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PRILIGY® Tablets Dapoxetine hydrochloride Consumer Medicine Information

What is in this leaflet PRILIGY, containing the active Do not take PRILIGY: ingredient dapoxetine, is a type of  If you are taking a MAOI drug called a selective This leaflet answers some common (monoamine oxidase inhibitor) reuptake inhibitor (SSRI) and questions about PRILIGY. It does used to treat depression, or have belongs to a group of drugs known as not contain all the available taken a MAOI within the last 14 other urologicals. PRILIGY increases information. It does not take the days (see Taking other your time to ejaculation and can place of talking to your doctor or medicines for examples of improve your control over pharmacist. MAOIs). ejaculation and reduce your distress  If you are taking This leaflet was last updated on the over how fast you ejaculate. This (Aldazine®) used to treat date at the end of this leaflet. may improve your satisfaction with schizophrenia, or have taken . Speak to your pharmacist or thioridazine within the last 14 doctor to obtain the most up to Ask your doctor if you have any days. date information on this medicine. questions about why this medicine has been prescribed for you.  If you are taking a selective You can also download the most up serotonin reuptake inhibitor to date leaflet from Your doctor may have prescribed it for another reason. (SSRI), other medicines used to www.menarini.com.au treat depression (see Taking All medicines have risks and This medicine is available only with other medicines for examples of benefits. Your doctor has weighed a doctor's prescription. SSRIs and other medicines used the risks of you taking PRILIGY WARNING: PRILIGY can make to treat depression) or other against the benefits they expect it you faint or make you feel dizzy or medicinal/ herbal products with will have for you. light-headed when you stand up serotonergic effects (St. John’s If you have any concerns about (see While you are taking Wort), or have taken these taking this medicine, ask your PRILIGY and Side Effects). medicines within the last 14 days. doctor or pharmacist.  If you are taking certain Keep this leaflet with the medicine. medicines to treat fungal You may need to read it again. infections or medicines to treat Before you take HIV (see Taking other medicines for examples of these PRILIGY medicines). Do not take PRILIGY if you have What PRILIGY is used When you must not take it heart problems, such as heart for Do not take PRILIGY if you have failure or problems with the heart an allergy to: rhythm. PRILIGY is a treatment for  any medicine containing Do not take PRILIGY if you have (PE) in men 18 dapoxetine moderate to severe to 64 years old who have all of the problems. following :  any of the ingredients listed at the end of this leaflet. Do not take PRILIGY if you are  ejaculation in less than 2 minutes under 18 years of age, or over 65 Some of the symptoms of an allergic following penetration, on most years of age. reaction may include: occasions, with little stimulation Safety and effectiveness in patients and before the man wishes to; and  shortness of breath under 18 years or over 65 years have  marked personal distress and  wheezing or difficulty breathing not been established. interpersonal difficulty as a result Do not take PRILIGY if you are of premature ejaculation  swelling of the face, lips, tongue or other parts of the body a woman. (premature ejaculation troubles Safety and effectiveness in women the man and his partner); and  rash, itching or hives on the skin. have not been established.  poor control over ejaculation.

