APO-Oxazepam Contains the active ingredient, oxazepam Consumer Medicine Information

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What is in this leaflet It is used to treat , or Before you take this trembling, confusion or anxiety medicine Read this leaflet carefully before associated with withdrawal. taking your medicine. Note that anxiety or tension associated with the normal stress of When you must not take it This leaflet answers some common everyday life usually does not require Do not take this medicine if: questions about oxazepam. It does treatment with medicines. not contain all the available • You have severe lung disease or information. It does not take the Ask your doctor if you have any breathing difficulties questions about why this medicine place of talking to your doctor or • You have sleep apnoea, a has been prescribed for you. Your pharmacist. condition where you have doctor may have prescribed this breathing problems when you The information in this leaflet was medicine for another reason. last updated on the date listed on the sleep. This medicine is available only with last page. More recent information on · The expiry date (EXP) printed on a doctor©s prescription. this medicine may be available. the pack has passed. Ask your doctor or pharmacist: How it works · The packaging is torn, shows · if there is anything you do not signs of tampering or it does not Oxazepam belongs to a group of understand in this leaflet, look quite right. medicines called . · if you are worried about taking They are thought to work by their • You have had an allergic your medicine, or action on brain chemicals. reaction to oxazepam, any other medicine from the · to obtain the most up-to-date In general, benzodiazepines such as group of information. oxazepam should be taken for short medicines or any of the All medicines have risks and periods only (2-4 weeks). Continuous ingredients listed at the end of benefits. Your doctor has weighed long-term use is not recommended this leaflet. the risks of you using this medicine unless advised by your doctor. The Symptoms of an allergic reaction against the benefits they expect it use of benzodiazepines may lead to may include shortness of breath, will have for you. dependence on the medicine. wheezing or difficulty breathing; Pharmaceutical companies cannot Use in children swelling of the face, lips, tongue, give you medical advice or an throat or other parts of the body, individual diagnosis. Do not give this medicine to itching or hives on the skin. children unless advised by the Keep this leaflet with your medicine. If you think you are having an child's doctor. You may want to read it again allergic reaction, contact your There is not enough information to doctor immediately or go to the recommend the use of this medicine Accident and Emergency in children under 16 years of age. department at the nearest What this medicine is hospital. used for Do not give this medicine to children under 16 years of age. The name of your medicine is APO- Oxazepam. It contains the active The safety and effectiveness of ingredient, oxazepam. oxazepam in children under 16 years have not been established.

APO-OXAZEPAM 1 Before you start to take it prescription from your pharmacy, you how many times during the day supermarket or health food shop. you should take oxazepam. Before you start taking this medicine, tell your doctor if: Some medicines and oxazepam may If you are over 65 years of age, or interfere with each other. These debilitated in any way, the dose may 1. You have allergies to: include: be smaller. · any other medicines · medicines to treat depression, If you need to break the tablet in half, · any other substances, such as anxiety or mental illness place it on a hard surface with the foods, preservatives or dyes. · sleeping tablets, or score line facing upwards, and press 2. You have or have had any tranquillisers gently on the tablet with your thumb. medical conditions, especially · strong pain relievers Do not stop taking your medicine or the following: change your dosage without first · muscle relaxants · , kidney or lung problems checking with your doctor · antihistamines, for allergies or · blood disorders hay fever How to take it · myasthenia gravis (a disease · (for or which causes severe muscle Swallow the tablet with a glass of epilepsy) weakness) water. This medicine can be taken · anaesthetics with or without food. · low blood pressure · any other medicines which may · narrow or acute angle glaucoma make you sleepy When to take it (raised pressure in the eye) · medicines to control fits Take it at about the same time each · depression or severe mental day. illness such as psychosis or These medicines may be affected by Taking your medicine at the same schizophrenia oxazepam or may affect how well it works. You may need different time each day will have the best · epilepsy (fits or convulsions). amounts of your medicines, or you effect. It will also help you remember 3. You are pregnant. may need to take different medicines. when to take it. Oxazepam may affect your Your doctor and pharmacist can tell How long to take it for developing baby if you take it you if you are taking any of these during . Do not take medicines. They may also have more Do not take this medicine for this medicine whilst pregnant information on medicines to be longer than your doctor says. until you and your doctor have careful with or avoid while taking Oxazepam is usually used for short discussed the risks and benefits oxazepam. periods only (2-4 weeks). involved. Other interactions not listed above Continuous long-term use is not 4. You are breast-feeding. may also occur. recommended unless advised by Oxazepam may pass into human your doctor. breast milk and cause drowsiness The use of benzodiazepines may lead and/or feeding difficulties in the to dependence on the medicine. infant. Do not take this medicine How to take this whilst breastfeeding until you and medicine However be sure not to stop taking your doctor have discussed the this medicine suddenly, because you risks and benefits involved. Follow carefully all directions given may get unwanted side effects. 5. You drink alcohol regularly. to you by your doctor or pharmacist. Make sure you have enough to last Their instructions may be different to over weekends and holidays. Alcohol may increase the effects the information in this leaflet. of oxazepam. If you forget to take it If you have not told your doctor How much to take If it is almost time to take your next about any of the above, tell them Your doctor or pharmacist will tell dose, skip the missed dose and take before you start taking this you how much of this medicine you your next dose at the usual time. medicine. should take. This will depend on Otherwise take it as soon as you your condition and whether you are remember and then go back to taking Taking other medicines taking any other medicines. your medicine as you would Tell your doctor or pharmacist if you Oxazepam may be taken up to four normally. are taking any other medicines, times a day at evenly spaced Do not take a double dose to make including any that you buy without a intervals. Your doctor will advise up for missed doses.

APO-OXAZEPAM 2 This may increase the chance of and change your treatment · Take your medicine to treat any unwanted side effects. unnecessarily. other condition unless your If you have trouble remembering to If you are being treated for doctor or pharmacist tells you to take your medicine, ask your anxiety, be sure to discuss with • Suddenly stop taking this pharmacist for some hints to help you your doctor any problems you may medicine if you suffer from remember. have and how you feel, especially if epilepsy. your anxiety attacks are getting • Stop taking your medicine, or If you take too much worse or more frequent. change the dosage, without first (overdose) This will help your doctor to decide checking with your doctor. If you think that you or anyone the best treatment for you. Stopping this medicine suddenly may else may have taken too much of Always discuss with your doctor cause some unwanted effects such as this medicine, immediately any problems or difficulties during disturbed sleep. Also, if you suffer telephone your doctor or the or after taking oxazepam. from epilepsy, stopping this medicine Poisons Information Centre (Tel: Go to your doctor regularly for a suddenly may make your epilepsy 13 11 26 in Australia) for advice. check-up. worse. Alternatively go to the Accident Your doctor needs to check your Your doctor may slowly reduce your and Emergency Department at dose of oxazepam before you can your nearest hospital. progress and see whether you need to keep taking oxazepam. stop taking it completely. Do this even if there are no signs of discomfort or poisoning. You may Tell any other doctors, dentists and Things to be careful of need urgent medical attention. pharmacists who are treating you that you take this medicine. Be careful while driving or If you take too much oxazepam you operating machinery until you It is best to avoid drinking alcohol may feel drowsy, confused, tired, know how oxazepam affects you. dizzy, have difficulty breathing, feel while taking this medicine. This medicine may cause dizziness weak or become unconscious. Combining oxazepam with alcohol and tiredness in some people. If you can make you more sleepy, dizzy or have any of these symptoms, do not light-headed. Your doctor may drive, or operate machinery or do suggest that you avoid alcohol or anything else that is dangerous. While you are taking reduce the amount of alcohol you this medicine drink while you are taking oxazepam. Even if you take oxazepam at night, you may still be drowsy or dizzy the Things you must not do next day. Things you must do Do not: Be careful when drinking alcohol Take oxazepam exactly as your while taking oxazepam. doctor has prescribed. • Drive or operate machinery until you know how this Combining oxazepam and alcohol Tell your doctor that you are taking medicine affects you. can make you more sleepy, dizzy or this medicine if: light-headed. Your doctor may It may cause drowsiness or · you are about to be started on any suggest that you avoid alcohol or dizziness in some people and new medicine reduce the amount of alcohol you therefore may affect alertness. drink while you are taking this · you are pregnant or are planning Even if you take this medicine at medicine. to become pregnant night, you may still be drowsy or · you are breastfeeding or are dizzy the next day. Be careful if you are elderly, unwell or taking other medicines. planning to breastfeed • Take this medicine for a longer Some people may experience side · you are about to have any blood time than your doctor has effects such as drowsiness, tests prescribed. confusion, dizziness, unsteadiness · you are going to have surgery or It should be taken for short and/ or a drop in blood pressure are going into hospital periods only (for example 2 to 4 which may increase the risk of a fall. weeks), unless advised by your · you feel this medicine is not doctor. Some people may also become helping your condition depressed or have problems · Give this medicine to anyone · for any reason, you have not breathing. else, even if their symptoms seem taken your medicine exactly as similar to yours Sometimes people may also have prescribed. Otherwise your doctor problems remembering things. may think that it was not effective

APO-OXAZEPAM 3 Possible side effects · fainting of time. If your anxiety problems · depression continue, consult your doctor. Tell your doctor or pharmacist as · hallucinations (seeing, feeling or Some medicines can cause soon as possible if you do not feel hearing things that are not there) dependence, especially when they are well while you are taking oxazepam or delusions used regularly for longer than a few or if you have any questions or weeks. People who have been concerns. · severe sleep disturbances or dependent on alcohol or other drugs unpleasant dreams Do not be alarmed by the following in the past may have a higher chance lists of side effects. You may not · yellowing of the skin or eyes, of becoming addicted to experience any of them. All and/or pale stools, dark urine benzodiazepines such as oxazepam. medicines can have side effects. (jaundice) If you have been addicted to alcohol Sometimes they are serious but most · fever or drugs in the past, it is important to tell your doctor before starting of the time they are not. · numbness and tingling oxazepam. Tell your doctor or pharmacist if · swelling of the hands, ankles or you notice any of the following and feet or other parts of the body Withdrawal Symptoms they worry you. · low blood pressure Sometimes when medicines are This list includes the more common · frequent infections such as fever, stopped suddenly, after being used side effects. Mostly, these are mild: severe chills, sore throat or mouth for a long time, withdrawal · mild drowsiness, especially when ulcers symptoms may occur. Symptoms of you first start taking oxazepam. It If you experience any of the withdrawal may include muscle pain, generally becomes less noticeable following, stop taking your sweating, vomiting, stomach or as you continue to take the medicine and contact your doctor muscle cramps, sensitivity to light, tablets. If it does not, then your immediately or go to the Accident touch or sound, headache, anxiety, doctor may lower your dose of and Emergency department at tension, restlessness, confusion, oxazepam your nearest hospital. giddiness, memory loss, strange · feeling exhausted or having no thoughts or feelings, numbness, These are very serious side effects energy tingling, palpitations, panic attacks, and are usually very rare. You may mood changes, irritability or feeling · muscle weakness need urgent medical attention or not part of your body. · feeling sick, dizzy, giddy or light- hospitalisation Speak to your doctor if any of the headed · occasionally the symptoms of above occurs. · stomach pain depression or other psychiatric Other side effects not listed above · memory loss conditions may include thoughts of harming yourself or may occur in some patients. Tell · feeling confused or disoriented committing suicide. your doctor if you notice anything · headache else that is making you feel unwell Make sure that you or anyone close when you are taking, or soon after · problems speaking, or feeling to you or caring for you watch for you have finished taking this wobbly on your feet, possibly these symptoms and tell your medicine. leading to falls doctor immediately or go to the · trembling or shaking nearest hospital if you have any Allergic reactions distressing thoughts or · blurred vision experiences. If you think you are having an · skin rash, which may be itchy, or allergic reaction to oxazepam, tell Unwanted side effects can occur with may look like a measles rash your doctor immediately or go to or without alcohol intake. Taking the Accident and Emergency · increased or decreased libido (sex alcohol will increase the risk of side department at your nearest drive). effects. hospital. Tell your doctor as soon as possible They can also occur at the dosage Symptoms of an allergic reaction if you notice any of the following. prescribed by your doctor. However, may include some or all of the there is an increased risk of side These may be serious side effects. following: You may need medical attention. effects if you take more tablets than · cough, shortness of breath, Most of these side effects are rare. the recommended dose. wheezing or difficulty breathing. · sudden aggression, excitation or These medicines should, in most · swelling of the face, lips, tongue, rage cases, be used only for short periods or other parts of the body

APO-OXAZEPAM 4 · rash, itching or hives on the skin Ingredients · fainting Each tablet contains 30 mg of · hayfever-like symptoms oxazepam as the active ingredient. It also contains the following inactive ingredients: · magnesium stearate Storage and disposal · methylcellulose Storage · polacrilin potassium · lactose Keep your medicine in its original packaging until it is time to take it. This medicine is gluten-free, sucrose- If you take your medicine out of its free, tartrazine-free and free of other original packaging it may not keep azo dyes. well. Australian Registration Keep your medicine in a cool dry Numbers place where the temperature will stay below 30°C. APO-Oxazepam 30 mg Tablets Do not store your medicine, or any Blister packs containing 25 tablets: other medicine, in the bathroom or AUST R 163213 near a sink. Do not leave it on a window sill or Distributor in the car. Apotex Pty Ltd Heat and dampness can destroy some 66 Waterloo Road medicines. North Ryde, NSW 2113 Keep it where children cannot Australia reach it. A locked cupboard at least one-and- a-half metres above the ground is a Apotex Pty Ltd is the licensee of the good place to store medicines. registered trade marks APO and APOTEX from the registered Disposal proprietor, Apotex Inc. If your doctor or pharmacist tells you to stop taking this medicine or it has This leaflet was revised in: passed its expiry date, ask your June 2010 pharmacist what to do with any medicine that is left over.

Product description

What APO-Oxazepam looks like APO-Oxazepam 30 mg Tablets White, round tablets with one side convex and embossed "30", and the other side flat with an Ezi-split breakline.

APO-OXAZEPAM 5