NOUMED SILDENAFIL sildenafil citrate tablets Consumer Medicine Information What is in this leaflet • swelling of the face, lips, tongue or other • a disease of the blood called sickle cell parts of the body anaemia This leaflet answers some common questions • rash, itching or hives on the skin. • any other medical conditions about NOUMED SILDENAFIL. Do not take NOUMED SILDENAFIL if Tell your doctor if you are receiving any It does not contain all the available you are being treated for angina (chest other treatment for impotence. information. It does not take the place of pain) or other heart conditions with talking to your doctor or pharmacist. If you have not told your doctor or certain medicines called nitrates. pharmacist about any of the above, tell All medicines have risks and benefits. Your Nitrate medicines include glyceryl trinitrate them before you start taking NOUMED doctor has weighed the risks of you taking (also called nitroglycerin) tablets, patches, SILDENAFIL. this medicine against the benefits they expect sprays and injections. Other drugs with Taking other medicines it will have for you. similar effects include isosorbide salts, It should only be used under strict medical sodium nitroprusside, amyl nitrite, nicorandil Tell your doctor or pharmacist if you are supervision. and organic nitrates. taking any other medicines, including any that you get without a prescription from If you have any concerns about taking this Do not take sildenafil if you are taking your pharmacy, supermarket or health medicine, ask your doctor or pharmacist. guanylate cyclase stimulators (GCS), such food shop. Keep this leaflet with the medicine. as riociguat. You may need to read it again. GCS is a type of medicine used to treat high Do not take NOUMED SILDENAFIL if blood pressure in the blood vessels of the you are using nitrates, guanylate cyclase lungs caused by blood clots (chronic stimulators, or other medicines described What NOUMED SILDENAFIL is in the above section When you must not used for thromboembolic pulmonary hypertension, CTEPH) or narrowing of the vessels that take it. This medicine is used to treat erectile carry blood from the heart to the lungs Some medicines and NOUMED dysfunction, more commonly known as (pulmonary arterial hypertension or PAH). SILDENAFIL may interfere with each other. impotence in men. This is when a man Do not take NOUMED SILDENAFIL if: These include: cannot get or keep a hard erect penis suitable • you have heart or blood vessel • cimetidine, a medicine used to treat for sexual activity. problems that make sexual ulcers It contains the active ingredient sildenafil (as intercourse inadvisable • some medicines used to treat fungal citrate). Sildenafil belongs to a group of • you have suffered a heart attack or infections including ketoconazole and medicines called phosphodiesterase type 5 stroke in the last six months itraconazole inhibitors. • you have severe liver problems • some antibiotics including erythromycin It works by relaxing the blood vessels in and rifampicin your penis when you are sexually excited. • your blood pressure is unusually high • some protease inhibitors such as This allows blood to flow into your penis, or low or is not effectively treated ritonavir and saquinavir for the treatment allowing you to get an erection in the natural • you have or had loss of vision in one of HIV infection way. or both eyes from an eye disease called • medicines called alpha-blockers. These NOUMED SILDENAFIL will work only if non-arteritic anterior ischaemic optic are used treat high blood pressure or you are sexually excited. It will not increase neuropathy (NAION) prostate problems your sex drive. • you have an eye disease called retinitis • bosentan, a medicine used to treat high NOUMED SILDENAFIL is not for use in pigmentosa blood pressure in the vessels of the women. • the packaging is torn or shows signs of lungs. This medicine is available only with a tampering, or if it is after the expiry These medicines may be affected by doctor's prescription. date printed on the pack. If it has expired or is damaged, return it NOUMED SILDENAFIL or may affect how Ask your doctor if you have any questions to your pharmacist for disposal. well it works. You may need different about why this medicine has been amounts of your medicines, or you may need If you are not sure whether you should prescribed for you. to take different medicines. Your doctor may have prescribed it for start taking this medicine, talk to your Your doctor and pharmacist have more another reason. doctor. information on medicines to be careful with Before you start to take it or avoid while taking this medicine. Before you take NOUMED Tell your