OxyContin® tablets Oxycodone hydrochloride (ox-ee-code-own hi-dro-klor-ide) Consumer Medicine Information

What is in this leaflet symptoms if you stop taking within the head, brain or spinal OxyContin tablets suddenly, so it is cord This leaflet answers some common important to take it exactly as  have sudden, severe abdominal questions about OxyContin tablets. directed by your doctor. It does not contain all the available This medicine is only available with  have a condition where your information. It does not take the a doctor's prescription. stomach empties more slowly place of talking to your doctor or than it should or have any pharmacist. condition that obstructs the bowel/stomach or affects bowel All medicines have risks and Before you take it benefits. Your doctor has weighed transit (movement of food or the risks of you taking this medicine ingested material along the Long term use of OxyContin tablets against the benefits they expect it bowel) may result in a decrease in sex will have for you.  have swallowing difficulties or hormone levels which may affect narrowing of the oesophagus If you have any concerns about sperm production in men and the taking this medicine, ask your menstrual cycles in females. Talk to  have severe or doctor or pharmacist. your doctor if you have any disease Keep this leaflet with the medicine. concerns.  are about to have an operation You may need to read it again. (including surgery on your spine When you must not take it for pain relief in the next 24 Do not take OxyContin tablets if hours) or have had an operation you: within the last 24 hours What OxyContin  have any breathing problems  take a medicine for depression tablets are taken for such as acute asthma, respiratory called a 'monoamine oxidase depression (breathing slows or inhibitor' or have taken any in the OxyContin tablets contain weakens) or other obstructive last two weeks. oxycodone hydrochloride. airways disease Do not take OxyContin tablets if Oxycodone belongs to a group of  are severely drowsy or have a you are allergic to oxycodone, medicines called . reduced level of consciousness opioid painkillers, or any of the OxyContin tablets are used to relieve ingredients listed at the end of this  suffer from irregular heartbeats moderate to severe chronic pain leaflet. or changes in the way the heart when other forms of treatment have beats Do not take this medicine after the failed or are otherwise inappropriate expiry date (EXP) printed on the to provide sufficient management of  have heart disease due to long pack. pain. term lung disease If you take it after the expiry date has Your doctor, however, may prescribe  have just consumed a large passed, it may not work very well. it for another purpose. amount of , regularly consume large amounts of Do not take it if the packaging is Ask your doctor if you have any alcohol or have confusion and torn or shows signs of tampering. questions about why it has been shaking due to alcohol Do not give this medicine to a child prescribed for you. withdrawal younger than 12 years of age. As with all strong painkillers, your  suffer from convulsions, fits or Safety and effectiveness in children body may become used to you taking seizures younger than 12 years of age have OxyContin tablets. Taking it may not been established. result in .  have a head injury, a brain Physical dependence means that you tumour or have raised pressure may experience withdrawal

OxyContin® tablets June 2021 1 Before you start to take it If you have not told your doctor  increased heart rate, breathing about any of the above, tell them  rate or pupil size Tell your doctor if you have before you take any OxyContin  watery eyes, runny nose, chills allergies to any other medicines, tablets. or foods, preservatives or dyes.  yawning Do not take this medicine if you Tell your doctor if you have or  increased sweating. are pregnant or intend to become have had any medical conditions, pregnant whilst taking this especially the following: Taking other medicines medicine.  sleep apnoea (temporarily Tell your doctor if you are taking Like most medicines of this kind, stopping breathing while you any other medicines or dietary OxyContin tablets are not sleep) supplements, including any that recommended to be taken during you buy without a prescription  low blood pressure pregnancy. Your doctor will discuss from your pharmacy, supermarket  increased prostate size or the risks of taking it if you are or health food shop. difficulty passing pregnant. Some medicines and OxyContin  chronic lung, liver or kidney tablets may interfere with each other. disease These include: You can become addicted to  disease of your gall bladder or OxyContin even if you take it exactly  medicines to treat depression, bile duct as prescribed. OxyContin may psychiatric or mental disorders  inflammation of the pancreas become habit forming causing mental  medicines to treat depression and physical dependence. If abused it  underactive adrenal glands may become less able to reduce pain. belonging to a group called 'monoamine oxidase inhibitors'  underactive thyroid gland must be stopped 14 days before  inflammatory bowel disease or Dependence OxyContin tablets are taken recent abdominal surgery As with all other opioid containing products, your body may become  antidepressants eg; fluoxetine,  diverticulitis (inflammation of used to you taking OxyContin. paroxetine bowel wall) Taking it may result in physical  medicines to help you sleep  oesophageal, stomach or dependence. Physical dependence intestinal disorders (including means that you may experience  medicines to put you to sleep cancer in these areas), resulting in withdrawal symptoms if you stop during an operation or procedure taking OxyContin suddenly, so it is narrowing of the oesophagus, important to take it exactly as  medicines to relax your muscles stomach or intestines directed by your doctor.  medicines to lower blood  severe mental condition involving pressure losing contact with reality, Tolerance  quinidine and other medicines to hearing voices or an inability to Tolerance to OxyContin may treat the heart think clearly develop, which means that the effect  medicines to treat convulsions  an addiction or history of abuse of the medicine may decrease. If this happens, more may be needed to e.g. phenytoin, of alcohol, or other . maintain the same effect.  medicines to thin the blood e.g.

coumarin derivatives such as Pregnancy and breastfeeding Withdrawal warfarin Continue taking your medicine for as This medicine is not recommended  cimetidine, a medicine to treat long as your doctor tells you. If you to be taken during labour. stop having this medicine suddenly, stomach ulcers or heartburn Oxycodone given to the mother your pain may worsen and you may  medicines to relieve stomach during labour may cause breathing experience some or all of the cramps or spasms, to prevent problems and signs of withdrawal in following withdrawal symptoms: travel sickness or symptoms of  nervousness, restlessness, the newborn. allergies  agitation, trouble sleeping or Tell your doctor if you are breast   medicines to treat Parkinson's feeding or planning to breastfeed.  body aches, weakness or disease Oxycodone can pass into the breast stomach  medicines to treat urinary  cramps milk and can affect the baby. Your incontinence doctor can discuss with you the risks  loss of appetite, ,  medicines to stop nausea or involved.  or diarrhoea vomiting e.g. metoclopramide

OxyContin® tablets June 2021 2  other pain relievers including Do not break, cut, chew, crush or  trouble sleeping other opioids dissolve the tablets.  increased sweating and yawning  antifungals e.g. ketoconazole OxyContin tablets are only designed  weakness to work properly if swallowed whole.  antibiotics e.g. clarithromycin,  nervousness or restlessness. rifampin The tablets may release all their contents at once if broken, cut,  medicine to treat HIV infection If you forget to take it chewed, crushed or dissolved which and AIDS e.g. can be dangerous and cause serious If you forget to take your tablets,  alcohol problems, such as an overdose, contact your doctor or pharmacist  St John's wort (a herbal which may be fatal. for advice. preparation) If you have trouble swallowing your Do not take a double to make  grapefruit and grapefruit juice tablets whole, talk to your doctor. up for the dose you have missed.  medicines to treat epilepsy, pain You must only take OxyContin This will increase the chance of you and anxiety eg; and tablets by mouth. getting unwanted side effects. . Taking this medicine in a manner If you have trouble remembering These medicines, dietary other than that prescribed by your when to take your medicine, ask supplements or alcohol may be doctor can be harmful to your health. your pharmacist for hints. affected by OxyContin tablets, may There are no data on rectal For example, take your medicine at affect how well OxyContin tablets administration of OxyContin tablets, the same time each morning and work or may increase side effects. therefore of evening such as 8 a.m. and 8 p.m. You may need to use different OxyContin tablets is not amounts of your medicines, or take recommended. If you take too much different medicines. (overdose) When to take it Your doctor or pharmacist has more If you or someone lese receive too information on medicines and dietary Take OxyContin tablets every 12 much (overdose), and experience supplements to be careful with or hours. one or more of the symptoms avoid while taking this medicine. Take OxyContin tablets regularly below, call 111 for an ambulance. to control the pain. Keep the person awake by talking to them or gently shaking them Taking them at the same time each every now and then. You should day will assist in ensuring the best How to take follow the steps even if someone effect in improving your pain. If OxyContin tablets other than you have accidentally however, you begin to experience used OxyContin that was worsening pain and you are taking How much to take prescribed for you. If someone your OxyContin tablets as takes and overdose, they may Your doctor will tell you exactly prescribed, contact your doctor as experience one or more of the how much to take. your dosage may have to be following symptoms: Follow the instructions given to reviewed.  slow, unusual or difficult you by your doctor and pharmacist How long to take it breathing exactly.  drowsiness, or Continue taking your medicine for unconsciousness How to take it as long as your doctor tells you.  slow or weak heartbeat  nausea or vomiting Swallow OxyContin tablets whole If you stop taking this medicine  convulsions or fits with a full glass of water or other suddenly, your pain may worsen and fluid. you may experience withdrawal OxyContin tablets should be taken symptoms such as: Immediately telephone your one tablet at a time with enough  body aches doctor, or the Poisons Information water to ensure complete  loss of appetite, nausea, stomach Centre (telephone 0800 POISON swallowing immediately after cramps or diarrhoea or 0800 764 766) for advice, or go placing it in the mouth. to Accident and Emergency at  fast heart rate your nearest hospital, if you think Do not pre-soak, lick or wet the  sneezing or runny nose you or anyone else may have taken tablet before placing in your too many OxyContin tablets. mouth.  chills, tremors, shivering or

OxyContin® tablets June 2021 3 Do this even if there are no signs of stopping breathing and loss of Tell your doctor if you suffer from discomfort or poisoning. consciousness. nausea or vomiting when taking Do not take OxyContin tablets to OxyContin tablets. treat any other complaint unless If you vomit after your dose, your your doctor tells you to. pain may come back, as you may not While you are taking it Do not give your medicine to have absorbed your medicine. If this anyone else, even if they have the happens, speak to your doctor. Your Things you must do same condition as you. doctor may prescribe some medicine to help you stop vomiting. Take OxyContin tablets exactly as Do not stop taking your medicine, your doctor has prescribed. exceed the dose recommended or Tell your doctor if taking OxyContin tablets causes Before you start on a new change the dosage without . medicine, remind your doctor and checking with your doctor. pharmacist that you are taking Over time your body may become Your doctor can advise about your OxyContin tablets. used to oxycodone. If you stop taking diet, the proper use of laxatives or alternative treatments, and suitable Tell any other doctors, dentists and it suddenly, your pain may worsen exercise you can do to help manage pharmacists who treat you that and you may experience unwanted this. you are taking this medicine. side effects such as withdrawal symptoms. This is called physical There is potential for abuse of If you are going to have surgery, dependence. oxycodone and the development of tell the surgeon or anaesthetist that addiction to oxycodone. It is you are taking this medicine. If you need to stop taking this medicine, your doctor will gradually important that you discuss this It may affect other medicines used reduce the amount you take each day, issue with your doctor. during surgery. if possible, before stopping the If you become pregnant while medicine completely. taking this medicine, tell your doctor immediately. Things to be careful of Side effects Keep all of your doctor's Do not drive or operate machinery All medicines may have some appointments so that your progress until you know how OxyContin unwanted side effects. Sometimes can be checked. tablets affect you. they are serious but most of the time Tell your doctor if your pain is OxyContin tablets may cause they are not. As for other medicines getting worse. Also tell your doctor drowsiness, dizziness, , of this type, that is opioid analgesics, if you are having any problems or disorientation, blurred vision or other many side effects tend to reduce over difficulties while you are being vision problems or may affect time, with the exception of treated with OxyContin tablets. alertness. If you are affected, you constipation. This means that the Tolerance to oxycodone may develop should not drive or operate longer you take this medicine, the which means that the effect of the machinery. Discuss these effects with less it may cause problems for you. medicine may decrease. If this your doctor. Your doctor has weighed the risks of happens, your doctor may review Be careful if you are elderly, this medicine against the benefits your dose so that you get adequate unwell or taking other medicines. they expect it will have for you. pain relief. Some people may experience side Do not be alarmed by this list of Keep enough OxyContin tablets effects such as drowsiness, possible side effects. with you to last over weekends and confusion, dizziness and Not everybody experiences them. holidays. unsteadiness, which may increase the Tell your doctor or pharmacist as risk of a fall. Things you must not do soon as possible if you do not feel If you feel light-headed, dizzy or well while you are taking Do not drink alcohol while you are faint when getting out of bed or OxyContin tablets. taking OxyContin tablets. standing up, get up slowly. This medicine helps most people Drinking alcohol whilst taking Standing up slowly will help your with moderate to severe pain, but it OxyContin tablets may make you body get used to the change in may have unwanted side effects in a feel more sleepy and increase the risk position and blood pressure. If this few people. Other side effects not of serious side effects, such as problem continues or gets worse, talk listed here may also occur in some with the risk of to your doctor. people.

OxyContin® tablets June 2021 4 Ask your doctor or pharmacist to The above list includes serious side Disposal answer any questions you may effects that may require medical If you no longer need to use this have. treatment. medicine or it is out of date, take it Tell your doctor if you notice any If any of the following happen, tell to any pharmacy for safe disposal. of the following and they worry your doctor immediately or go to Do not use this medicine after the you: Accident and Emergency at your expiry date.  mild abdominal problems such as nearest hospital: diarrhoea, feeling sick (nausea),  your breathing slows or weakens decreased appetite or constipation  you have an allergic reaction:  dry mouth, , sore throat, , wheezing, Product description or changes in voice shallow or difficult breathing;  excessive sweating swelling of the face, lips, tongue, What it looks like throat or other parts of the body;  feeling anxious or nervous, ® rash, itching or hives on the skin OxyContin tablets are round, film- trouble sleeping or abnormal coated tablets. They are available in  seizures, fits or convulsions dreams six strengths* which are as follows:  fast or irregular heartbeats  trouble with your balance 10 mg - white, marked "ON" on one  new problems with your eyesight  chest pain or chest tightness. side and 10 on the other  skin rash, itching, chills or fever The above list includes very serious 15 mg - grey, marked "ON" on one side effects. You may need urgent side and 15 on the other  muscle problems such as spasms, medical attention or 20 mg - pink, marked "ON" on one twitching or tremors hospitalisation. side and 20 on the other  swelling of legs or ankles When seeking medical attention, 30 mg - brown, marked "ON" on one  absence of menstrual periods take this leaflet and any remaining side and 30 on the other  impotence tablets with you to show the doctor. 40 mg - yellow, marked "ON" on one  decreased sexual drive. side and 40 on the other Tell your doctor as soon as possible 80 mg - green, marked "ON" on one if you notice any of the following side and 80 on the other. and they worry you: After taking it *Not all strengths are available in  stomach discomfort, vomiting, NZ. indigestion or Storage OxyContin® tablets (come in boxes  choking, gagging, regurgitation, Keep your tablets in the blister containing blister packs of 20 or 28 tablets stuck in throat or trouble pack until it is time to take them. tablets. ) swallowing the tablets If you take the tablets out of the Ingredients  abnormal thinking, changes in blister pack they may not keep as mood or feeling deep sadness well. Active ingredients:  drowsiness, feeling faint or Keep your tablets in a cool, dry  10 mg tablets contain 10 mg fainting or dizziness especially place, where the temperature stays oxycodone hydrochloride when standing up below 25°C.  15 mg tablets contain 15 mg  slow or noticeable heartbeats Do not store it or any other oxycodone hydrochloride  headache or confusion medicine in the bathroom, near a  20 mg tablets contain 20 mg  unusual weakness, loss of sink or on a window sill. oxycodone hydrochloride strength or trouble walking Do not leave it in the car on hot  30 mg tablets contain 30 mg  fatigue, feeling of tiredness, days. oxycodone hydrochloride drowsiness or lack of energy Heat and damp can destroy some  40 mg tablets contain 40 mg  changes in passing urine such as medicines. oxycodone hydrochloride the volume passed, pain or Keep it where children cannot  80 mg tablets contain 80 mg feeling the need to urinate reach it. oxycodone hydrochloride. urgently. A locked cupboard at least one-and- a-half metres above the ground is a Inactive ingredients: good place to store medicines.

OxyContin® tablets June 2021 5  polyethylene oxide  butylated hydroxytoluene (BHT)  magnesium stearate  hypromellose  macrogol 400  titanium dioxide  hydroxypropyl cellulose (10mg and 80mg tablets)  polysorbate 80 (20mg, 30mg and 40mg tablets)  iron oxide red, E172 (15mg, 20mg and 30mg tablets)  iron oxide yellow, E172 (15mg, 30mg, 40mg and 80mg tablets)  iron oxide black, E172 (15mg and 30mg tablets)  Indigo Carmine Aluminium Lake (80mg tablets)

In addition, the reformulated tablets also contain the ingredients listed below:

• 10 mg - Opadry White • 15 mg - Opadry complete film coating system Grey • 20 mg - Opadry Pink • 30 mg - Opadry Brown • 40 mg - Opadry Yellow • 80 mg - Opadry Green . This medicine does not contain lactose, sucrose, gluten or tartrazine.

Sponsor Mundipharma NZ Limited C/- Pharmaco (NZ) Ltd PO Box 4079 Auckland 1140 Toll Free (Medical Enquiries) 0800 733 310

®: OxyContin is a Registered Trademark of Mundipharma This leaflet was updated in June 2021 Please check with your pharmacist that this is the latest version of the leaflet available.

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