SILDENAFIL ACTAVIS film coated tablet contains sildenafil (as citrate)

Consumer Medicine Information

WHAT IS IN THIS Sildenafil Actavis will work only if 1. you are being treated for angina LEAFLET you are sexually excited. (chest pain) or other heart conditions with certain medicines Sildenafil Actavis will not increase called nitrates. This leaflet answers some common your sex drive. questions about Sildenafil Actavis Nitrate medicines include Sildenafil Actavis is not for use in tablets. It does not contain all the glyceryl trinitrate (also called women. This medicine is available available information. It does not nitroglycerin). Common trade only with a doctor's prescription. take the place of talking to your names include tablets; such as doctor or pharmacist. Anginine, Lycinate and Nitrostat; patches such as Nitro-Dur, All medicines have risks and Transiderm-Nitro, Nitroderm benefits. Your doctor has weighed BEFORE YOU TAKE TTS and Minitran; sprays such as the risks of you taking Sildenafil SILDENAFIL ACTAVIS Nitrolingual and Glytrin and Actavis against the benefits they injections such as Gliceryl expect it will have for you. YOU MUST NOT TAKE trinitrate concentrate. It should be used only under strict SILDENAFIL ACTAVIS IF YOU Common trade names for other medical supervision. ARE TAKING ANY NITRATE nitrate preparations include MEDICATION. IT MAY LEAD tablets such as Imdur Durules, If you have any concerns about TO A SEVERE DROP IN YOUR Monodur durules, Sorbidin, using this medicine, ask your BLOOD PRESSURE, WHICH pharmacist or doctor. Isordil, Corangin, ISMO 20, MAY BE DIFFICULT TO Imtrate, Duride, Isomonit, Ikorel TREAT. Keep this leaflet with the medicine. and Sodium Nitroprusside. There You may need to read it again. BECAUSE SEXUAL ACTIVITY may be other trade names not MAY PLACE A STRAIN ON listed here. YOUR HEART, YOUR DOCTOR 2. you are using amyl nitrite WILL NEED TO CHECK 3. you have heart or blood vessel WHETHER YOU ARE FIT WHAT SILDENAFIL problems that make sexual ACTAVIS IS USED ENOUGH TO TAKE SILDENAFIL ACTAVIS. intercourse inadvisable FOR 4. you have suffered a heart attack or stroke in the last 6 months Sildenafil Actavis is used to treat When you must not take it 5. you have severe liver problems erectile dysfunction, more commonly Do not take Sildenafil Actavis if: known as impotence, in men. This is 6. your blood pressure is unusually when a man cannot get, or keep, a high or low or is not effectively hard erect penis suitable for sexual treated activity. 7. you have loss of vision in one or both eyes from an eye disease Sildenafil Actavis belongs to a group called non-arteritic anterior of medicines called ischaemic optic neuropathy phosphodiesterase type 5 inhibitors. (NAION) It works by relaxing the blood 8. you have an eye disease called vessels in your penis when you are retinitis pigmentosa sexually excited. This allows blood to flow into your penis, allowing you to get an erection in the natural way.

