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Cleareyes 0.12mg/Ml Eye Drops Solution

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MCEDCP_PIL_Vlb_2 0.03.15_draft.qxp 20/3/15 09:38 Page 1

Artwork reference guide

file name	MCEDCP PIL VI b 20.03.15 draft
product	Clear eyes (two words)
item	PIL	colours Black only
status	draft
version	VI b
date	20.03.15	dimensions 120x276mm

contacts

Package Leaflet: Information for the User

Clear<seyes,

0.12mg/ml eye drops, solution, naphazoline hydrochloride

Read all of this leaflet carefully before you start using this medicine because It contains important information for you. CLEAR EYES 0.12mg/ml Eye Drops, Solution will be referred to as CLEAR EYES throughout this leaflet.

Always use this medicine exactly as described in this leaflet or as your 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

24 hours._

What is in this leaflet:

1. What CLEAR EYES is and what it is used for

2. What you need to know before you use CLEAR EYES

3. How to use CLEAR EYES

4. Possible side effects

5. How to store CLEAR EYES

6. Contents of the pack and other information

1. What CLEAR EYES is and what it is used for

This medicine contains the active ingredient naphazoline hydrochloride which belongs to the group of medicines called local vasoconstrictors which act by narrowing the blood vessels in the eye, thereby reducing redness and swelling.

CLEAR EYES is an eye drop solution. It is used to relieve occasional, minor redness and irritation in eyes.

CLEAR EYES starts working within 1 minute and lasts for at least 3 hours.

This product is for intermittent or occasional use only.

CLEAR EYES is indicated in adults and children aged 12 years and over.

You must talk to a doctor if you do not feel better or if you feel worse after 24 hours.

2. What you need to know before you use CLEAR EYES

Do not use:

• if you are allergic to naphazoline hydrochloride or any of the other ingredients in this medicine (listed in section 6)

• if you suffer from raised pressure inside your eyeball (glaucoma)

• if you have narrow chamber angle (you are at risk of acute glaucoma)

• if you suffer from damage to your corneas (outer layer of the eyes)

• if you suffer from inflammation of the iris (the coloured part of the eye)

This product must not be used prior to peripheral iridectomy in eyes susceptible to angle closure.

Warnings and precautions

This product is for intermittent or occasional use only. Following long term or excessive use, naphazoline hydrochloride may not work as effectively or may make the redness worse. Talk to your doctor before using CLEAR EYES if you suffer from an eye condition characterised by continued redness, pain, or blurring of vision.

Children

CLEAR EYES is not recommended in children under 12 years of age.

You should stop using this medicine and consult a doctor if there is any eye

pain, vision changes, photophobia, continued redness or irritation of the eye, or if after 24 hours the condition worsens or shows no sign of improvement.

Use with contact lenses

CLEAR EYES contains benzalkonium chloride which is known to discolour soft contact lenses. Take out contact lenses before putting these drops into your eyes. You may reinsert your contact lenses about 15 minutes after putting the drops into your eyes.

Pregnancy, breast-feeding and fertility

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 using this medicine.

Driving and using machines

If you experience blurring of vision, do not drive or operate machinery until your sight has cleared.

Continued overleaf

Important information about the ingredients

This product contains benzalkonium chloride which can cause eye irritation in some people. If you know you are sensitive to this ingredient, you should not use this product.

3. How to use CLEAR EYES

Always use this medicine exactly as described in this leaflet or as your pharmacist has told you. Check with your pharmacist if you are not sure.

This medicine is for use only in the eyes.

Directions for use:

Adults and Children 12 years and over:

• Wash your hands before use.

• You should avoid touching the dropper on to any surface.

• Gently squeeze 1 or 2 drops into each eye 2 or 3 times daily.

This product is for intermittent or occasional use only.

Other medicines and CLEAR EYES

You should wait about 15 minutes between using CLEAR EYES and administering any other product into the eye and any eye ointment should always be applied last.

If you use more of these eye drops than you should

Overuse may produce increased redness of the eye. Should this occur, discontinue use. If the redness continues consult a doctor.

If you accidentally overdose or swallow the contents of the bottle, seek medical advice urgently and report any fall in body temperature, drowsiness, and coma, particularly in a child.

4. Possible side effects

Like all medicines, CLEAR EYES can cause side effects, although not everybody gets them.

After putting in the eye drops, very occasionally you may notice a slight irritation such as stinging, slight blurring of vision or slight widening of your pupil (the black circle in the centre of your eye). These are expected and temporary effects. Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly via the national reporting system. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store CLEAR EYES

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

Do not store the bottle above 25°C.

Do not refrigerate or freeze.

Discard any unused contents one month after first opening the bottle.

Do not use this medicine after the expiry date which is stated on the carton and bottle label after EXP. The expiry date refers to the last day of that month.

Do not use this medicine if the solution changes colour or becomes cloudy.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What CLEAR EYES contains

• The active substance is naphazoline hydrochloride 0.12mg/ml.

• The other ingredients are benzalkonium chloride solution, boric acid (E284), borax (E285), disodium edetate, and purified water.

What CLEAR EYES looks like and contents of pack

The eye drops solution is a clear, colourless liquid presented in a white HDPE plastic bottle with drop-forming LDPE plastic plug and polypropylene plastic cap. Each bottle contains 5ml or 10ml.

Marketing Authorisation Holder and Manufacturer

Prestige Brands (UK) Ltd, 57 High Street, Yatton, Somerset, BS49 4EQ, UK

This medicine is manufactured at:

Tubilux Pharma S.p.A., Via Costarica 20/22,00040 Pomezia (Roma), Italy

This medicinal product is authorised in the Member States of the EEA under the following names:

Sweden and Finland - Cleari, Norway - Cleye, Denmark - Cleareyes

This leaflet was last approved in

03/2015

MCEDCPV1 b20.03.15