ABILIFY(TM) - Discount Pharmacy Australia

ABILIFY(TM)AripiprazoleConsumer Medicine InformationWhat is in this leafletThis leaflet answers some commonquestions about ABILIFY. It doesnot contain all the availableinformation. Some of theinformation contained in this leafletmay not apply to you.It does not take the place of talkingto your doctor or pharmacist.All medicines have risks andbenefits. Your doctor has weighedthe risks of you taking ABILIFYagainst the benefits it is expected tohave for you.If you have any concerns abouttaking this medicine, ask yourdoctor or pharmacist.Keep this leaflet with the medicine.You may need to read it again.What ABILIFY is usedforABILIFY is a trade name(manufacturer's name) for themedicine aripiprazole(Ari-pip-rah-zol). ABILIFY is usedto treat symptoms of schizophrenia.Schizophrenia is a mental illnesswith disturbances in thinking,feelings and behaviour.ABILIFY belongs to a group ofmedicines called antipsychoticagents. It helps to correct chemicalimbalances in the brain, which maycause schizophrenia.Your doctor may have prescribedABILIFY for another reason. Askyour doctor if you have anyquestions about why ABILIFY hasbeen prescribed for you.There is no evidence that ABILIFYis addictive.This medicine is available only witha doctor's prescription.ABILIFY is not recommended foruse in children under the age of 18,as safety and efficacy have not beenestablished in this age group.Before you takeABILIFYWhen you must not take itDo not take ABILIFY if you havean allergy to:* aripiprazole* any of the ingredients listed at theend of this leafletSymptoms of an allergic reactioninclude:* rash, itching or hives on the skin* shortness of breath, wheezing ordifficulty breathing* swelling of the face, lips, tongue,throat or other parts of the bodyDo not take ABILIFY after theexpiry or use by date printed onthe pack.If you take this medicine after thisdate has passed, it may not work aswell.Do not take ABILIFY if thepackaging is torn or shows signs oftampering.If this is the case, return it to yourpharmacist.If you are not sure whether youshould start taking ABILIFY, talkto your doctor or pharmacist.Before you start to take itTell your doctor or pharmacist ifyou have allergies to:* any other medicines* any other substances such asfoods, preservatives or dyesTell your doctor if you arepregnant or intend to becomepregnant.Like most antipsychotic medicines,ABILIFY is not recommended foruse during pregnancy. If you need totake ABILIFY during yourpregnancy, your doctor will discusswith you the benefits and risks oftaking it.Tell your doctor or pharmacist ifyou are breast-feeding or plan tobreast-feed.It is recommended that you do notbreast-feed while taking ABILIFY,as it may pass into breast milk andtherefore there is a possibility thatthe breast-fed baby may be affected.Tell your doctor if you have, orhave had any medical conditions,especially the following* a reaction to some medicines witha sudden increase in bodytemperature, sweating, fast heartbeat, muscle stiffness andfluctuating blood pressure, whichmay lead to coma. This reactionis called neuroleptic malignantsyndrome.* A reaction to some medicineswith abnormal movements of thetongue, or other uncontrolledABILIFY(TM) 1

movements of the mouth, tongue,cheeks or jaw which mayprogress to the arms and legs.This reaction is called tardivedyskinesia.* low blood pressure* epilepsy, seizures or fits* problems with your oesophagussuch as difficulty in swallowing.Tell your doctor if you drinkalcohol.Your doctor may advise you to avoidalcohol as it can magnify theside-effects of this medicine.If you have not told your doctor orpharmacist about any of the above,tell them before you start takingABILIFY.Taking other medicinesTell your doctor or pharmacist ifyou are taking any othermedicines, including any that youbuy without a prescription fromyour pharmacy, supermarket orhealth food shop.Some medicines and ABILIFY mayinterfere with each other. Theseinclude:* medicines used to treat braindisorders such as, anxiety,depression, mood swings,epilepsy or seizures, Parkinson'sdisease or insomnia.