Vigrodit®

Patient Information

Vigrodit^® contains the active substance sildenafil which 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. VIAGRA will only help you to get an erection if you are sexually stimulated.

What Vigrodit^® is used for:

Vigrodit^® is a treatment for adult men with erectile dysfunction, sometimes known as impotence. This is when a man can’nt get, or keep a hard, erect penis suitable for sexual activity.

Tell your doctor or pharmacist before using Vigrodit^® if :

• You have sickle cell anaemia, leukaemia, multiple myeloma.
• You have a deformity of your penis or Peyronie’s Disease.
• You have problems with your heart. Your doctor should carefully check whether your heart
• can take the additional strain of having sex.
• You currently have a stomach ulcer, or a bleeding problems (such as haemophilia).
• You experience sudden decrease or loss of vision, stop taking Vigrodit^® and contact your
• doctor immediately.
• You use any other oral or local treatments for erectile dysfunction.
• You use treatments for pulmonary arterial hypertension (PAH) containing sildenafil or any other PDE5 inhibitors.
• You do not have erectile dysfunction.
• You are a woman.

Know all the medicines you take. Keep a list of them with you to show your doctor and pharmacist.

Who should not take Vigrodit^®:

• If you are allergic to sildenafil or any of the other ingredients of this medicine.
• If you are taking medicines called nitrates, as the combination may lead to a dangerous fall in your blood pressure.
• 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.
• 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).

How to take your Vigrodit^®:

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

• Vigrodit^® can be taken with or without food. However, you may find that Vigrodit^® 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 Vigrodit^®.
• Vigrodit^® can cause dizziness and can affect vision. You should be aware of how you react to Vigrodit^® before you drive or use machinery.
• You should not take Vigrodit^® more than once a day.
• Do not take Vigrodit^® film-coated tablets in combination with VIAGRA orodispersible tablets.
• You should take Vigrodit^® about one hour before you plan to have sex. Swallow the tablet whole with a glass of water.
• If you feel that the effect of VIAGRA is too strong or too weak, talk to your doctor or pharmacist.
• Vigrodit^® will only help you to get an erection if you are sexually stimulated. The amount of time Vigrodit^® takes to work varies from person to person, but it normally takes between half an hour and one hour. You may find that Vigrodit^® takes longer to work if you take it with a heavy meal.
• If Vigrodit^® 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.

 While taking your medicine :

Call your doctor right away if you have experience any of the following serious side effects, stop taking Vigrodit^® and seek medical help immediately:

• An allergic reaction:Symptoms include sudden wheeziness, difficulty in breathing or dizziness, swelling of the eyelids, face, lips or throat.
• Chest pains: 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: 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.
• Serious skin reactions.
• Seizures or fits.

What to do if you take too many tablets :

Contact your doctor if you take more tablets than you should.

 Side effects :

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

• Very common: headache.
• Common: 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: 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.

Reporting of side effects:

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed here.

You can also report side effects directly via the Yellow Card Scheme at: www.dorsapharma.com/ (ADR form)

By reporting side effects, you can help provide more information on the safety of this medicine.