Sildenafil 50 mg film-coated tablets

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Sildenafil tablets are and what they are used for?
2. What you need to know before you take Sildenafil tablets?
3. How to use Sildenafil tablets?
4. Possible side effects
5. How to store Sildenafil tablets?
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 called nitrates, as the combination may lead to a dangerous fall 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 medicines known as nitric oxide donors, such as amyl nitrite ("poppers"), as the combination may also lead to a dangerous fall in your blood pressure.
• 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 tablets, 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 a severe heart or liver problem.
• If you have recently had a stroke or a heart attack or 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).

Talk to your doctor or pharmacist or nurse before using Sildenafil tablets

• If you have sickle cell anaemia (an abnormality of red blood cells), leukaemia (cancer of blood cells) or 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 carefully check whether your heart can take the additional strain of having sex.
• If you currently have a stomach ulcer, or a bleeding problem (such as haemophilia).
• If you experience sudden decrease or loss of vision, stop taking this medicine and contact your doctor immediately.

You should not use this medicine with any other oral or local treatments for erectile dysfunction.

You should not use this medicine with treatments for Pulmonary arterial hypertension (PAH) containing sildenafil or any other PDE5 inhibitors.

You should not take this medicine if you do not have erectile dysfunction.

You should not use this medicine if you are a woman.

Special considerations for 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.

Children and adolescents

This medicine should not be given to individuals under the age of 18.

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

This medicine may interfere with some medicines, especially those used to treat chest pain. In the event of a medical emergency, you should tell your doctor, pharmacist or nurse that you have taken this medicine and when you did. Do not take this medicine with other medicines unless your doctor tells you that you can.

You should not take this medicine if you are taking medicines called "nitrates" as the combination of these medicines may lead to a dangerous fall in your blood pressure. Always tell your doctor, pharmacist or nurse 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 this medicine if you are using any of the medicines known as nitric oxide donors such as amyl nitrite ("poppers"), as the combination may also lead to a dangerous fall in your blood pressure.

Tell your doctor or pharmacist if you are already taking riociguat.

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 sildenafil.

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 this medicine with alpha-blockers. This is most likely to happen within 4 hours after taking this medicine. In order to reduce the chance that these symptoms might happen, you should be on a regular daily dose of your alpha-blocker before you start this medicine. Your doctor may start you on a lower dose (25 mg) of this medicine.

Tell your doctor or pharmacist if you are taking medicines containing sacubitril/valsartan, used to treat heart failure.

This medicine can be taken with or without food. However, you may find that Sildenafil tablets 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 this medicine.

This product is not indicated for use by women.

This medicine can cause dizziness and can affect vision. You should be aware of how you react to this medicine before you drive or use machinery.

If you have been told by your doctor that you have an intolerance to some sugars, such as lactose, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol sodium (23mg) per tablet, that is to say essentially “sodium-free”.

You may experience an increase in side effects and their severity. Doses above 100 mg do not increase the efficacy.

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

Contact your doctor if you have taken more tablets than you should.

• An allergic reaction - this occurs uncommonly (may affect up to 1 in 100 people) Symptoms include sudden wheeziness, difficulty in breathing or dizziness, swelling of the eyelids, face, lips or throat.
• Chest pain - this occurs uncommonly
  If this occurs during or after intercourse
• Get in a semi-sitting position and try to relax.
• Do not use nitrates to treat your chest pain.
• Prolonged and sometimes painful erections - this occurs rarely (may affect up to 1 in 1 000 people).
  If you have an erection which lasts for more than 4 hours, you should contact a doctor immediately.
• A sudden decrease or loss of vision - this occurs rarely
• Serious skin reactions - this occurs rarely
  Symptoms may include severe peeling and swelling of the skin, blistering of the mouth, genitals and around the eyes, fever.
• Seizures or fits- this occurs rarely.

Very common (may affect more than 1 in 10 people): headache.

Common (may affect up to 1 in 10 people): nausea, facial flushing, hot flush (symptoms include a sudden feeling of heat in your upper body), indigestion, colour tinge to vision, blurred vision, visual disturbance, stuffy nose and dizziness.

Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, bloodshot eyes / red eyes, eye pain, seeing flashes of light, visual brightness, light sensitivity, watery eyes, pounding heartbeat, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling sleepy, reduced sense of touch, vertigo, ringing in the ears, dry mouth, blocked or stuffy sinuses, inflammation of the lining of the nose (symptoms include runny nose, sneezing and stuffy nose), upper abdominal pain, gastro-oesophageal reflux disease (symptoms include heartburn), presence of blood in urine, pain in the arms or legs, nosebleed, feeling hot and feeling tired.

Rare (may affect up to 1 in 1 000 people): fainting, stroke, heart attack, irregular heartbeat, temporary decreased blood flow to parts of the brain, feeling of tightening of the throat, numb mouth, bleeding at the back of the eye, double vision, reduced sharpness of vision, abnormal sensation in the eye, swelling of the eye or eyelid, small particles or spots in your vision, seeing halos around lights, dilation of the pupil of the eye, discolouration of the whites of the eye, penile bleeding, presence of blood in semen, dry nose, swelling of the inside of the nose, feeling irritable and sudden decrease or loss of hearing.

From post-marketing experience cases of unstable angina (a heart condition) and sudden death have been reported rarely. Of note, most, but not all, of the men who experienced these side effects had heart problems before taking this medicine. It is not possible to determine whether these events were directly related to this medicine.

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 us obtain more information about the safety of this medicine.

The active substance is sildenafil.

• Each tablet contains 50 mg sildenafil (as sildenafil citrate).
• Each tablet contains 100 mg sildenafil (as sildenafil citrate).

The other ingredients are:

Tablet core

Calcium hydrogen phosphate

Cellulose, microcrystalline

Croscarmellose sodium

Silica, colloidal

Magnesium stearate

Film coat

Hypromellose (E464)

Indigo carmine (E132)

Lactose monohydrate

Titanium dioxide (E171)

Triacetin (E1518)

50 mg tablets

Pale blue to blue, capsule-shaped tablets, debossed with "SL50" on one side and plain on other side.

100 mg tablets

Pale blue to blue, capsule-shaped tablets, debossed with "SL100" on one side and plain on other side.

The tablets are available in blister packs of 2, 4, 8, 12 or 24 tablets.

Not all pack sizes may be marketed.