sildenafil citrate tablets
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about NOUMED SILDENAFIL.
It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you.
It should only be used under strict medical supervision.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
What NOUMED SILDENAFIL is used for
This medicine is used to treat erectile dysfunction, more commonly known as impotence in men. This is when a man cannot get or keep a hard erect penis suitable for sexual activity.
It contains the active ingredient sildenafil (as citrate). Sildenafil belongs to a group of medicines called phosphodiesterase type 5 inhibitors.
It works by relaxing the blood vessels in your penis when you are sexually excited. This allows blood to flow into your penis, allowing you to get an erection in the natural way.
NOUMED SILDENAFIL will work only if you are sexually excited. It will not increase your sex drive.
NOUMED SILDENAFIL is not for use in women.
This medicine is available only with a doctor’s prescription.
Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.
Before you take NOUMED SILDENAFIL
You must not take NOUMED SILDENAFIL if you are taking any nitrate medication. It may lead to a severe drop in blood pressure, which may be difficult to treat.
Because sexual activity may place a strain on your heart, your doctor will need to check whether you are fit enough to take NOUMED SILDENAFIL.
When you must not take it
Do not take this medicine if you have an allergy to:
- sildenafil, the active ingredient, or to any of the other ingredient listed at the end of this leaflet under Product Description
- any other similar medicines.
Some of the symptoms of an allergic reaction may include:
- shortness of breath
- wheezing or difficulty breathing
- swelling of the face, lips, tongue or other parts of the body
- rash, itching or hives on the skin.
Do not take NOUMED SILDENAFIL if you are being treated for angina (chest pain) or other heart conditions with certain medicines called nitrates. Nitrate medicines include glyceryl trinitrate (also called nitroglycerin) tablets, patches, sprays and injections. Other drugs with similar effects include isosorbide salts, sodium nitroprusside, amyl nitrite, nicorandil and organic nitrates.
Do not take sildenafil if you are taking guanylate cyclase stimulators (GCS), such as riociguat. GCS is a type of medicine used to treat high blood pressure in the blood vessels of the lungs caused by blood clots (chronic thromboembolic pulmonary hypertension, CTEPH) or narrowing of the vessels that carry blood from the heart to the lungs (pulmonary arterial hypertension or PAH).
Do not take NOUMED SILDENAFIL if:
- you have heart or blood vessel problems that make sexual intercourse inadvisable
- you have suffered a heart attack or stroke in the last six months
- you have severe liver problems
- your blood pressure is unusually high or low or is not effectively treated
- you have or had loss of vision in one or both eyes from an eye disease called non-arteritic anterior ischaemic optic neuropathy (NAION)
- you have an eye disease called retinitis pigmentosa
- the packaging is torn or shows signs of tampering, or if it is after the expiry date printed on the pack.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Before you start to take it
Tell your doctor if you have allergies to any other medicines or any other substances such as foods, preservatives or dyes.
Tell your doctor if you have or have had any of the following medical conditions:
- heart or blood vessel problems
- pulmonary hypertension (CTEPH or PAH)
- sudden loss of eyesight in one or both eyes
- colour vision problems
- diabetes, especially if you also have eye problems
- kidney or liver problems
- leukaemia (cancer of the blood cells)
- multiple myeloma (a cancer of the bone marrow)
- any disease or deformity of your penis
- any bleeding disorder such as haemophilia
- stomach ulcers
- a disease of the blood called sickle cell anaemia
- any other medical conditions
Tell your doctor if you are receiving any other treatment for impotence.
If you have not told your doctor or pharmacist about any of the above, tell them before you start taking NOUMED SILDENAFIL.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
Do not take NOUMED SILDENAFIL if you are using nitrates, guanylate cyclase stimulators, or other medicines described in the above section When you must not take it.
Some medicines and NOUMED SILDENAFIL may interfere with each other. These include:
- cimetidine, a medicine used to treat ulcers
- some medicines used to treat fungal infections including ketoconazole and itraconazole
- some antibiotics including erythromycin and rifampicin
- some protease inhibitors such as ritonavir and saquinavir for the treatment of HIV infection
- medicines called alpha-blockers. These are used treat high blood pressure or prostate problems
- bosentan, a medicine used to treat high blood pressure in the vessels of the lungs.
These medicines may be affected by NOUMED SILDENAFIL or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.
Ask your doctor or pharmacist, if you are not sure if you are taking any of these medicines.
How to take NOUMED SILDENAFIL
Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.
If you do not understand the instructions on the pack, ask your doctor or pharmacist for help.
How much to take
The usual dose is 50 mg taken as needed approximately one hour before sexual activity, but your doctor will decide the correct dose for you depending on your condition and response.
Do not take more than one dose of NOUMED SILDENAFIL in a day.
How to take it
Swallow the tablet with a full glass of water.
NOUMED SILDENAFIL tablets have a breaking notch and may be broken if necessary.
When to take NOUMED SILDENAFIL
Take your dose of NOUMED SILDENAFIL about one hour before you intend to have sex. The amount of time NOUMED SILDENAFIL takes to start working varies from person to person, but it normally takes between half an hour and one hour.
