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Tears Naturale

Document: leaflet MAH BRAND_PL 00649-0031 change

34251-9

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Package Leaflet - Information for the User

TEARS NATURALE® eye drops, solution

Dextran 70 and 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 TEARS NATURALE 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 TEARS NATURALE is and what it is used for

2.    Before you use TEARS NATURALE

3.    How to use TEARS NATURALE


4.    Possible side effects

5.    How to store TEARS NATURALE

6.    Further information


1| WHAT TEARS NATURALE® IS AND WHAT IT IS USED FOR |


TEARS NATURALE 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 missing natural tears with an artificial tear helps to soothe and lubricate your eyes and provide relief from irritation.


2


BEFORE YOU USE TEARS NATURALE®


Do not use TEARS NATURALE ...

• If you are allergic to dextran 70, hypromellose or any of the other ingredients listed in section 6

If any of these apply, ask your doctor for advice.

Take special care ...

Only use TEARS NATURALE in your eye(s).

This medicine is available without a prescription. However, you still need to use TEARS NATURALE 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 TEARS NATURALE.

TEARS NATURALE can be used during pregnancy or breast-feeding.


Driving and using machines

You may experience blurred vision after using TEARS NATURALE. Do not drive or use 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.

If you are using more than one type of eye medicine, the medicines must be used at least 5 minutes apart. Eye ointments should be used last.

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 TEARS NATURALE (benzalkonium chloride) that can discolour soft contact lenses.


3


HOW TO USE TEARS NATURALE®


The usual dose

The usual dose is 1 or 2 drops in your eye(s) as often as you require to relieve the irritation.

If you experience eye pain, headaches, changes in vision, persistent redness or irritation of your eyes, or if your condition worsens or does not improve within 3 days, stop using TEARS NATURALE and consult a doctor.


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

Always use TEARS NATURALE exactly as recommended. You should check with your doctor or pharmacist if you are not sure.


Continued over ►


3


HOW TO USE TEARS NATURALE® (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).




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 have any further questions on the

If you use more TEARS NATURALE than    use of TEARS NATURALE, askur d°ct°r °r

you should do not worry as it will not cause    pharmacist.

you any harm. If necessary TEARS NATURALE can be washed out of your eye with warm water.

•    If you swallow TEARS NATURALE do not worry, it will not harm you.


4| POSSIBLE SIDE EFFECTS


Like all medicines, TEARS NATURALE can cause side effects, although not everybody gets them.

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

Very common (affects more than 1 user in 10): blurred vision

Common (affects 1 to 10 users in 100): dryness, discomfort, abnormal sensation, feeling of something in the eye, eyelid problem Uncommon (affects 1 to 10 users in 1,000): sensitivity to light, decreased sensation, itching, irritation, redness

Not known (cannot be estimated from the available data): pain, swelling, discharge, eyelid redness or crusting, increased tear production


You may also experience effects in other areas of your body including:

Uncommon : headache, discomfort (skin)

Not known : hypersensitivity

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 TEARS NATURALE®


•    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 TEARS NATURALE contains

•    The active substances are dextran 70 1 mg /ml and hypromellose 3 mg /ml.

•    The other ingredients are disodium edetate, sodium chloride, potassium chloride, benzalkonium chloride, hydrochloric acid and/or sodium hydroxide (to adjust pH) and purified water.


What TEARS NATURALE looks like and contents of the pack

TEARS NATURALE is a clear, colourless liquid supplied in a pack containing a 15 ml plastic bottle with a screw cap.


Marketing authorisation holder:

Alcon Laboratories (UK) Ltd.

Frimley Business Park,

Frimley, Camberley,

Surrey, GU16 7SR, United Kingdom.


Manufacturer :

SA Alcon-Couvreur NV Rijksweg 14, B-2870 Puurs, Belgium.

This leaflet was last revised in January 2015.


10-2014


a Novartis company


© 2005, 2010, 2013, 2014 Novartis 34251-9