STOCRIN

STOCRIN®EfavirenzConsumer Medicine InformationWhat is in this leaflet This leaflet answers some common questions about STOCRIN. It does not contain all the available information.It does not take the place of talking to your doctor or pharmacist.All medicines have risks and benefits. Your doctor has weighed the risks of you taking STOCRIN against the benefits they expect it will have for you.If you have any concerns about taking this medicine, ask your doctor, pharmacist or treatments officer at your local AIDS Council. Keep this leaflet with the medicine. You may need to read it again.What STOCRIN is used forSTOCRIN is used to help treat HIV (Human Immunodeficiency Virus) infection. It is used in combination with other appropriate medicines used to treat the HIV virus. Examples include protease inhibitors such as indinavir (Crixivan*) and nelfinavir (Viracept*). They also include nucleoside analogue reverse transcriptase inhibitors (NRTIs) such as zidovudine (AZT, Retrovir*) or lamivudine (3TC).STOCRIN belongs to a group of medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs). It works by interrupting the formation of new HIV particles in already infected cells. When HIV is attacked by STOCRIN, the virus is not able to reproduce normally. Thishelps reduce the amount of virus inthe blood. Although STOCRIN helpsreduce the amount of virus in theblood and thus increases the CD4count, it has not yet been shown toimprove survival or slow theprogression of the disease.You may continue to developinfections or other illnessesassociated with HIV disease whileyou are taking STOCRIN.Before you takeSTOCRINWhen you must not take itDo not take STOCRIN if:•you have an allergy toSTOCRIN or any of theingredients listed at the end ofthis leaflet•the packaging is torn or showssigns of tampering•the expiry date on the pack haspassed.I f you take this medicine after theexpiry date has passed, it may notwork.•you are breast feeding or planto breast feedI t is not known whetherSTOCRIN passes into breastmilk. You should not breast-feedif you are taking STOCRIN.If you are not sure whether youshould start taking STOCRIN, talkto your doctor.Do not give STOCRIN to childrenunder 3 years of age or those whoweigh less than 13 kg.The safety and effectiveness ofSTOCRIN in these children have notbeen established.Before you start to take itTell your doctor if:1.you have any allergies to anyother medicines or any othersubstances, such as foods,preservatives or dyes2.you have or have had anymedical conditions, especiallythe following:•liver disease, including hepatitisB or C•high cholesterol•mental illness•seizures or fits3.you consume large amounts ofalcohol or use recreationaldrugs4.you are pregnant or intend tobecome pregnantI f there is a need to takeSTOCRIN when you arepregnant, your doctor will discussthe possible risks and benefits toyou and the unborn baby.5.you are taking a medicine thatcontains efavirenz (e.g.,ATRIPLA).S TOCRIN should not be takentogether with ATRIPLA or othermedicines that contain efavirenz.If you have not told your doctorabout any of the above, tell thembefore you take any STOCRIN.Taking other medicinesTell your doctor if you are takingany other medicines, herbalproducts, or dietary supplements,including those that you buy without a prescription from your pharmacy, supermarket or health food shop.Some medicines should not be taken with STOCRIN as they may cause a life-threatening interaction. These include:•terfenadine (Teldane*) andastemizole (Hismanal*),antihistamines used for allergicconditions, including hayfever•cisapride (Prepulsid*), used to treat stomach reflux•triazolam (Halcion*), used to treat anxiety, depression or forsleeplessness•midazolam (Hypnovel*), used asa sedative before surgicalprocedures•some medicines used to treat migraine, including Cafergot*,Cafergot S*, Ergodryl*, ErgodrylMono*, Dihydergot*, Migral*.•pimozide (not available inAustralia)•bepridil (not available inAustralia)•STOCRIN should not be taken together with ATRIPLA or othermedicines that contain efavirenz.In addition, STOCRIN should not be taken with St. John's wort (Hypericum perforatum), a herbal product sold as a dietary supplement, or products containing St. John's wort as it may decrease the effect of STOCRIN.Some medicines and STOCRIN may interfere with each other. These include:-•saquinavir (Invirase*),amprenavir (Agenerase*) andlopinavir/ritonavir (Kaletra*)protease inhibitors used to treatHIV infection•clarithromycin (Klacid*), an antibiotic used to treat bacterialinfections•rifampicin (Rifadin*, Rimycin*) and rifabutin (Mycobutin*),antibiotics used to treat TB andinfections caused by MAC •warfarin, a medicine used toprevent blood clots•ethinyl oestradiol, used in someoral contraceptives•phenobarbitone, phenytoin andcarbamazepine, medicines used totreat epilepsy and/or convulsions•methadone, a medicine used totreat opioid drug dependency•sertraline (Zoloft*) used to treatdepression, obsessive compulsivedisorder and panic disorderThese medicines may be affected bySTOCRIN, or may affect how well itworks. You may need differentamounts of your medicine, or youmay need to take different medicines.STOCRIN is taken in combinationwith other medicines commonly usedto help treat HIV-infection. Theseinclude the protease inhibitors suchas indinavir (Crixivan*) andnelfinavir (Viracept*). They alsoinclude nucleoside analogue reversetranscriptase inhibitors (NRTIs) suchas zidovudine (AZT, Retrovir*) orlamivudine (3TC). The optimal doseof indinavir, when given incombination with efavirenz, is notknown.In some patients with advanced HIVinfection (AIDS) and a history ofopportunistic infection, signs andsymptoms of inflammation fromprevious infections may occur whencombination antiretroviral treatmentis started.Make sure your doctor andpharmacist know about all of themedicines you are taking, as theyhave more information onmedicines to be careful with oravoid while taking STOCRIN.How to take STOCRINHow much to takeTake STOCRIN only whenprescribed by your doctor.Your doctor will tell you how manycapsules or tablets or how muchsolution you need to take each day.For adults and children weighingmore than 40 kg, the normal dose is600 mg once a day or 24 mL of thesolution once a day. It is importantthat you are started and continue onthis dose.For children and teenagers 3 to 17years old, the dose depends on bodyweight. Your child's doctor willdecide the dose.Please note that the dose ofSTOCRIN oral solution in mg ofefavirenz is not the same as forSTOCRIN capsules and tablets.Carefully follow all directionsgiven to you by your doctor.They may differ from theinformation contained in this leaflet.If you do not understand theinstructions on the bottle or box,ask your doctor or pharmacist forhelp.How to take itSwallow STOCRIN with a glass ofwater.Measure the dose of STOCRINoral solution using the syringesupplied in the box.Follow the instructions on the leafletinside the box.Take STOCRIN on an emptystomach, preferably just beforebedtime.If you take STOCRIN with food, thiscan increase the risk of side effects.When to take itTake STOCRIN at about the sametime each day.Taking your capsules, tablets orsolution at the same time each day isimportant because keeping a constantlevel of STOCRIN in your bodyhelps prevent resistance. Resistancemeans that the medicine may lose itseffectiveness over time.Your doctor may ask you to takeSTOCRIN at bedtime to avoid orreduce certain side effects, such as dizziness and sleepiness.How long to take it STOCRIN helps control your HIV infection but does not cure it. Therefore STOCRIN must be taken every day. Continue taking STOCRIN for as long as your doctor prescribes.Do not stop taking STOCRIN or change the dose without first checking with your doctor. Do not let yourself run out of medicine over weekends or on holidays.If you have a break in therapy or reduce your dose temporarily, the virus may develop resistance and therefore STOCRIN may no longer be effective.If, for any reason, your therapy with STOCRIN is interrupted or stopped, tell your doctor.If you forget to take itIf you miss a dose, take it as soon as you remember, and then go back to taking your capsules, tablet or solution as you would normally. However, if it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.If you are not sure whether to skip the dose, talk to your doctor or pharmacist.Do not take a double dose to make up for the dose that you missed.If you have trouble remembering to take your capsules, tablets or solution, ask your pharmacist for some hints.If you take too much (overdose)Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) for advice, or go to accident and emergency at your nearest hospital, if you think that you or anyone else may have taken too much STOCRIN. Do this even if there are no signs of discomfort or poisoning.While you are usingSTOCRINThings you must doReport any changes in