Zactin(R) - Discount Pharmacy Australia

Zactin(R)contains the active ingredient fluoxetine hydrochlorideCONSUMER MEDICINE INFORMATIONWhat is in this leafletThis leaflet answers some commonquestions about Zactin.It does not contain all the availableinformation. It does not take theplace of talking to your doctor orpharmacist.All medicines have benefits andrisks. Your doctor has weighed therisks of you taking Zactin against thebenefits expected for you.If you have any concerns abouttaking this medicine, talk to yourdoctor or pharmacist.Keep this leaflet with yourmedicine.You may need to read it again.What Zactin is used forZactin is used to treat depression andobsessive compulsive disorder(OCD).Zactin belongs to a group ofmedicines called selective serotoninreuptake inhibitors (SSRIs). SSRIsare thought to work by their actionon brain chemicals called amineswhich are involved in controllingmood.Zactin is not recommended for use inchildren and adolescents under 18years of age.Zactin is available only with adoctor's prescription.Ask your doctor if you have anyquestions about why Zactin hasbeen prescribed for you.Your doctor may have prescribedZactin for another reason.Before you take ZactinWhen you must not take itDo not take ZACTIN if you areallergic to any other medicinescontaining fluoxetine (such asProzac and Lovan) or any of theingredients listed at the end of thisleaflet.Some of the symptoms of an allergicreaction may include skin rash,itching or hives; swelling of the face,lips or tongue which may causedifficulty in swallowing orbreathing, wheezing or shortness ofbreath.Do not take Zactin if you aretaking, or have taken within thelast 14 days, another medicine fordepression called a monoamineoxidase inhibitor (MAOI).Taking Zactin with a MAOI maycause a serious reaction with shaking(tremor), shivering, muscle stiffness,fever, rapid pulse, rapid breathing orconfusion. You must not take Zactinfor 14 days after you have stoppedtaking a MAOI. Ask your doctor orpharmacist if you are not sure if youhave been taking one of thesemedicines.Do not take Zactin after the expirydate (EXP.) printed on the packhas passed.If you take this medicine after theexpiry date, it may not work as well.Do not take Zactin if the packagingshows signs of tampering or thecapsules do not look quite right.If you are not sure whether youshould start taking this medicine,talk to your doctor.Before you start to take itTell your doctor if you are allergicto any other medicines, foods, dyesor preservatives.Tell your doctor if you arepregnant or plan to becomepregnant.Your doctor will discuss the risksand benefits of taking Zactin duringpregnancy. If Lovan is taken duringpregnancy, you should be careful,particularly at the end of yourpregnancy. Transitory withdrawalsymptoms have been reported rarelyin the newborn baby after maternaluse during the last 3 months ofpregnancy.Tell your doctor if you arebreastfeeding or wish tobreastfeed.Like many other medicines, Zactincan pass into breast milk. Yourdoctor will discuss the risks andbenefits of taking Zactin whenbreastfeeding.ZACTIN(R) 1

Tell your doctor if you have, orhave had, any medical conditions,especially the following:* kidney problems* liver problems* diabetes* fits (seizures)* a bleeding disorder or a tendencyto bleed more than usual.Your doctor may want to take specialcare if you have any of theseconditions.Tell your doctor if you drinkalcohol.Although drinking alcohol isunlikely to affect your response toLovan, your doctor may suggestavoiding alcohol while you are beingtreated for depression.If you have not told your doctorabout any of the above, tellhim/her before you start takingZactin.Taking other medicinesTell your doctor if you are takingany other medicines, including anythat you buy without aprescription from a pharmacy,supermarket or health food shop.Some medicines may be affected byZactin, or may affect how well itworks. These include:* monoamine oxidase inhibitors(MAOIs), medicines used to treatsome types of depression.Stop taking MAOIs at least twoweeks before starting Zactin.