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PACKAGE LEAFLET: INFORMATION FOR THE USER 3. How to take Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular Sildenafil 25 mg, 50 mg, 100 mg Film-Coated Tablets Always take this medicine exactly as your heartbeat, temporary decreased blood flow doctor or pharmacist has told you. Check Sildenafil to parts of the brain, feeling of tightening of with your doctor or pharmacist if you are not the throat, numb mouth, bleeding at the Read all of this leaflet carefully before you start taking this medicine because it sure. The recommended starting dose is back of the eye, double vision, reduced contains important information for you. 50 mg. sharpness of vision, abnormal sensation in - Keep this leaflet. You may need to read it again. You should not take Sildenafil more than the eye, swelling of the eye or eyelid, small - If you have any further questions, ask your doctor, pharmacist or nurse. once a day. particles or spots in your vision, seeing - This medicine has been prescribed for you only. Do not pass it on to others. It may harm Do not take Sildenafil film-coated tablets in halos around lights, dilation of the pupil of them, even if their signs of illness are the same as yours. combination with Sildenafil orodispersible the eye, discolouration of the white of the - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any tablets. eye, penile bleeding, presence of blood in possible side effects not listed in this leaflet. See section 4. You should take Sildenafil about one hour semen, dry nose, swelling of the inside of What is in this leaflet: You should not use Sildenafil with before you plan to have sex. Swallow the the nose, feeling irritable and sudden 1. What Sildenafil is and what it is used for treatments for pulmonary arterial tablet whole with a glass of water. decrease or loss of hearing. 2. What you need to know before you take hypertension (PAH) containing sildenafil or If you feel that the effect of Sildenafil is too From post-marketing experience cases of Sildenafil any other PDE5 inhibitors. strong or too weak, talk to your doctor or unstable (a heart condition) and 3. How to take Sildenafil You should not take Sildenafil if you do not pharmacist. sudden death have been reported rarely. Of 4. Possible side effects have erectile dysfunction. note, most, but not all, of the men who 5. How to store Sildenafil Sildenafil will only help you to get an experienced these side effects had heart 6. Contents of the pack and other You should not take Sildenafil if you are a erection if you are sexually stimulated. The problems before taking this medicine. It is information woman. amount of time Sildenafil takes to work not possible to determine whether these varies from person to person, but it normally Special considerations for patients with events were directly related to Sildenafil. 1. What Sildenafil is and what it takes between half an hour and one hour. kidney or liver problems is used for You may find that Sildenafil takes longer to Reporting of side effects You should tell your doctor if you have work if you take it with a heavy meal. If you get any side effects, talk to your Sildenafil contains the active substance kidney or liver problems. Your doctor may doctor or pharmacist or nurse. This includes sildenafil which belongs to a group of decide on a lower dose for you. If Sildenafil does not help you to get an any possible side effects not listed in this medicines called phosphodiesterase type 5 erection, or if your erection does not last leaflet. You can also report side effects (PDE5) inhibitors. It works by helping to Children and adolescents long enough for you to complete sexual directly via the Yellow Card Scheme relax the blood vessels in your penis, Sildenafil should not be given to individuals intercourse you should tell your doctor. website: www.mhra.gov.uk/yellowcard allowing blood to flow into your penis when under the age of 18. If you take more Sildenafil than you By reporting side effects you can help you get sexually excited. Sildenafil will only Other medicines and Sildenafil should: provide more information on the safety of help you to get an erection if you are Tell your doctor or pharmacist if you are You may experience an increase in side this medicine. sexually stimulated. taking, have recently taken or might take effects and their severity. Doses above 100 any other medicines. 