yourcondition to your doctorimmediately.This is to make sure that anyinfections which occur due to yourlow immunity (called opportunisticinfections) are treated promptly.Continue to use safe sexualpractices.STOCRIN has not been shown todecrease the chance of transmittingHIV to others through sexual contactor blood contamination.Women taking STOCRIN shouldavoid pregnancy during treatmentand for 12 weeks after they'vestopped taking treatment. Usebarrier contraception even if youare using other methods (eg. oralcontraceptive pill or otherhormonal contraceptives).If you become pregnant whiletaking STOCRIN or in the 12weeks after you've stopped takingit, tell your doctor immediately.If you are about to be started onany new medicine, tell your doctorand pharmacist that you are takingSTOCRIN.Tell all the doctors, dentists andpharmacists who are treating youthat you are taking STOCRIN.Things you must not doDo not stop taking STOCRIN orchange the dose without firstchecking with your doctor. Do notlet yourself run out of medicineover weekends or on holidays.If you have a break in therapy orreduce your dose temporarily, thevirus may develop resistance andtherefore STOCRIN may no longerbe effective.If, for any reason, your therapywith STOCRIN is interrupted orstopped, tell your doctor.Do not give STOCRIN to anyoneelse, even if they have the samecondition as you.Things to be careful ofBe careful driving or operatingmachinery until you know howSTOCRIN affects you.STOCRIN may cause dizziness,drowsiness or affect concentration insome people, especially during thefirst few days. Make sure you knowhow you react to STOCRIN beforeyou drive a car or operate machinery.If you drink alcohol, dizziness ordrowsiness may be worse.Side EffectsTell your doctor or pharmacist assoon as possible if you do not feelwell while you are takingSTOCRIN.STOCRIN helps most people withHIV infection, but it may haveunwanted side effects. All medicinescan have side effects. Sometimesthey are serious, most of the timethey are not. You may need medicaltreatment if you get some of the sideeffects.Frequently it is difficult to tellwhether side effects are the result oftaking STOCRIN, effects of the HIVdisease or side effects of othermedicines you may be taking. Forthis reason it is very important toinform your doctor of any change inyour condition. Your doctor maywant to change your dose or adviseyou to stop taking STOCRIN.Ask your doctor or pharmacist toanswer any questions you mayhave.In adults:Tell your doctor if you notice anyof the following and they worryyou:•skin rash or itchiness or increasedsensitivity to sunlight•dizziness, tiredness, or sleepiness•nausea•stomach pain•headache•inability to concentrate •abnormal dreaming•difficulty sleeping•breast enlargement in men •increased fat appearing in areas such as the back of the neck,breasts, stomach and/or back •loss of body fat from areas such as face, arms and/or legs •changes in your co-ordination or ability to balance•flushing•tremors•ringing in the earsSome of these are the more common side effects of STOCRIN. They generally resolve after the first few weeks. Taking STOCRIN at night may help to reduce some of these side effects.Some of these side effects may be worse if you:•drink alcohol•take medicines for certain mental illnesses, including depression,schizophrenia, psychoses, anxiety •take recreational drugsIn children 3 to 16 years old: Tell your doctor if your child has any of the following and they worry you:•skin rash or itchiness or increased sensitivity to sunlight •dizziness•headache•fever•nausea or vomiting•stomach pain, diarrhoea •cough•aches or pains•increased fat appearing in areas such as the back of the neck,breasts, stomach and/or back •loss of body fat from areas suchas face, arms and/or legsThese are the more common sideeffects of STOCRIN in children.In adults and childrenTell your doctor immediately ifyou notice any of the following:•severe dizziness, spinningsensation•tingling or numbness of the handsor feet•blurred vision•mental changes, including seeing,feeling or hearing things that arenot there (also calledhallucinations)•mood changes, includingdepression, suicidal thoughts oractually committing suicide,angry behaviour, strangethoughts, anxiousness (peoplewho have or have had mentalillnesses appear to be at greaterrisk of these effects)Because some of these may beserious side effects, you may needurgent medical attention.Tell your doctor immediately or goto accident