helps. Do not touch your eye or eyelid, surrounding areas or other surfaces with the dropper. It could infect the drops. Gently press on the base of the bottle to release one drop at a time (picture 2). Do not squeeze the bottle, only a gentle press on the bottom is needed. If you use drops in both eyes, repeat the steps for your other eye. Put the bottle cap firmly back on immediately after use. If a drop misses your eye, try again. If you forget to take Tobradex, do not worry, just take it as soon as possible. Do not take a double dose to make up. If you use more Tobradex than you should it can be washed out with warm water. If you have any further questions on the use of Tobradex, ask your doctor or pharmacist.
5) How to store Tobradex
Keep out of the reach and sight of children. Do not store above 25C. Do not refrigerate or freeze. Do not use this medicine after the expiry date (shown as "EXP" on the bottle and carton). Once the bottle has been opened then this medicine must be thrown away four weeks after opening. Any leftover or out of date drops should be returned to your pharmacist who will dispose of them safely for you. If the eye drops become discoloured or show signs of any deterioration, you should seek the advice of your pharmacist. 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 to protect the environment. Do not pass this medicine on to others. It may harm them, even if their symptoms are the same as yours.
6) Further information
What Tobradex contains Each ml of Tobradex Eye Drops, Suspension contains 1mg of dexamethasone and 3mg of tobramycin as the active ingredients. They also contain benzalkonium chloride, disodium edetate, tyloxapol, sodium chloride, sodium sulphate, hydroxyethylcellulose and purified water. Tiny amounts of sulphuric acid or sodium hydroxide are sometimes added to keep acidity levels (pH levels) normal. What Tobradex looks like and contents of the pack Tobradex Eye Drops is an eye drop suspension packaged in a 5-ml white low density plastic bottle, with a dispensing nozzle and a white tamper evident polypropylene closure. PL 10383/1805 Tobradex Eye Drops, Suspension POM
4) Possible side effects
Like all medicines, Tobradex can cause side effects, although not everybody gets them. You may experience some or all of the following effects in your eye(s): Uncommon (affect 1 to 10 people in 1000) : Irritation, pain, itching, redness, watery eyes, discomfort, feeling of something in your eye, blurred vision, dry eye, raised pressure in your eye, which may lead to headaches and disturbances of vision. Swelling and redness of the eyelid and sensitivity to light may also occur. You may also experience effects in other areas of your body including: Uncommon: Headache, runny nose, tightness of the throat. If Tobradex is used for more than 24 days, it may make you more likely to get an infection and the healing of your wound may also be delayed. If any of the side effects get serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Who makes and repackages your medicine? Your medicine is manufactured by Alcon Cusi S.A. Camil Fabra 58, El Masnou, Barcelona Spain. Procured from within the EU and repackaged by Product Licence Holder: Primecrown Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS. Leaflet date: 16.11.2011
(Tobramycin and dexamethasone) This product is available using the above name but will be referred to as Tobradex throughout this leaflet. Patient Information Leaflet Read all of this leaflet carefully before you start using this medicine Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or your pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if their symptoms are the same as yours. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1) What Tobradex is and what it is used for 2) Before you use Tobradex 3) How to use Tobradex 4) Possible side effects 5) How to store Tobradex 6) Further information Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. If you are also using other eye drops, wait at least 10 minutes between using each one. Pregnancy and breast-feeding If you are pregnant or might get pregnant, or if you are breast-feeding a baby, talk to your doctor before you use Tobradex. Driving and using machines If you experience temporary blurred vision after using Tobradex you should not drive or operate machinery until your vision is clear. Important information if you wear Contact Lenses Benzalkonium chloride, used as a preservative in Tobradex, may cause eye irritation and discolour soft contact lenses. If you wear soft contact lenses remove them before using Tobradex and wait at least 15 minutes before putting them back in.
1) What Tobradex is and what it is used for
Tobradex contains dexamethasone, a corticosteroid and tobramycin, an antibiotic which is active against a wide range of bacteria that may infect the eye. It is used to reduce inflammation and prevent possible infection of the eye after cataract surgery.
