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Isopto Alkaline

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November 7, 2014 10:09:27


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Package Leaflet - Information for the User

ISOPTO® ALKALINE 1 % w/v eye drops, solution

Hypromellose

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without a prescription. However, you still need to use ISOPTO ALKALINE carefully to get the best results from it.

   Keep this leaflet. You may need to read it again.

   Ask your pharmacist if you need more information or advice.

•    You must contact a doctor if your symptoms worsen or do not improve after 3 days.

   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 ISOPTO ALKALINE is and what it is used for

2.    Before you use ISOPTO ALKALINE

3.    How to use ISOPTO ALKALINE

4.    Possible side effects

5.    How to store ISOPTO ALKALINE

6.    Further information

WHAT ISOPTO® ALKALINE IS AND WHAT IT IS USED FOR |

ISOPTO ALKALINE is a slightly viscous solution that acts as an artificial tear.

It is used to treat dry eyes caused by a lack of tears in the eye(s).

Replacement of the reduced natural tears with an artificial tear helps to soothe and lubricate your eyes and provide relief from irritation.

It can also be used as a lubricant for artificial eyes.

~2| BEFORE YOU USE ISOPTO® ALKALINE

Do not use ISOPTO ALKALINE...

• If you are allergic to hypromellose or any of the other ingredients listed in section 6.

Ask your doctor for advice.

Take special care...

This medicine is available without a prescription. However, you still need to use ISOPTO ALKALINE carefully to get the best results from it.

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 ISOPTO ALKALINE.

Driving and using machines

You may experience blurred vision after using ISOPTO ALKALINE. Do not drive or operate any machines unless your vision is clear.

Using other medicines

Tell your doctor or pharmacist if you are

taking or have recently taken any other medicines, including medicines obtained without a prescription.

Important information if you wear Contact Lenses

Do not use the drops while wearing contact lenses. Wait at least 15 minutes after use before putting your lenses back in. There is a preservative in ISOPTO ALKALINE (benzalkonium chloride) that can discolour soft contact lenses.

~3| HOW TO USE ISOPTO® ALKALINE

The usual dose

The usual dose is 1 or 2 drops in each affected eye 3 times daily or as specified by your doctor or pharmacist.

If the irritation in your eyes does not get better or gets worse after 3 days or if you start to experience headache, eye pain, vision changes or continued redness in your eyes, stop using ISOPTO ALKALINE and see your doctor.

Remove the loose collar from the cap when the bottle is first opened.

Always use ISOPTO ALKALINE exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Continued over ►

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With approval in Catalyst you confirm that this proof contains an accurate translation of the English Corporate Standard text, and is in compliance with the registered information and the legal rules. Please also carefully check: local barcodes if any, formula, shelflife if mentioned, storage conditions and trademarks.


V2 BELGIUM

44287-6

140 x 335 / 140 x 22 mm

Isopto Alkaline 10 ml

recto-verso

GB

AANTAL KLEUREN : 1

VC 07-11-2014

~3[ HOW TO USE ISOPTO® ALKALINE (continued)

How to use

•    Wash your hands before you start.

•    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).



November 7, 2014 10:09:27


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 ISOPTO ALKALINE,

do not worry, just take it as soon as possible.

If you use too much ISOPTO ALKALINE, it

can be washed out of your eye with warm water.

If you have any further questions on the use

of ISOPTO ALKALINE, ask your doctor or pharmacist.

~4[ POSSIBLE SIDE EFFECTS

Like all medicines, ISOPTO ALKALINE can cause side effects, although not everybody gets them.

You may experience some or all of the following effects in your eye(s):

Blurred vision, eye pain, foreign body sensation in eyes, eye irritation, redness.

In very rare cases, some patients with severe damage to the clear layer at the front of the eye (the cornea) have developed cloudy patches on the cornea due to calcium build-up during treatment.

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 ISOPTO® ALKALINE

•    Keep out of the reach and sight of children.

•    Do not refrigerate or store above 25°C.

•    Keep the bottle tightly closed.

•    Do not use the drops after the expiry date (marked ‘Exp’) on the bottle and the carton. The expiry date refers to the last day of that month.

   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.

~6| FURTHER INFORMATION

What ISOPTO ALKALINE contains

•    The active substance is hypromellose 10 mg /ml.

•    The other ingredients are sodium citrate dihydrate, disodium phosphate anhydrous, sodium biphosphate, sodium chloride, benzalkonium chloride and purified water.

What ISOPTO ALKALINE looks like and contents of the pack

ISOPTO ALKALINE is a clear, colourless liquid supplied in a pack containing a 10 ml plastic bottle with a screw cap.

Marketing authorisation holder:    Manufacturer:

Alcon Laboratories (UK) Ltd.    SA Alcon - Couvreur NV

Frimley Business Park,    Rijksweg 14, B-2870 Puurs, Belgium.

Frimley, Camberley,

Surrey, GU16 7SR,    This leaflet was last revised in October 2014.

United Kingdom.

© 2009, 2013, 2014 Novartis 10 - 2014


a Novartis company


44287-6


InDesign CS4

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BFSO

With approval in Catalyst you confirm that this proof contains an accurate translation of the English Corporate Standard text, and is in compliance with the registered information and the legal rules. Please also carefully check: local barcodes if any, formula, shelflife if mentioned, storage conditions and trademarks.


V2 BELGIUM

44287-6

140 x 335 / 140 x 22 mm

Isopto Alkaline 10 ml

recto-verso

GB

AANTAL KLEUREN : 1

VC 07-11-2014