Tobradex 3mg/Ml/1mg/Ml Eye Drops Suspension
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Package Leaflet - Information for the User
TOBRADEX 3 mg/ml/1 mg/ml Eye Drops, Suspension Tobramycin and Dexamethasone
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
• 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 you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
In this Patient Information leaflet you will find information about
1. What TOBRADEX is and what it is used for
2. What you need to know before you use TOBRADEX
3. How to use TOBRADEX
4. Possible side effects
5. How to store TOBRADEX
6. Content of the pack and other information
What TOBRADEX* is and what it is used for
TOBRADEX contains dexamethasone It is used to prevent and treat inflammation
a corticosteroid and tobramycin, an antibiotic and prevent possible infection of the eye after
which is active against a wide range of bacteria cataract surgery in adults and children aged that may infect the eye. 2 years and older.
g | What you need to know 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.
Warnings and precautions
• 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.
• If you experience allergic reactions such as eyelid itching, swelling or, redness of the eye with TOBRADEX, discontinue use and consult your doctor. This allergic sensitivity may occur with other topical or systemic antibiotic of aminoglycoside type.
• If your symptoms get worse or suddenly return, please consult your doctor. You may become more susceptible to eye infections with the use of this product.
• If you are using other antibiotic treatment, including oral, with TOBRADEX, ask your doctor for advice.
• If you use TOBRADEX for a long period of time, you may become more susceptible to eye infections, have increased pressure in your eye(s) or develop cataracts.
You may still be able to use TOBRADEX, but discuss it with your doctor first.
• Intraocular pressure should be checked frequently, this is especially important in children below 6 years of age receiving dexamethasone-containi ng products.
• Do not give TOBRADEX to children below
2 years old because the safety and efficacy in this population has not been established.
Other medicines and TOBRADEX
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 using other eye drops or eye ointments, wait at least 5 minutes between using each one. Eye ointments should be administered last.
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
Contact lens wear is not recommended during treatment of an ocular infection or inflammation. 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.
H How to use TOBRADEX1
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
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.
| 4 | Possible side effects ~|
Like all medicines, TOBRADEX can cause side effects, although not everybody gets them.
The following side effects have been seen with TOBRADEX
Uncommon side effects
(may affect up to 1 in 100 people)
Effects in the eye: increased pressure in your eye (s), eyelid redness, eyelid swelling, eye irritation, eye pain, eye itching, watery eyes, eye discomfort.
General side effects: headache, runny nose, tightness of the throat.
Rare side effects
(may affect up to 1 in 1000 people)
Effects in the eye: redness, blurred vision, dry eye, eye allergy, eye surface inflammation. General side effects: bad taste.
Not known (frequency cannot be estimated from available data)
• 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.
Effects in the eye: increase in pupil size, eyelid redness, increased tear production, eye surface inflammation.
General side effects: allergy (hypersensitivity), dizziness, nausea, abdominal discomfort, rash, swelling of the face, itching.
If TOBRADEX is used for more than 24 days,
it may cause you 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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system (see details below).
By reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
How to store TOBRADEX
• Stop using the bottle 4 weeks after first opening, to prevent infections.
• 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.
j @ | Further information
What TOBRADEX contains
• The active substances are tobramycin 3 mg/ml and dexamethasone 1 mg/ml.
• The other ingredients are disodium edetate, tyloxapol, sodium chloride, sodium sulphate, hydroxyethylcellulose, benzalkonium chloride, sulphuric acid and/or sodium hydroxide
(to adjust pH) and purified water.
What TOBRADEX looks like and contents of the pack
TOBRADEX is a white to off-white suspension supplied in a pack containing a 5 ml plastic bottle with a screw cap.
Marketing authorisation holder:
Alcon Laboratories (UK) Ltd.
Frimley Business Park,
Frimley, Camberley,
Surrey, GU16 7SR,
United Kingdom.
* a trademark of Novartis
©2009, 2010, 2012, 2013, 2014 Novartis
04-2014
Manufacturer:
SA Alcon-Couvreur NV
Rijksweg 14, B-2870 Puurs, Belgium.
This leaflet was revised in March 2014.
Alcori
a Novartis company 45030-4
Keep out of the sight and reach of children.
• This medicinal product does not require any special temperature storage conditions.
• Keep the bottle tightly closed.
• 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.