and emergency at yournearest hospital if you develop anyof the following:•any severe skin reaction•pinkish, itchy swellings on theskin, also called hives ornettlerash•fainting•fast or irregular heart beat•wheeziness due to tightness in thechest•convulsions or fits•liver disease with nausea,vomiting, loss of appetite, feelinggenerally unwell, fever, itching,yellowing of the skin and eyes,and/or dark coloured urineBecause these side effects areserious, you may need urgentmedical attention.Other side effects not listed abovemay also occur in some patients.The long-term effects of STOCRINare unknown at this time. Tell yourdoctor if you notice any othereffects.Do not be alarmed by this list ofpossible side effects. You may notexperience any of them.After using STOCRINStorageKeep your capsules, tablets orsolution in the original bottle, untilit is time to take them.If you take the capsules out of thebottle or blister pack, or solution outof the bottle, they may not keep well.Keep STOCRIN in a cool dry placewhere the temperature stays below30°C. Do not store it or any othermedicine in the bathroom or near asink. Do not leave it in the car oron window sills.Heat and dampness can destroy somemedicines.Keep it where children cannotreach it.A locked cupboard at least one-and-a-half metres above the ground is agood place to store medicines.DisposalWrite the date on the bottle ofsolution when you opened it, andthrow out any remaining solutionafter one month.The solution contains a preservativewhich helps prevent germs growingin the solution for the first monthafter opening the bottle. After thistime, there is a greater risk that thesolution may become contaminated.A new bottle should be opened.If your doctor tells you to stoptaking STOCRIN, or the capsules,tablets or solution have passedtheir expiry date, ask yourpharmacist what to do with anythat are left over.Product descriptionWhat it looks likeSTOCRIN is available in three strengths of capsules, three strengths of tablets and one strength of solution:•50 mg capsule- white and gold capsule with 3805 marked inpurple on the capsule•50 mg tablet- yellow round tablet with "113" on one side & plain on the other•100 mg - white capsule with 3807 marked in purple on the capsule •200 mg capsule - gold capsule with 3809 marked in purple onthe capsule•200 mg tablet- yellow round tablet with "223" on one side &plain on the other•600 mg - yellow capsule-shaped tablet with 225 debossed on oneside & plain on the other.•30 mg/mL oral solution - clear to slightly yellow liquid. CapsulesA bottle of STOCRIN 50 mg capsules contains 30 capsules.A bottle of STOCRIN 100 mg contains 30 capsules.A bottle of STOCRIN 200 mg capsules contains 90 capsules. TabletsA bottle of STOCRIN 50 mg tablets contains 30 tablets.A bottle of STOCRIN 200 mg tablets contains 90 tablets.A bottle of STOCRIN 600 mg contains 30 tablets.LiquidA bottle of STOCRIN oral solution contains 180 mLIngredientsActive ingredient:•STOCRIN 50 mg contains 50 mg efavirenz •STOCRIN 100 mg contains 100mg efavirenz•STOCRIN 200 mg contains 200mg efavirenz•STOCRIN 600 mg contains600mg efavirenz•STOCRIN 30 mg/mL contains 30mg efavirenz per mL.Inactive ingredients:Capsules•lactose•magnesium stearate•sodium lauryl sulfate•sodium starch glycollate•gelatin•titanium dioxide•yellow iron oxide (50 mg and 200mg capsules only)•silicon dioxide•indigo carmine CI73015Tablets•lactose•magnesium stearate•croscarmellose sodium•cellulose-microcrystalline•sodium lauryl sulfate•hydroxypropylcellulose•hypromellose•titanium dioxide•macrogol 400•iron oxide yellow CI 77492 (50mg, 200 mg and 600 mg tabletsonly)•carnauba waxLiquid•medium chain triglycerides•benzoic acid•strawberry/mint flavourSTOCRIN does not contain gluten,sucrose, tartrazine or any other azodyes.SupplierS TOCRIN is supplied in Australiaby:M erck Sharp & Dohme (Australia)Pty LimitedA.B.N. 14 000 173 50854-68 Ferndell StreetS OUTH GRANVILLE NSW 2142T his leaflet was prepared December2009A ustralian Register Numbers:Capsules50 mg bottle - AUST R 65478- notcurrently available in Australia100 mg bottle - AUST R 65479- notcurrently available in Australia200 mg bottle - AUST R 65480- notcurrently available in AustraliaTablets50 mg bottle - AUST R 125198 - notcurrently available in Australia200 mg bottle - AUST 125199600 mg bottle - AUST R 82789Liquid30 mg/mL oral solution - AUST R82790®Registered Trademark of Merck &Co. Inc.,C opyright © 2008 Merck & Co., IncA ll rights reserved.。