* lithium, a medicine used to treatmood swings and some types ofdepression* other medicines for depression orobsessive compulsive disorder* sleeping tablets or sedatives* medicines used to relieve anxiety* medicines used to treat certainmental and emotional conditions,also called antipsychotics* medicines used to control fits* medicines used to relieve pain,such as tramadol* sumatriptan, a medicine used totreat migraine* tryptophan, an amino acidavailable in food supplementsand multivitamin preparations* medicines used to prevent bloodclots, such as warfarin* flecainide, a medicine used totreat irregular heart beat* St John's Wort (Hypericumperforatum), a herbal remedy.Your doctor can tell you what to doif you are taking any of thesemedicines.If you are not sure whether you aretaking any of these medicines,check with your doctor orpharmacist.Your doctor and pharmacist havemore information on medicines to becareful with or avoid while takingZactin.Do not start taking other medicinesfor depression without checkingwith your doctor. Do this even ifyou have already stopped takingZactin.Monoamine oxidase inhibitors(MAOIs), which are other medicinesused for depression, may interferewith Zactin.If your doctor decides to start youon a MAOI medicine, wait at least5 weeks between stopping Zactinand starting your MAOI medicine.Serious reactions can occur if youstart taking MAOIs too soon afterstopping Zactin.How to take ZactinFollow all directions given to youby your doctor and pharmacistcarefully.They may differ from theinformation contained in this leaflet.If you do not understand theinstructions on the pack, ask yourdoctor or pharmacist.How much to takeThe dose varies from person toperson.Your doctor will tell you how muchZactin you need to take each day.The usual dose for Zactin is onecapsule taken once a day in themorning. Your doctor may changeyour dose depending on how yourespond to the medicine.How to take ZactinSwallow the capsules whole with aglass of water.When to take ZactinLovan is usually taken as a singledose in the morning. If your doctortells you to take it twice a day, take adose in the morning and at noon.Take your medicine at about thesame time each day.Taking it at the same time each daywill have the best effect. It will alsohelp you remember when to take it.Zactin can be taken with or withoutfood.How long to take Zactin forKeep taking Zactin for as long asyour doctor recommends.The length of treatment with Zactinwill depend on how quickly yoursymptoms improve. Most medicinesof this type take time to work sodon't be discouraged if you do notfeel better right away. While somesymptoms will be relieved soonerthan others, Zactin commonly takestwo to four weeks beforeimprovement is really apparent.If you do not start to feel better inabout four weeks, check with yourdoctor.ZACTIN(R) 2

If you forget to take ZactinSkip the dose you missed and takeyour next dose when you are meantto.Do not take a double dose to makeup for the dose you missed.If you are not sure what to do orhave any questions, ask yourdoctor or pharmacist.If you take too much Zactin(overdose)Immediately telephone yourdoctor, or the Poisons InformationCentre (telephone 13 11 26), or goto Accident and Emergency at thenearest hospital, if you think youor anyone else may have taken toomuch Zactin. Do this even if thereare no signs of discomfort orpoisoning.If you have taken too much Zactin,you may feel sick in the stomach,vomit, feel restless, agitated orexcited.While you are takingZactinThings you must doBefore starting any new medicine,tell your doctor or pharmacist thatyou are taking Zactin.Tell all the doctors, dentists andpharmacists who are treating youthat you are taking Zactin.Tell your doctor if you areplanning to become pregnant orbecome pregnant while takingZactin.Your doctor will discuss the risksand benefits of taking Zactin duringpregnancy. If Zactin is taken duringpregnancy, you should be careful,particularly at the end of yourpregnancy. Transitory withdrawalsymptoms have been reported rarelyin the newborn baby after maternaluse during the last 3 months ofpregnancy.Tell your doctor immediately ifyou have any thoughts aboutsuicide or other mental/moodchanges.Contact your doctor or a mentalhealth professional immediately orgo to the nearest hospital fortreatment if you or someone youknow is demonstrating any of thefollowing warning signs:* thoughts or talk about death orsuicide* thoughts or talk of self-harm orharm to others* any recent attempts at self-harm.All mentions of suicide or violencemust be taken seriously.If you are being treated fordepression, be sure to discuss withyour doctor any problems you mayhave and how you feel, especiallyany feelings of severe sadness orbursts of unusual energy or anger.This will help your doctor todetermine the best treatment for you.Visit your doctor regularly so thatthey can check your progress.Tell your doctor if, for any reason,you have not taken your medicineexactly as prescribed.Otherwise, your doctor may thinkthat it was not effective and changeyour treatment unnecessarily.Tell your doctor if you feel themedicine is not helping yourcondition.Be sure to keep all of yourappointments with your doctor sothat your progress can be checked.Your