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Dosulepin Mylan contains the active ingredient dosulepin (dothiepin) hydrochloride CONSUMER MEDICINE INFORMATION

What is in this leaflet Ask your doctor if you have any Dosulepin Mylan may increase the questions about why Dosulepin chance of fitting or having This leaflet answers some common Mylan has been prescribed for you. convulsions. questions about Dosulepin Mylan. Your doctor may have prescribed · recently had a heart attack, for It does not contain all the available Dosulepin Mylan for another reason. example within the past two information. It does not take the Dosulepin Mylan is not approved months place of talking to your doctor or for use in children and adolescents Dosulepin Mylan may cause irregular pharmacist. below 18 years of age for the and/or rapid heartbeat. All medicines have benefits and treatment of . · failure. risks. Your doctor has weighed the The safe use and effectiveness of Your body may not be able to risks of you taking Dosulepin Mylan Dosulepin Mylan in treating remove Dosulepin Mylan from your against the benefits expected for you. depression, for this age group, has body. not been established. If you have any concerns about Do not take Dosulepin Mylan if taking this medicine, talk to your Dosulepin Mylan is available only you are taking a medicine called a doctor or pharmacist. with a doctor©s prescription. monoamine oxidase inhibitor Please read this leaflet carefully (MAOI), or have taken a MAOI and keep it with your medicine. within the last 14 days. You may need to read it again. Stop taking MAOIs at least 14 days Before you take before starting Dosulepin Mylan. Dosulepin Mylan Taking Dosulepin Mylan with a MAOI may cause a serious reaction When you must not take it What Dosulepin Mylan with a sudden increase in body is used for Do not take Dosulepin Mylan if temperature, extremely high blood you are allergic to medicines pressure and severe convulsions. Dosulepin Mylan is used to treat containing dothiepin (e.g. Ask your doctor or pharmacist if depression. Prothiaden) or any of the you are not sure if you have been Dosulepin Mylan 25 mg capsules can ingredients listed at the end of this taking a MAOI medicine. be used at any stage in the treatment leaflet. MAOIs are medicines used to treat of depression. However, the higher Some of the symptoms of an allergic depression and symptoms of strength Dosulepin Mylan 75 mg reaction may include Parkinson©s disease, such as tablets are approved only for the · shortness of breath (Nardil), maintenance treatment of depression (Parnate), (eg. Aurorix (after your symptoms have · wheezing or difficulty breathing Arima) and (Eldepryl, improved). · swelling of the face, lips, tongue Selgene). Dosulepin Mylan belongs to a group or other parts of the body Do not take Dosulepin Mylan if the of medicines called · rash, itching or hives on the skin expiry date (EXP.) printed on the (TCAs). TCA · discolouration of the skin upon pack has passed. medicines work by correcting the exposure to sunlight imbalance of certain chemicals in the If you take this medicine after the brain. These chemicals, called expiry date has passed, it may not , are involved in controlling Do not take Dosulepin Mylan if work as well. mood. By correcting this imbalance, you have: Do not take Dosulepin Mylan if the TCAs can help relieve the symptoms · packaging shows signs of of depression.

