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WARNING: PRILIGY can make you faint. You may experience warning symptoms such as nausea, dizziness or light-headedness before you faint. Immediately lie down or sit down with your head between your knees if you feel nauseous, dizzy or light-headed until the symptoms pass. This will prevent falls and injury. (see While you are taking PRILIGY and Side Effects). Do not take more than one PRILIGY tablet once every 24 hours due to the increased risk of fainting.

PRILIGY® dapoxetine hydrochloride

Consumer Medicine Information (CMI)

What is in this leaflet of • any of the ingredients listed at the (premature ejaculation troubles end of this leaflet. This leaflet answers some common the man and his partner); and Some of the symptoms of an allergic questions about PRILIGY. • poor control over ejaculation. reaction may include: It does not contain all the available PRILIGY contains the active • shortness of breath information. It does not take the ingredient dapoxetine and is a type of • wheezing or difficulty breathing place of talking to your doctor or drug called a selective pharmacist. reuptake inhibitor (SSRI) and it is • swelling of the face, lips, tongue or other parts of the body All medicines have risks and also known as a urological medicine. benefits. Your doctor has weighed PRILIGY increases your time to • rash, itching or hives on the skin. the risks of you taking PRILIGY ejaculation and can improve your Do not take PRILIGY: control over ejaculation and reduce against the benefits they expect it • if you are taking a monoamine your distress over how fast you will have for you. oxidase inhibitor (MAOI ) ejaculate. This may improve your medicine used to treat depression, If you have any concerns about satisfaction with . taking this medicine, ask your or have taken a MAOI within the doctor or pharmacist. Ask your doctor if you have any last 14 days (see Taking other questions about why this medicine medicines for examples of Keep this leaflet with the medicine. has been prescribed for you. MAOIs). Once you stop taking You may need to read it again. Your doctor may have prescribed it PRILIGY you will need to wait 7 for another reason. days before taking an MAOI. This medicine is available only with • if you are taking used a doctor's prescription. to treat schizophrenia, or have What PRILIGY is used taken thioridazine within the last for 14 days. Once you stop taking PRILIGY you will need to wait 7 PRILIGY is a treatment for days before taking thioridazine. premature ejaculation (PE) in men 18 Before you take to 64 years old who have all of the PRILIGY • if you are taking a selective following: serotonin reuptake inhibitor (SSRI), and certain other • ejaculation in less than 2 minutes When you must not take it medicines and herbal products to following vaginal penetration, on Do not take PRILIGY if you have treat depression or have taken most occasions, with little an allergy to: these medicines within the last 14 stimulation and before the man • any medicine containing days. (see Taking other medicines wishes to; and dapoxetine for examples of SSRIs and other • marked personal distress and medicines used to treat interpersonal difficulty as a result

PRILIGY® 1 depression). Once you stop taking make sure that your blood pressure • such as PRILIGY you will need to wait 7 doesn’t drop too much when you . It is not days before taking these stand up from sitting or lying down. known whether PRILIGY can medications/herbal products. Tell your doctor if: worsen these conditions. • if you are taking certain • you have any allergies to any • eye problems such as glaucoma, medicines to treat fungal other medicines, foods, (high pressure in the eye ) infections or medicines to treat preservatives or dyes. • HIV HIV (see Taking other medicines for examples of these medicines). • you have not been diagnosed with If you have not told your doctor premature ejaculation. about any of the above, tell them • if you have a history of mania or before you start taking PRILIGY. severe depression • you use recreational drugs such as ecstasy or LSD. Taking PRILIGY Do not take PRILIGY if you have with these drugs can cause Taking other medicines heart problems, such as heart serious reactions. Tell your doctor or pharmacist if failure or problems with the heart • you take narcotics (strong pain you are taking any other rhythm. medicines) or benzodiazepines medicines, including any that you Do not take PRILIGY if you have such as Valium. These medicines get without a prescription from moderate to severe problems. can increase the drowsiness and your pharmacy, supermarket or Do not take PRILIGY if you are dizziness of PRILIGY. health food shop. prone to fainting or passing out • you consume alcohol. Alcohol Some medicines and PRILIGY may caused by a temporary drop in can increase the risk of fainting interfere with each other. These blood pressure (Syncope). and should be avoided while include: Do not take PRILIGY if you are taking PRILIGY. • monoamine oxidase inhibitors under 18 years of age, or over 65 • you are being treated for (MAOIs) used to treat depression, years of age. depression. such as moclobemide, phenelzine and tranylcypromine. Safety and effectiveness in patients • you are currently using under 18 years or over 65 years have medications to treat fungal • medicines used to treat not been established. infections. depression such as , , , Do not take PRILIGY if you are a Tell your doctor if you have or , , , woman. have had any of the following , , PRILIGY has been studied for use by medical conditions: , , men with premature ejaculation. Its • history of dizziness from low , or safety in women has not been blood pressure . established. • heart and blood vessel problems • triptans, medicines (used to treat This medicine contains lactose (a migraine (e.g. sumatriptan,) type of sugar). If you have been told • bleeding tendencies by your doctor that you have an • depression • , used for pain intolerance to some sugars, contact • fainting (see Things to be careful • lithium, used for mood disorders your doctor before taking this of) • thioridazine used to treat medicine. • you have any thoughts of suicide schizophrenia. Do not take this medicine after the or harming yourself • linezolid, an antibiotic used to expiry date printed on the pack or • psychiatric disorders, such as treat infection. if the packaging is torn or shows schizophrenia signs of tampering. • tryptophan, used to help your • history of mania (great mood and help you sleep. If it has expired or is damaged, return excitement, hallucinations, it to your pharmacist for disposal. • St John's wort (hypericum difficulty in concentrating or perforatum), a herbal preparation If you are not sure whether you staying still) or bipolar disorder PRILIGY should not be taken with should start taking this medicine, (extreme mood swings) or the above listed medicines/ herbal talk to your doctor. develop these disorders preparations or within 14 days of • seizures (fits) or have Before you start to take it stopping these medicines. uncontrolled epilepsy Before you start taking this medicine, Once you stop taking PRILIGY you • moderate or severe liver problems your doctor should perform a test to will need to wait 7 days before taking • severe problems these medicines/ herbal preparations.