* medicines used to treat highblood pressure* medicines used to treat fungalinfections* medicines used to treat heartrhythm disturbances* medicines used to treat bacterialor viral infections* a medicine called cyclosporin(Cysporin(R); Neoral(R);Sandimmun(R))* a medicine called cimetidine(Tagamet(R); Magicul(R);Sigmetadine(R))These medicines may be affected byABILIFY, or may affect how well itworks. Your doctor may need toadjust your dose of Abilify or of theother medicine.Eating grapefruit or drinkinggrapefruit juice may affect howABILIFY works.Your doctor or pharmacist may havemore information on medicines to becareful with or avoid while takingABILIFY.How to take ABILIFYFollow all directions given to youby your doctor or pharmacistcarefully.They may differ from theinformation contained in this leaflet.Your doctor or pharmacist will tellyou how much you will need to takeeach day. This will depend on yourcondition and whether you are takingany other medicines.The label put on the carton by thepharmacist will tell you how muchyou should take.If you do not understand theinstructions on the carton, askyour doctor or pharmacist forhelp.How to take itABILIFY tablets should beswallowed whole and washed downwith a glass of water.Take ABILIFY at about the sametime each day.Unless your doctor gives you otherdirections, you should take ABILIFYonly once a day.Taking the medicine at the same timeeach day will have the best effect. Itwill also help you remember when totake it.It does not matter whether you takeABILIFY with or without food.If you forget to take itIf it is almost time for your nextdose, skip the dose you missed andtake your next dose when you aremeant to.Otherwise, take it as soon as youremember, and then go back totaking your medicine as you wouldnormally.Do not take a double dose to makeup for the dose that you missed.This may increase the chance of yougetting an unwanted side effect.If you are not sure what to do, askyour doctor or pharmacist.If you have trouble rememberingto take your medicine, ask yourpharmacist for some hints.How long to take itContinue taking ABILIFY for aslong as your doctor tells you.ABILIFY helps to control yourcondition but does not cure it.Therefore you must take ABILIFYevery day. Do not stop taking itunless your doctor tells you to - evenif you feel better.If you take too much(overdose)Immediately telephone your doctoror pharmacist or the PoisonsInformation Centre (telephone131126), or go to the AccidentEmergency Centre at your nearesthospital, if you or anyone else mayhave taken too much ABILIFY.Do this even if there are no signs ofdiscomfort or poisoning.You may need urgent medicalattention.While you are takingABILIFYThings you must doTell any doctors, dentists orpharmacists who are treating youthat you are taking ABILIFY.If you are about to be started onany new medicine, tell your doctor,dentist and pharmacist that youare taking ABILIFY.ABILIFY(TM) 2

If you plan to have any kind ofsurgery that needs a generalanaesthetic, tell your doctor ordentist that you are takingABILIFY.If you become pregnant whiletaking ABILIFY, tell your doctorimmediately.Be sure to keep all of your doctor'sappoinents so that your progresscan be checked.Things you must not doDo not give ABILIFY to anyoneelse, even if their symptoms seemsimilar or they have the samecondition as you.Do not take ABILIFY to treat anyother complaints unless yourdoctor or pharmacist tells you to.Do not stop taking ABILIFY orlower the dosage, even if you arefeeling better, without checkingwith your doctor.If you stop taking ABILIFYsuddenly your condition mayworsen.Do not take more of this medicineand do not take it more often thanyour doctor has ordered.Things to be careful ofMake sure that you know how youreact to ABILIFY before you drivea car, operate machinery or doanything else that could bedangerous if you are dizzy or lightheaded or not alert.ABILIFY may cause some people tobecome drowsy or less alert than theyare normally or causelight-headedness, dizziness ortiredness. If this occurs do notundertake the activity.If ABILIFY makes you feellight-headed, dizzy or faint, becareful when getting up from asitting or lying position.Getting up slowly may help.Be careful when drinking alcoholwhile taking ABILIFYYour doctor may suggest you avoidalcohol while you are being treatedwith ABILIFY.Make sure you keep cool in hotweather and keep warm in coolweather.ABILIFY may affect the way yourbody reacts to temperature changes.It may prevent sweating, even duringheatwaves. You