DOSULEPIN MYLAN 1 tampering or the tablets or If you have not told your doctor Your doctor and pharmacist have capsules do not look quite right. about any of the above, tell them more information on medicines to be If you are not sure whether you before you start taking Dosulepin careful with or avoid while taking should start taking this medicine, Mylan. Dosulepin Mylan. talk to your doctor. Taking other medicines Before you start to take it Do not take Dosulepin Mylan if you are taking a monoamine How to take Dosulepin Tell your doctor if you are allergic Mylan to any other medicines, foods, dyes oxidase inhibitor (MAOI) such as: · phenelzine (Nardil) and or preservatives. Follow all directions given to you tranylcypromine (Parnate), Tell your doctor if you are by your doctor and pharmacist moclobemide (eg. Aurorix, pregnant or plan to become carefully. Arima), used to treat depression pregnant. They may differ from the · selegiline (Eldepryl, Selgene), There have been reports of some information contained in this leaflet. babies experiencing complications used to treat symptoms of If you do not understand the immediately after delivery. Your Parkinson©s disease. instructions on the pack, ask your doctor will discuss the possible risks Wait at least 14 days after stopping doctor or pharmacist. and benefits of taking Dosulepin your MAOI before starting Mylan during pregnancy. Dosulepin Mylan. How much to take Tell your doctor if you are Tell your doctor if you are taking The dose varies from person to breastfeeding or wish to any other medicines, including any person. breastfeed. that you buy without a Your doctor will tell you how much Like many other medicines, prescription from a pharmacy, Dosulepin Mylan you need to take Dosulepin Mylan passes into breast supermarket or health food shop. each day and when to take it. This milk. Medicines that may be affected by depends how well you respond to Dosulepin Mylan or may affect how Your doctor will discuss the risks and Dosulepin Mylan and whether or not well it works include: benefits of taking Dosulepin Mylan you are taking any other medicines. when breastfeeding. · sleeping tablets/sedatives, anti- The usual starting dose is 25 mg anxiety medicines Tell your doctor if you have, or three times daily for one to two have had, any medical conditions, · medicines used to treat epilepsy weeks. Your doctor may then especially the following: · some medicines used to treat high increase your dose, up to a maximum · heart or blood vessel problems blood pressure or other heart of 200 mg per day. · liver problems or conditions Once your symptoms improve, your · kidney problems or difficulty · some medicines used to relieve doctor will then slowly reduce your passing (water) stomach cramps dose to the lowest effective dose which maintains relief of symptoms. · glaucoma, a condition · medicines used to treat characterised by an increased Parkinson©s disease Elderly people over 65 years of age pressure in the eye · medicines for travel sickness and those with liver or kidney problems may need smaller doses. · prostate problems · some cough and cold preparations · difficulty in passing urine · some medicines for hayfever and How to take it allergies · thyroid problems Swallow the tablets or capsules · any other mental illness, such as · certain medicines for weight loss with a glass of water. schizophrenia or manic · thyroid hormone medicines. The 75 mg tablets can be divided in depression (alternating periods of Your doctor can tell you what to do if half along the breakline if advised by elation/overactivity and depressed you are taking any of these your doctor or pharmacist. mood) medicines. When to take it · family history of suicide or manic If you are not sure whether you are depression. taking any of these medicines, Dosulepin Mylan can be taken as a Tell your doctor if you plan to have check with your doctor or single dose (e.g. at bedtime) or as surgery or if you are undergoing pharmacist. divided doses (e.g. three times a electroshock therapy. day). Your doctor will advise you.

DOSULEPIN MYLAN 2 Take your medicine at about the If you have trouble remembering likely to occur in young adults under same time each day. to take your medicine, ask your 25 years of age. Taking it at the same time each day pharmacist for some hints. Contact your doctor or a mental will have the best effect. It will also health professional right away or help you remember when to take it. If you take too much go to the nearest hospital for (overdose) treatment if you or someone you How long to take it for Immediately telephone your know is showing any of the following warning signs of suicide: Keep taking Dosulepin Mylan for doctor, or the Poisons Information as long as your doctor Centre (telephone 13 11 26) for · worsening of your depression recommends. advice, or go to Accident and · thoughts or talk of death or Emergency at the nearest hospital, The length of treatment will depend suicide if you think you or anyone else on how quickly your symptoms may have taken too much · thoughts or talk of self-harm or improve. Dosulepin Mylan. harm to others Most medicines for depression take Do this even