PRILIGY® 2 Other medicines and PRILIGY may How to take PRILIGY or go to Accident and Emergency interfere with each other. These at the nearest hospital, if you think include: Follow all directions given to you that you or anyone else may have • medicines to thin your blood, by your doctor or pharmacist taken too much PRILIGY. Do this such as warfarin carefully. even if there are no signs of discomfort or poisoning. • certain medicines for fungal They may differ from the infections, including information contained in this leaflet. You may need urgent medical , itraconazole and attention. fluconazole How much to take • certain medicines for HIV, The recommended dose is a single including , saquinavir tablet (30mg), taken when you need and atazanavir While you are using it, about 1 to 3 hours before sexual PRILIGY • certain medicines used to treat activity. high blood pressure and chest Do not take more than a single WARNING: PRILIGY can make pain (angina), enlarged prostate, tablet in 24 hours. you faint or make you feel dizzy or or erectile dysfunction light-headed. (impotence), as these medicines How to take it To help lower the chance of this may lower your blood pressure, happening: possibly upon standing Swallow the tablets whole with at least one full glass of water. • Take PRILIGY with at least one • anti-inflammatory medicines such PRILIGY may be taken with or full glass of water. as ibuprofen or aspirin without food. • Do not take PRILIGY if you are • certain antibiotics for treating dehydrated (you do not have infection, such as erythromycin Avoid alcohol when taking enough water in your body). and clarithromycin PRILIGY. • This can happen if: • aprepitant used to treat nausea Do not drink grapefruit juice within 24 hours prior to taking - You have not had water to • grapefruit. Do not drink PRILIGY. drink in the past 4 to 6 hours grapefruit juice within 24 hours Grapefruit juice can increase the prior to taking PRILIGY - You have been sweating for a level of this medicine in your body. long time • narcotics (strong pain medicines) - You have an illness where or benzodiazepines such as When to take it valium. These medicines can you have a high temperature, increase the drowsiness and Take the tablet when you need it diarrhoea or being sick dizziness of PRILIGY. about 1 to 3 hours before sexual - You have had alcohol activity. • alcohol. Alcohol can increase the • If you feel like you might faint PRILIGY should be used on an as- risk of fainting and should be (such as feeling sick, feeling needed basis when sexual activity is avoided while taking PRILIGY. dizzy, light-headed, feeling weak, anticipated. It is not intended for Ask your doctor or pharmacist if confused, sweaty or an abnormal continuous daily use. you are not sure if you are taking heart beat), or feel light-headed any of these medicines. Do not take more than one tablet when you stand up, immediately once every 24 hours due to lie down so your head is lower These medicines may be affected by increased risk of side effects and than the rest of your body or sit PRILIGY or may affect how well it lack of additional benefit. down with your head between works. You may need different your knees until you feel better. amounts of your medicines, or you If you forget to take it This will stop you from falling may need to take different medicines. As PRILIGY is only taken when and hurting yourself if you do Other medicines not listed here may needed, it is not a problem if you faint. be affected by PRILIGY or may forget to take it. • Do not stand up quickly after you affect how well it works. Your doctor have been sitting or lying down and pharmacist have more for a long time. information on medicines to be If you take too much careful with or avoid while taking (overdose) • Do not drive or use any tools or this medicine. Immediately telephone your doctor machines if you feel faint when or the Poisons Information Centre taking this medicine. on 13 11 26 (Australia) for advice,

