Sildenafil 20 mg film-coated tablets

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Sildenafil 20 mg is and what it is used for
2. What you need to know before you take Sildenafil 20 mg
3. How to take Sildenafil 20 mg
4. Possible side effects
5. How to store Sildenafil 20 mg
6. Contents of the pack and other information

• if you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
• if you are taking medicines containing nitrates, or nitric oxide donors such as amyl nitrate (“poppers”). These medicines are often given for relief of chest pain (or “angina pectoris”). Sildenafil 20 mg can cause a serious increase in the effects of these medicines. Tell your doctor if you are taking any of these medicines. If you are not certain, ask your doctor or pharmacist.
• if you are taking riociguat. This drug is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs secondary to blood clots). PDE5 inhibitors, such as Sildenafil 20 mg, have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure, tell your doctor.
• if you have recently had a stroke, a heart attack or if you have severe liver disease or very low blood pressure (< 90/50 mmHg).
• if you are taking a medicine to treat fungal infections such as ketoconazole or itraconazole or medicines containing ritonavir (for HIV).
• if you have ever had loss of vision because of a problem with blood flow to the nerve in the eye called non-arteritic anterior ischaemic optic neuropathy (NAION).

Talk to your doctor before taking Sildenafil 20 mg if you:

• have a disease due to a blocked or narrow vein in the lungs rather than a blocked or narrow artery.
• have a severe heart problem.
• have a problem with the pumping chambers of your heart.
• have high blood pressure in the blood vessels in the lungs.
• have low blood pressure at rest.
• lose a large amount of body fluids (dehydration) which can occur when you sweat a lot or do not drink enough liquids. This can happen if you are sick with a fever, vomiting, or diarrhoea.
• have a rare inherited eye disease (retinitis pigmentosa).
• have an abnormality of red blood cells (sickle cell anaemia), cancer of blood cells (leukaemia), cancer of bone marrow (multiple myeloma), or any disease or deformity of the penis.
• currently have a stomach ulcer, a bleeding disorder (such as haemophilia) or problems with nose bleeds.
• take medicines for erectile dysfunction.

When used to treat male erectile dysfunction (ED), the following visual side effects have been reported with PDE5 inhibitors, including sildenafil at an unknown frequency; partial, sudden, temporary, or permanent decrease or loss of vision in one or both eyes.

If you experience sudden decrease or loss of vision, stop taking Sildenafil 20 mg and contact your doctor immediately (see also section 4).

Prolonged and sometimes painful erections have been reported in men after taking sildenafil. If you have an erection, which lasts continuously for more than 4 hours, stop taking Sildenafil 20 mg and contact your doctor immediately (see also section 4).

Special considerations for patients with kidney or liver problems

You should tell your doctor if you have kidney or liver problems, as your dose may need to be adjusted.

Sildenafil 20 mg should not be given to children below 1 year of age.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

• Medicines containing nitrates, or nitric oxide donors such as amyl nitrate (“poppers”). These medicines are often given for relief of angina pectoris or “chest pain” (see section 2. Before you take Sildenafil 20 mg).
• Tell your doctor or pharmacist if you are already taking riociguat.
• Therapies for pulmonary hypertension (e.g. bosentan, iloprost).
• Medicines containing St. John’s Wort (herbal medicinal product), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin and phenobarbital (used, among others, to treat epilepsy).
• Blood thinning medicines (for example warfarin) although these did not result in any side effect.
• Medicines containing erythromycin, clarithromycin, telithromycin (these are antibiotics used to treat certain bacterial infections), saquinavir (for HIV) or nefazodone (for mental depression), as your dose may need to be adjusted.
• Alpha-blocker therapy (e.g. doxazosin) for the treatment of high blood pressure or prostate problems, as the combination of the two medicines may cause symptoms resulting in the lowering of your blood pressure (e.g. dizziness, light headedness).
• Medicines containing sacubitril/valsartan, used to treat heart failure.

You should not drink grapefruit juice while you are being treated with Sildenafil 20 mg.

If you are pregnant, or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Sildenafil 20 mg should not be used during pregnancy unless strictly necessary.

Sildenafil 20 mg should not be given to women of child bearing potential unless using appropriate contraceptive methods.

Sildenafil 20 mg passes into your breast milk at very low levels and would not be expected to harm your baby.

Sildenafil 20 mg can cause dizziness and can affect vision. You should be aware of how you react to the medicine before you drive or use machines.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Sildenafil 20 mg tablets contain less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

For children and adolescents aged 1 year to 17 years old, the recommended dose is either 10 mg three times a day for children and adolescents ≤ 20 kg or 20 mg three times a day for children and adolescents > 20 kg, taken with or without food. Higher doses should not be used in children. This medicine should be used only in case of administration of 20 mg three times a day. Other pharmaceutical forms may be more appropriate for administration to patients ≤ 20 kg and other younger patients who are not able to swallow tablets.

You should not take more medicine than your doctor tells you to.

If you take more medicine than you have been told to take contact your doctor immediately. Taking more Sildenafil 20 mg than you should may increase the risk of known side effects.

If you forget to take Sildenafil 20 mg film-coated tablet, take a dose as soon as you remember, then continue to take your medicine at the usual times. Do not take a double dose to make up for a forgotten dose.

Suddenly stopping your treatment with Sildenafil 20 mg may lead to your symptoms getting worse. Do not stop taking Sildenafil 20 mg unless your doctor tells you to. Your doctor may tell you to reduce the dose over a few days before stopping completely.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is sildenafil. Each tablet contains 20 mg of sildenafil (as sildenafil citrate).
• The other ingredients are:

Tablet core: Cellulose, microcrystalline, Calcium hydrogen phosphate (anhydrous), Croscarmellose sodium, Silica colloidal, Magnesium stearate.

Film coat: Hypromellose, Titanium dioxide (E171), Lactose monohydrate, Triacetin

Sildenafil 20 mg film-coated tablets are white, 6.5 mm round shaped film-coated tablets, debossed with "1A4" on one side and plain on other side.

The tablets are provided in PVC/aluminium blister packs containing 1 tablet, 10 tablets, 90 tablets and 300 tablets.

Not all pack sizes may be marketed.

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