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Home , Agomelatine

VALDOXAN® 25mg Agomelatine (pronounced a-go-mel-a-tin)

Consumer Medicine Information

WHAT IS IN THIS positive benefits on mood and sleep • you are currently taking LEAFLET in depression. (a drug used in the VALDOXAN is not addictive. treatment of depression) or ciprofloxacin (an antibiotic This leaflet answers some common VALDOXAN does not cause used to treat infections) questions about VALDOXAN. It discontinuation symptoms and can be does not contain all the available stopped without the need to taper • you have an allergy to information. You can obtain more dose. VALDOXAN or any of the information about VALDOXAN by ingredients (including lactose) In clinical studies VALDOXAN had talking to your doctor or pharmacist. listed at the end of this leaflet no effect on sexual function. All have risks and • the packaging is torn or shows VALDOXAN is not recommended benefits. Your doctor has weighed signs of tampering for children, adolescents (under 18 the risks of you taking VALDOXAN years old) or elderly patients aged 75 • the expiry date (EXP) printed against the benefits this medicine is or older. on the pack has passed. expected to have for you. Your doctor may prescribe If you have any concerns about Before you start to take VALDOXAN for another purpose. taking this medicine, ask your VALDOXAN Ask your doctor if you have any doctor or pharmacist. Keep this questions about why VALDOXAN A routine blood test should be leaflet with the medicine. has been prescribed for you. performed before treatment to You may need to read it again. check how your is functioning. If you have increased levels of liver enzymes your doctor BEFORE YOU TAKE will decide if VALDOXAN is right WHAT VALDOXAN IS VALDOXAN for you. USED FOR You may be at risk of liver There are some people who shouldn©t problems if you are overweight, VALDOXAN is used in the take VALDOXAN. Please read the obese or have diabetes or if you are treatment of depression or to help list below. If you think any of these taking medicines known to affect prevent depression returning, and is situations apply to you or you have your liver (ask your doctor if you only available with a doctor©s any questions, please see your are unsure which medicines these prescription. The symptoms of doctor. might be). depression vary from one person to another, but commonly include Tell your doctor if you have ever When you must not take experienced or develop an episode persistent sadness, loss of interest in VALDOXAN favourite activities, feelings of of bipolar disorder, or worthlessness, sleep problems, • Do not take VALDOXAN if: (extreme upward mood swings or irritable mood). feeling of being slowed down, • you suffer from or feelings of anxiety or changes in you know your liver does not Your doctor should be made aware appetite and weight. Changes in your work properly (hepatic if you have a history of . daily sleep and appetite patterns are impairment) Tell your doctor if you are examples of disturbances of your • routine blood tests show levels pregnant, plan to become pregnant ©body clock© that occur commonly in of liver enzymes have increased or are breast-feeding. depression. to more than 3 times the upper Talk to your doctor about how VALDOXAN can help regulate your limit of normal much you drink. People ©body clock© () with who drink excessive quantities of alcohol should not take

VALDOXAN® (AGOMELATINE) 1 VALDOXAN. Excessive alcohol months or longer provides the best If you take too much may cause liver problems and may opportunity of long-term recovery (overdose) make depression worse. from a first episode of depression. It is important that you do not take For those who have previously had Tell your doctor if you are smoking more VALDOXAN tablets than depression, a longer period of more than 15 cigarettes/day. your doctor has prescribed. treatment will usually be If you have any doubts or recommended. The experience of overdoses with questions about taking VALDOXAN is limited but reported With VALDOXAN, some people VALDOXAN consult with your symptoms include stomach pain, doctor. experience improvements in mood and sleep within two weeks of drowsiness, tiredness, agitation, anxiety, dizziness, blue-ish starting treatment. As people respond Taking other medications discolouration of the skin or mucous differently to medications, do not membranes and/or a general feeling Tell your doctor if you are taking become discouraged if you do not of being unwell. any other medications, including notice a difference right away. medications you buy without a Continue taking VALDOXAN until If you do take more than you have prescription from a pharmacy, your doctor advises you to stop. Even been prescribed, contact your supermarket, health food shop or when you are feeling better, your doctor immediately for advice. naturopath/herbalist. doctor would usually continue to If anyone accidentally swallows any Tell your doctor if you are taking give you VALDOXAN for some of your VALDOXAN tablets, call (a medicine sometimes time to help to prevent your your nearest Poisons Information used to treat heart problems). depression from returning. Centre for advice (Australian telephone: 13 11 26), or go to When you and your doctor have Accident and Emergency at your decided to stop VALDOXAN, there nearest hospital. Keep the telephone is no need to taper the dose as number for these places handy whilst HOW TO TAKE VALDOXAN does not cause taking any medications. VALDOXAN discontinuation symptoms after stopping treatment. Always take VALDOXAN exactly as your doctor has told you. You If you forget to take it should check with your doctor or WHILE YOU ARE pharmacist if you are not sure. If you forget to take your TAKING VALDOXAN VALDOXAN skip the dose you Swallow VALDOXAN tablets missed, take your next planned dose whole with some water in the at the usual time and continue as Your liver function evening at bedtime. normal. VALDOXAN is processed by the VALDOXAN can be taken with or To avoid confusion, it is liver. Before you started taking without food. recommended that you leave the VALDOXAN a blood test was tablet you missed in the tablet strip required to check your liver How much to take and continue on with the next day©s function. While you are taking The usual dose of VALDOXAN is tablet as indicated on the tablet strip VALDOXAN you will need further one tablet in the evening at bedtime. calendar. blood tests to check your liver In some cases your doctor may continues to function properly. Do not try to make up for missed prescribe two tablets (50 mg) to be These tests should be performed: doses. Simply take one dose per day. taken together in the evening at • before the start of treatment The calendar printed on the tablet bedtime. You should not take more and before a dose increase to strip should help you remember than the maximum recommended 50mg (dose should only be when you last took a VALDOXAN dose of 50 mg daily. increased by your doctor). tablet. It is also a good reminder of Do not change your dose without how much VALDOXAN you have and then around: the advice of your doctor even if left so you can get your prescription • 3 weeks, you feel better. refilled if you need to. • 6 weeks, How long to take it • 12 weeks and Current experience with • 24 weeks. medications to treat depression These blood test results will help shows that treatment for six your doctor decide whether

VALDOXAN® (AGOMELATINE) 2 VALDOXAN is suitable for you. not effective and change your Things you must not do VALDOXAN may sometimes affect treatment unnecessarily. You should not take VALDOXAN the results of these blood tests. Tell your doctor if you feel the together with certain medications You may also have tests to check that tablets are not helping your (see also under "When you must your liver is working properly if you condition. not take VALDOXAN") such as: start to take medicines that interfere Keep all of your doctor's fluvoxamine (another medicine with how the body processes appointments so that your progress used in the treatment of VALDOXAN. can be checked. depression) or ciprofloxacin (an Talk to your doctor about how much If you are being treated for antibiotic). alcohol you drink. depression, be sure to discuss with Do not give this medicine to anyone your doctor any problems you may else even if their symptoms seem Things you must do have and how you feel, especially similar to yours or if they have the To make sure you have the best any feelings of severe sadness or same condition as you. opportunity of long-term recovery bursts of unusual energy or anger. from your depression, continue to If you have any thoughts about Things to be careful of take VALDOXAN as long as your suicide or doing harm to yourself As with all medications used to treat doctor recommends you to. call your doctor immediately and depression, you should make sure Tell your doctor if you have also contact someone you trust. that you know how you react to experienced or develop an episode of All thoughts or talk about suicide or VALDOXAN before you drive or bipolar disorder, mania or hypomania violence towards others or yourself operate machinery. Speak to your (extreme upward mood swings or are serious. Such thoughts may even doctor if you have any concerns. irritable mood). occur after commencing It is recommended to avoid drinking Check with your doctor that your treatment, particularly alcohol while taking any liver function tests are done as before the full antidepressant effect is antidepressant including described in the YOUR LIVER seen. Such thoughts are more likely VALDOXAN. FUNCTION section above. to occur in young adults under 25 years of age. Seek advice from your doctor immediately if you develop signs or If you or someone you know is symptoms of potential liver showing any of the following UNWANTED EFFECTS problems (such as dark urine, light common warning signs, either POTENTIALLY DUE coloured faeces, yellow skin or contact your doctor or healthcare TO TREATMENT AND/ eyes, pain in your upper right professional or go to the nearest OR YOUR abdomen, new-onset and hospital for treatment: DEPRESSION unexplained fatigue). Your doctor · worsening of your depression may advise you to stop taking Tell your doctor or pharmacist or · thoughts or talk about death or VALDOXAN. go to the nearest Accident and suicide Tell your doctor immediately if you Emergency at the nearest hospital · thoughts or talk about self-harm become pregnant while taking as soon as possible if you do not or doing harm to others VALDOXAN. feel well while you are taking · any recent attempts of self-harm VALDOXAN. Tell all doctors, dentists and healthcare professionals who are · an increase in aggressive If any of the signs below occur then treating you that you are taking behaviour, or agitation. tell your doctor immediately or go to the Accident and Emergency VALDOXAN. In addition to talking to your department at your nearest Do not take any other medications, doctor, confidential support and hospital. whether they require a prescription or counselling services are available not, without first telling your doctor (in Australia) from LifeLine by The possibility of a severe liver that you are taking VALDOXAN as calling 13 11 14. reaction exists, especially with sometimes the action of one You may find it helpful to tell a excessive alcohol consumption and/ medicine may interfere with another. relative or close friend that you are or with any other processed by the liver, e.g. Tell your doctor if, for any reason, depressed and ask them to read this leaflet. You might ask them to tell VALDOXAN. Symptoms of severe you have not taken your medicine liver reactions may include: exactly as prescribed. Otherwise, you if they think your depression is your doctor may think that it was getting worse, or if they are worried • yellow colouring of the skin or about changes in your behaviour. whites of the eyes ()

VALDOXAN® (AGOMELATINE) 3 • abnormal bleeding or bruising · feeling sick (nausea), diarrhoea, · inability to remain still (due to • confusion, loss of consciousness constipation, abdominal pain, physical and mental unrest) or . vomiting · inability to completely empty the The possibility of a severe allergic · back pain bladder. reaction exists with any · tiredness Do not be alarmed, you may not medication. The following are · anxiety experience any of these. Other general signs and symptoms of an unwanted effects have been · increased levels of liver enzymes allergic reaction: uncommonly reported and you in your blood • itching, skin rash or should ask your doctor or · weight increased. pharmacist if you want to know • shortness of breath, wheezing Uncommon side effects (may affect more. or trouble breathing up to 1 in 100 people): See your doctor if you experience • swelling of the face, lips, tongue · mania/hypomania (see also under any of these or notice anything else or other parts of the body ©Before you start to take that is making you feel unwell. which may cause difficulty in VALDOXAN©) swallowing or breathing. Ask your doctor or pharmacist if · suicidal thoughts or behaviour you don't understand something in Severe liver reactions and severe this list. allergic reactions are very serious. · migraine Medical attention or · pins and needles in the fingers hospitalisation may be required and toes (paraesthesia), restless and should be sought urgently legs syndrome (a disorder that is from a doctor or Accident and AFTER TAKING characterised by an VALDOXAN Emergency at the nearest hospital. uncontrollable urge to move the VALDOXAN has been developed to legs) Storage treat people with depression and is · blurred vision usually well tolerated, however all Keep your tablets in the pack until · ringing in the ears medications may have unwanted it is time to take them. Keep them effects in some people. · excessive sweating in a cool, dry place where it stays (hyperhidrosis). Increases in liver enzymes, and rarely below 30°C. Keep them where inflammation of the liver, have been · eczema, pruritus, urticaria (hives) children cannot reach them. observed in some patients treated · agitation, irritability, restlessness, Disposal with VALDOXAN. When aggressive behaviour VALDOXAN was discontinued in · nightmares If your doctor tells you to stop these patients, the increases in liver taking VALDOXAN, or the tablets · confusion enzymes usually returned to normal have passed their expiry date, levels. This is why your doctor has · weight decreased return any leftover tablets to your asked you to have routine blood tests. · muscle pain. pharmacist for disposal. Some people taking VALDOXAN Rare side effects (may affect up to 1 for depression have reported the Product description in 1,000 people): following adverse reactions, which VALDOXAN is registered on the may relate to their depression, · serious skin eruption (erythematous rash), face oedema Australian register of Therapeutic general health or any of their Goods and has the Australian treatments: (swelling) and angioedema (swelling of the face, lips, tongue Register number: AUST R 159712. Very common side effects (may and/or throat that may cause affect more than 1 in 10 people): difficulty in breathing or What it looks like · swallowing) VALDOXAN 25 mg film-coated Common side effects (may affect up · hepatitis, yellow coloration of the tablets are oblong, orange-yellow to 1 in 10 people): skin or the whites of the eyes with blue imprint of the company logo on one side. · sleepiness (somnolence), (jaundice), hepatic failure difficulty in sleeping () (isolated cases of death or liver VALDOXAN 25 mg tablets are transplantation have been contained in a foil blister strip with a · dizziness, abnormal dreams reported in patients with hepatic calendar printed on the blister to help risk factors) you remember when you last took a · hallucinations tablet of VALDOXAN.

VALDOXAN® (AGOMELATINE) 4 Ingredients Each film-coated tablet of VALDOXAN contains 25 mg of agomelatine as the active ingredient and the following inactive ingredients: lactose monohydrate, maize starch, povidone, sodium starch glycollate, stearic acid, magnesium stearate, colloidal anhydrous silica, hypromellose, iron oxide yellow, glycerol, macrogol 6000 and titanium dioxide, shellac, indigo carmine and propylene glycol. VALDOXAN contains sugars as lactose.

Manufacturer/Sponsor VALDOXAN is a product discovered by Servier Research International. It is distributed in Australia by: Servier Laboratories (Aust.) Pty Ltd 8 Cato Street PO Box 196 Hawthorn 3122, Victoria Telephone: 1800 153 590 Internet: www.servier.com.au

This document was last revised in January 2021

VALDOXAN® (AGOMELATINE) 5