SILDENAFIL ACTAVIS Published by MIMS September 2014 1 9. you have an allergy to: • You are taking medicines to treat If you require further advice, you - Sildenafil Actavis or similar high blood pressure in the blood should talk with your doctor or medicines vessels in the lungs (pulmonary pharmacist. - any of the ingredients listed at arterial hypertension) including the end of this leaflet. Revatio or tracleer (bosentan). An allergic reaction can include: • You have any other medical - hives, itching or skin rash conditions. HOW TO TAKE - swelling of the face, lips or If you have not told your doctor SILDENAFIL ACTAVIS tongue which may lead to about any of the above, tell difficulty swallowing or breathing him/her before you start taking Follow all directions given to you 10. the packaging is torn or shows Sildenafil Actavis. by your doctor or pharmacist signs of tampering, or does not carefully. look quite right even if the tablets Taking other medicines They may differ from the may look alright information contained in this leaflet. Tell your doctor or pharmacist if 11. the expiry date on the pack has If you do not understand the you are taking any other passed. If it has expired or is instructions printed on the medicines, including any that you damaged, return it to your pharmacist label, ask your doctor get without a prescription from pharmacist for disposal. or pharmacist for help. your pharmacy, supermarket or health food shop. Before you start to take it How much to take Do not take Sildenafil Actavis if you Tell your doctor if: are using nitrate medicines for Your doctor will decide the correct • You have any allergies to any angina. dose for you depending on your other medicines or any other Some medicines and Sildenafil condition and response. substances such as foods, Actavis may interfere with each This can be one 25 mg tablet a day or preservatives or dyes. other. These include: one 50 mg tablet a day or one 100 • You have any other heart or • cimetidine, a medicine used to mg tablet a day. blood vessel problems. treat ulcers Do not take more than one dose of • You have previously had sudden • some medicines used to treat Sildenafil Actavis a day. loss of eyesight in one or both fungal infections including It is important to take Sildenafil eyes. ketoconazole and itraconazole • You have any of the following Actavis exactly as your doctor or • some antibiotics including pharmacist has told you. medical conditions: erythromycin and rifampicin - diabetes, especially if you also • some protease inhibitors such as have eye problems When to take it ritonavir and saquinavir for the - kidney or liver problems treatment of HIV infection Take your dose of Sildenafil Actavis - leukaemia (cancer of the blood • about one hour before you intend to cells) medicines called alpha-blockers. have sex. Swallow the tablet whole - multiple myeloma (a cancer of These are used to treat high blood with a full glass of water. the bone marrow) pressure or prostate problems - any disease or deformity of your • medicines used to treat high The amount of time Sildenafil penis blood pressure in the blood Actavis takes to start working varies - any bleeding disorder such as vessels in the lungs (pulmonary from person to person, but it haemophilia arterial hypertension) including normally takes between half an hour - stomach ulcer Tracleer (bosentan). and one hour. - a disease of the blood called These medicines may be affected by You may find Sildenafil Actavis sickle cell anaemia Sildenafil Actavis, or may affect how takes longer to work if you take it - colour vision problems well it works. You may need with a heavy meal. - previously experienced sudden different amounts of your medicines Sildenafil Actavis will work only if decrease or loss of hearing. or you may need to take different you are sexually excited. • You are receiving any other medicines. treatment for impotence. Your doctor and pharmacist have more information on medicines that you need to be careful with or avoid while taking this medicine.

SILDENAFIL ACTAVIS Published by MIMS September 2014 2 If you take too much If you get an angina attack do not • swelling of your nose (overdose) take nitrate medicines to relieve • diarrhoea the pain but tell your doctor • rash Immediately telephone your doctor immediately. Make sure your • or the Poisons Information Centre doctor knows you are taking dry mouth or dry throat on 13 11 26 for advice, or go to Sildenafil Actavis. • dry nose Accident and Emergency at the • Do not give your medicine to dry eye nearest hospital, if you think that anyone else, even if they have the • tightness in your throat you or anyone else may have taken same condition as you. • too much Sildenafil Actavis. feeling hot or irritable • redness in your mouth or tongue. Do this even if there are no signs of Things to be careful of discomfort or poisoning. Tell your doctor as soon as possible You may need urgent medical Be careful drinking alcohol while if you notice any of the following: attention. taking Sildenafil Actavis. Drinking • unusual heart beat alcohol can temporarily impair the If you take too much Sildenafil • urinary tract infection (stinging or ability to get an erection. Do not burning urine, more frequent need Actavis you are more likely to drink large amounts of alcohol to pass urine) experience side effects. before sexual activity. • blood in the urine If you experience changes in vision, • persistent headache or fainting or dizziness, when taking Sildenafil • Actavis, you should not drive or bleeding from the nose WHILE YOU ARE operate machinery. • pain or tingling in your hands, TAKING SILDENAFIL toes or feet ACTAVIS • decreased sensitivity or numbness in your mouth • irritation or feeling of having Things you must do SIDE EFFECTS something in the eye Tell any doctors, dentists and Tell your doctor or pharmacist as • swollen or puffy eye(s) pharmacists who treat you that soon as possible if you do not feel • fatigue, pain in or around the eyes well while you are taking Sildenafil you are taking this medicine. • Actavis. "red eye" due to swollen blood Stop using Sildenafil Actavis if you This medicine helps most people, but vessels in the white part of the have a loss of eyesight in one or it may have unwanted side effects in eye and in the eyelids. both eyes, experienced loss of If any of the following happen, tell hearing or have an erection that a few people. your doctor immediately or go to persists more than 4 hours. Seek All medicines can have side effects. Accident and Emergency at your medical attention urgently. Sometimes they are serious, most of nearest hospital: the time they are not. You may need If Sildenafil Actavis does not help • signs of allergy such as shortness you get an erection or if your medical attention if you get some of of breath, wheezing or difficulty erection does not last long enough the side effects. breathing; swelling of the face, to complete sexual intercourse, tell Do not be alarmed by this list of lips, tongue or other parts your doctor. In these cases, your possible side effects. You may not • chest pain doctor may decide that you need a get any of them. higher dose. • increased heart rate Ask your doctor or pharmacist to • sudden decrease or loss of If you are about to start taking any answer any questions you may hearing new medicines, especially nitrates, have. tell your doctor and pharmacist • seizures, fits or convulsions that you are taking Sildenafil If you notice any of the following • your erection be increased, Actavis. See "Before you take side effects and they worry you, tell painful or may persist for longer Sildenafil Actavis" for a list of your doctor or pharmacist: than usual. If your erection common nitrate medications. • headache, dizziness continues for four hours, or • flushing sooner if there is pain, you should Things you must not do • indigestion seek medical attention urgently. Do not use the drug amyl nitrite • heartburn (sometimes called "poppers") • nasal congestion while you are taking Sildenafil • sinus congestion Actavis.

SILDENAFIL ACTAVIS Published by MIMS September 2014 3 • rarely men have lost eyesight Keep your tablets in the pack until • colloidal anhydrous silica sometime after taking drugs to it is time to take them. • hypromellose If you take the tablets out of the pack treat erectile dysfunction (known • macrogol 400 as impotence). If you lose they may not keep well. • magnesium stearate eyesight in one or more eyes, or • Opadry complete film coating experience changes in vision such Disposal as blurring, a blue colour to your system 06B580001 white • vision or a greater awareness of If your doctor tells you to stop Opadry AMB complete film light, seek medical attention taking this medicine or the expiry coating system OY-S29019 clear urgently. date has passed, ask your pharmacist what to do with any • Supplier changes to your normal vision medicine that is left over. such as: Sildenafil Actavis is supplied in - red or yellow colour tinges to Australia by: your vision or colourless objects Actavis Pty Ltd appear coloured Level 5, 117 Harrington Street - you see a halo around lights, PRODUCT DESCRIPTION The Rocks, Sydney NSW 2000 sparks or lights when your eyes Australia are closed. This leaflet was prepared in June This is not a complete list of all What it looks like 2014. possible side effects. Others may • occur in some people and there may Sildenafil Actavis (sildenafil Australian Register Numbers be side effects not yet known. citrate) 25 mg are white to off- 25 mg tablet: AUST R 202925 white coloured, diamond shaped, 50 mg tablet: AUST R 202924 If you notice any other symptoms biconvex, film coated tablets with 100 mg tablet: AUST R 202923 that worry you, check with your "U" debossed on one side and doctor. "25" debossed on other side. Ask your doctor or pharmacist if • Sildenafil Actavis (sildenafil you don't understand anything in citrate) 50 mg are white to off- this list. white coloured, diamond shaped, biconvex, film coated tablets with "U" debossed on one side and "50" debossed on other side. AFTER TAKING • Sildenafil Actavis (sildenafil SILDENAFIL ACTAVIS citrate) 100 mg are white to off- white coloured, diamond shaped, biconvex, film coated tablets with Storage "U" debossed on one side and "100" debossed on other side. Keep it where children cannot reach it. Available* in blister cartons of 4, 8 A locked cupboard at least one-and-a and 12 tablets. half metres above the ground is a *not all pack sizes are currently good place to store medicines. marketed. Keep your tablets in a cool dry place where the temperature stays Ingredients below 25°C. Each Sildenafil Actavis tablet Do not store it or any other contains: medicine in the bathroom, near a sink, or on a window-sill. Active ingredient: • Do not leave it in the car. sildenafil citrate Heat and damp can destroy some Inactive ingredients: medicines. • lactose • maize starch • sodium starch glycollate Type A • povidone

SILDENAFIL ACTAVIS Published by MIMS September 2014 4