PRILIGY ® 1 Do not take this medicine after the Taking other medicines medicines may lower your blood expiry date printed on the pack or pressure, possibly upon standing. if the packaging is torn or shows Tell your doctor or pharmacist if you are taking any other  Anti-inflammatory medicines signs of tampering. ® If it has expired or is damaged, return medicines, including any that you such as ibuprofen (Nurofen ) or it to your pharmacist for disposal. get without a prescription from aspirin. your pharmacy, supermarket or  Certain antibiotics for treating If you are not sure whether you health food shop. should start taking this medicine, infection, such as erythromycin Some medicines and PRILIGY may talk to your doctor. and clarithromycin. interfere with each other. These include:  Aprepitant (Emend®) used to treat Before you start to take it nausea.  MAOIs (monoamine oxidase Tell your doctor if you have inhibitors) used to treat depression,  Midazolam (Hypnovel®) used as allergies to any other medicines, such as moclobemide, phenelzine a sedative. foods, preservatives or dyes. and tranylcypromine (Aurorix®, ® ® These medicines may be affected by Tell your doctor if you have not Nardil , Parnate ) PRILIGY or may affect how well it been diagnosed with premature  Selective serotonin reuptake works. You may need different ejaculation. inhibitors (SSRIs) or other amounts of your medicines, or you Tell your doctor if you use medicines used to treat may need to take different medicines. recreational drugs such as depression: , Other medicines not listed here may ecstasy, LSD, narcotics, or , , , be affected by PRILIGY or may benzodiazepines. , , affect how well it works. Your doctor Tell your doctor if you have or mirtazepine, , and pharmacist have more , , information on medicines to be have had any of the following ® (e.g. Allegron , careful with or avoid while taking medical conditions: ® ® ® Aropax , Avanza , Cipramil , this medicine.  History of dizziness from low ® ® ® blood pressure Dothep , Efexor , Lexapro , Luvox®, Prozac®, Lovan®,  Heart and blood vessel problems Serzone®, Sinequan®, Zoloft®). ®  Bleeding tendencies  Thioridazine (Aldazine ) used to How to take PRILIGY  Depression treat schizophrenia  Fainting (see Things to be  Triptans, medicines used to treat Follow all directions given to you careful of) migraine (e.g. sumatriptan, by your doctor or pharmacist Imigran®). carefully.  You have any thoughts of suicide ® They may differ from the or harming yourself  (Tramal ), used for pain. information contained in this leaflet.  Psychiatric disorders, such as ® If you do not understand the schizophrenia  Lithium (Lithicarb ), used for mood disorders. instructions on the box, ask your  History of mania (great doctor or pharmacist for help. excitement, hallucinations,  St John’s wort (hypericum difficulty in concentrating or perforatum), a herbal preparation. How much to take staying still) or bipolar disorder  Medicines to thin your blood, The recommended dose is a single (extreme mood swings) or such as warfarin (Coumadin®, develop these disorders ® tablet (30mg), taken when you need Marevan ). it about 1 to 3 hours before sexual  Seizures (fits) or have  Certain medicines for fungal activity. uncontrolled epilepsy infections, including ® Do not exceed taking a single tablet  Severe liver or problems (Nizoral ), in 24 hours. itraconazole (Sporanox®) and  (impaired fluconazole (Diflucan®). sexual function in males) How to take it  Certain medicines for HIV,  Glaucoma, a condition that may including (Norvir®), Swallow the tablets whole with at or may not be characterised by saquinavir (Invirase®), nelfinavir least one full glass of water. high pressure in the eye and can (Viracept®) and atazanavir PRILIGY may be taken with or lead to blindness. (Reyataz®). without food. If you have not told your doctor  Certain medicines used to treat Avoid alcohol when taking about any of the above, tell them high blood pressure and chest PRILIGY. before you start taking PRILIGY. pain (angina), enlarged prostate (Flomaxtra®), or (impotence), as these

PRILIGY ® 2 When to take it you stand up, immediately lie a long period or have an illness down so your head is lower than involving fever, diarrhoea or Take the tablet when you need it the rest of your body or sit down vomiting. about 1 to 3 hours before sexual with your head between your activity. PRILIGY may cause fainting. To knees until you feel better. This help lessen your chance of fainting Do not take more than one tablet will stop you from falling and or being injured by fainting: once every 24 hours due to hurting yourself if you do faint.  Take PRILIGY with at least one increased risk of side effects and  Do not stand up quickly after you full glass of water lack of additional benefit. have been sitting or lying down  If you begin to feel dizzy, light- for a long time. If you forget to take it headed, sweaty, shaky, clammy,  Do not drive or use any tools or nauseated, or otherwise unwell, lie As PRILIGY is only taken when machines if you feel faint when down immediately so you don’t needed, it is not a problem if you taking this medicine. get hurt falling from a fainting forget to take it.  Tell your doctor if you faint when spell. taking this medicine. If you take too much  If you are sitting or lying down, do not stand up quickly after you (overdose) Things you must do take PRILIGY Immediately telephone your doctor If you are about to be started on  If you experience any of these or or the Poisons Information Centre any new medicine, remind your similar effects, you should avoid (in Australia telephone 13 11 26) doctor and pharmacist that you driving and using machines. for advice, or go to Emergency at are taking PRILIGY. the nearest hospital, if you think that you or anyone else may have Tell any other doctors, dentists, taken too much PRILIGY. Do this and pharmacists who treat you even if there are no signs of that you are taking this medicine. Side effects discomfort or poisoning. Keep all of your doctor's You may need urgent medical appointments so that your progress Tell your doctor or pharmacist as attention. can be checked. soon as possible if you do not feel well while you are taking Things you must not do PRILIGY. This medicine helps most people, but Do not take PRILIGY to treat any it may have unwanted side effects in While you are taking other complaints unless your a few people. All medicines can have doctor tells you to. PRILIGY side effects. Sometimes they are Do not give your medicine to serious, most of the time they are not. WARNING: PRILIGY can make anyone else, even if they have the You may need medical attention if you faint or make you feel dizzy or same condition as you. you get some of the side effects. light-headed when you stand up. Do not be alarmed by the following To help lower the chance of this Things to be careful of lists of side effects. You may not happening: Be careful driving or operating experience any of them.  Take PRILIGY with at least one machinery until you know how Ask your doctor or pharmacist to full glass of water. PRILIGY affects you. answer any questions you may  Do not take PRILIGY if you are This medicine may cause dizziness, have. light-headedness, tiredness, dehydrated (you do not have Stop taking PRILIGY and see drowsiness, or fainting in some enough water in your body). your doctor right away if: people. If you have any of these  This can happen if: symptoms, do not drive, operate  you have fits (seizures) - You have not had water to drink machinery or do anything else that  you faint or feel light-headed in the past 4 to 6 hours could be dangerous. when you stand up Avoid alcohol while you are taking - You have been sweating for a  you notice any changes in your this medicine. mood long time The effects of alcohol, such as  you have any thoughts of suicide - You have an illness where you dizziness, drowsiness, slow reflexes or harming yourself have a high temperature, or impaired judgement, may be Tell your doctor or pharmacist if diarrhoea or being sick increased if taken with PRILIGY. you notice any of the following and Make sure you are not dehydrated  If you feel like you might faint they worry you: (don’t have enough water in your (such as feeling sick, feeling  nausea dizzy, light-headed, confused, body). sweaty or an abnormal heart This can occur if you have not had  headache anything to drink in the past 4-6 beat), or feel light-headed when  dizziness hours or you have been sweating for

