Sildenafil

• Erection pill
• Used to treat impotence
• Take tablet one hour before sexual activity
• Maximum use once a day
• Can cause dizziness and eye problems (caution with driving!)

Sildenafil belongs to a group of medicines called phosphodiesterase type 5 (PDE 5) inhibitors. This medicine causes the blood vessels in the penis to relax, allowing more blood to enter the penis when you are sexually aroused. Sildenafil only produces an erection in response to sexual stimulation.

Sildenafil Mylan should not be taken by men without erectile dysfunction (ED). Sildenafil Mylan is not indicated for use in women.

Sildenafil Mylan is used to treat adult 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.

Always take this medicine exactly as your doctor or pharmacist has told you. When in doubt, ask your doctor or pharmacist.

The recommended starting dose is 50 mg.

Sildenafil Mylan should be taken about one hour before sexual activity. The tablet should be swallowed whole with a glass of water. This medicine can be taken with or without food. Avoid grapefruit juice while you are taking Sildenafil Mylan. Grapefruit can seriously affect how this medicine works. Limit or stop drinking alcohol while taking this medicine. Drinking alcohol can temporarily impair your ability to get an erection and thus make Sildenafil Mylan less effective.

If you feel the effect of Sildenafil Mylan is too weak or too strong, contact your doctor or pharmacist. Sildenafil Mylan only produces an erection when you are sexually aroused.

Sildenafil Mylan normally takes about 30 to 60 minutes to take effect (or longer if you have had a rich meal), although this may vary per person.

If Sildenafil Mylan does not produce an erection, or if you lose your erection prematurely, consult your doctor.

Do not take more than one tablet of Sildenafil Mylan a day. Do not take more tablets than the doctor has indicated. If you accidentally take more tablets than prescribed, contact your doctor.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

When not to use this medicine

Do not use this medicine if:

• You are allergic to any of the ingredients in this medicine (see section'What Sildenafil Mylan contains').
• You are taking any form of nitrate medication, as this can result in dangerously low blood pressure.
• You are taking products that release nitrogen monoxide, such as amyl nitrite (‘poppers’). This too can result in dangerously low blood pressure.
• You have a serious heart or liver condition.
• You have had a recent stroke or heart attack, or have low pressure.
• You have a rare hereditary eye condition called retinitis pigmentosa.
• You have ever had loss of vision because of non-arteritic anterior ischemic optic neuropathy (NAION).

When should this medicine be used with caution?

Talk to your doctor or pharmacist before taking this medicine if:

• You have sickle cell anaemia (an abnormality of red blood cells), multiple myeloma (cancer of the bone marrow), leukaemia (cancer of the blood cells).
• You have anatomical deformation of the penis or Peyronie’s disease.
• You have heart problems. You should ask your doctor if your heart is healthy enough to handle the extra strain of having sex.
• You have a stomach ulcer or bleeding disorder (such as haemophilia).

You should not take Sildenafil Mylan if you do not have erectile dysfunction.

You should not take Sildenafil Mylan if you are a woman.

Sildenafil Mylan should not be given to individuals under the age of 18.

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 Sildenafil Mylan

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

Sildenafil Mylan 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 Mylan and when you did. Do not take Sildenafil Mylan with other medicines unless your doctor tells you that you can.

You should not take Sildenafil Mylan if you are taking medicines called nitrates or nicorandil (a nitrate-like medicine) as the combination of these products 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 (chest pain).

You should not take Sildenafil Mylan with medicines that release nitrogen monoxide, such as amyl nitrite (‘poppers’) as the combination may also lead to a dangerous fall 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 Mylan.

Certain medicines, such as ketoconazole, itraconazole, erythromycin and cimetidine can increase the effects of sildenafil while medicines such as rifampicin can make it less effective.

Some patients who take alpha-blocker therapy may experience dizziness or light-headedness. This is most likely to happen within four hours after taking Sildenafil Mylan. To reduce the chance that these symptoms might happen, your doctor may start you on a lower dose (25 mg) of Sildenafil Mylan.

You should not use Sildenafil Mylan in combination with other oral or topical ED medicines known as phosphodiesterase type 5 (PDE5) inhibitors, such as tadalafil.

You should not use Sildenafil Mylan with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or bosentan.

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects of Sildenafil Mylan are almost always mild to moderate and short lived. The most common side effects are:

• Headache.
• Nausea.
• Facial flushing.
• Hot flashes.
• Indigestion.
• Effects on vision (colour tinge to vision, blurred vision, visual disturbances).
• Nasal congestion.
• Dizziness.
• Vomiting.
• Skin rash.
• Eye irritation (e.g., eye pain, bloodshot eyes, light sensitivity, itching).
• Pounding or rapid heartbeat.
• High/low blood pressure.
• Muscle ache.
• Sleepiness.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

The active ingredient in this medicine is sildenafil.

• Each tablet contains 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 (E132), triacetin.

The manufacturer of Sildenafil is:

McDermott Laboratories Limited trading as Gerard Laboratories
35/36 Baldoyle Industrial Estate
Grange Road
Dublin 13
Ireland

Mylan Hungary Kft
H-2900 Komarom
Mylan utca 1
Hungary

Read the package leaflet closely before using Sildenafil.