Patient Information 4472/PRI/FEB/2013/STH Date of preparation: June 2013

Transcription

1 Patient Information 4472/PRI/FEB/2013/STH Date of preparation: June 2013

2 A patient s guide to treating Premature Ejaculation with PRILIGY (dapoxetine) It is human nature to have questions when we come across or try something new. When something new is related to our health, it s even more important that we know where to find the right information to make us feel comfortable about the situation. If you are preparing to use PRILIGY for the first time to treat premature ejaculation, you are likely to be curious as to what it is, how it works and how often you will need to take it.

3 Working in collaboration with key patient organisations, Menarini have produced this leaflet to help you understand and better manage your premature ejaculation by: Exploring the condition Providing you with information on PRILIGY and how it works Explaining how to take PRILIGY Answering frequently asked questions Sharing other useful sources of information Menarini hopes this leaflet helps you take the next step in your treatment journey with PRILIGY. Please also make sure you read the Patient Information Leaflet which accompanies your medication for further information on PRILIGY or, talk with your doctor or pharmacist if you have any remaining questions.

4 What is Premature Ejaculation? The definition of premature ejaculation varies but the condition is characterised by: Uncontrolled ejaculation which occurs with minimal sexual stimulation Ejaculating before or during sexual intercourse to the detriment of you or your partner, which has a significant impact on your relationship 1 The condition can also be defined using the intra-vaginal ejaculatory latency time (IELT), which measures the time taken to ejaculate upon penetration; an IELT of less than one to two minutes characterises premature ejaculation. 2 This compares to an average IELT of almost five and a half minutes in men not experiencing premature ejaculation. 3 Premature ejaculation can be divided into two main categories: Lifelong premature ejaculation 1 Onset from the first sexual experience which remains throughout life Acquired premature ejaculation 1 Sudden or gradual onset following normal ejaculation experiences

5 Ejaculation is defined as the release of semen from the penis during orgasm How common is premature ejaculation? Premature ejaculation is the most common male sexual dysfunction, 4 with more than one in five men affected. 5 It is not dependent on age and affects men of all ages. 6 What are the causes of premature ejaculation? The exact cause of premature ejaculation is unknown. Like other physical conditions, there may be a psychological component. 4 Premature ejaculation also involves a physical component involving neurotransmission (chemical activity in the brain) and experts believe it is caused by a chemical imbalance of serotonin. 5 How is premature ejaculation diagnosed? The diagnosis of premature ejaculation is based on your medical and sexual history. Your doctor will ask questions to determine whether your premature ejaculation is lifelong or acquired, and establish whether the condition is situational (under specific circumstances or with particular partners) or consistent. You may also be asked questions about the length of time it takes to ejaculate, the amount of sexual stimulation required for ejaculation and the impact of the condition on sexual activity and you and your partner s quality of life. 2 Your doctor may ask you to complete a questionnaire to help make an appropriate diagnosis, and a physical examination may also be required. 2

6 What is the impact of premature ejaculation? Men with premature ejaculation are more likely to experience low satisfaction with their sexual relationship and sexual intercourse, difficulty relaxing during intercourse, and less frequent intercourse. However, the negative impact of premature ejaculation can extend beyond sexual dysfunction. Premature ejaculation has a negative effect on self-confidence and your relationship with your partner, and may cause mental distress, anxiety, embarrassment and depression. 2 You have been given this leaflet as the decision has been made to treat you with PRILIGY. Please do not share your PRILIGY with others even if they are experiencing similar signs or symptoms of premature ejaculation. They may have additional conditions or be taking medications that could put them at risk of side effects if they take your PRILIGY. They should seek medical advice regarding the treatment of their condition.

7 A step-by-step guide to PRILIGY What is PRILIGY? PRILIGY is the only licensed, oral medication for the treatment of premature ejaculation in the UK. 1 It is a short-acting, fast onset Selective Serotonin Reuptake Inhibitor (SSRI), specifically developed for the treatment of premature ejaculation. 5,7 PRILIGY is shown to help men with premature ejaculation last longer during sexual intercourse, 8 and can help men feel that they have better control over their ejaculation than those men not taking PRILIGY. 5,8 PRILIGY can also help men with premature ejaculation and their partners to improve their sexual satisfaction. 8 PRILIGY is suitable for men with premature ejaculation aged years, and is only available on prescription. How does PRILIGY work?

8 PRILIGY is presumed to work by targeting the neurotransmission (chemical activity in the brain) of serotonin, and to address the imbalance of serotonin in the body. 5 Serotonin is a chemical found in the nervous system which is thought to be involved in the ejaculatory process. 9 PRILIGY works by increasing the level of serotonin in the nervous system 5 which may lead to an increase in the time to ejaculation. [insert image]

9 You should not take PRILIGY more than once every 24 hours How is PRILIGY taken? PRILIGY should be taken 1 to 3 hours before anticipated sexual activity. It is recommended that tablets are swallowed whole with a full glass of water. PRILIGY can be taken either with or without food. PRILIGY 60mg PRILIGY 30mg

10 Your PRILIGY questions answered What improvements can I expect to see during treatment with PRILIGY? During your treatment with PRILIGY you may experience: 5 An increased sense of control over ejaculation An increase in time to ejaculation An increase in sexual satisfaction The impression that your premature ejaculation has improved A decrease in levels of distress associated with your premature ejaculation Some men experience these improvements the first time they use PRILIGY, while others may need to use PRILIGY a few times before they notice any changes. What if I don t see any improvement? The recommended starting dose of PRILIGY is 30mg for all patients. If you do not see any improvements your doctor may recommend increasing your dose to 60mg. How often can I use PRILIGY? Do not increase your dose unless advised by a health professional. 60mg is the maximum recommended dose. What should I do if I take too much PRILIGY? You should not take PRILIGY more than once every 24 hours. If you have taken too many PRILIGY tablets contact your doctor immediately. Stopping Priligy Abrupt discontinuation of regular treatment may cause withdrawal side effects such as insomnia and dizziness. Overuse of the product should therefore be avoided.

11 Can I take PRILIGY with other medications? PRILIGY should not be taken with the following: Medicines containing monoamine oxidase inhibitors (MAOIs) or other medication for depression Thioridazine used for schizophrenia Certain medicines for fungal infections Certain medicines for HIV Certain antibiotics for treating infections Lithium a medicine for bipolar disorder Tryptophan a medicine used to help you sleep St. John s wort (a herbal medicine) Tramadol used to treat serious pain Medicines used to treat migraine Medication for erectile dysfunction (PDE-5 inhibitors) To be sure, you should review all your medicines, including any herbal medicines you are taking, with your healthcare professional. If you are unsure whether you can take PRILIGY with your current medication please consult your doctor.

12 If you are unsure whether you can take PRILIGY please consult your healthcare professional What are the possible side effects of PRILIGY? Like all medicines, PRILIGY can cause side effects. As we are all different these will vary from one person to another. The most common side effects are: Feeling dizzy Headache Nausea Take care whilst taking PRILIGY as it may cause fainting or dizziness. If you feel like you might faint (such as feeling dizzy or light-headed), lie down immediately so your head is lower than the rest of your body, or sit down with your head between your knees until you feel better. This will keep you from falling and hurting yourself if you do faint. To decrease the risk of fainting, follow these three easy steps: 1. Take PRILIGY with a full glass of water and do not take PRILIGY if you are dehydrated. Dehydration can occur if you have not had anything to drink for 4 to 6 hours, have an illness where you have a high temperature or are sick, have diarrhoea or if you have been sweating excessively. 2. Do not stand up quickly after you have been sitting or lying down after taking PRILIGY. 3. If you feel faint or light headed when you stand up, you should lie down with your head lower than the rest of your body, or sit with your head between your knees until you feel better.

13 Signs that fainting may occur include feeling sick, sweaty, confused, light-headed, dizzy or an abnormal heartbeat. You should stop taking PRILIGY immediately and see your doctor straight away if you experience fits or seizures, lightheadedness when you stand up, changes in your mood, thoughts of suicide or harming yourself. For a full list of possible side effects, please refer to the Patient Information Leaflet (found in the pack) provided with your PRILIGY tablets. Can I drink alcohol whilst taking PRILIGY? You should avoid combining PRILIGY with alcohol as this may increase the chances of fainting, and may also exacerbate alcoholrelated effects such as feeling dizzy, sleepy, slow reaction times or accidental injury. Can I take PRILIGY with recreational drugs? Do not use PRILIGY in combination with recreational drugs (such as ecstasy, LSD, narcotics or benzodiazepines), as this may lead to potentially serious reactions. Can I drive or operate machinery whilst taking PRILIGY? PRILIGY may cause fainting or dizziness. If you experience these symptoms you should not drive or use machinery.

14 If you suspect you do not have the real PRILIGY contact your doctor or pharmacist When should I not take PRILIGY? You should not take PRILIGY if: Your doctor has not diagnosed you with premature ejaculation You have an allergy to dapoxetine or any other ingredients in PRILIGY You have heart problems (such as heart failure or problems with heart rhythm, severe ischaemic heart disease or valvular disease) A history of fainting You have moderate or severe liver problems You suffer, or have previously suffered from mania or severe depression If you are taking any recreational drugs listed in the earlier question If you are unsure whether you can take PRILIGY please consult your healthcare professional. How is PRILIGY stored? PRILIGY does not have any special storage conditions, however, keep it out of the reach and sight of children and do not use PRILIGY after the expiry date (which is provided on the pack). How do I know my PRILIGY is genuine? PRILIGY is packaged in blister packs containing 3 or 6 film-coated tablets. The blister packs are enclosed in a trifold package, and sealed with a silver tamper-evident sticker. Once the seal has been removed, it will leave behind a sticky residue and a chequered pattern. If the seal is open or missing, please do not use the product. It is important to be wary of counterfeit medicines that could be harmful to your health. To be confident that your PRILIGY product is genuine, you should:

15 Only obtain PRILIGY from a legitimate source such as your local pharmacy or well-known pharmacy chains Be aware of what the product and package should look like; if you notice any differences in the appearance of your pack do not take the product Verify your PRILIGY at by entering the 12-digit serial number printed on the back of your pack (you do not need to enter the letters SN ) If you suspect that you do not have the real PRILIGY, do not take the product. Talk to your health care provider or pharmacist for further advice, and call the Menarini hotline ( ) If you still have questions surrounding the use of PRILIGY please ask your doctor who will be able to answer these and provide you with more information as appropriate.

16 Useful sources of information To find out more about managing premature ejaculation please visit the following websites and organisations The Sexual Advice Association T E info@sexualadviceassociation.co.uk W Relate T W The Men s Health Forum T W PRILIGY Patient Website References 1. Mohee A and Eardley I. Ther Adv Urol 2011: 3: Wespes E et al. European Association of Urology Waldinger M et al. J Sex Med 2: Hellstrom W. Int J Clin Prac 2011; 65: Pryor J et al. Lancet 2006; 368: Hatzimouratidis K et al. Eur Urol 2010; 57: Anderson K-E. Sex Med 2006; 97: Buvat J et al. Eur Urol 2009; 55: Giuliano F. Trends Neuro 2006; 30: 79-84