In this leaflet:1. What Otex is and what it is used for2. Before you use Otex 3. How to use Otex 4. Possible side effects5. How to store Otex 6. Further information

1. WHAT OTEX IS AND WHAT IT IS USED FOR

• Otex ear drops are used to help remove hardened wax from the ear canal.

• Otexissuitableforusebyadults, children and the elderly.

• Theactive ingredient is urea hydrogen peroxide. It works by breaking down the ear wax into small pieces.

• Excessive,hardenedearwaxisquite common. It causes problems when it builds up and blocks the ear canal. Thefirstsymptomisusuallyafeeling of discomfort and fullness in the ear. Thiscanbecomepainfulandcause dizziness and some loss of hearing if left untreated.

• Otexmakesremovalofearwaxeasier, and in many cases avoids the need for ear syringing.

2. BEFORE YOU USE OTEX Do not use Otex: • ifyouareallergic (hypersensitive) to urea

hydrogen peroxide or any of the other ingredients of Otex listed in Section 6.

• ifyouhaveahistoryofearproblems,unless used under the close supervision ofyourdoctor,nurseorpharmacist.

• ifyouarealsoputtinganythingelsein the ear (such as other ear drops or a hearing aid).

• ifyoureardrumis(orhasbeen)damaged.

• ifyousufferfromdizziness.

• ifthereisanythingelsewrongwithyourear-suchaspain,swelling,discharge,infection or tinnitus (ringing sounds in the ear).

• ifyouhavetriedtoremovetheearwaxusingfingernails,cottonbudsorotherimplements.(Thisisbecauseyoumighthave damaged the delicate inner lining oftheear,leadingtoswellingor infection.)Thiscouldmakeitpainful to use the ear drops.

• ifyouhavehadyourearsyringedinthelast 2 to 3 days – this could also make it painful to use the eardrops.

Take special care when using this product: • Ifyouareinanydoubtwhetherthis

productissuitableforyou,talktoyourdoctor,nurseorpharmacistbeforeuse.

If Otex gets into the eyes • TakecaretoavoidgettingOtexin

your eyes. • Ifthishappens,rinsetheeyeimmediately

withwaterfor10to15minutes,holdingthe eyelids apart and avoiding getting therinseliquidintheothereye.

• Tellyourdoctororpharmacistifirritationpersists.

Taking other medicines and using hearing aids • ItisimportantnottouseOtexatthesame

time you are putting anything else in the ear (such as other ear drops or a hearing aid).

• Otexisnotknowntoaffect,ortobeaffectedby,anyotherkindsofmedicinesthat you may be using.

Pregnancy and breast-feeding Otex can be used during pregnancy and whilebreast-feeding.Theingredientshavebeen in widespread use in this and similar preparationsformanyyears,withoutreportsofproblems.However,safetytrialshavenotbeen conducted.

Driving and using machinery Using this product is not known to affect your ability to drive or use machinery. However,thebuildupofearwaxcancausedizziness,andthismaybemadeworsebyusing the ear drops (see Section 4). If you areaffected,donotdriveorusemachinery.

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urea hydrogen peroxide 5% w/w

PACKAGE LEAFLETInformation for the user

Please read all of this leaflet carefully before you start using this product. Keep this leaflet. You may need to read it again. Ask your doctor, nurse or pharmacist if you need

more information or advice. You must contact a doctor if your symptoms worsen or do not improve within a reasonable period.

EAR DROPS EAR DROPS

3. HOW TO USE OTEX Only use Otex in the ears.

For adults, children and the elderly:Repeat the following once or twice daily, normally for 3 to 4 days,untilyounoticean improvement in your hearing and less discomfort: • Turnthecapanti-clockwise.

(Thiswillbreakthesealwhenyouuse the drops for the first time).

• Removethecaptorevealthe applicator nozzle.

• Tiltyourheadandgentlysqueeze up to 5 drops into the ear.

• Keepyourheadtiltedforafewminutes so that the drops stay in the ear.

• Thenwipeawayanysurpluswithatissue.• Repeatintheotherear,ifnecessary.• Washhandsafteruse.• Do not “plug” the ears with loose

cotton wool.• Alwaysreplacethecapafteruseand

return the bottle to the carton.

Note that in some cases excessive ear wax maypersistformorethan3to4days, despitesoftening.Ifthewaxisveryhard, the ear drops alone may not be able to cleartheearcanal.Thismaycausesometemporary loss of hearing. In these cases youshouldconsultyourdoctor,nurseorpharmacist for further advice.

If you use more Otex than you shouldDo not worry if you use too much Otex. Simply wipe away any surplus running from the ear with a tissue.

If you forget to use OtexDo not worry if you occasionally forget to useOtex.Whenyouremember,justcarry on using this product once or twice daily as usual.Ifyouhaveanyfurtherquestionsonthe useofthisproduct,askyourdoctororpharmacist.

4. POSSIBLE SIDE EFFECTSLikeallmedicines,Otexcancausesideeffects,althoughnoteverybodygetsthem.• Atemporarymildbubblingsensation

in the ear can occur (due to the release of oxygen as the drops break down the ear wax).

• Theeardropscanmakethesymptoms ofexcessiveearwaxworse,including somediscomfort,irratationorpain,loss ofhearing,dizzinessandtinnitus(ringingsound in the ear).

• Veryrarely,anunpleasanttastehas been reported. Stop using the ear drops immediately if this happens and tell your doctor.

Stop using this product and tell your doctor or pharmacist if: • symptomspersistor,• ifanyofthesideeffectsgetserious or you notice any other side effects not mentioned in this leaflet.

5. HOW TO STORE OTEX• Keepoutofthereachandsight

of children.• Donotuseaftertheexpirydateshown

onthebottleandthecarton.Theexpirydate refers to the last day of that month.

• Onceopened,donotkeepthebottleforlonger than 4 weeks.

• Donotstoreabove25°C.• Alwaysreplacethecaptightlyafteruse.• Storethebottleuprightintheouter

carton to avoid spillage.• Medicinesshouldnotbedisposedofvia

wastewaterorhouseholdwaste.Askyourpharmacist how to dispose of medicines nolongerrequired.Thesemeasureswillhelp to protect the environment.

6. FURTHER INFORMATION ABOUT OTEXWhat Otex contains:Theactive ingredient is urea hydrogen peroxide (5% w/w). Theother ingredients are 8-hydroxyquinolineandglycerol.

What Otex looks like and contents of the pack• Thebottlecontains8mlofOtexear

drops.Theplasticbottleisfittedwith a dropper and screwcap.

• Theproductisaclear,strawcolouredsolution.

The Marketing Authorisation holder is DiomedDevelopmentsLtd,Hitchin,Herts, SG47QR,UK.The Manufacturer isDDDLtd, 94RickmansworthRoad,Watford,Herts, WD187JJ,UK.This Leaflet was last approved in September 2007.

TolistentoorrequestacopyofthisleafletinBraille,largeprintoraudio,pleasecallfreeofcharge:08001985000(UKonly).Please be ready to give the following information: OtexEarDrops,00173/00151.ThisisaserviceprovidedbytheRoyalNationalInstituteofBlindPeople(RNIB).

SD8/07/6