VIAGRA 25 mg FILM-COATED TABLETS

Introduction

Patient Information: Summary of Product Characteristics

VIAGRA 25 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 and other information

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 non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Before taking VIAGRA, tell your doctor 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).

• Have a deformity of your penis or Peyronie's disease.

• Have heart problems. Your doctor will need to check carefully if your heart can cope with the extra strain of having sex.

• Have stomach ulcers or bleeding problems (such as hemophilia).

• Experience sudden severe decrease or loss of vision, stop taking VIAGRA and contact your doctor immediately.

It is not recommended to take VIAGRA with other treatments 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

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 that you have taken VIAGRA and when you 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 enlargement, may experience dizziness or fainting when standing up quickly. Some patients have experienced these symptoms when taking VIAGRA with alpha-blockers. This is more likely to happen within 4 hours of taking VIAGRA.

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 advise you to 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 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 advised 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 sodium (23 mg) per tablet, which is essentially “sodium-free”.

3. How to take VIAGRA

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

Do not take more than one dose of VIAGRA per day.

Do not take VIAGRA film-coated tablets at the same time as other medicines for erectile dysfunction.

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

Swallow the tablet whole with a glass of water.

If you experience the effect of VIAGRA as too strong or too weak, talk to your doctor or pharmacist.

VIAGRA will only help you to get an erection if you are sexually stimulated. The time VIAGRA takes 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 do not get an erection after taking VIAGRA, or if the erection does not last long enough 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 has recommended.

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, chest pain, shortness of breath, or swelling of the face, lips, tongue, 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 severe decrease or loss of vision - this occurs rarely

• Severe skin reactions - this occurs rarely

Symptoms can include severe flaking or peeling of the skin, blistering of the mouth, genitals, and around the eyes, and 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 swelling/redness, eye pain, seeing flashes of light, increased light sensitivity, eye discomfort, 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 mucous membrane of the nose (including symptoms such as stuffiness, runny nose, and sneezing), 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 eye, double vision, decreased sharpness of vision, abnormal sensation in the eye, swelling of the eye or eyelid, small particles or spots in the eyes, seeing halos around lights, dilation of the pupil, change in color of the white part of the eye, bleeding from the penis, presence of blood in the semen, dry nose, swelling inside the nose, feeling irritable, and sudden decrease or loss of hearing.

During post-marketing experience, there have been rare reports of unstable angina (heart disease) and sudden death. 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 VIAGRA.

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 in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: 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. This 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 25 mg of sildenafil (as citrate).
• The other ingredients are:
• Core of the tablet: microcrystalline cellulose, calcium phosphate (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 indigo 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 25” on the other. VIAGRA is available in blisters containing 2, 4, 8, or 12 tablets. 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 ask for 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/YYYY}

Other sources of information

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