You may find that NOUMED SILDENAFIL takes longer to work if you take it with a heavy meal.
NOUMED SILDENAFIL will work only if you are sexually excited.
If you take too much (overdose)
Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much NOUMED SILDENAFIL. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
If you take too much NOUMED SILDENAFIL, you are more likely to experience side effects.
While you are taking NOUMED SILDENAFIL
Things you must do
Stop taking NOUMED SILDENAFIL if you have a loss of eyesight in one or both eyes, experience loss of hearing or have an erection that persists more than 4 hours. Seek medical attention urgently.
If NOUMED SILDENAFIL does not help you get an erection or if your erection does not last long enough to complete sexual intercourse, tell your doctor. In these cases, your doctor may decide that you need a higher dose.
If you are about to start taking any new medicines, especially nitrates or riociguat, tell your doctor and pharmacist that you are taking NOUMED SILDENAFIL.
Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.
Things you must not do
Do not use the drug amyl nitrite (sometimes called “poppers”) while you are taking NOUMED SILDENAFIL.
If you get an angina attack, do not take nitrate medicines to relieve the pain, but instead tell your doctor immediately. Make sure your doctor knows you are taking NOUMED SILDENAFIL.
Do not give your medicine to anyone else, even if they have the same condition as you.
Things to be careful of
Be careful drinking alcohol while taking NOUMED SILDENAFIL. Drinking alcohol can temporarily impair the ability to get an erection. Do not drink large amounts of alcohol before sexual activity.
If you experience changes in vision, or dizziness, when taking NOUMED SILDENAFIL, you should not drive or operate machinery.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking NOUMED SILDENAFIL.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
Do not be alarmed by the following lists of side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
- headache, dizziness
- hot flushes
- heart burn
- nasal congestion
- sinus congestion
- dry mouth or dry throat
- dry nose
- dry eye
- tightness in your throat
- feeling hot or irritable
- redness in your mouth or tongue
Tell your doctor as soon as possible if you notice any of the following:
- unusual heart beat
- urinary tract infection (stinging or burning urine, more frequent need to pass urine)
- blood in urine
- changes in vision such as blurring, a blue colour to your vision or a greater awareness of light
- persistent headache or fainting
- bleeding from the nose
- pain or tingling in your hands, toes or feet
- decreased sensitivity or numbness in your mouth
- irritation or feeling of having something in the eye
- swollen or puffy eye(s)
- fatigue, pain in or around the eyes
- ”red eye” due to swollen blood vessels in the white part of the eye and in the eyelids.
If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
- signs of allergy such as shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts
- chest pain
- sudden decrease or loss of hearing
- seizures, fits or convulsions
- very rarely, your erection may persist for longer than usual.
If your erection is painful or continues for four hours, you should seek medical attention urgently.
- rarely, men have lost eyesight some time after taking medicines to treat erectile dysfunction (known as impotence). It is not known at this time if NOUMED SILDENAFIL causes this.
If you lose eyesight in one or both eyes or experience changes in vision such as blurring, a blue colour to your vision or a greater awareness of light, seek medical attention urgently.
- changes to your normal vision such as:
− red or yellow colour tinges to your vision or colourless objects appear coloured
− you see a halo around lights, sparks or lights when your eyes are closed.
This is not a complete list of all possible side effects. Others may occur in some people and there may be side effects not yet known.
If you notice any other symptoms that worry you, check with your doctor. Ask your doctor or pharmacist if you don’t understand anything in this list.
After using NOUMED SILDENAFIL
Keep your medicine in the original container. If you take it out of its original container it may not keep well.
Keep your medicine in a cool dry place where the temperature stays below 30°C.
Do not store NOUMED SILDENAFIL or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.
Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.
What it looks like
NOUMED SILDENAFIL tablets are available in three strengths:
NOUMED SILDENAFIL 25mg – light blue, slightly dotted, round tablets, with a breaking notch and marked “25”. Available in blisters of 4 tablets.
NOUMED SILDENAFIL 50mg – light blue, slightly dotted, round tablets, with a cross breaking notch and marked “50”. Available in blisters of 4 and 12 tablets.
NOUMED SILDENAFIL 100mg – light blue, slightly dotted, round tablets, with a cross breaking notch and marked “100”. Available in blisters of 4 and 12 tablets.
- NOUMED SILDENAFIL 25mg – 25mg sildenafil (as citrate)
- NOUMED SILDENAFIL 50mg – 50mg sildenafil (as citrate)
- NOUMED SILDENAFIL 100mg – 100mg sildenafil (as citrate)
- microcrystalline cellulose
- calcium hydrogen phosphate
- croscarmellose sodium
- magnesium stearate
- sodium saccharin
- indigo carmine aluminium lake.
This medicine does not contain lactose, gluten, tartrazine or any other azo dyes.
Avallon Pharmaceuticals Pty Ltd
Level 5, Eden Park Drive
Macquarie Park NSW 2113
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.
Published by MIMS March 2020