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Hypnodorm - Discount Pharmacy Australia

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<strong>Hypnodorm</strong>contains the active ingredient flunitrazepamCONSUMER MEDICINE INFORMATIONWhat is in this leafletThis leaflet answers some commonquestions about <strong>Hypnodorm</strong>.It does not contain all of theavailable information. It does nottake the place of talking to yourdoctor or pharmacist.All medicines have benefits andrisks. Your doctor has weighed therisks of you taking <strong>Hypnodorm</strong>against the benefits they expect itwill have for you.If you have any concerns abouttaking this medicine, talk to yourdoctor or pharmacist.Keep this leaflet with your medicine.You may need to read it again.What <strong>Hypnodorm</strong> isused for<strong>Hypnodorm</strong> is used to treat severecases of insomnia (trouble sleeping).<strong>Hypnodorm</strong> belongs to a group ofmedicines called benzodiazepines.These medicines are thought to workby their action on brain chemicals.In general, benzodiazepines such as<strong>Hypnodorm</strong> need only be taken for afew nights and then discontinued bygradually decreasing the dosage.Continuous long term use of<strong>Hypnodorm</strong> is not recommended.The use of benzodiazepines may leadto dependence on the medicine.Your doctor may have prescribed<strong>Hypnodorm</strong> for another reason. Askyour doctor if you have anyquestions about why <strong>Hypnodorm</strong> hasbeen prescribed for you.<strong>Hypnodorm</strong> is available only with adoctor's prescription.Before you take<strong>Hypnodorm</strong>When you must not take itDo not take <strong>Hypnodorm</strong> if you areallergic to medicines containingflunitrazepam, any otherbenzodiazepine 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 <strong>Hypnodorm</strong> if youhave:* severe and chronic lung disease* myasthenia gravis, conditionwhere there is severe muscleweakness* sleep apnoea, condition whereyou temporarily stop breathingwhile you are asleep* severe liver disease.Do not take <strong>Hypnodorm</strong> if you arebreastfeeding.<strong>Hypnodorm</strong> passes into breast milkand may affect your baby.Do not take <strong>Hypnodorm</strong> if theexpiry date (Exp.) printed on thepack has passed.Do not take <strong>Hypnodorm</strong> if thepackaging shows signs oftampering or the tablets do notlook quite right.Do not give <strong>Hypnodorm</strong> tochildren.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 <strong>Hypnodorm</strong>during pregnancy.Tell your doctor if you plan tobreastfeed.<strong>Hypnodorm</strong> passes into breast milkand is not recommended for usewhen breastfeeding.Tell your doctor if you have, orhave had, any medical conditions,especially the following:* hypotension (low blood pressure)* myasthenia gravis (severe muscleweakness)* liver or kidney problems* lung problems* a blood disorder* glaucoma (increased pressure inthe eye)* depression, psychosis orschizophrenia* epilepsy (convulsions).Your doctor may want to take specialcare if you have any of theseconditions.HYPNODORM 1