PRILIGY® 3 • Tell your doctor if you faint when involving fever, diarrhoea or Tell your doctor or pharmacist if taking this medicine. vomiting. you notice any of the following and PRILIGY may cause fainting. To they worry you: Things you must do help lessen your chance of fainting • nausea If you are about to be started on or being injured by fainting: • headache any new medicine, remind your • Take PRILIGY with at least one • dizziness doctor and pharmacist that you full glass of water are taking PRILIGY. Tell your doctor as soon as possible • If you begin to feel dizzy, light- if you notice any of the following: Tell any other doctors, dentists, headed, sweaty, shaky, clammy, • fainting or feeling dizzy upon and pharmacists who treat you nauseated, or otherwise unwell, standing (see While you are that you are taking this medicine. lie down immediately so you taking PRILIGY) Keep all of your doctor's don't get hurt falling from a appointments so that your progress fainting spell. • increased blood pressure can be checked. • If you are sitting or lying down, • trembling Talk to your doctor before you do not stand up quickly after you • tingling or numbness take PRILIGY stop taking this medicine. You may • blurred vision have problems sleeping and feel • If you experience any of these or • eye pain dizzy after you stop taking it, even similar effects, you should avoid if you have not taken it every day. driving and using machines. • ringing in the ears • nasal congestion Things you must not do • diarrhoea, abdominal pain, dry Do not take PRILIGY to treat any mouth, vomiting, ingestion, other complaints unless your Side effects intestinal gas, constipation, doctor tells you to. bloating Tell your doctor or pharmacist as Do not give your medicine to soon as possible if you do not feel • excessive sweating anyone else, even if they have the well while you are taking • fatigue, sleepiness and yawning same condition as you. PRILIGY. • difficulty paying attention and Things to be careful of This medicine helps most people, but feeling irritable it may have unwanted side effects in • erectile dysfunction (difficulty Be careful driving or operating a few people. All medicines can have getting or keeping an erection) machinery until you know how side effects. Sometimes they are PRILIGY affects you. serious, most of the time they are not. • difficulty sleeping This medicine may cause dizziness, You may need medical attention if • , nervousness, decreased light-headedness, tiredness, you get some of the side effects. sexual desire, depression, indifference drowsiness, or fainting in some Do not be alarmed by the following people. If you have any of these lists of side effects. You may not • abnormal dreams symptoms, do not drive, operate experience any of them. If any of the following happen, tell machinery or do anything else that your doctor immediately or go to could be dangerous. Ask your doctor or pharmacist to answer any questions you may Accident and Emergency at your Avoid alcohol while you are taking have. nearest hospital: this medicine. Stop taking PRILIGY and see your • Signs of allergy such as rash, The effects of alcohol, such as doctor right away if: itching or hives on the skin; dizziness, drowsiness, slow reflexes • you have fits (seizures) shortness of breath, wheezing or or impaired judgement, may be difficulty breathing; swelling of increased if taken with PRILIGY. • you faint or feel light-headed the face, lips, tongue or other when you stand up Make sure you are not dehydrated parts of the body. (don't have enough water in your • you notice any changes in your Tell your doctor or pharmacist if body). mood you notice anything that is making This can occur if you have not had • you have any thoughts of suicide you feel unwell. anything to drink in the past 4-6 or harming yourself Other side effects not listed above hours or you have been sweating for may also occur in some people. a long period or have an illness

PRILIGY® 4 After using PRILIGY • hypromellose • titanium dioxide Storage • iron oxide black Keep your tablets in the pack until • iron oxide yellow it is time to take them. • triacetin If you take the tablets out of the pack This medicine does not contain they may not keep well. sucrose, gluten, tartrazine or any Keep your tablets in a cool, dry other azo dyes. place where the temperature stays below 25°C. Supplier Do not store PRILIGY or any PRILIGY is supplied in Australia by: other medicine in the bathroom, A. Menarini Australia Pty Ltd near a sink. Do not leave it on a Level 8, 67 Albert Ave windowsill or in the car. Chatswood NSW 2067 Heat and dampness can destroy some medicines. Medical Information: 1800 644 542 Keep it where children cannot ® PRILIGY is a registered trademark reach it. of Berlin-Chemie AG A locked cupboard at least one-and- Australian Registration Number: a-half metres above the ground is a AUST R 147946 good place to store medicines. This leaflet was revised in December Disposal 2020. If your doctor tells you to stop taking this medicine, or the expiry date has passed, ask your For the most up to date version of pharmacist what to do with any this leaflet, please go to medicine that is left over. www.menarini.com.au/cmi [vA09-0]

Product description

What it looks like PRILIGY 30 mg film-coated tablets are light grey, round and marked "30" inside a triangle on one side. PRILIGY is supplied in blister packs containing 3 or 6 tablets.

Ingredients PRILIGY contains 30 mg of dapoxetine hydrochloride as the active ingredient. It also contains: • lactose monohydrate • microcrystalline cellulose • croscarmellose sodium • colloidal anhydrous silica • magnesium stearate

PRILIGY® 5