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AGOMELATINE SANDOZ Agomelatine-citric acid

Consumer Medicine Information

What is in this leaflet benefits on mood and sleep in • any medicine containing depression. agomelatine This leaflet answers some common Ask your doctor if you have any • any of the ingredients listed at questions about AGOMELATINE questions about why this the end of this leaflet. SANDOZ. It does not contain all medicine has been prescribed for Some of the symptoms of an the available information. It does you. allergic reaction may include: not take the place of talking to your Your doctor may have prescribed it • shortness of breath doctor or pharmacist. for another reason. • wheezing or difficulty breathing All medicines have risks and This medicine is not addictive. • swelling of the face, lips, tongue benefits. Your doctor has weighed This medicine is only available with or other parts of the body the risks of you taking a doctor's prescription. AGOMELATINE SANDOZ • rash, itching or on the skin In clinical studies AGOMELATINE against the benefits they expect it • add any other specific reactions SANDOZ had no effect on sexual will have for you. listed in the PI. function. If you have any concerns about Do not take this medicine after taking this medicine, ask your AGOMELATINE SANDOZ is not the expiry date printed on the doctor or pharmacist. recommended for children, pack or if the packaging is torn or adolescents (under 18 years old) or shows signs of tampering. Keep this leaflet with the elderly patients aged 75 or older. If it has expired or is damaged, medicine. return it to your pharmacist for You may need to read it again. disposal. If you are not sure whether you Before you take should start taking this medicine, What AGOMELATINE AGOMELATINE talk to your doctor. SANDOZ SANDOZ is used for Before you start to take it AGOMELATINE SANDOZ is used When you must not take it A routine blood test should be to treat depression or to help Do not take AGOMELATINE performed before treatment to check prevent depression returning. SANDOZ if: how your is functioning. If you have increased levels of liver The symptoms of depression vary • you suffer from or enzymes your doctor will decide if from one person to another, but you know your liver does not AGOMELATINE SANDOZ is commonly include persistent work properly (hepatic right for you. sadness, loss of interest in favourite impairment) activities, feelings of worthlessness, • your routine blood tests show You may be at risk of liver sleep problems, feeling of being levels of liver enzymes have problems if you are overweight, slowed down, feelings of anxiety or increased to more than 3 times obese or have diabetes or if you are changes in appetite and weight. the upper limit of normal taking medicines known to affect Changes in your daily sleep and your liver (ask your doctor if you • you are currently taking appetite patterns are examples of are unsure which medicines these (a drug used in the disturbances of your 'body clock' might be). treatment of depression) or that occur commonly in depression. ciprofloxacin (an antibiotic used Tell your doctor if you have ever AGOMELATINE SANDOZ can to treat infections) experienced or develop an episode help regulate your 'body clock' Do not take AGOMELATINE of bipolar disorder, or () with positive SANDOZ if you have an allergy (extreme upward mood to: swings or irritable mood).

AGOMELATINE SANDOZ Published by MIMS January 2021 1 Your doctor should be made aware How to take differently to , do not if you have a history of . AGOMELATINE become discouraged if you do not Tell your doctor if you have SANDOZ notice a difference right away. allergies to any other medicines, Continue taking AGOMELATINE foods, preservatives or dyes. Follow all directions given to you SANDOZ until your doctor advises Tell your doctor if you are by your doctor or pharmacist you to stop. Even when you are pregnant or plan to become carefully. feeling better, your doctor would pregnant or are breast-feeding. They may differ from the usually continue to give you Your doctor can discuss with you information contained in this leaflet. AGOMELATINE SANDOZ for the risks and benefits involved. If you do not understand the some time to help to prevent your Talk to your doctor about how instructions on the box, ask your depression from returning. much you drink. People doctor or pharmacist for help. who drink excessive quantities of If you forget to take it How much to take alcohol should not take If you forget to take your AGOMELATINE SANDOZ. The usual dose of AGOMELATINE SANDOZ skip Excessive alcohol may cause liver AGOMELATINE SANDOZ is one the dose you missed, take your next problems and may make depression tablet in the evening at bedtime. In planned dose at the usual time and worse. some cases your doctor may continue as normal. prescribe two tablets (50 mg) to be Tell your doctor if you are smoking Do not try to make up for missed taken together in the evening at more than 15 cigarettes/day. doses. Simply take one dose per bedtime. You should not take more If you have not told your doctor day. about any of the above, tell them than the maximum recommended dose of 50 mg daily. If you are not sure what to do, ask before you start taking your doctor or pharmacist. AGOMELATINE SANDOZ. Do not change your dose without the advice of your doctor even if If you have trouble remembering Taking other medicines you feel better. to take your medicine, ask your pharmacist for some hints. Tell your doctor or pharmacist if How to take it you are taking any other If you take too much medicines, including any that you Swallow the tablets whole with (overdose) get without a prescription from some water. your pharmacy, supermarket or Immediately telephone your AGOMELATINE SANDOZ can be health food shop. doctor or the Poisons Information taken with or without food. Centre (telephone 13 11 26) for Some medicines and advice, or go to Accident and AGOMELATINE SANDOZ may When to take it Emergency at the nearest interfere with each other. These hospital, if you think that you or include: Take your medicine in the evening at bedtime. anyone else may have taken too • (a medicine much AGOMELATINE SANDOZ. Do this even if there sometimes used to treat heart How long to take it problems) are no signs of discomfort or poisoning. • rifampicin (an antibiotic used to Current experience with You may need urgent medical treat infections). medications to treat depression shows that treatment for six months attention. These medicines may be affected by or longer provides the best It is important that you do not AGOMELATINE SANDOZ or opportunity of long-term recovery take more AGOMELATINE may affect how well it works. You from a first episode of depression. SANDOZ tablets than your may need different amounts of your For those who have previously had doctor has prescribed. medicines, or you may need to take depression, a longer period of Symptoms of an overdose may different medicines. treatment will usually be include stomach pain, drowsiness, Your doctor and pharmacist have recommended. tiredness, agitation, anxiety, more information on medicines to With AGOMELATINE SANDOZ, dizziness, blue-ish discolouration of be careful with or avoid while some people experience the skin or mucous membranes taking this medicine. improvements in mood and sleep and/or a general feeling of being within two weeks of starting unwell. treatment. As people respond

AGOMELATINE SANDOZ Published by MIMS January 2021 2 While you are taking Check with your doctor that your thoughts are more likely to occur in AGOMELATINE liver function tests are done as young adults under 25 years of age. SANDOZ described in the YOUR LIVER If you or someone you know is FUNCTION section above. showing any of the following common warning signs, either Your liver function Seek advice from your doctor immediately if you develop signs or contact your doctor or healthcare professional or go to the nearest AGOMELATINE SANDOZ is symptoms of potential liver hospital for treatment: processed by the liver. Before you problems (such as dark urine, light started taking AGOMEALTINE coloured faeces, yellow skin or • worsening of your depression SANDOZ a blood test was eyes, pain in your upper right • thoughts or talk about death or required to check your liver function. While you are taking abdomen, new-onset and suicide AGOMELATINE SANDOZ you unexplained fatigue). Your doctor • thoughts or talk about self-harm will need further blood tests to may advise you to stop taking or doing harm to others check your liver continues to AGOMELATINE SANDOZ. • any recent attempts of self-harm function properly. If you are about to be started on • an increase in aggressive These tests should be performed: any new medicine, remind your behaviour, or doctor and pharmacist that you • before the start of treatment agitation. are taking AGOMELATINE and before a dose increase to SANDOZ. In addition to talking to your 50mg (dose should only be doctor, confidential support and Tell any other doctors, dentists increased by your doctor). counselling services are available and pharmacists who treat you and then around: (in Australia) from LifeLine by that you are taking this medicine. calling 13 11 14. • 3 weeks, If you become pregnant while You may find it helpful to tell a • 6 weeks, taking this medicine, tell your relative or close friend that you are doctor immediately. • 12 weeks and depressed and ask them to read this • 24 weeks. Tell your doctor if, for any leaflet. You might ask them to tell reason, you have not taken your These blood test results will help you if they think your depression is medicine exactly as prescribed. your doctor decide whether getting worse, or if they are worried Otherwise, your doctor may think AGOMELATINE SANDOZ is that it was not effective and about changes in your behaviour. suitable for you. AGOMELATINE change your treatment SANDOZ may sometimes affect the unnecessarily. Things you must not do results of these blood tests. Tell your doctor if you feel the You should not take You may also have tests to check tablets are not helping your AGOMELATINE SANDOZ that your liver is working properly condition. together with certain medications if you start to take medicines that (see also under "When you must Keep all of your doctor's not take AGOMELATINE interfere with how the body appointments so that your processes AGOMELATINE SANDOZ") such as: fluvoxamine progress can be checked. (another medicine used in the SANDOZ. If you are being treated for treatment of depression) or Talk to your doctor about how depression, be sure to discuss with ciprofloxacin (an antibiotic). much alcohol you drink. your doctor any problems you may Do not take AGOMELATINE have and how you feel, especially SANDOZ to treat any other Things you must do any feelings of severe sadness or complaints unless your doctor To make sure you have the best bursts of unusual energy or anger. tells you to. opportunity of long-term recovery If you have any thoughts about Do not give your medicine to from your depression, continue to suicide or doing harm to yourself anyone else, even if they have the take AGOMELATINE SANDOZ as call your doctor immediately and same condition as you. long as your doctor recommends also contact someone you trust. you to. All thoughts or talk about suicide or Things to be careful of violence towards others or yourself Tell your doctor if you have Be careful driving or operating are serious. Such thoughts may experienced or develop an episode machinery until you know how even occur after commencing of bipolar disorder, mania or AGOMELATINE SANDOZ treatment, affects you. hypomania (extreme upward mood particularly before the full swings or irritable mood). Speak to your doctor if you have antidepressant effect is seen. Such any concerns.