Tell your doctor if you drinkalcohol regularly.Alcohol may increase the effects of<strong>Hypnodorm</strong> and should be avoidedwhile you are being treated with<strong>Hypnodorm</strong>.Tell your doctor if you need todrive, operate dangerousmachinery, or are involved inactivities requiring concentration.<strong>Hypnodorm</strong> may cause drowsiness ordizziness up until the next day.Tell your doctor if you plan to havesurgery.If you have not told your doctorabout any of the above, tell thembefore you start taking<strong>Hypnodorm</strong>.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 by<strong>Hypnodorm</strong>, or may affect how wellit works. These include:* other sleeping tablets, sedativesor tranquillisers* medicines for depression* medicines used to treat mentalillness* medicines to treat epilepsy* antihistamines, medicines forallergies or colds* muscle relaxants* cimetidine, medicine used to treatstomach ulcers* cisapride, medicine used to treatreflux* strong pain relievers* disulfiram, medicine used in thetreatment of alcohol dependence* anticholinergics, medicines fortravel sickness, stomach crampsor Parkinson's Disease.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 tobe careful with or avoid whiletaking <strong>Hypnodorm</strong>.How to take<strong>Hypnodorm</strong>How much to takeThe dose varies from patient topatient. Your doctor will decide theright dose for you.The usual dose is 1 mg to 2 mg (oneto two tablets) at bedtime.The usual dose for elderly patients is0.5 mg to 1 mg (half to one tablet) atbedtime.Follow all directions given to youby your doctor and pharmacistcarefully.How to take <strong>Hypnodorm</strong>Swallow the tablets with a glass ofwater.<strong>Hypnodorm</strong> tablets can be broken inhalf if your doctor has prescribedhalf a tablet.When to take <strong>Hypnodorm</strong><strong>Hypnodorm</strong> should be taken whenyou go to bed. Only take<strong>Hypnodorm</strong> if you feel you will needhelp sleeping.<strong>Hypnodorm</strong> can be taken with orwithout food.If you forget to take<strong>Hypnodorm</strong>If you forget to take <strong>Hypnodorm</strong>before you go to bed and you wakeup late in the night or early in themorning, do not take <strong>Hypnodorm</strong>as you may have trouble waking inthe morning.Do not take a double dose to makeup for the dose you missed.If you are not sure what to do, askyour doctor or pharmacist.How long to take <strong>Hypnodorm</strong>forTake <strong>Hypnodorm</strong> only for as longas your doctor recommends.Usually, <strong>Hypnodorm</strong> need only betaken for a few nights and thendiscontinued by gradually decreasingthe dosage. Continuous long termuse is not recommended unlessadvised by your doctor. The use ofbenzodiazepines may lead todependence on the medicine.If you take too much<strong>Hypnodorm</strong> (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 <strong>Hypnodorm</strong>. Do this even ifthere are no signs of discomfort orpoisoning.You may need urgent medicalattention.If you take too much <strong>Hypnodorm</strong>,you may feel drowsy, confused, tired,unsteady when walking, weak inmuscle strength, dizzy, lightheaded,have trouble breathing or becomeunconsious.While you are taking<strong>Hypnodorm</strong>Things you must doUse <strong>Hypnodorm</strong> exactly asprescribed by your doctor.Before starting any new medicine,tell your doctor or pharmacist thatyou are taking <strong>Hypnodorm</strong>.HYPNODORM 2


