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PRILIGY® dapoxetine hydrochloride

Consumer Medicine Information

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.

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

PRILIGY® Published by MIMS February 2021 1 HIV (see Taking other • you have any allergies to any • eye problems such as glaucoma, medicines for examples of these other medicines, foods, (high pressure in the eye ) medicines). preservatives or dyes. • HIV • if you have a history of mania or • you have not been diagnosed If you have not told your doctor severe depression with premature ejaculation. about any of the above, tell them Do not take PRILIGY if you have • you use recreational drugs such before you start taking PRILIGY. heart problems, such as heart as ecstasy or LSD. Taking failure or problems with the heart PRILIGY with these drugs can Taking other medicines rhythm. cause serious reactions. Tell your doctor or pharmacist if Do not take PRILIGY if you have • you take narcotics (strong pain you are taking any other moderate to severe medicines) or benzodiazepines medicines, including any that you problems. such as Valium. These get without a prescription from Do not take PRILIGY if you are medicines can increase the your pharmacy, supermarket or prone to fainting or passing out drowsiness and dizziness of health food shop. caused by a temporary drop in PRILIGY. Some medicines and PRILIGY may blood pressure (Syncope). • you consume alcohol. Alcohol interfere with each other. These Do not take PRILIGY if you are can increase the risk of fainting include: under 18 years of age, or over 65 and should be avoided while • monoamine oxidase inhibitors years of age. taking PRILIGY. (MAOIs) used to treat Safety and effectiveness in patients • you are being treated for depression, such as under 18 years or over 65 years depression. moclobemide, phenelzine and have not been established. • you are currently using tranylcypromine. Do not take PRILIGY if you are a medications to treat fungal • medicines used to treat woman. infections. depression such as , PRILIGY has been studied for use , , by men with premature ejaculation. Tell your doctor if you have or have had any of the following , , Its safety in women has not been medical conditions: , , established. • history of dizziness from low , , This medicine contains lactose (a blood pressure , , type of sugar). If you have been told or . • heart and blood vessel problems by your doctor that you have an • triptans, medicines (used to treat • bleeding tendencies intolerance to some sugars, contact migraine (e.g. sumatriptan,) your doctor before taking this • depression • , used for pain medicine. • fainting (see Things to be • lithium, used for mood disorders Do not take this medicine after careful of) • thioridazine used to treat the expiry date printed on the • you have any thoughts of schizophrenia. pack or if the packaging is torn or suicide or harming yourself shows signs of tampering. • linezolid, an antibiotic used to • psychiatric disorders, such as If it has expired or is damaged, treat infection. schizophrenia return it to your pharmacist for • tryptophan, used to help your • history of mania (great disposal. mood and help you sleep. excitement, hallucinations, If you are not sure whether you difficulty in concentrating or • St John's wort (hypericum should start taking this medicine, staying still) or bipolar disorder perforatum), a herbal talk to your doctor. (extreme mood swings) or preparation develop these disorders PRILIGY should not be taken with Before you start to take it • seizures (fits) or have the above listed medicines/ herbal Before you start taking this uncontrolled epilepsy preparations or within 14 days of stopping these medicines. medicine, your doctor should • moderate or severe liver perform a test to make sure that problems Once you stop taking PRILIGY you your blood pressure doesn’t drop • severe problems will need to wait 7 days before too much when you stand up from taking these medicines/ herbal • such as sitting or lying down. preparations. . It is not Tell your doctor if: known whether PRILIGY can worsen these conditions.

PRILIGY® Published by MIMS February 2021 2 Other medicines and PRILIGY may How to take PRILIGY Emergency at the nearest interfere with each other. These hospital, if you think that you or include: Follow all directions given to you anyone else may have taken too much PRILIGY. Do this even if • medicines to thin your blood, by your doctor or pharmacist carefully. there are no signs of discomfort such as warfarin or poisoning. They may differ from the • certain medicines for fungal You may need urgent medical information contained in this leaflet. infections, including attention. , itraconazole and How much to take fluconazole • certain medicines for HIV, The recommended dose is a single including , saquinavir tablet (30mg), taken when you need While you are using and atazanavir 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 you faint or make you feel dizzy pain (angina), enlarged prostate, tablet in 24 hours. or light-headed. or erectile dysfunction (impotence), as these medicines How to take it To help lower the chance of this happening: may lower your blood pressure, Swallow the tablets whole with at possibly upon standing least one full glass of water. • Take PRILIGY with at least one full glass of water. • anti-inflammatory medicines PRILIGY may be taken with or such as ibuprofen or aspirin without food. • Do not take PRILIGY if you are dehydrated (you do not have • certain antibiotics for treating Avoid alcohol when taking enough water in your body). infection, such as erythromycin PRILIGY. and clarithromycin • This can happen if: Do not drink grapefruit juice - You have not had water to • aprepitant used to treat nausea within 24 hours prior to taking drink in the past 4 to 6 hours • grapefruit. Do not drink PRILIGY. - You have been sweating for a grapefruit juice within 24 hours Grapefruit juice can increase the long time prior to taking PRILIGY level of this medicine in your body. - You have an illness where you • narcotics (strong pain have a high temperature, medicines) or benzodiazepines When to take it diarrhoea or being sick such as valium. These medicines Take the tablet when you need it - You have had alcohol can increase the drowsiness and about 1 to 3 hours before sexual • If you feel like you might faint dizziness of PRILIGY. activity. (such as feeling sick, feeling • alcohol. Alcohol can increase PRILIGY should be used on an as- dizzy, light-headed, feeling the risk of fainting and should needed basis when sexual activity is weak, confused, sweaty or an be avoided while taking anticipated. It is not intended for abnormal heart beat), or feel PRILIGY. continuous daily use. light-headed when you stand up, Ask your doctor or pharmacist if Do not take more than one tablet immediately lie down so your you are not sure if you are taking once every 24 hours due to head is lower than the rest of any of these medicines. increased risk of side effects and your body or sit down with your These medicines may be affected by lack of additional benefit. head between your knees until PRILIGY or may affect how well it you feel better. This will stop works. You may need different If you forget to take it you from falling and hurting amounts of your medicines, or you As PRILIGY is only taken when yourself if you do faint. may need to take different needed, it is not a problem if you • Do not stand up quickly after medicines. forget to take it. you have been sitting or lying Other medicines not listed here may down for a long time. be affected by PRILIGY or may If you take too much • Do not drive or use any tools or affect how well it works. Your (overdose) machines if you feel faint when doctor and pharmacist have more taking this medicine. Immediately telephone your information on medicines to be doctor or the Poisons Information • Tell your doctor if you faint careful with or avoid while taking Centre on 13 11 26 (Australia) for when taking this medicine. this medicine. advice, or go to Accident and

