BASIMGLURANT to a child under 18 years. The effect

BASIMGLURANTBasimgluranttablets Consumer Medicine Information (CMI)  What this leaflet contains Thisleaflet contains information that can help you use Basimglurant safely andeffectively.   Yourdoctor may have more information about Basimglurant, therefore this leafletshould not act as a substitute for a conversation with your doctor or pharmacist. For any further concerns about usingBasimglurant, ask your doctor.  This leaflet should be kept with themedicine.   What it is used for  Basimglurantis available in mild release capsules or hard gelatin capsules for immediaterelease of 1.5 mg.1  Basimglurantis used to treat:•    Major Depressive Disorder, morecommonly known as depression2•    Anxiety 2•    Fragile X syndrome, also known asFXS or Martin-Bell Syndrome2 Basimglurantis one of a group of medicines called metabotropic glutamate receptormodulators.

3 Basimglurantworks by regulating a chemical in the brain known as glutamate, which isinvolved in controlling mood.3  If you are unsure why you have beenprescribed Basimglurant, contact your doctor.  Notethat you may have been prescribed Basimglurant to treat a different conditionor illness. Contact your doctor if you are still unsure.  Thereis not enough information available to advise the use of Basimglurant forchildren under 18 years old.  Before you take it  Whenyou must not take it Do not take Basimglurant if you aretaking another medicine called fluvoxamine to treat obsessive compulsivedisorder (OCD) or depression. Taking fluvoxamine with Basimglurant may alterhow long it takes for the drugs to leave your body, which will affect how oftenyou should be taking the drug.

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4 Do not take Basimglurant if you areallergic to:·   any other medicine that also containsBasimglurant ·   any of the ingredients listed on thelast page of this leaflet. Someof the symptoms of an allergic reaction may include:·   watery or itchy eyes·   runny nose, blocked nose·   sore throat·   difficulty breathing·   swelling of any parts of the body·   itchy skin and/or a rash Do not take Basimglurant if you arepregnant.Currentresearch has not yet revealed whether there are harmful effects of takingBasimglurant while pregnant. Therefore, as a precaution, Basimglurant shouldnot be taken when pregnant.  Do not give Basimglurant to a childunder 18 years.

Theeffect of Basimglurant on children younger than 18 years has not beenestablished yet.  Do not take Basimglurant after ithas expired or if the packaging is torn or tampered withIfthe packaging is damaged or the tablets have expired, return the tablets to thepharmacist. See the packaging for an expiry date.  If you aren’t sure about the expirydate or other information printed on the packaging, consult your doctor orpharmacist.   Before youstart to take itLet your doctor know if you have, orcurrently suffer from any of the following:·   Manic episodes1 ·   Meniere’s disease3·   Bipolar disorder5·   Mood disorders due to other medical conditions,substance or drug abuse3·   or other conditions that could cause vertigo ordizziness3 Based onclinical trial results, Basimglurant may worsen these conditions.  Let your doctor know if you are allergic to anypreservatives or dyes that may be used in Basimglurant tablets.  Let your doctor know if you are orplan to become pregnant or if you are breast feeding. Currentresearch has not established the risks of taking Basimglurant whilst pregnantor breast feeding, therefore it is best not to take Basimglurant if you arepregnant or breastfeeding.

 Risksof taking basimglurant whilst breastfeeding or pregnant are unknown as of now.  Ensure you let your doctor knowabout any of the above information before taking Basimglurant.   Takingother medicinesLet your doctor know if you aretaking any other medicines, even medicines that you can get without aprescription.

TakingBasimglurant can interfere with other medicines, including: ·   Medicines used to treat ObsessiveCompulsive Disorder (E.g. Fluvoxamine)4·   Medicines used to treat epilepsy(E.g. Carbamazepine)4·   Medicines used to treat anxiety(E.g. Diazepam)4·   Medicines used to treat migraine(E.g.

Triptans, NSAIDs)4·   Medicines used to treat vertigo(E.g. Ondansetron)3·   Medicines used to treat depression (E.

g. SSRIs, tricyclicantidepressants4 There maybe more medicines that can interfere with Basimglurant that haven’t beenconfirmed yet. The above list is based off clinical trial results.   Basimglurantmight affect how these medicines work. Alternatively, these medicines mightaffect how basimglurant works.

 Yourdoctor may need to change how much of each medicine you take.  How to take it Carefully follow all instructions givento you by your doctor. Your doctor might give you differentinstructions compared to this leaflet. Follow your doctor’s instructions.  If you do not understand theinstructions, let your doctor know and they will be able to help.

 How much totakeTheusual dose is one capsule once per day.1 Your doctor might changethis dose depending on your condition. How to takeitNo specific method of taking thetablet has been proven to be better, therefore taking with a glass of water isrecommended.

 When totake itTakeBasimglurant in the morning when you wake up. It is best taken on an emptystomach.1  (Theabove information is based on clinical trials where patients took basimgluranton an empty stomach.

)  It is recommended to take  Baasimglurant at the same time each day   Havinga repetitive routine will help you remember to take your medicine at the righttime.    (Currentresearch has yet to confirm whether taking the drug fasted or unfasted has a significantdifference. Phase II trials showed promising results when subjects took thedrug fasted)1 How long totake itTake Basimglurant for as long asyour doctor has told you toKeeptaking Basimglurant even if you feel better.

 Don’tworry if you do not feel better as soon as you take Basimglurant. Animprovement might only be felt a week after taking the medicine.3   (Thisinformation is an estimate from data from Phase II studies) Continue taking Basimglurant  until the pack is finished   If youforget to take itInformation about skipping doses ofbasimglurant is unknown at the moment.  (Speculative)Do not take two dosesat once to make up for the dose that you missed. Youmay experience worsened side effects if you take too much Basimglurant at once. For further questions about missinga dose or for tips on how to remember to take your medicine, ask your doctor.  If you taketoo much Basimglurant (overdose)Call your doctor and contact the  Poisons Information Centre (13 11 26) as soonas possible, or go to your nearest hospital. Do this if you think you, oranyone else has overdosed on Basimglurant.

Do this even if you feel fine afteroverdosing. Youmay still need medical attention even if you feel fine immediately afteroverdosing.   Symptomsof an overdose may include dizziness, feeling very excited and restlessness.1 While you are taking it Things youmust doIf your doctor prescribes anothermedicine for another condition, make sure you let them know that you are takingBasimglurant.  If any other doctor or dentist orpharmacist is treating you, let them know that you are taking Basimglurant.

 If you are going to have surgery, letthe surgeon know that you are taking Basimglurant. Incase basimglurant affects other medicines used during surgery. (Clinical trialshave not established this yet) If you become pregnant while takingthis medicine, tell your doctor immediately. Things youmust NOT doDo not take Basimglurant to treatanything other than what the doctor has prescribed it for.  Do not operate machinery or driveuntil you know how basimglurant affects youThismedicine may cause dizziness, sleepiness and attention disturbances in some people.1 If you have any ofthese symptoms, do not drive, operate machinery or do anything else that requiresclose attention.

  Thisinformation is also unconfirmed and based off results from published Phase IItrials.  Do not give Basimglurant to otherpeople, even though they may have the same condition as you Do not stop taking Basimglurant anddo not change the dose without consulting your doctor. Ifyou stop taking it suddenly, your condition may worsen or you may have unwantedside effects such as anxiety, nausea, dizziness.1 Thisis based on side effects of the drug found in Phase II. Things tobe careful ofBe careful when drinking alcohol whentaking Basimglurant.

Researchhas not clarified how much alcohol you can drink if you take this drug.  Side Effects  If you do not feel well while youare taking Basimglurant, let your doctor know as soon as you canThismedicine helps most people with depression,but it may have unwanted side effectsin a few people. You may need medical attention if you experience some of theseside effects.

How bad the side effects are changes from person to person.  Note that it is normal not to experienceany of the following side effects. Side effects vary from person to person.  If any of the following side effectsare persistent or cause you concern, let your doctor know:·   Persistent dizziness, nausea,vertigo1·   Drowsiness1·   Overexcitement, mania1·   Inability to concentrate1·   More side effects unconfirmed Theabove is a list of the common side effects of Basimglurant observed duringresearch.

Research shows they are tolerable and short lived.1 Letyour doctor know if you experience side effects that worry you.  Do not hesitate to tell your doctorif you experience anything that make you feel unwellItis possible that other side effects not listed above may appear.  After using basimglurant  Keep your capsules in the pack untilit is time to take them.Ifyou take them out, they may not keep well Store at ____ to ____ (temperature)Testshave shown that if not stored correctly, ______ (consequence unknown at themoment) Do not store Basimglurant at extremetemperatures or in areas that may get wet easily, such as the bathroom sink. Basimgluranttablets might be destroyed or degraded by high temperatures or moisture.

 Keep Basimglurant out of reach ofchildren Agood place to store it would be a cupboard located high above ground.    DisposalIf your doctor tells you to stoptaking Basimglurant, or if the pack has expired, ask the pharmacist to confirmthe best way to dispose of the medicine.  Product Description  What itlooks like1.5mg Basimglurant is a hard capsule  Colour,markings on the drug have yet to be specified.  IngredientsBasimglurantcontains 1.5 mg of basimglurant asthe active ingredient. Italso contains:·   Other ingredients not yet confirmed·   Probably a preservative and maybe acolouring dye Manufacturer/distributorBasimglurant is made or distributedin Australia by:Address of Roche Australia  Endof Leaflet.