Tell all the doctors, dentists andpharmacists who are treating youthat you are taking <strong>Hypnodorm</strong>.If you become pregnant whiletaking <strong>Hypnodorm</strong>, tell yourdoctor immediately.If you plan to have surgery,including dental surgery, tell yourdoctor or dentist that you aretaking <strong>Hypnodorm</strong>.If you have to have any clinicaltests such as an EEG, tell yourdoctor that you are taking<strong>Hypnodorm</strong>.<strong>Hypnodorm</strong> may affect the results ofsome tests.Visit your doctor regularly so theycan check on your progress.Your doctor needs to check yourprogress and see whether you need tocontinue taking <strong>Hypnodorm</strong>.Tell your doctor, if for any reason,you have not taken <strong>Hypnodorm</strong>exactly as prescribed.Otherwise, your doctor may thinkthat your medicine is not workingproperly and change your treatmentunnecessarily.Things you must not doDo not drive or operate machineryuntil you know how <strong>Hypnodorm</strong>affects you.<strong>Hypnodorm</strong> may cause drowsiness,dizziness or lightheadedness in somepeople. If any of these occur, do notdrive, operate machinery or doanything else that could bedangerous.Even if you take <strong>Hypnodorm</strong> atnight, you may still feel drowsy ordizzy the next day.Do not take <strong>Hypnodorm</strong> for alonger time than your doctor hasprescribed.<strong>Hypnodorm</strong> should be taken for shortperiods only unless advisedotherwise by your doctor.Do not stop taking <strong>Hypnodorm</strong>, orchange the dose, without checkingwith your doctor.Stopping <strong>Hypnodorm</strong> suddenly maycause some unwanted effects. Yourdoctor will gradually reduce theamount of <strong>Hypnodorm</strong> you aretaking before stopping completely.Do not suddenly stop taking<strong>Hypnodorm</strong> if you suffer fromepilepsy.Stopping this medicine suddenly maymake your epilepsy worse.Do not use <strong>Hypnodorm</strong> to treatany other conditions unless yourdoctor tells you to.Do not give <strong>Hypnodorm</strong> to anyoneelse, even if they have the samecondition as you.Things to be careful ofBe careful when drinking alcoholwhile taking <strong>Hypnodorm</strong>.Combining <strong>Hypnodorm</strong> and alcoholcan make you more sleepy, dizzy orlightheaded.Your doctor may suggest that youavoid alcohol while you are taking<strong>Hypnodorm</strong>.Be careful if you are elderly,unwell or taking other medicines.Some people may experience sideeffects such as drowsiness,confusion, dizziness andunsteadiness, which may increase therisk of a fall.Side effectsTell your doctor or pharmacist assoon as possible if you do not feelwell while you are taking<strong>Hypnodorm</strong>.<strong>Hypnodorm</strong> helps most people withinsomnia, but it may have unwantedside effects in some people.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.If you are over 65 years of age, youmay have an increased chance ofgetting side effects.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:* tiredness or drowsiness* hangover feeling in the morning,headache, confusion* dizziness, unsteadiness whenwalking* stomach upsets* dry mouth* slurred speech.The above list includes the morecommon side effects.Tell your doctor immediately or goto Accident and Emergency at thenearest hospital if you notice anyof the following:* skin rash* fast heart beat* muscle weakness* aggressive behaviour* delusions, hallucinations* sudden excitation or anxiety* severe sleep disturbances,nightmares* loss of memory* swelling of the face, lips mouth,tongue or throat which may causedifficulty swallowing orbreathing.These are serious side effects and youmay need urgent medical attention.Serious side effects are rare.HYPNODORM 3


Other side effects not listed abovemay also occur in some patients.Tell your doctor if you noticeanything that is making you feelunwell.After taking<strong>Hypnodorm</strong>StorageKeep <strong>Hypnodorm</strong> where childrencannot reach it.A locked cupboard at leastone-and-a-half metres above theground is a good place to storemedicines.Keep your tablets in the bottleuntil it is time to take them.If you take the tablets out of thebottle they may not keep well.Keep your tablets in a cool dryplace where the temperature staysbelow 30 degrees C.Do not store <strong>Hypnodorm</strong> or anyother medicine in the bathroom ornear a sink.Do not leave <strong>Hypnodorm</strong> in the caror on window sills.Heat and dampness can destroy somemedicines.DisposalIngredientsThe active ingredient in <strong>Hypnodorm</strong>is flunitrazepam.Each <strong>Hypnodorm</strong> tablet contains1mg of flunitrazepam.The tablets also contain:* lactose* maize starch* pregelatinised maize starch* magnesium stearate* Indigo carmine CI73015* Opadry Green OY-LS-21051.The tablets are gluten free.Manufacturer<strong>Hypnodorm</strong> is made in <strong>Australia</strong> by:Alphapharm Pty Limited(ABN 93 002 359 739)Chase Building 2Wentworth Park RoadGlebe NSW 2037Phone: (02) 9298 3999Medical InformationPhone: 1800 028 365<strong>Australia</strong>n registration number:<strong>Hypnodorm</strong> - Aust R 78344This leaflet was prepared on4 October 2001.If your doctor tells you to stoptaking <strong>Hypnodorm</strong>, or your tabletshave passed their expiry date, askyour pharmacist what to do withany that are left over.Product descriptionWhat it looks like<strong>Hypnodorm</strong> is a green, oval filmcoatedtablet with "FM|1" on oneside and a Greek alpha symbol on theother.Each pack contains 30 tablets.HYPNODORM 4

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