Patient Information Leaflet: Package Leaflet

VIAGRA 50 mg Film-Coated Tablets

sildenafil

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

VIAGRA contains the active ingredient sildenafilo, which belongs to a group of medicines

known as phosphodiesterase type 5 (PDE5) inhibitors. It works by dilating the blood vessels in the penis, allowing blood to flow when sexually stimulated. VIAGRA will only help you get an erection if you are sexually stimulated.

VIAGRA is indicated for the treatment of erectile dysfunction in adult men, sometimes referred to as impotence. This occurs when a man cannot obtain or maintain a firm, adequate erection for satisfactory sexual activity.

Do not take VIAGRA

• If you are allergic to sildenafil or any of the other ingredients in this medication (listed in section 6).

• If you are taking certain medications called nitrates, as the combination may lead to a dangerous drop in your blood pressure. Consult your doctor if you are taking any of these medications, which are often used to relieve chest pain (or "angina"). If you are unsure, consult your doctor or pharmacist.

• If you are using any of the medications called nitric oxide donors such as amyl nitrite ("poppers"), as the combination may lead to a dangerous drop in your blood pressure.

• If you are taking riociguat. This medication 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 clots). Phosphodiesterase type 5 inhibitors, such as Viagra, have shown to increase the hypotensive effect of this medication. 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 disorder (such as retinitis pigmentosa).

• If you have experienced previous vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take VIAGRA:

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

• If you have a penile deformity or Peyronie's disease.

• If you have heart problems. Your doctor must carefully check if your heart can handle the additional strain of sexual activity.

• If you have a current stomach ulcer or bleeding problems (such as hemophilia).

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

VIAGRA is not recommended to be taken simultaneously with any other oral or local treatment for erectile dysfunction.

Do not take VIAGRA with medications for pulmonary arterial hypertension (PAH) that contain sildenafil or any other phosphodiesterase type 5 inhibitor.

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

VIAGRA is not indicated for use in women.

Special considerations in patients with renal or hepatic problems

You must inform your doctor if you have kidney or liver problems. Your doctor may decide to reduce your dose.

Children and adolescents

VIAGRA is not indicated for use in individuals under 18 years of age.

Use of VIAGRA with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

VIAGRA tablets may interact with some medications, especially those used to treat chest pain. In case of a medical emergency, inform your doctor, pharmacist, or nurse that you are taking VIAGRA and when you took it. Do not take VIAGRA with other medications unless your doctor advises you to.

Do not take VIAGRA if you are taking nitrates, as the combination of these medications may lead to a dangerous drop in your blood pressure. Always inform your doctor, pharmacist, or nurse if you are taking any of these medications, which are often used to relieve chest pain (or "angina").

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

Inform your doctor or pharmacist if you are taking riociguat.

If you are taking medications known as protease inhibitors, such as those used to treat HIV, your doctor may recommend that you start treatment with the lowest dose (25 mg) of VIAGRA.

Some patients taking an alpha-blocker, a medication used to treat high blood pressure or prostate enlargement, may experience dizziness or lightheadedness caused by a drop in blood pressure when standing up or sitting down. Some patients have experienced these symptoms when taking VIAGRA with alpha-blockers. This is more likely to occur within 4 hours after taking VIAGRA.

To reduce the likelihood of these symptoms, you should be receiving your regular daily dose of the alpha-blocker before starting VIAGRA. Your doctor may recommend that you start treatment with the lower dose (25 mg) of VIAGRA.

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

Use of VIAGRA with food, drinks, and alcohol

VIAGRA can be taken with or without food. However, you may notice that VIAGRA takes a bit longer to take effect if taken with a large meal.

Consuming alcohol may temporarily impair your ability to achieve an erection. Therefore, to get the maximum benefit from the medication, it is recommended not to consume large amounts of alcohol before taking VIAGRA.

Pregnancy, breastfeeding, and fertility

VIAGRA is not indicated for use in women.

