Viagra 25 mg film-coated tablets
Spain
Table of Contents
Patient Information Leaflet
Introduction
Package Leaflet: Information for the Patient
VIAGRA 25 mg film-coated tablets
sildenafil
Read the entire leaflet carefully before you start taking this medicine, as 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 and must not be given to others, even if they have the same symptoms as you, because it may harm them.
- If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.
Leaflet Contents
- What VIAGRA is and what it is used for
- What you need to know before taking VIAGRA
- How to take VIAGRA
- Possible side effects
- How to store VIAGRA
- Contents of the pack and other information
1. What VIAGRA is and what it is 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 flow into it when sexually stimulated. VIAGRA will only help you achieve 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 is unable to achieve or maintain a firm erection suitable for satisfactory sexual activity.
2. What you need to know before taking 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 drop in blood pressure. Consult your doctor if you are taking any of these medicines, which are often prescribed to relieve angina (or "chest pain"). If you are unsure, consult your doctor or pharmacist.
-
If you are using any medicines known as nitric oxide donors, such as amyl nitrite ("poppers"), as the combination may cause a dangerous drop in 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 been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or are unsure, consult your doctor.
-
If you have a serious 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 previously experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before starting VIAGRA:
-
If you have sickle cell anemia (an abnormality of red blood cells), leukemia (cancer of 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 should carefully assess whether your heart can tolerate the additional strain of sexual activity.
-
If you currently have a stomach ulcer or bleeding disorders (such as hemophilia).
-
If you experience sudden decrease or loss of vision, stop taking VIAGRA and contact your doctor immediately.
It is not recommended to use VIAGRA simultaneously with any other oral or local treatments for erectile dysfunction.
You should not take VIAGRA with treatments for pulmonary arterial hypertension (PAH) that contain sildenafil or any other PDE5 inhibitor.
You should not take VIAGRA if you do not have erectile dysfunction.
The use of VIAGRA is not indicated in women.
Special considerations in patients with kidney or liver problems
Inform your doctor if you have kidney or liver problems. Your doctor may decide to reduce your dose.
Children and adolescents
The use of VIAGRA is not indicated in individuals under 18 years of age.
Taking VIAGRA with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
VIAGRA tablets may interact with certain medicines, especially those used to treat chest pain. In a medical emergency, you must inform your doctor, pharmacist, or nurse that you are taking VIAGRA and when you took it. Do not take VIAGRA with other medicines unless your doctor advises you to do so.
Do not take VIAGRA if you are taking medicines called nitrates, as the combination of these medicines may cause a dangerous drop in blood pressure. Always inform your doctor, pharmacist, or nurse if you are taking any of these medicines, which are often used to relieve angina (or "chest pain").
Do not take VIAGRA if you are taking medicines known as nitric oxide donors, such as amyl nitrite ("poppers"), as the combination may also cause a dangerous drop in blood pressure.
Inform your doctor or pharmacist if you are taking riociguat.
If you are taking medicines known as protease inhibitors, such as those used in the treatment of HIV, your doctor may recommend starting treatment with the lowest dose (25 mg) of VIAGRA.
Some patients receiving an alpha-blocker, a medicine used to treat high blood pressure or benign prostatic hyperplasia, may experience dizziness or lightheadedness caused by a drop in blood pressure when sitting down or standing up quickly. 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 already be on a regular daily dose of the alpha-blocker before starting VIAGRA. Your doctor may advise you to start treatment with the lowest dose (25 mg) of VIAGRA.
Inform your doctor or pharmacist if you are taking medicines containing sacubitril/valsartan, used to treat heart failure.
Taking VIAGRA with food, drinks, and alcohol
VIAGRA can be taken with or without food. However, you may notice that VIAGRA takes slightly longer to work if taken with a heavy meal.
Drinking alcohol may temporarily impair your ability to get an erection. Therefore, to achieve the maximum benefit from the medicine, it is advisable 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 vision. You should know how you react to VIAGRA before driving or operating machinery.
VIAGRA contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, such as lactose, consult with him before taking VIAGRA.
