Ritalin(R) 10 - Discount Pharmacy Australia

Ritalin(R) 10methylphenidate hydrochlorideConsumer Medicine InformationWhat is in this leafletThis leaflet answers some commonquestions about Ritalin 10 tablets.It does not contain all the availableinformation. It does not take theplace of talking to your doctor orpharmacist.All medicines have risks andbenefits. Your doctor has weighedthe risks of you or your child takingthis medicine against the benefitsthey expect it will provide.If you have any concerns about thismedicine, ask your doctor orpharmacist.Keep this leaflet with the medicine.You may need to read it again.What Ritalin 10 is usedforRitalin 10 tablets have two uses.* They are used to treat AttentionDeficit Hyperactivity Disorder(ADHD).About 3% of children suffer fromADHD. It makes them unable to sitstill or concentrate on tasks for anylength of time. They may havetrouble learning and doing schoolwork. They frequently becomedifficult to manage, both in schooland at home.Ritalin 10 is a central nervous systemstimulant. It is thought to work byregulating specific chemicals in thebrain that affect behaviour. It helpsto focus attention, shut outdistraction and allows impulsivepeople to think before they act. Ifsuccessful, it will enhance aninattentive person's natural ability.This medicine is part of a treatmentprogram that usually includespsychological, educational and socialtherapy.* Ritalin 10 tablets are also used totreat narcolepsy, a sleep-attackdisorder.People with narcolepsy haverecurring attacks of irresistibleday-time sleepiness in spite ofhaving enough sleep at night.Narcolepsy can be diagnosed by adoctor by recording wake-sleeppatterns.Narcolepsy is not a normal fatiguestate. This medicine should not beused to prevent or treat normalfatigue.Ask your doctor if you have anyquestions about why this medicinehas been prescribed for you oryour child.Your doctor may have prescribed itfor another purpose.This medicine is only available witha doctor's prescription and yourdoctor has special permission toprescribe it.There is not enough information torecommend its use in children under6 years old.Before you take Ritalin10When you must not take itDo not take Ritalin 10 if you areallergic to methylphenidate (theactive ingredient) or to any of theother ingredients listed at the endof this leaflet.Some of the symptoms of an allergicreaction may include shortness ofbreath, wheezing or difficultybreathing; swelling of the face, lips,tongue or other parts of the body;rash, itching or hives on the skin.Do not take Ritalin 10 if you haveany of the following medicalconditions:* periods of severe anxiety, tensionor agitation* tics (muscle twitching which isusually in the face or shoulders)or if your brothers or sisters havetics* Tourettes's syndrome or you havea family history of this disorder* glaucoma (increased pressure inthe eye)* an overactive thyroid* an irregular heartbeat* severe angina (chest pain)If you are not sure whether any ofthe above medical conditions applyto you, check with your doctor.Do not take this medicine after theexpiry date printed on the pack orif the packaging is torn or showssigns of tampering.In that case, return it to yourpharmacist.RITALIN(R) 10 1

Before you start to take itTell your doctor if you are allergicto any other medicines, foods, dyesor preservatives.Your doctor will want to know if youare prone to allergies.Tell your doctor if you have anintolerance to lactose or gluten.This medicine contains lactose andwheat starch.Tell your doctor if you have any ofthe following medical conditions:* severe depression or other mentalillness* epilepsy (seizures or fits)* high blood pressure* alcoholism* drug dependenceYour doctor may want to take specialprecautions if you have any of theabove conditions.Tell your doctor if you arepregnant or breast-feeding. Askyour doctor about the risks andbenefits of taking Ritalin 10 in thiscase.This medicine may affect yourdeveloping baby if you take it whileyou are pregnant. It is not known ifthe active ingredient in Ritalin 10passes into the breast milk.Breast-feeding is not recommendedwhile taking this medicine.Taking other medicinesTell your doctor if you are takingany other medicines, includingmedicines that you buy without aprescription from a pharmacy,supermarket or health food shop.Some medicines and Ritalin 10 mayinterfere with each other. Theseinclude:* medicines that increase bloodpressure* warfarin, a medicine used toprevent blood clots* medicines for epilepsy (fits)* medicines for depression, such astricyclic antidepressants andMAO inhibitors* phenylbutazone* guanethidineYou may need to take differentamounts of your medicines or youmay need to take different medicines.Your doctor and pharmacist havemore information.If you have not told your doctorabout any of these things, tellhim/her before you start takingthis medicine.How to take Ritalin 10Follow 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 label, ask yourdoctor or pharmacist for help.How much to takeRitalin 10 is available in tabletscontaining 10 mg of methylphenidatehydrochloride as the activeingredient.For children aged 6 or over, the usualstarting dose is 5 mg (half a tablet)once or twice each day. If necessary,the dose can be increased by 5 or 10mg each week up to a maximum of60 mg (6 tablets) each day.For adults, the usual dose is 20 to 30mg (2-3 tablets) each day but somepeople may need more or less thanthat. The maximum dose is 60 mg (6tablets) each day.How to take itTake the tablets with a full glass ofwater. If they upset your stomach,you can take them with food, butalways take them in the same way(e.g. always with food or alwayswithout food).That way the effect will always bethe same.Take the tablets in 2 or 3 dosesover the day unless your doctortells you otherwise. If you findthat you have trouble sleeping, talkto your doctor about the best timeto take the last dose of the day.Each dose is usually taken 1 or 2hours before the greatest effect isneeded. For example, a child maytake a dose at 7:00 a.m. so thatimproved concentration begins whenschool starts.How long to take itContinue taking Ritalin 10 for aslong as your doctor tells you.This medicine helps to control yoursymptoms but does not cure yourcondition. Your doctor will checkyour progress to make sure themedicine is working and will discusswith you how long your treatmentshould continue.During treatment for ADHD, yourdoctor may stop Ritalin 10 every sooften (e.g. over weekends or schoolholidays) to see whether it is stillneeded. Breaks from treatment alsohelp to prevent a slow-down ingrowth that sometimes happens whenchildren take this medicine for a longtime.If you forget to take itIf you forget to take a dose ofRitalin 10, take the dose as soon asyou remember. Then make sure towait the same amount of time asusual before you take the nextdose. For example, if there areusually 4 hours between doses, wait4 hours before taking the next doseand so on for the rest of that day.On the next day go back to yourusual times.Do not take a double dose to makeup for the one that you missed.Your chance of an unwanted sideeffect may be increased if you do.If you have trouble rememberingwhen to take your medicine, askyour pharmacist for some hints.RITALIN(R) 10 2

If you take too much(overdose)Immediately telephone your doctoror the Poisons Information Centre(telephone 13 11 26), or go toAccident and Emergency at yournearest hospital if you think thatyou or anyone else may have takentoo much Ritalin 10. Do this even ifthere are no signs of discomfort orpoisoning. Keep the telephonenumbers for these places handy.Some of the symptoms of anoverdose may include vomiting,agitation, headache, tremors, muscletwitching, irregular heart beat,flushing, fever, sweating, dilatedpupils, breathing problems,confusion and seizures.While you are takingRitalin 10Things you must doTake Ritalin 10 exactly as yourdoctor has prescribed.Like all stimulants, this medicinemay become habit-forming and canbe abused by some people. If youtake it correctly as instructed by yourdoctor, abuse or dependence shouldnot be a problem, either now or laterin life.Be sure to keep all of your doctor'sappointments so that yourprogress can be checked.Your doctor will want to check yourblood pressure and do blood testsfrom time to time to preventunwanted side effects fromhappening.If you become pregnant whiletaking Ritalin 10, tell your doctor.Your doctor can discuss with you therisks and benefits of taking it whileyou are pregnant.If you are about to be started onany new medicine, remind yourdoctor and pharmacist that youare taking Ritalin 10.Tell any doctor, dentist orpharmacist who treats you thatyou are taking Ritalin 10.Things you must not doDo