VIAGRA 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

VIAGRA 50 mg Film-Coated Tablets

sildenafil

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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.

Contents of the pack

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

1. What is VIAGRA and what is it used for

VIAGRA contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by dilating the blood vessels in the penis, allowing blood to flow in when you are sexually stimulated. VIAGRA will only help you to get an erection if you are sexually stimulated.

VIAGRA is used to treat adult men with erectile dysfunction, sometimes called impotence. This is when a man cannot get, or keep, a hard erection that is sufficient for satisfactory sexual activity.

2. What you need to know before you take VIAGRA

Do not take VIAGRA

• 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 decrease in your blood pressure. Tell your doctor if you are taking any of these medicines, often used to treat angina (or “chest pain”). If you are not sure, 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 lead to a dangerous decrease in your blood pressure.

• If you are taking riociguat. This medicine 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 caused by blood clots). PDE5 inhibitors, such as VIAGRA, have shown an increase in the hypotensive effect of this medicine. If you are taking riociguat or are unsure, consult your doctor.

• If you have a severe heart or liver problem.

• If you have recently had a stroke or heart attack, or if you have low blood pressure.

• If you have a rare inherited eye disease, such as retinitis pigmentosa.

• If you have ever had loss of vision due to a condition called non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Tell your doctor, pharmacist, or nurse before you start taking VIAGRA:

• If you have sickle cell anemia (a disease of the red blood cells), leukemia (cancer of the blood cells), or multiple myeloma (cancer of the bone marrow).

• If you have a deformity of your penis or Peyronie's disease.

• If you have heart problems. Your doctor will need to check carefully whether your heart can take the additional strain of having sex.

• If you have stomach ulcers or bleeding problems (such as hemophilia).

• If you experience sudden or decreased vision loss, stop taking VIAGRA and contact your doctor immediately.

It is not recommended to take VIAGRA at the same time as any other oral or local treatment for erectile dysfunction.

Do not take VIAGRA with treatments for pulmonary arterial hypertension (PAH) that contain sildenafil or any other PDE5 inhibitor.

Do not take VIAGRA if you do not have erectile dysfunction.

The use of VIAGRA is not indicated in women.

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 to lower your dose.

Children and adolescents

The use of VIAGRA is not indicated in persons under 18 years of age.

Using VIAGRA with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

VIAGRA tablets may interact 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 are taking VIAGRA and when you last took it. Do not take VIAGRA with other medicines unless your doctor tells you to.

Do not take VIAGRA if you are taking medicines called nitrates, as the combination may lead to a dangerous decrease in your blood pressure. Always tell your doctor, pharmacist, or nurse if you are taking any of these medicines, often used to relieve angina (or “chest pain”).

Do not take VIAGRA if you are taking medicines called nitric oxide donors, such as amyl nitrite (“poppers”), as the combination may also lead to a dangerous decrease in your blood pressure.

Tell your doctor or pharmacist if you are taking riociguat.

If you are taking medicines known as protease inhibitors, such as those used to treat HIV, your doctor may recommend that you start with a 25 mg dose of VIAGRA.

Some patients who are taking alpha-blockers (used to treat high blood pressure or prostate problems) may experience dizziness or fainting when taking VIAGRA. Some patients have experienced these symptoms when taking VIAGRA with alpha-blockers. This is more likely to happen within 4 hours of taking VIAGRA.

In order to minimize the likelihood of these symptoms, you should be on a regular daily dose of your alpha-blocker before starting VIAGRA. Your doctor may recommend that you start with a lower dose (25 mg) of VIAGRA.

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

Using VIAGRA with food, drinks, and alcohol

VIAGRA can be taken with or without food. However, you may notice that VIAGRA takes a little longer to start working if you take it with a large meal.

Drinking alcohol may temporarily impair your ability to get an erection. Therefore, to get the maximum benefit from the medicine, it is recommended not to drink large amounts of alcohol before taking VIAGRA.

Pregnancy, breastfeeding, and fertility

The use of VIAGRA is not indicated in women.

Driving and using machines

VIAGRA may cause dizziness and affect your vision. You should know how you react to VIAGRA before driving or operating machinery.

VIAGRA contains lactose

If your doctor has told you that you have an intolerance to some sugars, such as lactose, ask your doctor before taking VIAGRA.

VIAGRA contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take VIAGRA

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. The recommended starting dose is 50 mg.

Do not take VIAGRA more than once a day.

Do not take VIAGRA film-coated tablets at the same time as any other medicines that contain sildenafil, including VIAGRA orodispersible tablets or VIAGRA buccal films.