if there are no signs of · any recent attempts of self-harm time to work, so do not be discomfort or poisoning. · increase in aggressive behaviour, discouraged if you do not feel better irritability or any other unusual right away. Some of your symptoms You may need urgent medical changes in behaviour or mood. may improve in 1 or 2 weeks but it attention. can take up to 4 or 6 weeks to feel Too much Dosulepin Mylan may All mentions of suicide or violence the full benefit of Dosulepin Mylan. make you tremble, agitated and/or must be taken seriously. Even when you feel well, you will have difficulty walking. Other signs Families and caregivers of children usually have to take Dosulepin include fitting or convulsions, and adolescents being treated with Mylan for several months or longer, unusual muscle movements, Dosulepin Mylan need to monitor to make sure that the benefits last. difficulty breathing, a very high these patients for the emergence temperature or irregular heartbeat as of: If you forget to take it well as other serious heart problems. · anxiety IF YOU TAKE ONE DOSE A Keep Dosulepin Mylan out of the · agitation reach of children. DAY (AT BEDTIME) · panic attacks Children are much more sensitive If you forget to take Dosulepin · insomnia than adults to medicines such as Mylan before you go to bed and Dosulepin Mylan. An accidental · irritability wake up late in the night or early overdose is especially dangerous in in the morning, do not take the · aggressiveness children. missed dose until you have checked · impulsivity with your doctor. · restlessness or difficulty sitting You may have difficulty waking up, still or experience drowsiness in the While you are taking · morning and during the day. Dosulepin Mylan · mania IF YOU TAKE MORE THAN ONE DOSE A DAY · unusual changes in behaviour Things you must do If it is almost time for your next This will help your doctor determine Tell your doctor immediately if dose, skip the dose you missed and the best way to control these feelings. you have any suicidal thoughts or take your next dose when you are Tell your doctor if you feel other mental/mood changes. meant to. Dosulepin Mylan is not helping Occasionally, the symptoms of Otherwise, take the missed dose as your condition. depression or other psychiatric soon as you remember, and then go Keep all of your appointments with conditions may include thoughts of back to taking Dosulepin Mylan as your doctor so that your progress harming yourself or committing you would normally. can be checked. suicide. Do not take a double dose to make If you are taking Dosulepin Mylan These symptoms may continue or get up for the dose you missed. for a long time, your doctor may ask worse during the first one to two you to have your eyes tested If you are not sure what to do, ask months of treatment until the full regularly. your doctor or pharmacist. effect of the medicine becomes apparent. This is more

DOSULEPIN MYLAN 3 Tell your doctor immediately if Do not use Dosulepin Mylan to All medicines can have side effects. you become pregnant while taking treat any other conditions unless Sometimes they are serious, most of Dosulepin Mylan. Do not stop your doctor tells you to. the time they are not. You may need taking your tablets or capsules Do not give Dosulepin Mylan to medical treatment if you get some of until you have spoken to your anyone else, even if they have the the side effects. doctor. same condition as you. Ask your doctor or pharmacist to Before starting any new medicine, answer any questions you may tell your doctor or pharmacist that Things to be careful of have. you are taking Dosulepin Mylan. Be careful when drinking Do not be alarmed by this list of Tell all the doctors, dentists and while taking Dosulepin Mylan. possible side effects. pharmacists who are treating you Combining Dosulepin Mylan and You may not experience any of them. that you are taking Dosulepin alcohol can make you more Tell your doctor if you notice any Mylan. drowsy, dizzy or lightheaded. of the following and they worry If you plan to have surgery, Your doctor may suggest you avoid you: including dental surgery, tell your alcohol while being treated for · dry mouth doctor that you are taking depression. Dosulepin Mylan. · increased sweating Be careful getting up from a sitting Your doctor may ask you to or lying position. · feeling sick (nausea), vomiting temporarily stop taking Dosulepin Dizziness, light-headedness or · constipation Mylan a few days before elective fainting may occur, especially when · blurred vision surgery. you get up quickly. Getting up · drowsiness, dizziness, light- Tell your doctor if, for any reason, slowly may help. headedness you have not taken your medicine Be careful if you are older than 65 exactly as prescribed. · tremor years of age. Otherwise, your doctor may think · increased or decreased sex drive. Elderly people may become confused that it was not effective and change when taking Dosulepin Mylan. The above list includes the common your treatment unnecessarily. Families and carers should be aware and mild side effects of Dosulepin of this. Special care may be needed. Mylan. Things you must not do Tell your