[product name] belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by helping to relax the blood vessels in your penis, allowing blood to flow into your penis when you get sexually excited. [product name] will only help you to get an erection if you are sexually stimulated. You should not take [product name] if you do not have erectile dysfunction. You should not take [product name] if you are a woman.
[product name] is a treatment for men with erectile dysfunction, sometimes known as impotence. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity.
2. What you need to know before you take [product name]
Do not take [product name]
- If you are taking medicines called nitrates, as the combination may cause a potentially dangerous decrease 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 drugs known as nitric oxide donors such as amyl nitrite (“poppers”), as the combination may also lead to a potentially dangerous decrease in your blood pressure.
- If you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
- If you have a severe heart or liver problem.
- If you have recently had a stroke or a heart attack.
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- 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 or pharmacist before taking [product name]
- 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 in that case 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 [product name] and contact your doctor immediately.
You should not use [product name] with any other oral or local treatments for erectile dysfunction.
Children and adolescents
[product name] should not be given to individuals under the age of 18.
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.
Other medicines and [product name]
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
[product name] tablets may interfere with some medicines, especially those used to treat chest pain. In the event of a medical emergency, you should tell any health care professional treating your condition that you have taken [product name] and when you did. Do not take [product name] with other medicines unless your doctor tells you that you can.
You should not take [product name] if you are taking medicines called nitrates, as the combination of these products may cause a potentially dangerous decrease in your blood pressure. Always tell your doctor or pharmacist 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 [product name] if you are using any of the drugs known as nitric oxide donors such as amyl nitrite (“poppers”) as the combination may also lead to a potentially dangerous decrease in your blood pressure.
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 [product name].
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 [product name] with alpha-blockers. This is most likely to occur within 4 hours after taking [product name]. In order to reduce the likelihood that these symptoms occur, you should be on a
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regular daily dose of your alpha-blocker before you start [product name]. Your doctor may start you on a lower dose (25 mg) of [product name].
[product name] with food, drink and alcohol
[product name] can be taken with or without food. However, you may find that [product name] 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 [product name].
Pregnancy, breast-feeding and fertility
[product name] is not indicated for use by women.
Driving and using machines
[product name] can cause dizziness and can affect vision. You should be aware of how you react to [product name] before you drive or use machinery.
