Alomide Allergy 0.1% Eye Drops Solution

PMS ZWART

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KAPVORM

November 6, 2014 10:52:53

44973-4

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Package Leaflet - Information for the User

ALOMIDE® Allergy eye drops, solution

Lodoxamide

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 ALOMIDE Allergy Eye Drops 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 2 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 ALOMIDE Allergy Eye Drops is and what it is used for

2. Before you use ALOMIDE Allergy Eye Drops

3. How to use ALOMIDE Allergy Eye Drops

4. Possible side effects

5. How to store ALOMIDE Allergy Eye Drops

6. Further information

WHAT ALOMIDE® ALLERGY EYE DROPS IS AND WHAT IT IS USED FOR

ALOMIDE Allergy Eye Drops belongs to a It is used for the relief and treatment of the

group of medicines called anti-allergics. eye symptoms of allergic conjunctivitis.

These symptoms include red, itchy, puffy and watery eyes.

BEFORE YOU USE ALOMIDE® ALLERGY EYE DROPS ~j

Do not use ALOMIDE Allergy Eye Drops...

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

• In CHILDREN below 4 years of age.

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

Take special care...

This medicine is available without a

prescription. However, you still need to use

ALOMIDE Allergy Eye Drops carefully to get the

best results from it.

• Only use ALOMIDE Allergy Eye Drops in your eye(s).

• You may experience eye discomfort, such as burning or stinging, at the beginning of treatment with ALOMIDE Allergy Eye Drops. These symptoms should wear off, however if they persist, ask your doctor for advice.

• Only use this medicine if you are sure that you have allergic conjunctivitis. You can be sure that you are suffering from allergic conjunctivitis if both of your eyes are affected and you have a runny or blocked nose but your vision is normal.

• Go and see your doctor before using these drops if only one eye is affected, your nose is not blocked or runny, your vision is affected, or you have a thick yellow discharge coming from your eyes.

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 ALOMIDE Allergy Eye Drops.

Driving and using machines

You may experience blurred vision after using ALOMIDE Allergy Eye Drops. 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.

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

Wearing contact lenses is not advisable if you have allergic conjunctivitis as it may make your condition worse. 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 ALOMIDE Allergy Eye Drops (benzalkonium chloride) that can discolour soft contact lenses.

~3[ HOW TO USE ALOMIDE® ALLERGY EYE DROPS

The usual dose

The usual dose for adults and children 4 years old and above is 1 or 2 drops in each eye 4 times a day at regular intervals.

Contact a doctor if your symptoms worsen or do not improve after 2 days and do not use for more than 4 weeks without seeking medical advice, even if your symptoms improve.

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

Always use ALOMIDE Allergy Eye Drops exactly as recommended. You should check with your pharmacist if you are not sure.

Continued over ►

November 6, 2014 10:52:53

HOW TO USE ALOMIDE® ALLERGY EYE DROPS

(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).

Release the lower eyelid and keep closed for 2 minutes.

Press the corner of your eye nearest to your nose with a finger for at least 2 minutes immediately after use. This will reduce the amount of the medicine getting to the rest of your body.

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 use ALOMIDE Allergy Eye Drops, do not worry, just use it as soon as possible and then continue with your regular routine. Do not take a double dose to make up.

• If you use more ALOMIDE Allergy Eye Drops than you should it can be washed out of your eye(s) with warm water.

If you have any further questions on the use

of ALOMIDE Allergy Eye Drops, ask your pharmacist.

POSSIBLE SIDE EFFECTS

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

You may experience slight discomfort or a

burning or stinging sensation at the time of using the drops. This will normally only last a short time.

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

Very common (effects more than 1 user in 10): discomfort

Common (effects 1 to 10 users in 100): blurred vision, dryness, itching, increased tear production, redness.

Uncommon (effects 1 to 10 users in 1,000): pain, swelling, tired eyes, white deposits on the eye surface (cornea), feeling of something in the eye, discharge, irritation, eyelid scales.

Rare (affects 1 to 10 users in 10,000): damage or scarring to eye surface (cornea), inflammation, eye allergy, impaired vision, eyelid swelling.

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

Uncommon: dizziness, headache, nausea, a feeling of warmth or flushing.

Rare: drowsiness, bad taste, dryness of the nose, sneezing, stomach discomfort, rash.

Not known (cannot be estimated from the available data): abnormal increase in heart rate.

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.

HOW TO STORE ALOMIDE® ALLERGY EyEdROPS~~M

• Keep out of the reach and sight of children.

• Do not store above 25°C.

• 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.

• Keep the bottle tightly closed.

• 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.

FURTHER INFORMATION

What ALOMIDE Allergy Eye Drops contains

• The active substance is lodoxamide 1 mg/ml (as lodoxamide trometamol)

• The other ingredients are benzalkonium chloride, mannitol, hypromellose, sodium citrate dihydrate, citric acid monohydrate, disodium edetate, tyloxapol, hydrochloric acid and/or sodium hydroxide (to adjust pH) and purified water.

What ALOMIDE Allergy Eye Drops looks like and contents of the pack

• ALOMIDE Allergy Eye Drops is a clear, colourless liquid supplied in a pack containing a 5 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 April 2015.

a Novartis company