not stop your treatmentwithout first checking with yourdoctor.If you suddenly stop taking thismedicine, your condition mayreappear or you may get unwantedeffects such as depression. Toprevent this, your doctor may want togradually reduce the amount ofmedicine you take each day beforestopping it completely.Do not take this medicine to treatany other complaints unless yourdoctor tells you to.Do not give it to anyone else, evenif their condition seems similar toyours.Things to be careful ofBe careful driving, operatingmachinery or doing jobs thatrequire you to be alert while youare taking Ritalin 10 until youknow how it affects you.This medicine may cause dizziness,drowsiness or blurred vision in somepeople. If you have any of thesesymptoms, do not drive or doanything else that could bedangerous.Be careful when drinking alcoholwhile you are taking Ritalin 10.Drinking alcohol is notrecommended because it can worsensome of the unwanted effects of thismedicine, such as dizziness anddrowsiness.Side effectsTell your doctor or pharmacist assoon as possible if you do not feelwell while you are taking Ritalin10.All medicines can have side effects.Sometimes they are serious, most ofthe time they are not. You may needmedical treatment if you get some ofthe side effects.Do not be alarmed by these lists ofpossible side effects. You may notexperience any of them. Ask yourdoctor or pharmacist to answerany questions you may have.Tell your doctor if you notice anyof the following and they worryyou:* nausea (feeling sick), vomiting orstomach pain* loss of appetite* loss of weight and slower growthin children* feeling nervous or unable to sleep* dry mouth* headache* drowsiness* dizziness* mood changes such as depressionor irritability* blurred vision or problemsfocussing your eyes* muscle cramps* hair lossTell your doctor immediately or goto Accident and Emergency atyour nearest hospital if you noticeany of the following:* signs of allergy such as swellingof the face, lips or tongue,shortness of breath, wheezing ortroubled breathing* rash, itching, red blotches, blistersor peeling of the skin* sudden increase in bodytemperature, sweating, fastheartbeat, muscle stiffness andfluctuating blood pressure, whichmay lead to coma* constant "flu-like" symptomssuch as chills, fever, sore throat,swollen glands, aching muscles orjoints* unusual bleeding or bruising* unusual tiredness, shortness ofbreath when exercising, dizziness,pale skin* uncontrollable twitching, jerkingor writhing movements* seizures (fits)RITALIN(R) 10 3

* pain or tightness in the chest* fast or irregular heartbeat* changes in blood pressure* yellow colour to the skin or eyes,dark coloured urine or lightcoloured bowel motions* confusion or hallucinations(seeing or feeling things that arenot really there)* severe or persistent headacheThe above side effects may beserious. You may need urgentmedical attention.Tell your doctor if you noticeanything else that is making youfeel unwell.Some people may have other sideeffects not yet known or mentionedin this leaflet.After taking Ritalin 10Storage* Keep your medicine in theoriginal container until it is timeto take a dose.* Store it in a cool dry place.* Do not store Ritalin 10 or anyother medicine in the bathroom ornear a sink.* Do not leave it in the car or onwindow sills.Keep this medicine where childrencannot reach it.A locked cupboard at leastone-and-a-half metres above theground is a good place to storemedicines.DisposalProduct descriptionWhat it looks likeRitalin 10 tablets are round whitetablets, marked CG on one side andAB with a break-line on the other;packs of 100 tablets.IngredientsRitalin 10 tablets contain 10 mg ofmethylphenidate hydrochloride as theactive ingredient. They also contain:* lactose* calcium phosphate* gelatin* magnesium stearate* purified talc* wheat starchSponsorRitalin 10 tablets are supplied inAustralia by:NOVARTIS PharmaceuticalsAustralia Pty LimitedACN 004 244 16054 Waterloo RoadNorth Ryde NSW 2113Telephone: 1 800 671 203Web site: www.novartis.com.au(R) = Registered TrademarkThis leaflet was prepared inDecember 2003.(rtl171203c.doc) based on PI(rtl150802i.doc)Australian Registration Number:Ritalin 10 tablet: AUST R 11052If your doctor tells you to stoptaking this medicine or the expirydate has passed, ask yourpharmacist what to do with anymedicine you have left over.RITALIN(R) 10 4