5. How to store Sildenafil Sildenafil is a treatment for adult men with mg do not increase the efficacy. erectile dysfunction, sometimes known as Sildenafil tablets may interfere with some Keep this medicine out of the sight and You should not take more tablets than impotence. This is when a man cannot get medicines, especially those used to treat reach of children. your doctor tells you to. Contact your or keep a hard, erect penis suitable for chest pain. In the event of a medical doctor if you take more tablets than you This medicinal product does not require any sexual activity. emergency, you should tell your doctor, should. special storage conditions. 2. What you need to know before pharmacist or nurse that you have taken Sildenafil and when you did. Do not take If you have any further questions on the use Do not use this medicine after the expiry you take Sildenafil Sildenafil with other medicines unless your of this medicine, ask your doctor, pharmacist date which is stated on the carton and Do not take Sildenafil doctor tells you that you can. or nurse. blister after EXP. The expiry date refers to the last day of that month. • If you are allergic to sildenafil or any of You should not take Sildenafil if you are 4. Possible side effects the other ingredients of this medicine taking medicines called , as the Do not throw away any medicines via (listed in setion 6). combination of these medicines may lead to Like all medicines, this medicine can cause wastewater or household waste. Ask your • If you are taking medicines called a dangerous fall in your . side effects although not everybody gets pharmacist how to throw away medicines nitrates, as the combination may lead Always tell your doctor, pharmacist or nurse them. The side effects reported in you no longer use. These measures will help to a dangerous fall in your blood if you are taking any of these medicines that association with the use of Sildenafil are protect the environment. pressure. Tell your doctor if you are are often used for the relief of angina usually mild to moderate and of a short taking any of these medicines which are pectoris (or “chest pain”). duration. 6. Contents of the pack and often given for relief of angina pectoris If you experience any of the following other information (or “chest pain”). If you are not certain, You should not take Sildenafil if you are serious side effects stop taking Sildenafil ask your doctor or pharmacist. using any of the medicines known as nitric and seek medical help immediately: What Sildenafil contains • If you are using any of the medicines oxide donors such as amyl The active substance is Sildenafil citrate. • An allergic reaction - this occurs known as donors such (“”) as the combination may also Each 25 mg tablet contains 35.12 mg uncommonly (may affect up to 1 in 100 as amyl nitrite (“poppers”), as the lead to a dangerous fall in your blood Sildenafil citrate equivalent to 25 mg people) Symptoms include sudden combination may also lead to a pressure. Sildenafil. wheeziness, difficulty in breathing or dangerous fall in your blood pressure. Each 50 mg tablet contains 70.24 mg Tell your doctor or pharmacist if you are dizziness, swelling of the eyelids, face, • If you are taking . This is Sildenafil citrate equivalent to 50 mg already taking riociguat. lips or throat. used to treat pulmonary arterial Sildenafil. hypertension (i.e., high blood pressure If you are taking medicines known as • Chest pains - this occurs uncommonly Each 100 mg tablet contains 140.48mg in the lungs) and chronic protease inhibitors, such as for the If this occurs during or after intercourse Sildenafil citrate equivalent to 100 mg thromboembolic pulmonary treatment of HIV, your doctor may start you - Get in a semi-sitting position Sildenafil. on the lowest dose (25 mg) of Sildenafil. hypertension (i.e., high blood pressure and try to relax. The other ingredients are: in the lungs secondary to blood clots). Do not use nitrates to treat your Some patients who take alpha-blocker - Tablet core: microcrystalline cellulose, PDE5 inhibitors, such as Sildenafil chest pain. therapy for the treatment of high blood calcium hydrogen phosphate dihydrate, have been shown to increase the pressure or prostate enlargement may • Prolonged and sometimes painful croscarmellose sodium, hydroxy propyl hypotensive effects of this medicine. If experience dizziness or light-headedness, erections – this occurs rarely (may cellulose, magnesium stearate. you are taking riociguat or are unsure which may be caused by low blood pressure affect up to 1 in 1,000 people) Tablet coating: hypromellose (E464), lactose tell your doctor. upon sitting or standing up quickly. Certain If you have an erection which lasts for monohydrate, triacetin (E1518), titanium • If you have a severe heart or liver patients have experienced these symptoms more than 4 hours, you should dioxide (E171), lake indigo carmine (E132). problem. when taking Sildenafil with alpha-blockers. contact a doctor immediately. • If you have recently had a stroke or a This is most likely to happen within 4 hours What Sildenafil looks like and heart attack, or if you have low after taking Sildenafil. To reduce the chance • A sudden decrease or loss of vision– contents of the pack blood pressure. that these symptoms might happen, you this occurs rarely Each 25 mg tablet is a blue coloured, round • If you have certain rare inherited eye film-coated tablet debossed with ‘SC’ on one should be on a regular daily dose of your • Serious skin reactions – this occurs diseases (such as retinitis pigmentosa). side and ‘25’ on other side. alpha-blocker before you start Sildenafil. rarely • If you have ever had loss of vision due Each 50 mg tablet is a blue coloured, round Your doctor may start you on a lower dose Symptoms may include severe peeling to non-arteritic anterior ischaemic film-coated tablet debossed with ‘SC’ on one (25 mg) of Sildenafil. and swelling of the skin, blistering of the optic neuropathy (NAION). side and ‘50’ on other side. mouth, genitals and around the eyes, Sildenafil with food and drink and Each 100 mg tablet is a blue coloured, Warnings and precautions fever. round film-coated tablet debossed with ‘SC’ Talk to your doctor, pharmacist or nurse Sildenafil can be taken with or without food. • Seizures or fits – this occurs rarely on one side and ‘100’ on other side. before taking Sildenafil However, you may find that Sildenafil takes • If you have sickle cell anaemia (an Other side effects: Tablets are packed in boxes of 2, 4, 8, 12 or longer to start working if you take it with a abnormality of red blood cells), 24 tablets. Not all pack sizes may be heavy meal. Very common (may affect more than 1 in leukaemia (cancer of blood cells), marketed. 10 people): headache. multiple myeloma (cancer of Drinking alcohol can temporarily impair your Marketing Authorisation Holder and bone marrow). ability to get an erection. To get the Common (may affect up to 1 in 10 people): • If you have a deformity of your penis or maximum benefit from your medicine, you , facial flushing, hot flush (symptoms Manufacturer Peyronie’s Disease. are advised not to drink excessive amounts include a sudden feeling of heat in your Dr. Reddy’s Laboratories (UK) Ltd., • If you have problems with your heart. of alcohol before taking Sildenafil. upper body), indigestion, colour tinge to 6 Riverview Road, Beverley, East Yorkshire, Your doctor should carefully check vision, blurred vision, visual disturbance, HU17 0LD, United Kingdom. Pregnancy, breast-feeding and whether your heart can take the stuffy nose and dizziness. This leaflet was last revised in 09/2016 additional strain of having sex. fertility • If you currently have a stomach ulcer, or Sildenafil is not indicated for use by women. Uncommon (may affect up to 1 in 100 a bleeding problem (such as people): , skin rash, eye irritation, haemophilia). Driving and using machines bloodshot eyes/red eyes, eye pain, seeing • If you experience sudden decrease or Sildenafil can cause dizziness and can flashes of light, visual brightness, light loss of vision, stop taking Sildenafil and affect vision. You should be aware of how sensitivity, watery eyes, pounding heartbeat, contact your doctor immediately. you react to Sildenafil before you drive or rapid heartbeat, high blood pressure, low use machinery. blood pressure , muscle pain, feeling sleepy, You should not use Sildenafil with any other reduced sense of touch, vertigo, ringing in oral or local treatments for erectile Sildenafil contains lactose the ears, dry mouth, blocked or stuffy dysfunction. If you have been told by your doctor that you sinuses, inflammation of the lining of the have an intolerance to some sugars, such nose (symptoms include runny nose, as lactose, contact your doctor before taking sneezing and stuffy nose), upper abdominal Sildenafil. pain, gastro-oesophageal reflux disease (symptoms include heartburn), presence of blood in urine, pain in the arms or legs, nosebleed, feeling hot and feeling tired. 3. How to take Sildenafil Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular Always take this medicine exactly as your heartbeat, temporary decreased blood flow doctor or pharmacist has told you. Check to parts of the brain, feeling of tightening of with your doctor or pharmacist if you are not the throat, numb mouth, bleeding at the sure. The recommended starting dose is back of the eye, double vision, reduced 50 mg. sharpness of vision, abnormal sensation in You should not take Sildenafil more than the eye, swelling of the eye or eyelid, small once a day. particles or spots in your vision, seeing Do not take Sildenafil film-coated tablets in halos around lights, dilation of the pupil of combination with Sildenafil orodispersible the eye, discolouration of the white of the tablets. eye, penile bleeding, presence of blood in You should take Sildenafil about one hour semen, dry nose, swelling of the inside of What is in this leaflet: You should not use Sildenafil with before you plan to have sex. Swallow the the nose, feeling irritable and sudden 1. What Sildenafil is and what it is used for treatments for pulmonary arterial tablet whole with a glass of water. decrease or loss of hearing. 2. What you need to know before you take hypertension (PAH) containing sildenafil or If you feel that the effect of Sildenafil is too From post-marketing experience cases of Sildenafil any other PDE5 inhibitors. strong or too weak, talk to your doctor or unstable angina (a heart condition) and 3. How to take Sildenafil You should not take Sildenafil if you do not pharmacist. sudden death have been reported rarely. Of 4. Possible side effects have erectile dysfunction. note, most, but not all, of the men who 5. How to store Sildenafil Sildenafil will only help you to get an experienced these side effects had heart 6. Contents of the pack and other You should not take Sildenafil if you are a erection if you are sexually stimulated. The problems before taking this medicine. It is information woman. amount of time Sildenafil takes to work not possible to determine whether these varies from person to person, but it normally Special considerations for patients with events were directly related to Sildenafil. 1. What Sildenafil is and what it takes between half an hour and one hour. kidney or liver problems is used for You may find that Sildenafil takes longer to Reporting of side effects You should tell your doctor if you have work if you take it with a heavy meal. If you get any side effects, talk to your Sildenafil contains the active substance kidney or liver problems. Your doctor may doctor or pharmacist or nurse. This includes sildenafil which belongs to a group of decide on a lower dose for you. If Sildenafil does not help you to get an any possible side effects not listed in this medicines called phosphodiesterase type 5 erection, or if your erection does not last leaflet. You can also report side effects (PDE5) inhibitors. It works by helping to Children and adolescents long enough for you to complete sexual directly via the Yellow Card Scheme relax the blood vessels in your penis, Sildenafil should not be given to individuals intercourse you should tell your doctor. website: www.mhra.gov.uk/yellowcard allowing blood to flow into your penis when under the age of 18. If you take more Sildenafil than you By reporting side effects you can help you get sexually excited. Sildenafil will only Other medicines and Sildenafil should: provide more information on the safety of help you to get an erection if you are Tell your doctor or pharmacist if you are You may experience an increase in side this medicine. sexually stimulated. taking, have recently taken or might take effects and their severity. Doses above 100 any other medicines. 5. How to store Sildenafil Sildenafil is a treatment for adult men with mg do not increase the efficacy. erectile dysfunction, sometimes known as Sildenafil tablets may interfere with some Keep this medicine out of the sight and You should not take more tablets than impotence. This is when a man cannot get medicines, especially those used to treat reach of children. your doctor tells you to. Contact your or keep a hard, erect penis suitable for chest pain. In the event of a medical doctor if you take more tablets than you This medicinal product does not require any sexual activity. emergency, you should tell your doctor, should. special storage conditions. 2. What you need to know before pharmacist or nurse that you have taken Sildenafil and when you did. Do not take If you have any further questions on the use Do not use this medicine after the expiry you take Sildenafil Sildenafil with other medicines unless your of this medicine, ask your doctor, pharmacist date which is stated on the carton and Do not take Sildenafil doctor tells you that you can. or nurse. blister after EXP. The expiry date refers to the last day of that month. • If you are allergic to sildenafil or any of You should not take Sildenafil if you are 4. Possible side effects the other ingredients of this medicine taking medicines called nitrates, as the Do not throw away any medicines via (listed in setion 6). combination of these medicines may lead to Like all medicines, this medicine can cause wastewater or household waste. Ask your • If you are taking medicines called a dangerous fall in your blood pressure. side effects although not everybody gets pharmacist how to throw away medicines nitrates, as the combination may lead Always tell your doctor, pharmacist or nurse them. The side effects reported in you no longer use. These measures will help to a dangerous fall in your blood if you are taking any of these medicines that association with the use of Sildenafil are protect the environment. pressure. Tell your doctor if you are are often used for the relief of angina usually mild to moderate and of a short taking any of these medicines which are pectoris (or “chest pain”). duration. 6. Contents of the pack and often given for relief of angina pectoris If you experience any of the following other information (or “chest pain”). If you are not certain, You should not take Sildenafil if you are serious side effects stop taking Sildenafil ask your doctor or pharmacist. using any of the medicines known as nitric and seek medical help immediately: What Sildenafil contains • If you are using any of the medicines oxide donors such as amyl nitrite The active substance is Sildenafil citrate. • An allergic reaction - this occurs known as nitric oxide donors such (“poppers”) as the combination may also Each 25 mg tablet contains 35.12 mg uncommonly (may affect up to 1 in 100 as amyl nitrite (“poppers”), as the lead to a dangerous fall in your blood Sildenafil citrate equivalent to 25 mg people) Symptoms include sudden combination may also lead to a pressure. Sildenafil. wheeziness, difficulty in breathing or dangerous fall in your blood pressure. Each 50 mg tablet contains 70.24 mg Tell your doctor or pharmacist if you are dizziness, swelling of the eyelids, face, • If you are taking riociguat. This drug is Sildenafil citrate equivalent to 50 mg already taking riociguat. lips or throat. used to treat pulmonary arterial Sildenafil. hypertension (i.e., high blood pressure If you are taking medicines known as • Chest pains - this occurs uncommonly Each 100 mg tablet contains 140.48mg in the lungs) and chronic protease inhibitors, such as for the If this occurs during or after intercourse Sildenafil citrate equivalent to 100 mg thromboembolic pulmonary treatment of HIV, your doctor may start you - Get in a semi-sitting position Sildenafil. on the lowest dose (25 mg) of Sildenafil. hypertension (i.e., high blood pressure and try to relax. The other ingredients are: in the lungs secondary to blood clots). Do not use nitrates to treat your Some patients who take alpha-blocker - Tablet core: microcrystalline cellulose, PDE5 inhibitors, such as Sildenafil chest pain. therapy for the treatment of high blood calcium hydrogen phosphate dihydrate, have been shown to increase the pressure or prostate enlargement may • Prolonged and sometimes painful croscarmellose sodium, hydroxy propyl hypotensive effects of this medicine. If experience dizziness or light-headedness, erections – this occurs rarely (may cellulose, magnesium stearate. you are taking riociguat or are unsure which may be caused by low blood pressure affect up to 1 in 1,000 people) Tablet coating: hypromellose (E464), lactose tell your doctor. upon sitting or standing up quickly. Certain If you have an erection which lasts for monohydrate, triacetin (E1518), titanium • If you have a severe heart or liver patients have experienced these symptoms more than 4 hours, you should dioxide (E171), lake indigo carmine (E132). problem. when taking Sildenafil with alpha-blockers. contact a doctor immediately. • If you have recently had a stroke or a This is most likely to happen within 4 hours What Sildenafil looks like and heart attack, or if you have low after taking Sildenafil. To reduce the chance • A sudden decrease or loss of vision– contents of the pack blood pressure. that these symptoms might happen, you this occurs rarely Each 25 mg tablet is a blue coloured, round • If you have certain rare inherited eye film-coated tablet debossed with ‘SC’ on one should be on a regular daily dose of your • Serious skin reactions – this occurs diseases (such as retinitis pigmentosa). side and ‘25’ on other side. alpha-blocker before you start Sildenafil. rarely • If you have ever had loss of vision due Each 50 mg tablet is a blue coloured, round Your doctor may start you on a lower dose Symptoms may include severe peeling to non-arteritic anterior ischaemic film-coated tablet debossed with ‘SC’ on one (25 mg) of Sildenafil. and swelling of the skin, blistering of the optic neuropathy (NAION). side and ‘50’ on other side. mouth, genitals and around the eyes, Sildenafil with food and drink and Each 100 mg tablet is a blue coloured, Warnings and precautions fever. round film-coated tablet debossed with ‘SC’ Talk to your doctor, pharmacist or nurse alcohol Sildenafil can be taken with or without food. • Seizures or fits – this occurs rarely on one side and ‘100’ on other side. before taking Sildenafil However, you may find that Sildenafil takes • If you have sickle cell anaemia (an Other side effects: Tablets are packed in boxes of 2, 4, 8, 12 or longer to start working if you take it with a abnormality of red blood cells), 24 tablets. Not all pack sizes may be heavy meal. Very common (may affect more than 1 in leukaemia (cancer of blood cells), marketed. 10 people): headache. multiple myeloma (cancer of Drinking alcohol can temporarily impair your Marketing Authorisation Holder and bone marrow). ability to get an erection. To get the Common (may affect up to 1 in 10 people): • If you have a deformity of your penis or maximum benefit from your medicine, you nausea, facial flushing, hot flush (symptoms Manufacturer Peyronie’s Disease. are advised not to drink excessive amounts include a sudden feeling of heat in your Dr. Reddy’s Laboratories (UK) Ltd., • If you have problems with your heart. of alcohol before taking Sildenafil. upper body), indigestion, colour tinge to 6 Riverview Road, Beverley, East Yorkshire, Your doctor should carefully check vision, blurred vision, visual disturbance, HU17 0LD, United Kingdom. Pregnancy, breast-feeding and whether your heart can take the stuffy nose and dizziness. This leaflet was last revised in 09/2016 additional strain of having sex. fertility • If you currently have a stomach ulcer, or Sildenafil is not indicated for use by women. Uncommon (may affect up to 1 in 100 a bleeding problem (such as people): vomiting, skin rash, eye irritation, haemophilia). Driving and using machines bloodshot eyes/red eyes, eye pain, seeing • If you experience sudden decrease or Sildenafil can cause dizziness and can flashes of light, visual brightness, light Please note that the medicine loss of vision, stop taking Sildenafil and affect vision. You should be aware of how sensitivity, watery eyes, pounding heartbeat, you are supplied with may be contact your doctor immediately. you react to Sildenafil before you drive or rapid heartbeat, high blood pressure, low from a different manufacturer use machinery. blood pressure , muscle pain, feeling sleepy, and the Patient Information You should not use Sildenafil with any other reduced sense of touch, vertigo, ringing in Leaflet with the medicine may oral or local treatments for erectile Sildenafil contains lactose the ears, dry mouth, blocked or stuffy dysfunction. If you have been told by your doctor that you sinuses, inflammation of the lining of the differ slightly. You should have an intolerance to some sugars, such nose (symptoms include runny nose, always read the Patient as lactose, contact your doctor before taking sneezing and stuffy nose), upper abdominal Information Leaflet supplied Sildenafil. pain, gastro-oesophageal reflux disease with your medicine before you (symptoms include heartburn), presence of start taking it. blood in urine, pain in the arms or legs, nosebleed, feeling hot and feeling tired.