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PACKAGE LEAFLET: INFORMATION FOR THE USER

HIPROVIZ 0.3% w/v EYE DROPS, SOLUTION

Hypromellose

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

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

-    Ask your pharmacist if you need more information or advice.

-    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.

-    You must talk to a doctor if you do not feel better or if you feel worse after 2 days.

This medicine is available without prescription. However, you still need to use Hiproviz Eye Drops carefully to get the best results from it.

What is in this leaflet:

1.    What Hiproviz Eye Drops is and what it is used for

2.    What you need to know before you use Hiproviz Eye Drops

3.    How to use Hiproviz Eye Drops

4.    Possible side effects

5.    How to store Hiproviz Eye Drops

6.    Contents of the pack and other information

1.    WHAT HIPROVIZ EYE DROPS IS AND WHAT IT IS USED FOR

Hiproviz 0.3% w/v Eye Drops are a soothing emollient solution used as artificial tears. It may be used to help moisten hard contact lenses and to lubricate ocular prosthetics (artificial eyes). It prevents damage to the cornea when the ocular surface is not properly lubricated and covered by the eyelids. Hiproviz 0.3% w/v provides relief of dry eye conditions (including those associated with the use of VDUs and TVs, infrequent blinking, certain medical treatments, atmospheric pollution and drying atmospheres, e.g. air conditioning, central heating, wind and sun).

You must talk to a doctor if you do not feel better or if you feel worse after 2 days.

2.    WHAT YOU NEED TO KNOW BEFORE YOU USE HIPROVIZ EYE DROPS

Do not use Hiproviz Eye Drops:

-    if you are allergic to hypromellose or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before you use Hiproviz Eye Drops, tell your doctor if you wear soft (hydrophilic) contact lenses.

Other Medicines And Hiproviz Eye Drops

Before using Hiproviz Eye Drops, please tell your doctor or pharmacist if you have any other eye disorder. Also, if you are using or have recently used, any other medicines for your eyes, including medicines obtained without a prescription.

Hiproviz Eye Drops may increase the time other medicines stay in the eye. Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Do not drive or operate machines if you have blurred vision after using Hiproviz Eye Drops. You should wait until this clears before driving or using machines.

Hiproviz Eye Drops contains the preservative benzalkonium chloride which may cause eye irritation and is known to discolour soft contact lenses. If you wear contact lenses, remove these before applying the eye drops. Wait at least 15 minutes before putting your lenses back.

3. HOW TO USE HIPROVIZ EYE DROPS

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

Avoid contact with soft contact lenses. If you wear soft contact lenses, remove them prior to the application of Hiproviz Eye Drops and then wait at least 15 minutes before reinsertion.

Use in adults, children and adolescents

The dose depends upon the need for eye lubrication. Usually 1-2 drops should be instilled into each eye three times daily, or as directed by your doctor.

Instructions for use:

Hiproviz Eye Drops is for use as eye drops only; do not swallow.

Always wash your hands before applying Hiproviz Eye Drops. Apply one drop of Hiproviz Eye Drops in each affected eye in the following way:

1.    Tilt your head back and look at the ceiling.

2.    Gently pull the lower eyelid down until there is a pocket.

3.    Squeeze the upturned dropper bottle with the other hand to release a drop into your eye.

4.    Release the lower eyelid. Blink a few times to spread the drop evenly over your eye.

5.    Replace and tighten the cap immediately after use.

To help keep the contents sterile, do not allow the dropper tip to touch your eyelids or any other surface.

Throw away the unused contents of the bottle after 28 days from first opening it.

If you use more Hiproviz Eye Drops than you should

There is no experience of an overdosage with Hiproviz Eye Drops which is unlikely when given as eyedrops. If you accidentally swallow them, contact your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Hiproviz Eye Drops can cause side effects although not everybody gets them.

Most of these side effects affect only the eye and do not last very long although it is not known how commonly they occur.

Side effects include:

-    stinging or burning sensation

-    blurring of vision

If you have any severe or persistent side effects you should stop using the drops and contact your doctor immediately.

No additional side effects have been reported in children and adolescents

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 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 HIPROVIZ EYE DROPS

Keep this medicine out of the sight and reach of children.

Do not use Hiproviz Eye Drops after the expiry date (EXP) which is stated on the label of the bottle and on the carton.

Discard the bottle 28 days after first opening, even if the bottle is not empty.

Do not store the bottle at a temperature above 25 °C.

Keep the container tightly closed.

Keep bottle in the outer carton to protect from light.

A slight haziness which may develop in the unopened product is normal; the product can be used safely.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help protect the environment.

6.    CONTENTS OF THE PACK AND OTHER INFORMATION

What Hiproviz Eye Drops contain

-    The active substance is hypromellose 0.3% w/v

-    The other ingredient(s) are: benzalkonium chloride (preservative), potassium chloride, sodium chloride, borax, boric acid, purified water, and sodium hydroxide and hydrochloric acid (to adjust pH)

What Hiproviz Eye Drops looks like and contents of the pack

It is a clear to slightly opalescent, colourless, practically free of particles and slightly viscous eye drops solution. Each bottle contains 10 ml of the solution

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:

Blumont Pharma Ltd., 23 Moortown Close, Grantham, United Kingdom NG31 9GG Manufacturer:

Tubilux Pharma SpA, Via Costarica 20/22, 00040 Pomezia, Italy

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This leaflet was last revised in 04/2014.