doctor may want to take someblood tests and check your heart andblood pressure from time to time.This helps prevent unwanted sideeffects.Things you must not doDo not stop taking Zactin, or lowerthe dose, without checking withyour doctor.Stopping Zactin suddenly may causeunwanted side effects. Some peoplemay suffer symptoms such asdizziness, anxiety, headache, feelingsick, or tingling or numbness of thehands or feet. Your doctor maydecide to gradually reduce theamount of Zactin you are takingbefore stopping completely.Do not give Zactin to anyone else;your doctor has prescribed itspecifically for you and yourcondition.Do not let yourself run out ofZactin over the weekend or onholidays.Do not use Zactin to treat anyother complaints unless yourdoctor tells you to.Do not take the herbal remedy StJohn's Wort (Hypericumperforatum) while you are beingtreated with Zactin.If you are already taking the herbalremedy, stop taking it and mention itto your doctor at your next visit.Things to be careful ofBe careful driving or operatingmachinery until you know howZactin affects you.Zactin may cause drowsiness in somepeople.Be careful when drinking alcoholwhile taking Zactin.Although drinking alcohol isunlikely to affect your response toZactin, your doctor may suggestavoiding alcohol while you are beingtreated for depression.ZACTIN(R) 3

Side effectsTell your doctor or pharmacist assoon as possible if you do not feelwell while you are taking Zactin.Like all other medicines, Zactin mayhave unwanted side effects in somepeople. Sometimes they are serious,most of the time they are not. Youmay need medical treatment if youget some of the side effects.Side effects vary from patient topatient and often go away withcontinued use.Do not be alarmed by this list ofpossible side effects.You may not experience any of them.Ask your doctor or pharmacist toanswer any questions you mayhave.Tell your doctor if you notice anyof the following and they worryyou:* nausea, vomiting* upset stomach, diarrhoea* loss of appetite, weight loss,changes in taste, dry mouth* trouble sleeping, unusual dreams* nervousness, anxiety* drowsiness, weakness* dizziness* excessive sweating, flushing,chills* sexual problems* more frequent urination* changes in vision.See your doctor immediately or goto Accident and Emergency at thenearest hospital if you notice anyof the following:* itching, skin rash or hives* shortness of breath, wheezing ortrouble breathing* swelling of the face, lips, tongueor other parts of the body* muscle spasms* tremors* convulsions or fits* twitches* fast, irregular heart beat* abnormal bleeding or bruising* sudden change in mood to one ofoveractivity and uninhibitedbehaviour.These side effects may be serious andneed urgent medical attention.Tell your doctor if you noticeanything that is making you feelunwell.This is not a complete list of allpossible side effects. Other sideeffects not listed above may alsooccur in some people. Some of theseside effects (for example, changes inliver function) can only be foundwhen your doctor does tests fromtime to time to check your progress.After taking ZactinStorageKeep Zactin where children cannotreach it.A locked cupboard at leastone-and-a-half metres above theground is a good place to storemedicines.Keep your capsules in the packuntil it is time to take them.If you take the capsules out of thepack they will not keep well.Keep your capsules in a cool dryplace where the temperature staysbelow 30 degrees C.Do not store Zactin or any othermedicine in the bathroom or near asink.Do not leave Zactin in the car or onwindow sills.Heat and dampness can destroy somemedicines.DisposalIf your doctor tells you to stoptaking Zactin, or if it has passedthe expiry date, ask yourpharmacist what to do with anythat are left over.Product descriptionWhat it looks likeZactin capsules are green and purple,marked FL 20 and a Greek alphasymbol.Each pack contains 28 capsules.IngredientsThe active ingredient in Zactin isfluoxetine (as fluoxetinehydrochloride). Each Zactin capsulecontains 20 mg of fluoxetine.The tablets also contain thefollowing inactive ingredients:* maize starch* dimethicone 350* gelatin* titanium dioxide* erythrosine CI45430* indigo carmine CI73015* quinoline yellow CI47005* brilliant blue FCF CI42090* edible black ink.Zactin capsules are gluten free.SupplierZactin is supplied by:Alphapharm Pty Limited(ABN 93 002 359 739)Chase Building 2Wentworth Park RoadGlebe NSW 2037Phone: (02) 9298 3999www.alphapharm.com.auMedical InformationPhone: 1800 028 365Australian registration number:AUST R 70502Zactin(R) is a registered Trade Mark.This leaflet was prepared on2 November 2004.ZACTIN(R) 4