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Tobradex Eye Drops

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Document: leaflet MAH BRAND_PLPI 16369-1115 change

PACKAGE LEAFLET: INFORMATION FOR THE USER TOBRADEX ® EYE DROPS (tobramycin / dexamethasone)

The name of your medicine is Tobradex® Eye drops but will be

referred to as Tobradex throughout the remainder of this leaflet.

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.    Contents of the pack and other information

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.

1. What Tobradex is and what it is used for


3. How to use Tobradex



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 prevent possible infection of the eye after cataract surgery in adults and children aged 2 years and older.

2. 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 T obradex 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-containing products.

•    Do not give Tobradex to children below 2 years old because the safety and efficacy in this population has not been established.

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.

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