PRILIGY ® 3 Tell your doctor as soon as possible Keep your tablets in a cool dry Supplier if you notice any of the following: place where the temperature stays below 25°C. PRILIGY is supplied in Australia by:  fainting or feeling dizzy upon Do not store PRILIGY or any A.Menarini Australia Pty. Ltd. standing (see While you are Level 8, 67 Albert Ave taking PRILIGY) other medicine in the bathroom or near a sink. Do not leave it on a Chatswood, NSW, 2067  increased blood pressure window sill or in the car. AUST R 147946  trembling Heat and dampness can destroy some ® PRILIGY is a registered trademark medicines.  tingling or numbness of ORTHO-MCNEIL Keep it where children cannot PHARMACEUTICAL for  blurred vision reach it. dapoxetine tablets  eye pain A locked cupboard at least one-and-a © Copyright 2013 A. Menarini Pty. half metres above the ground is a  ringing in the ears Ltd. good place to store medicines.  nasal congestion This leaflet was prepared in March 2013  diarrhoea, abdominal pain, dry Disposal mouth, vomiting, ingestion, If your doctor tells you to stop intestinal gas, constipation, taking this medicine or the expiry bloating date has passed, ask your  excessive sweating pharmacist what to do with any  fatigue, sleepiness and yawning medicine that is left over.  difficulty paying attention and feeling irritable  erectile dysfunction (difficulty Product description getting or keeping an erection)  difficulty sleeping What it looks like  , nervousness, decreased PRILIGY 30 mg film-coated tablets sexual desire, depression, are light grey, round and marked indifference “30” inside a triangle on one side.  abnormal dreams PRILIGY is supplied in blister packs If any of the following happen, tell containing 3 or 6 tablets. your doctor immediately or go to Emergency at your nearest Ingredients hospital: PRILIGY contains 30 mg of  Signs of allergy such as rash, dapoxetine hydrochloride as the itching or hives on the skin; active ingredient. shortness of breath, wheezing or It also contains: difficulty breathing; swelling of the face, lips, tongue or other  lactose parts of the body.  cellulose – microcrystalline Tell your doctor or pharmacist if  croscarmellose sodium you notice anything that is making  silica - colloidal anhydrous you feel unwell. Other side effects not listed above  magnesium stearate may also occur in some people.  hypromellose  titanium dioxide  iron oxide black After using PRILIGY  iron oxide yellow  glycerol triacetate. Storage This medicine does not contain Keep your tablets in the pack until sucrose, gluten, tartrazine or any it is time to take them. other azo dyes. If you take the tablets out of the pack they may not keep well.

PRILIGY ® 4