doctor or dentist if your Tell your doctor as soon as possible Do not drive or operate machinery mouth continues to feel dry for if you notice any of the following: until you know how Dosulepin more than 2 weeks. · fast or irregular heart beat Mylan affects you. Dosulepin Mylan may cause dry · ongoing difficulty with passing Dosulepin Mylan may cause mouth. This can be relieved by urine drowsiness, dizziness or light- frequent sips of water, sucking · signs of frequent infections such headedness in some people. If any of sugarless lollies or chewing sugarless these occur, do not drive, operate as fever, chills, sore throat or gum. However, continuing dryness of mouth ulcers machinery or do anything else that the mouth may increase the chance of could be dangerous. dental disease, including tooth decay · unusual bruising or bleeding Do not stop taking Dosulepin and gum disease. · tingling or numbness of the hands Mylan, or lower the dose, without or feet checking with your doctor. · severe pain in the stomach with If you stop taking Dosulepin Mylan bloating, gut cramps and suddenly you may feel sick (nausea), Side effects vomiting irritable, have a headache, difficulty · symptoms of liver disease such as Tell your doctor or pharmacist as sleeping or excessive sweating. Other yellowing of the eyes or skin soon as possible if you do not feel more serious complications such as () and passing dark well while you are taking fits (convulsions) or blood clots may coloured urine occur. Dosulepin Mylan. · feeling anxious, restless, or Dosulepin Mylan helps most people Your doctor will tell you how to confused gradually reduce the amount of with depression, but it may have · abnormal ideas, Dosulepin mylan you are taking unwanted side effects in some before stopping completely. people. · sudden mood swings alternating from one of excitement,

DOSULEPIN MYLAN 4 overactivity and uninhibited Heat and dampness can destroy some · quinoline yellow CI 47005 (104). behaviour to a depressed mood medicines. Dosulepin Mylan 75 tablets · uncontrollable movements, Active ingredient: including trembling and shaking Disposal · dothiepin hydrochloride 75 mg. of the hands and fingers, twisting If your doctor tells you to stop movements of the body, shuffling taking Dosulepin Mylan, or your Ingredients of known effect: walk or stiffness of the arms and medicine has passed its expiry · lactose legs. date, ask your pharmacist what to · sulfites (present in trace amounts) The above side effects are serious do with any that is left over. · soya bean products (present in and may require medical attention. trace amounts) Tell your doctor immediately or go Inactive ingredients: to Accident and Emergency at the nearest hospital if you notice any of Product description · maize starch the following: · povidone What it looks like · chest pain · sodium starch glycollate · fainting or collapse Dosulepin Mylan is available in two · purified talc strengths: · allergic symptoms such as skin · stearate blisters, rash, itching or hives; · Dosulepin Mylan 25 - hard · Opadry Red OY-B-25005 swelling of the face, mouth, lips, capsule with green and red cap in (includes colours brilliant scarlet throat or neck; difficulty PVC/PVdC/aluminium blister 4R CI 16255 [124], titanium swallowing or breathing; packs. Each pack contains 50 capsules. dioxide [171]). · seizures or fits. · Dosulepin Mylan 75 - round, red, Dosulepin Mylan tablets and The above side effects are not scored film-coated tablet marked capsules are gluten free. common but very serious. You may "DT" over a breakline over "75" require urgent medical attention or on one side and a Greek alpha Manufacturer even hospitalisation if they occur. symbol on the other. Each pack Dosulepin Mylan is made in Tell your doctor if you notice contains 30 tablets. by: anything that is making you feel Alphapharm Pty Limited unwell. Ingredients (ABN 93 002 359 739) Other side effects not listed above Dosulepin Mylan 25 capsules may also occur in some patients. Level 1, 30 The Bond Active ingredient: 30-34 Hickson Road · dothiepin hydrochloride 25 mg. Millers Point NSW 2000 Ingredients of known effect: Phone: (02) 9298 3999 After taking Dosulepin · lactose (monohydrate and Mylan anhydrous) www.mylan.com.au · sulfites (present in trace amounts) Storage Inactive ingredients: Australian registration numbers: Keep Dosulepin Mylan where · povidone Dosulepin Mylan 25 - AUST R children cannot reach it. 289783 · sodium starch glycollate A locked cupboard at least one-and- Dosulepin Mylan 75 - AUST R a-half metres above the ground is a · purified talc 289784 good place to store medicines. · magnesium stearate Keep Dosulepin Mylan in a cool, · sodium lauryl sulfate This leaflet was prepared on dry place where the temperature · colloidal anhydrous silica stays below 30 °C for tablets and 05 July 2019. below 25 °C for capsules. · gelatin Do not store Dosulepin Mylan or · erythrosine CI 45430 (127) Dosulepin Mylan_cmi\Jul19/00 any other medicine in the · iron oxide red CI 77491 (172) bathroom or near a sink. Do not · titanium dioxide (171) leave Dosulepin Mylan in the car or on window sills. · brilliant blue FCF CI 42090 (133)

DOSULEPIN MYLAN 5