Tobradex 3mg/Ml/1mg/Ml Eye Drops Suspension
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Tobradex® 3mg/ml/1mg/ml Eye Drops, Suspension
(tobramycin and dexamethasone)
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.
• The name of this medicine is Tobradex® 3mg/ml/1 mg/ml Eye Drops, Suspension but will be referred to as Tobradex throughout the remainder of this leaflet.
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
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 prevent and treat inflammation and possible infection of the eye after cataract surgery in adults and children 2 years and older.
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.
Take special care
• If you have a disorder causing a thinning of the eye tissues, such as rheumatoid arthritis, Fuch’s 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.
• Intraocular pressure should be checked frequently, especially in children below 6 years of age receiving dexamethasone- containing products.
• Do not give Tobradex to children below 2 years old because the safety and efficacy in this population has not been established.
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.
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.
Tobradex may be used in children 2 years of age and older at the same dose as in adults.
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.
How to use
• 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. The drop will go in here (picture 1).
• Bring the bottle tip close to the eye.
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.
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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Tobradex
• Keep out of the sight and reach of children.
• Do not store above 25oC.
• Do not freeze.
• Keep the bottle tightly closed.
• Keep the bottle upright.
• Do not use the drops after the expiry date which is stated on the bottle and the carton after ‘Exp:'. The expiry date refers to the last day of that month.
• Stop using the bottle 4 weeks after first opening, to prevent infections.
• If your medicine becomes discoloured or shows any sign of deterioration, return it to your pharmacist.
• Medicines should not be disposed of via waste water 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 contains 3mg of tobramycin and 1 mg of dexamethasone as the active ingredients.
• The other ingredients are benzalkonium chloride, disodium edetate, sodium chloride, sodium sulphate anhydrous (E514), tyloxapol, hydroxyethylcellulose, sulphuric acid and / or sodium hydroxide (to adjust pH), and purified water.
What Tobradex looks like and contents of the pack
White to off-white, eye-drops suspension contained in a 5ml opaque
plastic dropper bottle with a tamper-evident screw cap.
Product Licence Holder
Procured from within the EU by the Product Licence holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way, Aldridge, Walsall WS9 8ER.
Repackaged by MPT Pharma Ltd
Manufacturer:
s.a. Alcon-Couvreur NV, Rijksweg 14, B-2870 Puurs, Belgium
Tobradex® 3mg/ml/1mg/ml Eye Drops, Suspension
PL: 33532/0453
POM
Leaflet dated: 22nd April 2014 Leaflet code xxxxxx
Tobradex® is a registered trademark of XXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXX.