PALEXIA® IR immediate release tablets

Tapentadol (as hydrochloride) (Ta-pen-ta-dol)

Consumer Medicine Information (CMI)

WARNING

Limitations of use PALEXIA® IR should only be used when your doctor decides that other treatment options are not able to effectively manage your pain or you cannot tolerate them.

Hazardous and harmful use PALEXIA® IR poses risks of abuse, misuse and addiction which can lead to overdose and death. Your doctor will monitor you regularly during treatment.

Life threatening respiratory depression PALEXIA® IR can cause life-threatening or fatal breathing problems (slow, shallow, unusual or no breathing), even when used as recommended. These problems can occur at any time during use, but the risk is higher when first starting PALEXIA® IR and after a dose increase, if you are older, or have an existing problem with your lungs. Your doctor will monitor you and change the dose as appropriate.

Use of other medicines while using PALEXIA® IR Using PALEXIA® IR with other medicines that can make you feel drowsy such as sleeping tablets (e.g. benzodiazepines), other pain relievers, antihistamines, antidepressants, antipsychotics, gabapentinoids (e.g. gabapentin and pregabalin), cannabis and alcohol may result in severe drowsiness, decreased awareness, breathing problems, coma and death. Your doctor will minimise the dose and duration of use; and monitor you for signs and symptoms of breathing difficulties and sedation. You must not drink alcohol while using PALEXIA® IR.

® What is in this leaflet Keep this leaflet with the PALEXIA IR has been medicine. You may need to read prescribed for you. it again. This leaflet answers some common questions about Before you take ® ® PALEXIA IR. What PALEXIA IR is ® PALEXIA IR It does not contain all the used for available information. When you must not take it PALEXIA® (tapentadol) IR is used It does not take the place of to relieve severe pain. This strong You must not take PALEXIA® IR talking to your doctor or pain reliever belongs to a group if you: pharmacist. of medicines known as opioid analgesics. • are allergic to tapentadol or All medicines have risks and any of the ingredients listed at benefits. Your doctor has This medicine is available only the end of this leaflet. Signs weighed the risks of you having with a doctor’s prescription. of allergic reaction may PALEXIA® IR against the benefits include a skin rash, itching, they expect it will have for you. Your doctor may have prescribed shortness of breath or ® If you have any concerns about PALEXIA IR for another reason. swelling of the face, lips or this medicine, ask your doctor, Ask your doctor if you have tongue nurse or pharmacist. any questions about why • have asthma or if your breathing is dangerously slow

1

or shallow (respiratory decrease. If this happens, more • have an addiction or history depression, hypercapnia) may be needed to maintain the of abuse of alcohol, opioids or • have paralysis of the gut same effect. other drugs • have acute poisoning with • have been told that you have alcohol, sleeping pills, pain Withdrawal an intolerance to some relievers or other Continue taking your medicine for sugars. Lactose is an psychotropic medicines as long as your doctor tells you. If ingredient in these tablets. (medicines that affect mood you stop having this medicine

and emotions) suddenly, your pain may worsen Tell your doctor if you are • are taking medicine for and you may experience some or pregnant or planning to depression containing a all of the following withdrawal become pregnant. You should monoamine oxidase inhibitor symptoms: ® not take PALEXIA IR during (MAOI) medicine (such as pregnancy unless your doctor Nardil, Parnate) or have • nervousness, restlessness, agitation, trouble sleeping or has told you to do so. Taking taken a MAOI within the last ® anxiety PALEXIA IR during pregnancy 14 days. Ask your doctor or may lead to withdrawal • body aches, weakness or pharmacist if any of your symptoms in the newborn stomach cramps medicines is an MAOI. baby. • loss of appetite, nausea, ® Do not take PALEXIA IR if the vomiting or diarrhoea You should not take PALEXIA® IR packaging is torn or shows • increased heart rate, during labour as it can cause signs of tampering or the breathing rate or pupil size breathing problems and signs of tablets do not look quite right. withdrawal in the newborn. • watery eyes, runny nose, Your doctor will discuss the risks ® chills or yawning Do not take PALEXIA IR if the and benefits of using PALEXIA® expiry date on the pack has • increased sweating. IR. passed.

If you are not sure whether you Tell your doctor if you are You should only start taking should start taking this ® breastfeeding. You should not PALEXIA IR under direct medicine, talk to your doctor. take PALEXIA® IR if you are supervision of your doctor due breastfeeding as it may pass to the following risks: Before you start to take it into your breast milk.

Addiction Tell your doctor if you: Taking other medicines You can become addicted to PALEXIA® IR even if you take it • have slow or shallow Tell your doctor if you are using exactly as prescribed. PALEXIA® breathing any other medicines, including IR may become habit forming • have sleep-related breathing any that you buy without a causing mental and physical disorders prescription from a pharmacy, dependence. If abused it may supermarket or health food shop. become less able to reduce pain. • suffer from increased pressure in the brain or Some medicines and PALEXIA® Dependence disturbed consciousness up to coma IR may interfere with each other. As with all other opioid containing These medicines include: • have had a head injury or a products, your body may become used to you taking PALEXIA® IR. brain tumour • medicines for depression, Taking it may result in physical • have had an epileptic fit or sleeplessness or mental dependence. Physical seizure or if you have an conditions such as selective dependence means that you may increased risk of having serotonin reuptake inhibitors experience withdrawal symptoms epileptic fits or seizures (SSRI’s), serotonin- if you stop taking PALEXIA® IR • suffer from a liver or kidney norephinephrine reuptake suddenly, so it is important to disease inhibitors (SNRI’s), tricyclic take it exactly as directed by your anti-depressants (TCAs), doctor. • suffer from a pancreatic or monoamine oxidase inhibitor biliary tract disease including (MAOIs) and triptans Tolerance pancreatitis ® • Tolerance to PALEXIA IR may • are breastfeeding other pain relievers such as develop, which means that the morphine or codeine • are pregnant, or planning to effect of the medicine may • become pregnant some cough medicines

2

• general anaesthetics such as If you are unsure ask your the medicine quickly and side propofol or midazolam doctor or pharmacist. effects may then occur. (examples are PropofolTM or MidazolamTM) How much to take How long to take it • medicines that slow the brain activity (central nervous The usual dose is 1 tablet every 4 This differs between individuals system (CNS) depressants or to 6 hours. depending on how severe your phenothiazines). These pain is, how you respond to ® medicines can be used to Your doctor may prescribe a PALEXIA IR and the cause of treat anxiety, muscle tension, different, more appropriate dose your pain. Ask your doctor for pain, insomnia, acute stress or interval of dosing, if this is advice on how long you need to ® reactions, panic attacks or necessary for you. take PALEXIA IR. seizure disorders such as sleeping pills, tranquilizers, If you feel that the effect of these Carefully follow all directions hypnotics or sedatives tablets is too strong or too weak, given to you by your doctor (examples are Stelazine™, talk to your doctor or pharmacist. and pharmacist. These Largactil™, Valium™, directions may differ from the ® Temaze™, or Xanax™). PALEXIA IR is not suitable for information contained in this children and adolescents below leaflet.

the age of 18 years. Taking these medicines with

PALEXIA® IR may increase the If you forget to take it In elderly patients (above 65 risk of possible side effects (see years) usually no dose Side Effects). Your breathing If you forget to take a dose, you adjustment is necessary. may become seriously slow or can take it as soon as you However, the excretion of shallow (respiratory depression) remember. The next dose should tapentadol may be delayed in and your blood pressure may be taken after four or six hours, or some patients of this age group. If decrease. Your consciousness as prescribed by your doctor. this applies to you, your doctor may be decreased, you may feel Do not take a double dose to may recommend a different drowsier or feel that you might make up for the dose that you dosage regimen. faint. If this happens tell your missed. doctor. Patients with severe liver If you take too much problems should not take these Do not take PALEXIA® IR with (overdose) tablets. If you have moderate alcohol. problems, your doctor will Some side effects such as If you or someone else receive recommend a different dosage drowsiness may be increased. too much (overdose), and regimen. experience one or more of the

Other medications can also symptoms below, call triple zero Patients with severe kidney interfere with PALEXIA® IR and (000) for an ambulance. Keep the problems should not take these make you feel drowsy (see person awake by talking to them tablets. Warning information at the start of or gently shaking them every now this document). Ask your doctor and then. You should follow the Carefully follow all directions given or pharmacist for more above steps even if someone to you by your doctor and information. other than you have accidentally pharmacist. These directions may used PALEXIA® IR that was differ from the information in this prescribed for you. If someone ® leaflet. How to take PALEXIA takes an overdose, they may IR experience one or more of the When and how should following symptoms:

you take the tablets You should only start taking ® • Slow, unusual or difficult PALEXIA IR under the direct PALEXIA® IR tablets should be breathing supervision of your doctor. swallowed whole with water. They • Drowsiness, dizziness or may be taken, before, with, or unconsciousness Your doctor will tell you how after food. much you should take, when and • Slow or weak heartbeat how often. It is important that you Do not chew, divide or break the • Nausea or vomiting take this medicine as directed by tablets. Chewing, dividing or your doctor. breaking the tablets will release • Convulsions or fits

3

If you think you or someone else medicine. It may affect other Sometimes they are serious, may have taken too much medicines used during surgery. most of the time they are not. PALEXIA® IR, you should Side effects not listed in this immediately: Things you must not do leaflet may occur in some patients. You may need to get • phone the Poisons If you wish to stop treatment, medical attention if you get some Information Centre (by calling please tell your doctor first before of the side effects. 13 11 26), or stopping treatment. Do not stop • contact your doctor, or taking this medicine unless your Ask your doctor or pharmacist • go to the Emergency doctor tells you to. If your doctor to answer any questions you Department at your nearest wants you to stop taking your may have. hospital. tablets, he/she will tell you how to do this. This may include a Very common: You should do this even if there gradual reduction in the dose. • nausea are no signs of discomfort or • vomiting poisoning. Some people may feel unwell if • dizziness they suddenly stop taking • drowsiness When seeking medical attention, PALEXIA® IR. If you suddenly • headache. take this leaflet and remaining stop taking PALEXIA® IR you may medicine with you to show the experience withdrawal symptoms Common: doctor. Also tell them about any (see Withdrawal section above). • decreased appetite other medicines or alcohol which • anxiety have been taken. Do not give PALEXIA® IR to • confusion anyone else, even if they have • hallucination the same condition as you. • difficulty sleeping While you are taking • abnormal dreams PALEXIA® IR Do not take PALEXIA® IR for • trembling any other complaints unless • flushing or reddening of the your doctor tells you to. face and neck Things you must do • constipation Things to be careful of • diarrhoea Be sure to keep all of your • indigestion doctor’s appointments so that Do not drive or operate heavy • dry mouth your progress can be checked. • itching machinery until you know how ® • increased sweating If you are about to be started PALEXIA IR affects you. PALEXIA® IR can make you • rash on any new medicine, tell your • muscle cramps doctor and pharmacist that you sleepy, dizzy, or lightheaded. ® • feeling of weakness are taking PALEXIA IR. • fatigue Do not drink alcohol while you ® • feeling of body temperature Tell your doctor if you believe are taking PALEXIA IR tablets. change. that PALEXIA® IR is not helping Drinking alcohol while taking ® your condition. PALEXIA IR may make you feel Uncommon: more sleepy and increase the risk of serious side effects, such as • depressed mood Tell your doctor if, for any • disorientation reason, you have not taken shallow breathing, with the risk of stopping breathing and loss of • excitability (agitation) your medicine exactly as • nervousness Otherwise your consciousness. prescribed. • restlessness doctor may think it is not working • euphoric mood effectively and change your • disturbance in attention treatment unnecessarily. Side effects • memory impairment

• near fainting Tell your doctor or pharmacist If you become pregnant while • sedation ® as soon as possible if you do you are taking PALEXIA IR, • difficulty in controlling tell your doctor immediately. not feel well while you are ® movements taking PALEXIA IR. • difficulty in speaking If you plan to have surgery, ® • numbness even at the dentist’s, tell your Like all medicines, PALEXIA IR can cause some unwanted side • abnormal sensations of the doctor, anaesthetist or dentist skin (e.g. tingling, prickling) that you are taking this effects in some people.

4

• muscle twitches leaflet, please inform your doctor, PALEXIA® IR 75 mg tablets • abnormal vision or pharmacist. Pale yellow round shaped film- • faster or irregular heart beat coated tablets of 8 mm diameter, • decreased blood pressure Do not be alarmed by this list of marked with Grünenthal logo on • dangerously slow or shallow possible side effects. You may one side and “H7” on the other breathing not experience any of them. side. • shortness of breath • abdominal discomfort PALEXIA® IR 100 mg tablets ® • hives After using PALEXIA Pale pink round shaped film- • sensation of heaviness IR coated tablets of 9 mm diameter, • delay in passing urine marked with Grünenthal logo on • frequent urination one side and “H8” on the other • drug withdrawal syndrome Storage side. (see “Things you must not do”) ® • accumulation or retention of Keep PALEXIA IR tablets in The registered pack sizes for water in the tissues (oedema) the blister pack until it is time PALEXIA® IR tablets are:5, 10, • feeling abnormal to take them. 14, 20, 28, 30, 40, 50, 56, 60, 90 • feeling drunk and 100 tablets. • irritability Keep your tablets in a cool, dry • feeling of relaxation. place where the temperature All strengths and pack sizes ° stays below 30 C. may not be available. Rare: ® • allergic reaction Do not store PALEXIA IR in PALEXIA® IR tablets are sealed • thinking abnormal thoughts the bathroom or near a sink. in a blister foil pack. • epileptic fit • depressed level of Do not leave them in a car or Ingredients consciousness on a window sill • abnormal coordination Active ingredients • slower heart beat Heat and dampness can destroy PALEXIA® IR 50 mg tablets - • impaired gastric emptying. some medicines. each tablet contains 50 mg

® tapentadol (as hydrochloride). If any of the following happen, Keep PALEXIA IR tablets tell your doctor or go to where children cannot reach PALEXIA® IR 75 mg tablets - accident and emergency at them. A locked cupboard at least each tablet contains 75 mg your nearest hospital one-and-a-half metres above the tapentadol (as hydrochloride). immediately: ground is a good place to store medicines. • skin rash (red spots or PALEXIA® IR 100 mg tablets - patches), itching, hives each tablet contains 100 mg • swelling of the face, lips, Disposal tapentadol (as hydrochloride). mouth or throat which may cause difficulty in swallowing If you no longer need to use Inactive ingredients or breathing this medicine or it is out of PALEXIA® IR tablets also contain • chest tightness, wheezing or date, take it to any pharmacy the following inactive ingredients: pain in the chest for safe disposal. • microcrystalline cellulose • heart palpitations • lactose monohydrate • faintness or collapse Do not use this medicine after the • croscarmellose sodium • hallucinations expiry date. • povidone (K30) • seizures, fits or convulsions. • magnesium stearate • polyvinyl alcohol These are very serious side Product Description • titanium dioxide (E171) effects. If you have them, you • macrogol 3350 may have had a serious allergic There are 3 distinct strengths of • purified talc ® ® reaction to PALEXIA IR. You PALEXIA IR tablets: • iron oxide yellow (E172) (75 may need urgent medical and 100 mg tablets only) ® attention or hospitalisation. PALEXIA IR 50 mg tablets • iron oxide red (E172) (75 and White round shaped film-coated 100 mg tablets only) If you notice any unwanted tablets of 7 mm diameter, marked • iron oxide black (E172) (100 effects not mentioned in this with Grünenthal logo on one side mg tablets only). and “H6” on the other side.

5

PALEXIA® IR contains lactose.

PALEXIA® IR does not contain: • gluten • preservative.

Further information

You can obtain more information from your doctor or pharmacist.

Australian sponsor: Seqirus Pty Ltd ABN 26 160 735 035 63 Poplar Road Parkville, VIC 3052 Australia

PALEXIA® IR is distributed in Australia by: Seqirus(Australia) Pty Ltd ABN 66 120 398 067 63 Poplar Road Parkville, VIC 3052 Australia

PALEXIA® IR is manufactured by: Grϋnenthal GmBH, Germany

Australian Registration Numbers: PALEXIA® IR 50 mg tablets AUST R 165310

PALEXIA® IR 75 mg tablets AUST R 165317

PALEXIA® IR 100 mg tablets AUST R 165318

This leaflet was prepared in September 2020.

PALEXIA® is a registered trademark of Grϋnenthal GmBH, used under licence.

6