3) How to use Tobradex
The usual dose The usual dose is 1 drop in the affected eye(s) every 4 to 6 hours while you are awake. During the initial 48 hours, your doctor may increase the dose to 1 drop every 2 hours. Do not use for more than 24 days. Not recommended for use in CHILDREN and adolescents under 18 years of age. Remove the loose collar from the cap when the bottle is first opened. Always use Tobradex exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Wash your hands before you start. Shake the bottle well. Twist off the bottle cap. Hold the bottle pointing down, between your thumb and fingers. Tilt your head back. Pull down your lower eyelid with a finger, until there is a 'pocket' between the eyelid and your eye. (picture 1). Bring the bottle tip close to the eye.
2) Before you use Tobradex
Do not use Tobradex If you have or think that you have any type of infection of the eye. Use of corticosteroids may make infections worse. If you have a sticky discharge from your eye. If you have a red eye that has not been seen by a doctor. If you are allergic to tobramycin or dexamethasone or to any of the other ingredients listed in section 6. If any of these apply ask your doctor for advice. Not recommended for use in CHILDREN and adolescents under 18 years of age. Take special care If you have a disorder causing a thinning of the eye tissues, such as rheumatoid arthritis, Fuchs dystrophy or following a corneal transplant. Corticosteroids may cause further thinning and possible perforation. You may still be able to use Tobradex, but discuss it with your doctor first.
Do this in front of a mirror if it helps. Do not touch your eye or eyelid, surrounding areas or other surfaces with the dropper. It could infect the drops. Gently press on the base of the bottle to release one drop at a time (picture 2). Do not squeeze the bottle, only a gentle press on the bottom is needed. If you use drops in both eyes, repeat the steps for your other eye. Put the bottle cap firmly back on immediately after use. If a drop misses your eye, try again. If you forget to take Tobradex, do not worry, just take it as soon as possible. Do not take a double dose to make up. If you use more Tobradex than you should it can be washed out with warm water. If you have any further questions on the use of Tobradex, ask your doctor or pharmacist.
5) How to store Tobradex
Keep out of the reach and sight of children. Do not store above 25C. Do not refrigerate or freeze. Do not use this medicine after the expiry date (shown as "EXP" on the bottle and carton). Once the bottle has been opened then this medicine must be thrown away four weeks after opening. Any leftover or out of date drops should be returned to your pharmacist who will dispose of them safely for you. If the eye drops become discoloured or show signs of any deterioration, you should seek the advice of your pharmacist. 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 to protect the environment. Do not pass this medicine on to others. It may harm them, even if their symptoms are the same as yours.
6) Further information
What Tobradex contains Each ml of Tobradex Eye Drops, Suspension contains 1mg of dexamethasone and 3mg of tobramycin as the active ingredients. They also contain benzalkonium chloride, disodium edetate, tyloxapol, sodium chloride, sodium sulphate, hydroxyethylcellulose and purified water. Tiny amounts of sulphuric acid or sodium hydroxide are sometimes added to keep acidity levels (pH levels) normal. What Tobradex looks like and contents of the pack Tobradex Eye Drops is an eye drop suspension packaged in a 5-ml white low density plastic bottle, with a dispensing nozzle and a white tamper evident polypropylene closure. PL 10383/1805 Tobradex Eye Drops, Suspension POM
4) Possible side effects
Like all medicines, Tobradex can cause side effects, although not everybody gets them. You may experience some or all of the following effects in your eye(s): Uncommon (affect 1 to 10 people in 1000) : Irritation, pain, itching, redness, watery eyes, discomfort, feeling of something in your eye, blurred vision, dry eye, raised pressure in your eye, which may lead to headaches and disturbances of vision. Swelling and redness of the eyelid and sensitivity to light may also occur. You may also experience effects in other areas of your body including: Uncommon: Headache, runny nose, tightness of the throat. If Tobradex is used for more than 24 days, it may make you more likely to get an infection and the healing of your wound may also be delayed. If any of the side effects get serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Who makes and repackages your medicine? Your medicine is manufactured by Alcon Cusi S.A. Camil Fabra 58, El Masnou, Barcelona Spain. Procured from within the EU and repackaged by Product Licence Holder: Primecrown Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS. Leaflet date: 16.11.2011
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