may feel dizzy orfaint if you are too hot. To stay coolin hot weather, try to do thefollowing:* wear light clothing* spend time in air-conditionedenvironments (or keep windowsopen and use electric fans)* drink plenty of water* take cool baths or showers andavoid hot baths and saunas* try to restrict exercise or heavywork to cool parts of the daySide-EffectsTell your doctor or pharmacist assoon as possible if you do not feelwell while you are takingABILIFY.Like other medicines ABILIFY maycause some unwanted side effects.These are likely to vary from patientto patient. ABILIFY is generallywell-tolerated and the side effects areoften hard to distinguish fromdisease symptoms. It is importantthat you tell your doctor as soon aspossible about any unwanted effects.Ask your doctor or pharmacist toanswer any questions you mayhave.Tell your doctor if you notice anyof the following side effects andthey worry you:* headache* indigestion* nausea* vomiting* insomnia* lightheadedness* drowsiness* agitation* anxietyThese are the more common sideeffects of ABILIFYTell your doctor if you notice thefollowing side effect* feeling dizzy especially whengetting up from a lying or sittingpositionThis side effect is less common.Tell your doctor immediately or goto Accident and Emergency atyour nearest hospital if you noticeany of the following:* seizure, fits or convulsions.* fainting* abnormal movements of thetongue, or other uncontrolledmovements of the tongue, mouth,cheeks, or jaw which mayprogress to the arms and legs.* sudden increase in bodytemperature, sweating, fast heartbeat, muscle stiffness, high bloodpressure and convulsions.* rash* allergic reaction (rash, itching orhives on the skin; shortness ofbreath, wheezing or dificulitybreathing; swelling of the face,lips, tongue, throat or other partsof the body).* muscle pain or weaknessThese are very serious side effects.You may need urgent medicalattention or hospitalisation.All of these side effects are very rare.Other side effects not listed abovemay occur in some patients. Tellyour doctor or pharmacist if younotice anything that is making youfeel unwell.Do not be alarmed by this list ofpossible side effects.You may not experience any or onlysome of them.ABILIFY(TM) 3

After using ABILIFYStorageStore ABILIFY in a cool placewhere the temperature stays below30 degrees C.Do not store it or any othermedicine in the bathroom. Do notleave it in the car or on windowsills.Heat and dampness can destroy somemedicines.Keep it where young childrencannot reach it.A locked cupboard at leastone-and-a-half metres above theground is a good place to storemedicines. Do not keep outdatedmedicine or medicine no longerneeded.DisposalIf your doctor tells you to stoptaking ABILIFY or the medicinehas passed its expiry date, ask yourpharmacist what to do with anyleft over medicine.Be sure that any discardedmedicine is out of the reach ofchildren.Product DescriptionWhat it looks like10mg ABILIFY tablets are pink,rectangular with a bevel edge and aremarked on one side with "A-008"and "10".15mg ABILIFY tablets are yellow,round with a bevel edge and aremarked on one side with "A-009"and "15".20mg ABILIFY tablets are white topale yellowish white , round with abevel edge and are marked on oneside with "A-010" and "20".30mg ABILIFY tablets are pink,round with a bevel edge and aremarked on one side with "A-011"and "30".ABILIFY tablets are packed inaluminium blisters in a carton. Eachcarton contains 30 tablets.IngredientsActive ingredients:aripiprazoleOther ingredients:lactose, maizestarch, microcrystalline cellulose,hydroxypropylcellulose andmagnesium stearate.The following colorants are alsopresent in the tablets:10mg tablets -red iron oxideCI7749115mg tablets -yellow iron oxideCI7749220mg tablets no colourants30mg tablets - red iron oxideCI77491ABILIFY does not contain sucrose,gluten, tartrazine or any other azodyes.Manufacturer/DistributorThis product is distributed inAustralia by:Bristol-Myers, Squibb Australia PtyLtd, ACN 004 333 322556 Princes Highway, Noble Park3174 VIC, AustraliaRegistration NumbersAUST R 90997 10mg tabletsAUST R 90998 15mg tabletsAUST R 90999 20mg tabletsAUST R 91000 30mg tabletsProduct under license from OtsukaPharmaceutical Co., Ltd., Tokyo101-8535 JapanLeaflet updated: October 2004Abilify(cmi)2.docABILIFY(TM) 4