iMedi.co.uk

Alomide 0.1% W/V

Informations for option: Alomide 0.1% W/V, show other option

KAPVORM


PMS ZWART a 100% - 20%


October 30, 2014 09:03:24


I I


I


I



Package Leaflet - Information for the User

ALOMIDE® 0.1 % w/v eye drops, solution

Lodoxamide


Read all of this leaflet carefully before you start using this medicine

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

   If you have any further questions, ask your doctor or your pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others.

•    It may harm them, even if their symptoms are the same as yours.

   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 is and what it is used for

2.    Before you use ALOMIDE

3.    How to use ALOMIDE


Possible side effects How to store ALOMIDE Further information


WHAT ALOMIDE IS AND WHAT IT IS USED FOR


ALOMIDE belongs to a group of medicines    It is used to treat the symptoms of allergic

called anti-allergics.    conjunctivitis such as red, itchy, puffy and

watery eyes.


~2| BEFORE YOU USE ALOMIDE


Do not use ALOMIDE...

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

•    In CHILDREN below 4 years of age.

Take special care...

•    Only use ALOMIDE in your eye(s).

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

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

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.

Driving and using machines

You may experience blurred vision after using ALOMIDE. 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

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 (benzalkonium chloride) that may cause eye irritation and can discolour soft contact lenses.


~3| HOW TO USE ALOMIDE


The usual dose

The usual dose is 1 or 2 drops into the

affected eye 4 times a day at regular intervals.

You should notice an improvement in your

symptoms within a few days, but longer treatment

for up to 4 weeks is sometimes required.

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.



Remove the loose collar from the cap when you open the bottle.

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


   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.


Continued over ►


KAPVORM


PMS ZWART a 100%


October 30, 2014 09:03:24


HOW TO USE ALOMIDE (continued)


   If a drop misses your eye, try again.

   If you forget to take ALOMIDE, do not

worry, just take it as soon as possible.

Do not take a double dose to make up.

   If you use more ALOMIDE than you should it can be washed out of your eye with warm water.


If you accidentally swallow ALOMIDE

consult your doctor immediately.

If you have any further questions on the use

of ALOMIDE, ask your doctor or pharmacist.


~4| POSSIBLE SIDE EFFECTS


Like all medicines, ALOMIDE 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): discomfort

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

Uncommon (affects 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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

Yellow Card Scheme

We bs ite : www. m h ra. g ov. u k/ye 11 owca rd

Ireland

HPRA Pharmacovigilance Earlsfort Terrace IRL - Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website : www.hpra.ie e-mail : medsafety@hpra.ie.


~5| HOW TO STORE ALOMIDE


•    Keep out of the reach and sight of children.

•    Do not store above 25°C.

•    Store upright.

•    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.

   Do not pass this medicine on to others.

It may harm them, even if their symptoms are the same as yours.


~6| FURTHER INFORMATION


What ALOMIDE contains

•    The active substance is lodoxamide 0.1 % w/v ( as lodoxamide trometamol ).

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


What ALOMIDE looks like and contents of the pack

ALOMIDE eye drops, solution is a clear, colourless liquid supplied in a pack containing a 10 ml plastic bottle with a screw cap.

Do not use ALOMIDE if it has changed colour or become cloudy.


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.


© 2010, 2013, 2014 Novartis 10-2014


a Novartis company


35389-8