VIAGRA contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; i.e., essentially "sodium-free".
3. How to take VIAGRA
Follow exactly the instructions for using this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. The recommended starting dose is 50 mg.
VIAGRA must not be taken more than once a day.
Do not take VIAGRA film-coated tablets together with other medicines containing sildenafil, including VIAGRA bucodispersable tablets or VIAGRA bucodispersable films.
You should 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 required for VIAGRA to take effect varies from person to person, usually between half an hour and one hour. The effect of VIAGRA may be delayed if taken with a heavy 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 the frequency and severity of adverse effects. Doses higher than 100 mg do not increase efficacy.
You must not take more tablets than recommended by your doctor.
Contact your doctor if you have taken more tablets than advised.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them. Adverse effects reported with the use of VIAGRA are generally mild to moderate in intensity and short-lived.
If you experience any of the following serious adverse effects, stop taking VIAGRA and seek immediate medical attention:
- Allergic reaction – this occurs uncommonly (may affect up to 1 in 100 people)
Symptoms include sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips, or throat.
- Chest pain – this occurs uncommonly
If chest pain occurs during or after sexual activity:
-
Sit in a semi-upright position and try to relax.
-
Do not use nitrates to 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 lasting more than 4 hours, you must contact your doctor immediately.
-
Sudden decrease or loss of vision – this occurs rarely
-
Severe skin reactions – this occurs rarely
Symptoms may include severe peeling and swelling of the skin, blistering in the mouth, genital area, and around the eyes, as well as fever.
- Seizures or fits – this occurs rarely
Other adverse 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 flushes (symptoms include sudden sensation of heat in the upper body), indigestion, abnormal colour 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 flashing lights, visual clarity, light sensitivity, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, reduced sense of touch, vertigo, tinnitus (ringing in the ears), dry mouth, nasal blockage or congestion, swelling of the nasal mucosa (symptoms include runny nose, sneezing, and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (symptoms include heartburn), blood in urine, pain in arms or legs, nosebleeds, sensation of warmth, and feeling of fatigue.
Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, transient reduction in blood flow to parts of the brain, sensation of throat tightness, numbness of the mouth, bleeding behind the eye, double vision, decreased visual acuity, abnormal sensation in the eye, eye or eyelid swelling, small particles or spots in vision, seeing halos around lights, pupil dilation, change in colour of the white part of the eye, penile bleeding, blood in semen, dry nose, swelling inside the nose, feeling irritable, 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 should be noted that most men who experienced these adverse effects, although not all, had pre-existing heart conditions before taking this medicine. It is not possible to determine whether these adverse effects were directly related to VIAGRA.
Reporting of adverse effects
If you experience any adverse effects, talk to your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of VIAGRA
Keep this medicine out of sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.
Store in the original packaging to protect it from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of VIAGRA
- The active substance in VIAGRA is sildenafil. Each tablet contains 25 mg of sildenafil (as citrate).
- The other components are:
- Tablet core: microcrystalline cellulose, calcium phosphate dibasic (anhydrous), sodium croscarmellose (see section 2 “VIAGRA contains sodium”), magnesium stearate.
- Film coating: hypromellose, titanium dioxide (E171), monohydrate lactose (see section 2 “VIAGRA contains lactose”), triacetin, aluminium lake containing indigo carmine (E132).
Appearance of the product and contents of the pack
VIAGRA film-coated tablets (tablets) are blue, diamond-shaped, with rounded edges. They are marked with “PFIZER” on one side and “VGR 25” on the other. VIAGRA is available in blisters containing 2, 4, 8 or 12 tablets. Only certain pack sizes may be marketed.
Marketing Authorization Holder
Upjohn EESV, Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, The Netherlands.
Manufacturer responsible for production
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 further information about this medicinal product by contacting the local representative of the Marketing Authorization Holder:
Spain
Viatris Pharmaceuticals, S.L.
Tel: +34 900 102 712
Date of the most recent revision of this leaflet: {MM/YYYY}
Other sources of information
Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu/