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PACKAGE LEAFLET: INFORMATION FOR THE USER

SILDENAFIL 25 mg FILM-COATED TABLETS SILDENAFIL 50 mg FILM-COATED TABLETS SILDENAFIL 100 mg FILM-COATED TABLETS

sildenafil

In this leaflet:

1.    What Sildenafil is and what it is used for

2.    Before you take Sildenafil

3.    How to take Sildenafil

4.    Possible side effects

5.    How to store Sildenafil

6.    Further information

1. WHAT SILDENAFIL IS AND WHAT IT IS USED FOR

Sildenafil belongs to a group of medicines called phosphodiesterase type 5 (PDE 5) 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. Sildenafil will only help you to get an erection if you are sexually stimulated. You should not take Sildenafil if you do not have erectile dysfunction.

You should not take Sildenafil if you are a woman.

Sildenafil 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.

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.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken other medicines, including medicines obtained without prescription.

Sildenafil tablets may interfere with some medicines, especially those used to treat chest pain. In the event of a medical emergency, you should tell any healthcare professional treating your condition that you have taken Sildenafil and when you did. Do not take Sildenafil with other medicines unless your doctor tells you that you can.

You should not take Sildenafil 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 Sildenafil 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 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 sildenafil with alpha-blockers. This is most likely to occur within 4 hours after taking Sildenafil. In order to reduce the likelihood that these symptoms occur, you should be on a regular daily dose of your alpha-blocker before you start Sildenafil. Your doctor may start you on a lower dose (25 mg) of Sildenafil.

2. BEFORE YOU TAKE SILDENAFIL

Do not take Sildenafil

•    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 (hypersensitive) to sildenafil or any of the other ingredients of Sildenafil.

•    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 because of non-arteritic anterior ischaemic optic neuropathy (NAION)

Take special care with Sildenafil

Tell your doctor

•    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 problem (such as haemophilia).

•    if you experience sudden decrease or loss of vision, stop taking Sildenafil and contact your doctor immediately.

You should not use Sildenafil with any other oral

or local treatments for erectile dysfunction.

Special considerations for children and

adolescents

Sildenafil should not be given to individuals

under the age of 18.

Taking Sildenafil with food and drink

Sildenafil can be taken with or without food. However, you may find that Sildenafil 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 Sildenafil.

Pregnancy and breast-feeding

Sildenafil is not indicated for use by women

Driving and using machines

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

3. HOW TO TAKE SILDENAFIL

Always take Sildenafil exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual starting dose is 50 mg.

You should not take Sildenafil more than once a day.

You should take Sildenafil about one hour before you plan to have sex. Swallow the tablet whole with a glass of water.

If you have the impression that the effect of Sildenafil is too strong or too weak, talk to your doctor or pharmacist. Sildenafil will only help you to get an erection if you are sexually stimulated. The amount of time Sildenafil takes to work varies from person to person, but it normally takes between half an hour and one hour. You may find that Sildenafil takes longer to work if you take it with a heavy meal.

If Sildenafil does not help you to get an erection, or if your erection does not last long enough for you to complete sexual intercourse you should tell your doctor.

You should not use Sildenafil more than once a day.

If you take more Sildenafil than you should

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 take more tablets than you should. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Sildenafil can cause side effects, although not everybody gets them. The side effects reported in association with the use of sildenafil are usually mild to moderate and of a short duration.

If any of the following happen, do not take more Sildenafil. Tell your doctor immediately or go to the casualty department at your nearest hospital:

All medicines including Sildenafil can cause allergic reactions. You should contact your doctor immediately if you experience any of the following symptoms after taking Sildenafil:

•    sudden wheeziness,

•    difficulty in breathing or dizziness,

•    swelling of the eyelids, face, lips or throat.

If you experience a stroke, stop taking Sildenafil and seek medical attention immediately.

If you have chest pains during or after intercourse:

•    Get in a semi-sitting position and try to relax

•    Do not use nitrates to treat your chest pain

•    Contact your doctor immediately

Prolonged and sometimes painful erections have been reported after taking Sildenafil.

If you have an erection which lasts for more than 4 hours, you should contact a doctor immediately.

If you experience a sudden decrease or loss of vision, stop taking Sildenafil and contact your doctor immediately.

Additional side effects reported from post-marketing experience include:

Sudden death, temporary decreased blood flow to parts of the brain or heart attack.

Most, but not all, of these men had heart problems before taking this medicine. It is not possible to determine whether these events were directly related to sildenafil.

Cases of convulsions or seizures and serious skin reactions characterised by rash, blisters, peeling skin and pain which require immediate medical attention have also been reported.

Other side effects reported:

Very common side effects (likely to occur in more than 1 in 10 patients):

•    headache

Common side effects (likely to occur in 1 to 10 patients in 100):

•    facial flushing, indigestion, effects on vision (including colour tinge to vision, light sensitivity, blurred vision or reduced sharpness of vision) stuffy nose and dizziness.

Uncommon side effects (likely to occur in 1 to 10 patients in 1000):

•    vomiting, skin rash, bleeding at the back of the eye, bloodshot eyes/red eyes, eye pain, double vision, abnormal sensation in the eye, irregular or rapid heartbeat, muscle pain, feeling sleepy, reduced sense of touch, vertigo, ringing in the ears, nausea, dry mouth, chest pain and feeling tired.

Rare side effects (likely to occur in 1 to 10 patients in 10000):

•    high blood pressure, low blood pressure, fainting, nosebleed and sudden decrease or loss of hearing.

Not known (frequency cannot be estimated from the available data):

•    pounding heartbeat.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet please tell your doctor.

Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy.

5.    HOW TO STORE SILDENAFIL

•    Keep out of the reach and sight of children.

•    This medicine does not require any special storage conditions.

•    Do not use Sildenafil after the expiry date which is stated on the carton and blister foil. The expiry date refers to the last day of the month.

•    Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    FURTHER INFORMATION

What Sildenafil contains

•    The active substance is sildenafil. Each tablet contain 25 mg, 50 mg or 100 mg of sildenafil (as sildenafil citrate)

•    The other ingredients are:

-    Tablet Core - Cellulose Microcrystalline, Calcium Hydrogen Phosphate Anhydrous, Croscarmellose Sodium, Magnesium Stearate

-    Film Coating - Hypromellose (E464), Titanium Dioxide (E171), Indigo Carmine Aluminium Lake (E132), Triacetin

What Sildenafil looks like and contents of the pack

The 25 mg tablets are blue film-coated, round biconvex tablets marked 'M' on one side and 'SL over 25' on the other side.

The 50 mg tablets are blue film-coated, round biconvex tablets marked 'M' on one side and 'SL over 50' on the other side.

The 100 mg tablets are blue film-coated, round biconvex tablets marked 'M' on one side and 'SL over 100' on the other side.

The tablets are provided in blister packs containing 1, 2, 4, 8 or 12 tablets. Some pack sizes may not be marketed.

Marketing Authorisation Holder

Mylan S.A.S.

117 Allee des Parcs,

69 800 Saint-Priest,

France

Manufacturers

McDermott Laboratories Limited t/a Gerard Laboratories

35/36 Baldoyle Industrial Estate,

Grange Road,

Dublin 13 Ireland

Mylan Hungary Kft.,

H-2900 Komarom, Mylan utca 1,

Hungary

This leaflet was last revised

in September 2013.    10005368