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Isopto Plain 0.5% Eye Drops Solution

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Informations for option: Isopto Plain 0.5% Eye Drops Solution, show other option

PMS ZWART

£ 100%

KAPVORM

November 6, 2014 11:24:15


44677-6

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Package Leaflet - Information for the User

ISOPTO® PLAIN 0.5% 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 PLAIN 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 PLAIN is and what it is used for

2.    Before you use ISOPTO PLAIN

3.    How to use ISOPTO PLAIN


4.    Possible side effects

5.    How to store ISOPTO PLAIN

6.    Further information


WHAT ISOPTO® PLAIN IS AND WHAT IT IS USED FOR~|

ISOPTO PLAIN 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® PLAIN

Do not use ISOPTO PLAIN...

• 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 PLAIN 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 PLAIN.

Driving and using machines

You may experience blurred vision after using ISOPTO PLAIN. Do not drive or operate hazardous machinery 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 PLAIN (benzalkonium chloride) that can discolour soft contact lenses.

~3| HOW TO USE ISOPTO® PLAIN

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 PLAIN and see your doctor.

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

Always use ISOPTO PLAIN 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

44677-6

140 x 335 / 140 x 22 mm

Isopto Plain 10 ml

recto-verso

GB

AANTAL KLEUREN : 1

WS 06-11-2014

~3[ HOW TO USE ISOPTO® PLAIN (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 6, 2014 11:24:15


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 PLAIN, do not

worry, just take it as soon as possible.

• If you use more ISOPTO PLAIN than you should, it can be washed out of your eye with warm water.

If you have any further questions on the use

of ISOPTO PLAIN, ask your doctor or pharmacist.

~4[ POSSIBLE SIDE EFFECTS

Like all medicines, ISOPTO PLAIN 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® PLAN

•    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 PLAIN contains

•    The active substance is hypromellose 5 mg/ml.

•    The other ingredients are sodium citrate, disodium hydrogen phosphate anhydrous, sodium dihydrogen phosphate monohydrate, sodium chloride, benzalkonium chloride and purified water.

What ISOPTO PLAIN looks like and contents of the pack

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

Manufacturer:


Marketing authorisation holder:

Alcon Laboratories (UK) Ltd.

Frimley Business Park,

Frimley, Camberley,

Surrey, GU16 7SR, United Kingdom.


SA Alcon-Couvreur NV

Rijksweg 14, B-2870 Puurs, Belgium.

This leaflet was last revised in October 2014.

© 2009, 2013, 2014 Novartis 10-2014

a Novartis company

InDesign CS4

V2

BELGIUM

44677-6

140 x 335 / 140 x 22 mm

Isopto Plain 10 ml

recto-verso

GB

AANTAL KLEUREN : 1

WS 06-11-2014


44677-6


D

i

L.

Q_

Q_

<

■003?

1

Se .

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.