You should take VIAGRA about one hour before you plan to have sex.

Swallow the tablet whole with a glass of water.

If you notice that the effect of VIAGRA is too strong or too weak, tell your doctor or pharmacist.

VIAGRA will only help you to get an erection if you are sexually stimulated. The time it takes for VIAGRA to work varies from person to person, but it normally takes between 30 minutes and 1 hour. The effect of VIAGRA may be delayed if you take it with a large meal.

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

If you take more VIAGRA than you should

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

Do not take more tablets than your doctor recommends.

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

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

4. Possible 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 VIAGRA are usually mild to moderate and are short-lived.

If you experience any of the following serious side effects, stop taking VIAGRA and seek medical attention immediately:

• Allergic reaction - this occurs uncommonly(may affect up to 1 in 100 people)

Symptoms include sudden wheezing, coughing, or shortness of breath, swelling of the eyelids, face, lips, or throat.

• Chest pain - this occurs uncommonly

If this occurs during or after intercourse:

• Sit in a semi-upright position and try to relax.
• Do not use nitratesto treat chest pain.

• Prolonged and sometimes painful erections - this occurs rarely(may affect up to 1 in 1,000 people).

If you have an erection that lasts more than 4 hours, you should contact your doctor immediately.

• Sudden or decreased vision loss - this occurs rarely

• Severe skin reactions - this occurs rarely

Symptoms can include severe skin peeling, swelling of the skin, blistering of the mouth, genitals, and around the eyes, as well as fever.

• Seizures or fits - this occurs rarely

Other side effects:

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 (including a feeling of warmth), indigestion, abnormal color vision, blurred vision, visual disturbance, nasal congestion, and dizziness.

Uncommon(may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, eye discharge/ red eyes, eye pain, seeing flashes of light, increased light sensitivity, eye swelling, palpitations, 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 nose, inflammation of the nasal mucosa (including symptoms such as runny nose, sneezing, and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (including symptoms such as heartburn), blood in urine, pain in arms or legs, nosebleeds, feeling hot, and feeling tired.

Rare(may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, temporary decrease in blood flow to some parts of the brain, feeling of tightness in the throat, numbness in the mouth, bleeding in the back of the eye, double vision, decreased sharpness of vision, abnormal sensation in the eye, eye swelling or eyelid swelling, small particles or spots in the vision, seeing halos around lights, dilation of the pupil, change in color of the white of the eye, bleeding from the penis, presence of blood in the semen, dry nose, swelling inside the nose, feeling irritable, and sudden or decreased hearing loss.

During post-marketing experience, rare cases of unstable angina (heart disease) and sudden death have been reported. Most of the men who experienced these side effects had pre-existing heart conditions before taking this medicine. It is not possible to determine whether these side effects were directly related to VIAGRA.

Reporting of side effects

If you experience 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 Spanish Medicines Surveillance System for Human Use: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing VIAGRA

Keep this medicine out of the sight and reach of children.

Do not store above 30°C.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date is the last day of the month shown.

Store in the original package to protect from moisture.

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 protect the environment.

6. Contents of the pack and other information

What VIAGRA contains

• The active substance of VIAGRA is sildenafil. Each tablet contains 50 mg of sildenafil (as citrate).
• The other ingredients are:
• Core of the tablet: microcrystalline cellulose, calcium phosphate dibasic (anhydrous), croscarmellose sodium (see section 2 “VIAGRA contains sodium”), magnesium stearate.
• Coating: hypromellose, titanium dioxide (E171), lactose monohydrate (see section 2 “VIAGRA contains lactose”), triacetin, aluminum lake containing carmine (E132).

Appearance and packaging

VIAGRA film-coated tablets (tablets) are blue, diamond-shaped, and have rounded edges. They are marked “PFIZER” on one side and “VGR 50” on the other. VIAGRA is available in blister packs containing 2, 4, 8, 12, or 24 tablets in a carton or blister pack. Not all pack sizes may be marketed.

Marketing Authorization Holder

Upjohn EESV, Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Netherlands.

Manufacturer

Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Pocé-sur-Cisse, France, or Mylan Hungary Kft., Mylan utca 1, Komárom, 2900, Hungary.

You can request more information about this medicine from the local representative of the Marketing Authorization Holder:

Spain

Viatris Pharmaceuticals, S.L.

Tel: +34 900 102 712

Date of last revision of this leaflet:{MM/AAAA}

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website http://www.ema.europa.eu/