AGOMELATINE SANDOZ Published by MIMS January 2021 3 It is recommended to avoid • increased level of liver enzymes • inability to completely empty drinking alcohol while taking any in your blood the bladder. antidepressant including • weight increase The above list includes serious side AGOMELATINE SANDOZ. • mania/hypomania (see also effects that may require medical under before you start to take attention. Serious side effects are AGOMELATINE SANDOZ) rare. Side effects • suicidal thoughts or behaviour If any of the following happen, • pins and needles in the fingers tell your doctor immediately or go Tell your doctor or pharmacist as and toes (paraesthesia), restless to Accident and Emergency at your nearest hospital: soon as possible if you do not feel legs syndrome (a disorder that is well while you are taking characterised by an The possibility of a severe liver AGOMELATINE SANDOZ. uncontrollable urge to move the reaction exists, especially with This medicine helps most people legs) excessive alcohol consumption and/ with depression, but it may have • tremor or with any other processed by the liver, e.g. unwanted side effects in a few • muscle aches or pains people. All medicines can have side AGOMLEATINE SANDOZ. • blurred vision effects. Sometimes they are serious, Symptoms of severe liver reactions most of the time they are not. You • ringing in the ears may include: • may need medical attention if you eczema, pruritus, urticarial • yellow colouring of the skin or get some of the side effects. (hives) whites of the eyes () • Do not be alarmed by the agitation, irritability, • abnormal bleeding or bruising restlessness, aggressive following lists of side effects. You • confusion, loss of consciousness may not experience any of them. behaviour or . • nightmares Ask your doctor or pharmacist to The possibility of a severe allergic answer any questions you may • confusion reaction exists with any medication. have. • weight decrease The following are general signs and Increases in liver enzymes, and • migraine symptoms of an allergic reaction: rarely inflammation of the liver, • excessive sweating • itching, skin rash or hives have been observed in some (hyperhidrosis). patients treated with • shortness of breath, wheezing or The above list includes the more AGOMELATINE SANDOZ. When trouble breathing common side effects of your AGOMELATINE SANDOZ was • swelling of the face, lips, tongue medicine. They are usually mild discontinued in these patients, the or other parts of the body which and short-lived. increases in liver enzymes usually may cause difficulty in returned to normal levels. This is Tell your doctor as soon as swallowing or breathing. possible if you notice any of the why your doctor has asked you to Severe liver reactions and severe following: have routine blood tests. allergic reactions are very serious. • serious skin eruption Tell your doctor or pharmacist if Medical attention or hospitalisation you notice any of the following (erythematous rash), face may be required and should be and they worry you: oedema (swelling) and sought urgently from a doctor or angioedema (swelling of the Accident and Emergency at the • face, lips, tongue and/or throat nearest hospital. • sleepiness (somnolence), that may cause difficulty in The above list includes very serious difficulty in sleeping () breathing or swallowing) side effects. You may need urgent • dizziness • hepatitis, yellow coloration of medical attention or hospitalisation. • abnormal dreams the skin or the whites of the eyes These side effects are very rare. • feeling sick (nausea), vomiting (jaundice), hepatic failure Tell your doctor or pharmacist if (isolated cases of death or liver • diarrhoea, constipation, you notice anything that is transplantation have been abdominal pain making you feel unwell. • dry mouth reported in patients with hepatic risk factors) Other side effects not listed above • back pain may also occur in some people. • hallucinations • tiredness • inability to remain still (due to • anxiety physical and mental unrest)

AGOMELATINE SANDOZ Published by MIMS January 2021 4 After taking • povidone AGOMELATINE • colloidal anhydrous silica SANDOZ • crospovidone • sodium stearylfumarate Storage • magnesium stearate Keep your tablets in the pack • stearic acid until it is time to take them. • hypromellose If you take the tablets out of the • macrogol 6000 pack they may not keep well. • titanium dioxide Keep your tablets in a cool dry • purified talc place where the temperature • iron oxide yellow. stays below 25°C. This medicine does not contain Do not store AGOMELATINE lactose, sucrose, gluten, tartrazine SANDOZ or any other medicine or any other azo dyes. in the bathroom or near a sink. Do not leave it on a window sill or in the car. Sponsor Heat and dampness can destroy Southern Cross Pharma Pty Ltd some medicines. Suite 5/118 Church Street Keep it where children cannot Hawthorn 3122, VIC reach it. Australia A locked cupboard at least one-and- Australian registration number: a-half metres above the ground is a AGOMELATINE SANDOZ good place to store medicines. AUST R 318687 Disposal This leaflet was prepared in November 2020. If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like AGOMELATINE SANDOZ is a yellow oblong biconvex film-coated tablet. Each pack contains 28 film-coated tablets.

Ingredients AGOMELATINE SANDOZ contains 25 mg of agomelatine as the active ingredient. The tablets also contain the following inactive ingredients: • silicified microcrystalline cellulose • mannitol

AGOMELATINE SANDOZ Published by MIMS January 2021 5