Product Details

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What you need to know before you take Dapoxetine

Do not take Dapoxetineif • you are allergic to dapoxetine or any of the other ingredients of this medicine (listed in section 6) • you have heart problems, such as heart failure or problems with the heart rhythm • you have a history of fainting • you have ever had mania (symptoms include feeling over−excited, irritable or not being able to think clearly) or severe depression • you have moderate or severe liver problems. • you are taking: o Medicines for depression called ‘monoamine oxidase inhibitors’ (MAOIs) 2 o Thioridazine used for schizophrenia o Other medicines for depression o Lithium − a medicine for bipolar disorder o Linezolid − an antibiotic used to treat infections o Tryptophan − a medicine to help you sleep o St John’s wort − a herbal medicine o Tramadol − used to treat serious pain o Medicines used to treat migraines. Do not take Dapoxetineat the same time as any of the medicines listed above. If you have taken any of these medicines, you will need to wait 14 days after you stop taking it before you can start taking Priligy. Once you have stopped taking Priligy, you will need to wait 7 days before taking any of the medicines listed above. If you are not sure about what to do, talk to your doctor or pharmacist before taking this medicine. o Certain medicines for fungal infection, including ketoconazole and itraconazole o Certain medicines for HIV, including ritonavir, saquinavir, nelfinavir and atazanavir o Certain antibiotics for treating infection, including telithromycin o Nefazodone − an antidepressant Also see section “Other medicines and Priligy”. Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine. Children and adolescents This medicine should not be used in children or adolescents under age 18 years. Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Dapoxetineif: • You have not been diagnosed with premature ejaculation • You also have another sexual problem, such as erectile dysfunction • You have a history of dizziness from low blood pressure • You use recreational drugs such as ecstasy, LSD, narcotics or benzodiazepines • You drink alcohol (see section “Dapoxetinewith food, drink and alcohol”) • You have ever had a mental health problem such as depression, mania (symptoms include feeling over−excited, irritable or not being able to think clearly), bipolar disorder (symptoms include serious mood swings between mania and depression) or schizophrenia (a psychiatric disease) • You have epilepsy • You have a history of bleeding or blood clotting problems • You have kidney problems • You have, or are at risk of, high pressure in the eye (glaucoma). If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking this medicine. Before you start taking this medicine, your doctor should perform a test to make sure that your blood pressure doesn’t drop too much when you stand up from lying down. Other medicines and DapoxetineTell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines you get without a prescription, such as herbal medicines. This is because Dapoxetinecan affect the way some other medicines work. Also some other medicines can affect the way Dapoxetineworks. Therefore, use of other medicines may affect the maximum dose of Dapoxetineyou’re allowed to take. 3 Do not take Dapoxetineat the same time as any of the following medicines: • Medicines for depression called ‘monoamine oxidase inhibitors’ (MAOIs) • Thioridazine used for schizophrenia • Other medicines for depression • Lithium − a medicine for bipolar disorder • Linezolid − an antibiotic used to treat infections • Tryptophan − a medicine to help you sleep • St John’s wort − a herbal medicine • Tramadol − used to treat serious pain • Medicines used to treat migraines. Do not take Dapoxetineat the same time as any of the medicines listed above. If you have taken any of these medicines, you will need to wait 14 days after you stop taking it before you can start taking Priligy. Once you have stopped taking Priligy, you will need to wait 7 days before taking any of the medicines listed above. If you are not sure about what to do, talk to your doctor or pharmacist before taking this medicine. • Certain medicines for fungal infection, including ketoconazole and itraconazole • Certain medicines for HIV, including ritonavir, saquinavir, nelfinavir and atazanavir • Certain antibiotics for treating infection, including telithromycin • Nefazodone − an antidepressant. Tell your doctor or pharmacist if you are taking any of the following medicines: • Medicines for mental health problems other than depression • Non−steroidal anti−inflammatory medicines such as ibuprofen or acetylsalicyclic acid • Medicines to thin your blood, such as warfarin • Certain medicines used to treat erectile dysfunction, such as sildenafil, tadalafil or vardenafil, as these medicines may lower your blood pressure, possibly upon standing • Certain medicines used to treat high blood pressure and chest pain (angina) (such as verapamil and diltiazem), or enlarged prostate, as these medicines may also lower your blood pressure, possibly upon standing • Certain other medicines for fungal infection, such as fluconazole • Certain other medicines for HIV, such as amprenavir and fosamprenavir • Certain other antibiotics for treating infection, such as erythromycin and clarithromycin • Aprepitant − used to treat nausea. If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking this medicine. Dapoxetinewith food, drink and alcohol • Do not drink grapefruit juice within 24 hours prior to taking this medicine as this can increase the level of this medicine in your body. • This medicine can be taken with or without food. • You should take this medicine with at least one full glass of water. • Avoid alcohol when taking this medicine. • The effects of alcohol such as feeling dizzy, sleepy and having slow reactions, may be increased if taken with this medicine. • Drinking alcohol while taking this medicine may increase your risk of injury from fainting or from other side effects. 4 Pregnancy, breast−feeding and fertility This medicine should not be taken by women. Driving and using machines You may feel sleepy, dizzy, faint, have difficulty concentrating and blurred vision while taking this medicine. If you experience any of these or similar effects, you should avoid driving or operating hazardous machinery. The effects of alcohol may be increased if taken with this medicine and you may be more at risk of injury from fainting or from other side effects if you take this medicine with alcohol.

What you need to know before you take SILDENAFIL

Do not take SILDENAFIL − If you are allergic to sildenafil or any of the other ingredients of this medicine . − If you are taking medicines called nitrates, as the combination may lead to a dangerous fall in your blood pressure. Tell your doctor if you are taking any of these medicines which are often given for relief of angina pectoris (or “chest pain”). If you are not certain, ask your doctor or pharmacist. − If you are using any of the medicines known as nitric oxide donors such as amyl nitrite (“poppers”), as the combination may also lead to a dangerous fall in your blood pressure. − If you are taking riociguat. This drug is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs secondary to blood clots). PDE5 inhibitors, such as Sildenafil have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor. Page 2 of 6 − If you have a severe heart or liver problem. − If you have recently had a stroke or a heart attack, or if you have low blood pressure. − If you have certain rare inherited eye diseases (such as retinitis pigmentosa). − If you have ever had loss of vision due to non-arteritic anterior ischaemic optic neuropathy (NAION). Warnings and precautions Talk to your doctor, pharmacist or nurse before taking SILDENAFIL − If you have sickle cell anaemia (an abnormality of red blood cells), leukaemia (cancer of blood cells), multiple myeloma (cancer of bone marrow). − If you have a deformity of your penis or Peyronie’s Disease. − If you have problems with your heart. Your doctor should carefully check whether your heart can take the additional strain of having sex. − If you currently have a stomach ulcer, or a bleeding problems (such as haemophilia). − If you experience sudden decrease or loss of vision, stop taking SILDENAFIL and contact your doctor immediately. You should not use SILDENAFIL with any other oral or local treatments for erectile dysfunction. You should not use SILDENAFIL with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or any other PDE5 inhibitors. You should not take SILDENAFIL if you do not have erectile dysfunction. You should not take SILDENAFIL if you are a woman. Special considerations for patients with kidney or liver problems You should tell your doctor if you have kidney or liver problems. Your doctor may decide on a lower dose for you. Children and adolescents SILDENAFIL should not be given to individuals under the age of 18. Other medicines and SILDENAFIL Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. SILDENAFIL tablets may interfere with some medicines, especially those used to treat chest pain. In the event of a medical emergency, you should tell your doctor, pharmacist or nurse that you have taken SILDENAFIL and when you did. Do not take SILDENAFIL with other medicines unless your doctor tells you that you can. You should not take SILDENAFIL if you are taking medicines called nitrates, as the combination of these medicines may lead to a dangerous fall in your blood pressure. Always tell your doctor, pharmacist or nurse if you are taking any of these medicines that are often used for the relief of angina pectoris (or “chest pain”). You should not take SILDENAFIL if you are using any of the medicines known as nitric oxide donors such as amyl nitrite (“poppers”) as the combination may also lead to a dangerous fall in your blood pressure. Page 3 of 6 Tell your doctor or pharmacist if you are already taking riociguat. If you are taking medicines known as protease inhibitors, such as for the treatment of HIV, your doctor may start you on the lowest dose (25 mg) of SILDENAFIL. Some patients who take alpha-blocker therapy for the treatment of high blood pressure or prostate enlargement may experience dizziness or light-headedness, which may be caused by low blood pressure upon sitting or standing up quickly. Certain patients have experienced these symptoms when taking SILDENAFIL with alpha-blockers. This is most likely to happen within 4 hours after taking SILDENAFIL. To reduce the chance that these symptoms might happen, you should be on a regular daily dose of your alpha-blocker before you start SILDENAFIL. Your doctor may start you on a lower dose (25 mg) of SILDENAFIL. SILDENAFIL with food and drink and alcohol SILDENAFIL can be taken with or without food. However, you may find that SILDENAFIL takes longer to start working if you take it with a heavy meal. Drinking alcohol can temporarily impair your ability to get an erection. To get the maximum benefit from your medicine, you are advised not to drink excessive amounts of alcohol before taking SILDENAFIL. Pregnancy, breast-feeding and fertility SILDENAFIL is not indicated for use by women. Driving and using machines SILDENAFIL can cause dizziness and can affect vision. You should be aware of how you react to SILDENAFIL before you drive or use machinery. SILDENAFIL contains lactose If you have been told by your doctor that you have an intolerance to some sugars, such as lactose, contact your doctor before taking SILDENAFIL. SILDENAFIL contains sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.