PRILIGY® Published by MIMS February 2021 3 Things you must do fainting or being injured by Tell your doctor as soon as fainting: possible if you notice any of the If you are about to be started on following: any new medicine, remind your • Take PRILIGY with at least one doctor and pharmacist that you full glass of water • fainting or feeling dizzy upon are taking PRILIGY. • If you begin to feel dizzy, light- standing (see While you are taking PRILIGY) Tell any other doctors, dentists, headed, sweaty, shaky, clammy, and pharmacists who treat you nauseated, or otherwise unwell, • increased blood pressure that you are taking this medicine. lie down immediately so you • trembling Keep all of your doctor's don't get hurt falling from a • tingling or numbness appointments so that your fainting spell. • blurred vision progress can be checked. • If you are sitting or lying down, • eye pain do not stand up quickly after Talk to your doctor before you • ringing in the ears stop taking this medicine. You you take PRILIGY • nasal congestion may have problems sleeping and • If you experience any of these or feel dizzy after you stop taking it, similar effects, you should avoid • diarrhoea, abdominal pain, dry even if you have not taken it every driving and using machines. mouth, vomiting, ingestion, day. intestinal gas, constipation, bloating Things you must not do • excessive sweating Do not take PRILIGY to treat Side effects • fatigue, sleepiness and yawning any other complaints unless your • difficulty paying attention and doctor tells you to. Tell your doctor or pharmacist as feeling irritable Do not give your medicine to soon as possible if you do not feel well while you are taking • erectile dysfunction (difficulty anyone else, even if they have the getting or keeping an erection) same condition as you. PRILIGY. • difficulty sleeping This medicine helps most people, Things to be careful of but it may have unwanted side • , nervousness, decreased effects in a few people. All sexual desire, depression, Be careful driving or operating indifference machinery until you know how medicines can have side effects. • abnormal dreams PRILIGY affects you. Sometimes they are serious, most of This medicine may cause dizziness, the time they are not. You may need If any of the following happen, light-headedness, tiredness, medical attention if you get some of tell your doctor immediately or go to Accident and Emergency at drowsiness, or fainting in some the side effects. your nearest hospital: people. If you have any of these Do not be alarmed by the symptoms, do not drive, operate following lists of side effects. You • Signs of allergy such as rash, machinery or do anything else that may not experience any of them. itching or hives on the skin; could be dangerous. Ask your doctor or pharmacist to shortness of breath, wheezing or difficulty breathing; swelling of Avoid alcohol while you are answer any questions you may taking this medicine. have. the face, lips, tongue or other The effects of alcohol, such as Stop taking PRILIGY and see parts of the body. dizziness, drowsiness, slow reflexes your doctor right away if: Tell your doctor or pharmacist if you notice anything that is or impaired judgement, may be • you have fits (seizures) making you feel unwell. increased if taken with PRILIGY. • you faint or feel light-headed Make sure you are not when you stand up Other side effects not listed above may also occur in some people. dehydrated (don't have enough • you notice any changes in your water in your body). mood This can occur if you have not had • you have any thoughts of anything to drink in the past 4-6 suicide or harming yourself hours or you have been sweating for a long period or have an illness Tell your doctor or pharmacist if involving fever, diarrhoea or you notice any of the following and they worry you: vomiting. PRILIGY may cause fainting. To • nausea help lessen your chance of • headache • dizziness

PRILIGY® Published by MIMS February 2021 4 After using PRILIGY • iron oxide black • iron oxide yellow Storage • triacetin Keep your tablets in the pack This medicine does not contain until it is time to take them. sucrose, gluten, tartrazine or any If you take the tablets out of the other azo dyes. pack they may not keep well. Supplier Keep your tablets in a cool, dry place where the temperature PRILIGY is supplied in Australia stays below 25°C. by: Do not store PRILIGY or any A. Menarini Australia Pty Ltd other medicine in the bathroom, Level 8, 67 Albert Ave near a sink. Do not leave it on a Chatswood NSW 2067 windowsill or in the car. Medical Information: 1800 644 542 Heat and dampness can destroy some medicines. ® PRILIGY is a registered trademark of Berlin-Chemie AG Keep it where children cannot reach it. Australian Registration Number: A locked cupboard at least one-and- AUST R 147946 a-half metres above the ground is a This leaflet was revised in good place to store medicines. December 2020. For the most up to date version of Disposal this leaflet, please go to If your doctor tells you to stop www.menarini.com.au/cmi taking this medicine, or the [vA09-0] expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

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 • hypromellose • titanium dioxide

PRILIGY® Published by MIMS February 2021 5