doctor if you have allergies to Ask your doctor or pharmacist, if you are not SILDENAFIL any other medicines or any other sure if you are taking any of these medicines. You must not take NOUMED substances such as foods, preservatives or dyes. SILDENAFIL if you are taking any How to take NOUMED SILDENAFIL nitrate medication. It may lead to a severe Tell your doctor if you have or have had drop in blood pressure, which may be any of the following medical conditions: Follow all directions given to you by your difficult to treat. • heart or blood vessel problems doctor or pharmacist carefully. They may differ from the information Because sexual activity may place a strain • pulmonary hypertension (CTEPH or contained in this leaflet. on your heart, your doctor will need to PAH) If you do not understand the instructions check whether you are fit enough to take • sudden loss of eyesight in one or both NOUMED SILDENAFIL. on the pack, ask your doctor or eyes pharmacist for help. When you must not take it • colour vision problems How much to take Do not take this medicine if you have an • diabetes, especially if you also have eye The usual dose is 50 mg taken as needed allergy to: problems approximately one hour before sexual • sildenafil, the active ingredient, or to any • kidney or liver problems activity, but your doctor will decide the of the other ingredient listed at the end • leukaemia (cancer of the blood cells) correct dose for you depending on your of this leaflet under Product Description • multiple myeloma (a cancer of the bone condition and response. • any other similar medicines. marrow) Do not take more than one dose of Some of the symptoms of an allergic reaction • any disease or deformity of your penis NOUMED SILDENAFIL in a day. may include: • any bleeding disorder such as How to take it • shortness of breath haemophilia Swallow the tablet with a full glass of • wheezing or difficulty breathing • stomach ulcers water.

NOUMED SILDENAFIL Published by MIMS March 2020 1 NOUMED SILDENAFIL tablets have a Side effects • rarely, men have lost eyesight some time breaking notch and may be broken if after taking medicines to treat erectile necessary. Tell your doctor or pharmacist as soon as dysfunction (known as impotence). It is possible if you do not feel well while you not known at this time if NOUMED When to take NOUMED are taking NOUMED SILDENAFIL. SILDENAFIL SILDENAFIL causes this. All medicines can have side effects. If you lose eyesight in one or both eyes Take your dose of NOUMED Sometimes they are serious, most of the time or experience changes in vision such SILDENAFIL about one hour before you they are not. You may need medical attention as blurring, a blue colour to your intend to have sex. if you get some of the side effects. vision or a greater awareness of light, The amount of time NOUMED Do not be alarmed by the following lists of seek medical attention urgently. SILDENAFIL takes to start working varies side effects. You may not experience any • changes to your normal vision such as: from person to person, but it normally takes of them. − red or yellow colour tinges to your between half an hour and one hour. Ask your doctor or pharmacist to answer vision or colourless objects appear You may find that NOUMED SILDENAFIL any questions you may have. coloured takes longer to work if you take it with a − you see a halo around lights, sparks or heavy meal. Tell your doctor or pharmacist if you notice any of the following and they worry lights when your eyes are closed. NOUMED SILDENAFIL will work only if you: This is not a complete list of all possible side you are sexually excited. • headache, dizziness effects. Others may occur in some people If you take too much (overdose) and there may be side effects not yet known. • flushing Immediately telephone your doctor or the If you notice any other symptoms that Poisons Information Centre (telephone 13 • hot flushes worry you, check with your doctor. Ask 11 26) for advice, or go to Accident and • indigestion your doctor or pharmacist if you don't Emergency at the nearest hospital, if you • heart burn understand anything in this list. think that you or anyone else may have • nasal congestion taken too much NOUMED SILDENAFIL. • sinus congestion After using NOUMED SILDENAFIL Do this even if there are no signs of discomfort or poisoning. • diarrhoea Storage You may need urgent medical attention. • rash Keep your medicine in the original If you take too much NOUMED • dry mouth or dry throat container. SILDENAFIL, you are more likely to • dry nose If you take it out of its original container it may not keep well. experience side effects. • dry eye Keep your medicine in a cool dry place • tightness in your throat While you are taking NOUMED where the temperature stays below 30°C. • feeling hot or irritable SILDENAFIL Do not store NOUMED SILDENAFIL or • redness in your mouth or tongue any other medicine in the bathroom or near a Things you must do Tell your doctor as soon as possible if you sink. Do not leave it on a window sill or in Stop taking NOUMED SILDENAFIL if notice any of the following: the car. Heat and dampness can destroy some you have a loss of eyesight in one or both • unusual heart beat medicines. eyes, experience loss of hearing or have an • urinary tract infection (stinging or Keep it where children cannot reach it. erection that persists more than 4 hours. A locked cupboard at least one-and-a-half Seek medical attention urgently. burning urine, more frequent need to pass urine) metres above the ground is a good place to If NOUMED SILDENAFIL does not help store medicines. • blood in urine you get an erection or if your erection does Disposal not last long enough to complete sexual • changes in vision such as blurring, a intercourse, tell your doctor. blue colour to your vision or a greater If your doctor tells you to stop taking this In these cases, your doctor may decide that awareness of light medicine or the expiry date has passed, you need a higher dose. • persistent headache or fainting ask your pharmacist what to do with any medicine that is left over. If you are about to start taking any new • bleeding from the nose medicines, especially nitrates or riociguat, • pain or tingling in your hands, toes or Product description tell your doctor and pharmacist that you feet are taking NOUMED SILDENAFIL. • decreased sensitivity or numbness in What it looks like Tell any other doctors, dentists, and your mouth NOUMED SILDENAFIL tablets are pharmacists who treat you that you are • irritation or feeling of having something available in three strengths: taking this medicine. in the eye NOUMED SILDENAFIL 25mg - light blue, Things you must not do • swollen or puffy eye(s) slightly dotted, round tablets, with a breaking notch and marked "25". Available in blisters Do not use the drug amyl nitrite • fatigue, pain in or around the eyes (sometimes called "poppers") while you of 4 tablets. • ''red eye'' due to swollen blood vessels in are taking NOUMED SILDENAFIL. NOUMED SILDENAFIL 50mg - light blue, the white part of the eye and in the slightly dotted, round tablets, with a cross If you get an angina attack, do not take eyelids. nitrate medicines to relieve the pain, but breaking notch and marked "50". Available If any of the following happen, tell your instead tell your doctor immediately. in blisters of 4 and 12 tablets. doctor immediately or go to Accident and Make sure your doctor knows you are NOUMED SILDENAFIL 100mg - light Emergency at your nearest hospital: taking NOUMED SILDENAFIL. blue, slightly dotted, round tablets, with a • signs of allergy such as shortness of Do not give your medicine to anyone else, cross breaking notch and marked "100". breath, wheezing or difficulty breathing; even if they have the same condition as Available in blisters of 4 and 12 tablets. swelling of the face, lips, tongue or other you. parts Ingredients Things to be careful of • chest pain Active ingredients: Be careful drinking alcohol while taking • sudden decrease or loss of hearing • NOUMED SILDENAFIL 25mg - 25mg NOUMED SILDENAFIL. sildenafil (as citrate) • seizures, fits or convulsions Drinking alcohol can temporarily impair the • NOUMED SILDENAFIL 50mg - 50mg ability to get an erection. Do not drink large • very rarely, your erection may persist for sildenafil (as citrate) longer than usual. amounts of alcohol before sexual activity. • NOUMED SILDENAFIL 100mg - If you experience changes in vision, or If your erection is painful or continues for four hours, you should seek 100mg sildenafil (as citrate) dizziness, when taking NOUMED Inactive ingredients: SILDENAFIL, you should not drive or medical attention urgently. operate machinery. • microcrystalline cellulose

NOUMED SILDENAFIL Published by MIMS March 2020 2 • calcium hydrogen phosphate • copovidone • croscarmellose sodium • magnesium stearate • sodium saccharin • indigo carmine aluminium lake. This medicine does not contain lactose, gluten, tartrazine or any other azo dyes. Sponsor Avallon Pharmaceuticals Pty Ltd Level 5, Eden Park Drive Macquarie Park NSW 2113 Australia Tel 1800 930 999 Australian Registration Numbers NOUMED SILDENAFIL 25mg tablets: AUST R 285698 (blisters) NOUMED SILDENAFIL 50mg tablets: AUST R 285699 (blisters) NOUMED SILDENAFIL 100mg tablets: AUST R 285700 (blisters) This leaflet was revised in January 2020.

NOUMED SILDENAFIL Published by MIMS March 2020 3