Driving and operating machinery

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

VIAGRA contains lactose

If your doctor has told you that you have a certain sugar intolerance, such as lactose intolerance, consult with them before taking VIAGRA.

VIAGRA contains sodium

This medication contains less than 1 mmol (23 mg) of sodium per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. The recommended starting dose is 50 mg.

Do not take VIAGRA more than once a day.

Do not take VIAGRA film-coated tablets with other medications that contain sildenafil, including VIAGRA buccal tablets or VIAGRA buccal films.

Take VIAGRA approximately one hour before planning to have sexual intercourse.

Swallow the tablet whole with a glass of water.

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

VIAGRA will only help you achieve an erection if you are sexually stimulated. The time it takes for VIAGRA to take effect varies from person to person, generally ranging from 30 minutes to one hour. The effect of VIAGRA may be delayed if taken with a large meal.

If VIAGRA does not help you achieve an erection or if the erection does not last long enough to complete sexual intercourse, consult your doctor.

If you take more VIAGRA than you should

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

Do not take more tablets than recommended by your doctor.

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

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. The side effects reported associated with the use of VIAGRA are generally of mild to moderate intensity and short duration.

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

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

The symptoms include sudden hissing while breathing, difficulty breathing or dizziness, swelling of the eyelids, face, lips, or throat.

• Chest pain - this occurs withinfrequent frequency

If they occur during or after sexual intercourse:

• Position yourself in a semi-recumbent position and try to relax.
• Do not use nitratesto treat chest pain.

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

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

• Sudden decrease or loss of vision - this occursinfrequently

• Severe skin reactions - this occursinfrequently

The symptoms may include severe peeling and swelling of the skin, vesiculation of the mouth, genitals, and around the eyes, as well as fever.

• Convulsions or seizures - this occursinfrequently

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, heat sensation (including sudden feeling of heat in the upperbody), indigestion, abnormal color perception, blurred vision, visual deterioration, nasal congestion, and dizziness.

Infrequent(may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, eye discharge/ red eyes, eye pain, flashing lights, visual clarity, light sensitivity, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling of drowsiness, reduced tactile sensation, vertigo, tinnitus in the ears, dry mouth, nasal congestion or blockage, nasal mucosa inflammation (including symptoms such as runny nose, sneezing, and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (including symptoms such as heartburn), blood in urine, arm or leg pain, nasal bleeding, feeling of heat, and feeling tired.

Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, transient decrease in blood flow to some parts of the brain, sensation of throat constriction, numbness of the mouth, bleeding in the back of the eye, double vision, visual acuity decrease, abnormal sensation in the eye, eye swelling or eyelid swelling, small particles or spots in vision, halos around lights, pupil dilation, change in color of the white part of the eye, bleeding of the penis, blood in semen, dry nose, nasal swelling, feeling of irritability, and sudden decrease or loss of hearing.

During post-marketing experience, rare cases of unstable angina (heart disease) and sudden death have been reported. It is worth noting that most men who experienced these side effects, although not all of them, had pre-existing heart problems before taking this medication. It is not possible to determine if these side effects were directly related to VIAGRA.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not store at a temperature above 30°C.

Do not use this medication after the expiration date that appears on the box and on the blister pack after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of VIAGRA

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

Appearance of the product and contents of the packaging

VIAGRA film-coated tablets are blue, rhomboid in shape, with rounded edges. They are marked with “PFIZER” on one face and “VGR 50” on the other. VIAGRA is presented in blisters containing 2, 4, 8, 12 or 24 tablets in a carton or card packaging. Possible commercialization of only some packaging sizes.

Holder of the Marketing Authorization

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

Responsible for manufacturing

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 by contacting the local representative of the marketing authorization holder:

Spain

Viatris Pharmaceuticals, S.L.

Phone: +34 900 102 712

Date of the last review of this leaflet:{MM/AAAA}

Other sources of information

The detailed information about this medicine is available on the website of the European Medicines Agencyhttp://www.ema.europa.eu/