25 mg film-coated tablets
sildenafil
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 inhibitors (PDE5 inhibitors). It works by making it easier for the blood vessels in your penis to dilate so that blood can flow in when you are sexually stimulated. VIAGRA only facilitates getting an erection if you are sexually stimulated.
VIAGRA is a treatment for adult men with erectile dysfunction, better known as impotence. This means that a man cannot get, or maintain, a hard erect penis sufficient for sexual intercourse.
What you need to know before using 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 known as nitrates, as they, in combination with VIAGRA, can lead to a severe drop in blood pressure. Tell your doctor if you are taking any of these medicines, which are often given to relieve angina pectoris or ‘chest pain’. Ask your doctor or pharmacist if you are unsure
- if you are taking medicines known as nitric oxide donors such as amyl nitrite (“poppers”), as a combination of such medicines with VIAGRA may also lead to a severe drop in blood pressure
- if you take riociguat. This medicine is used to treat pulmonary arterial hypertension (ie high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (ie high blood pressure in the lungs due to blood clots). PDE5 inhibitors, such as VIAGRA, have been shown to increase the blood pressure-lowering effect of this drug. If you are taking riociguat or if you are not sure, talk to your doctor.
- if you have serious heart or liver problems
- if you have recently had a stroke or heart attack or if you have low blood pressure
- if you have certain, rare, hereditary eye diseases (such as retinitis pigmentosa )
- if you have ever lost your sight due to non-arteritic anterior ischemic optic infarct/neuropathy (NAION).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking VIAGRA
- if you have sickle cell anemia (abnormal red blood cells ), leukemia (blood cell cancer), multiple myeloma (cancer of the bone marrow )
- if you have a deformed penis or any disease of the penis such as Peyronie’s disease
- if you have heart problems. Your doctor should carefully check whether your heart can withstand the increased strain of sexual activity.
- if you currently have a stomach ulcer or a bleeding disorder (such as hemophilia)
- if you experience a sudden worsening or loss of vision, stop taking VIAGRA and contact your doctor immediately
You should not use VIAGRA at the same time as any other ( oral or local) treatment for erectile dysfunction.
You should not use VIAGRA at the same time as any treatment for pulmonary arterial hypertension (PAH) that contains sildenafil or any other PDE5 inhibitors.
You should not take VIAGRA if you do not have erectile dysfunction.
You should not take VIAGRA if you are a woman.
Especially to be taken into account when it comes to patients with liver or kidney problems
You should tell your doctor if you have kidney or liver problems. Your doctor can decide your dose should be lower.
Children and young people
VIAGRA should not be given to people under 18 years of age.
Other medicines and VIAGRA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
VIAGRA tablets can affect the effectiveness of certain medicines, especially those used to treat chest pain. If you become acutely ill, you should inform the doctor, pharmacist, or nurse that you have taken VIAGRA and when you did so. Do not take VIAGRA with other medications unless your doctor says you can.
You should not take VIAGRA if you are taking medicines called nitrates, as the combination of these medicines can cause a severe drop in blood pressure. Always tell your doctor, pharmacist, or nurse if you are taking any of these medicines, which are often given to relieve angina pectoris or ‘chest pain’.
You should not take VIAGRA if you are taking medicines known as nitric oxide donors such as amyl nitrite (“poppers”), as a combination of such medicines with VIAGRA can also lead to a severe drop in blood pressure.
Tell your doctor or pharmacist if you are already taking riociguat.
If you are taking so-called protease inhibitors for the treatment of HIV, your doctor may prescribe that you start with the lowest dose of VIAGRA (25 mg).
Some patients taking alpha-receptor blockers to treat high blood pressure or prostate enlargement may experience dizziness or fainting, which may be caused by low blood pressure when standing up or standing up quickly. Some patients have experienced these symptoms when taking VIAGRA with alpha-receptor blockers. This most likely happens within 4 hours after taking VIAGRA. To reduce the risk of these symptoms, you should take alpha-receptor blockers regularly at a fixed daily dose before you start taking VIAGRA. Your doctor may prescribe a lower dose (25 mg) of VIAGRA.
Tell your doctor or pharmacist if you are taking medicines containing sacubitril/valsartan, which are used to treat heart failure.
VIAGRA with food, drink, and alcohol
VIAGRA can be taken with or without food, but if you take it with a heavy meal it may take a little longer to work.
Alcohol intake can temporarily reduce the ability to get an erection. To get the maximum effect from your medication, you should not drink large amounts of alcohol before taking VIAGRA.
Pregnancy, breastfeeding, and fertility
VIAGRA should not be used by women.
Driving ability and use of machinery
VIAGRA may cause dizziness and may affect vision. You should be aware of how you react to VIAGRA before driving or using machinery.
VIAGRA contains lactose
If you are intolerant to certain sugars, such as lactose, you should contact your doctor before taking VIAGRA.
VIAGRA contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is almost ‘sodium-free’.
How to use VIAGRA
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure. The recommended starting dose is 50 mg.
You should not take VIAGRA more than once a day.
Do not take VIAGRA film-coated tablets together with VIAGRA orodispersible tablets.
You should take VIAGRA about an 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, contact your doctor or pharmacist.
VIAGRA only gives you an erection if you are sexually stimulated. The time it takes for VIAGRA to work varies from person to person, but normally it takes between half an hour and an hour. You may notice that it takes longer for VIAGRA to work if you take it with a heavy meal.
If VIAGRA does not help you get an erection or if an erection does not last long enough to complete sexual intercourse, tell your doctor.
If you have used too much VIAGRA
You may experience side effects and their severity increase. Doses above 100 mg do not increase the effect.
Do not take more tablets than your doctor tells you to.
Contact your doctor if you take more tablets than you should.
If you have further questions about this medicine, contact your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects reported in connection with the use of VIAGRA are usually mild to moderate and last only a short time.
Stop using VIAGRA and contact your doctor immediately if you experience any of the following serious symptoms:
– An allergic reaction – less common (may affect up to 1 in 100 users)
Symptoms include sudden wheezing, difficulty breathing or dizziness, and swelling of the eyelids, face, lips, or throat.
– Chest pain – less common
If this happens during or after intercourse:
– Stand up in a semi-sitting position and try to relax.
– Do not take nitrates to treat the chest pains.
– Prolonged and sometimes painful erections – rare (may affect up to 1 in 1,000 users)
If you get such an erection that lasts longer than 4 hours, you should contact a doctor immediately.
– Sudden decrease or loss of vision – rare
– Serious skin reaction – rare
Symptoms include severe scaling and swelling of the skin, blistering of the mouth, genitals, and around the eyes, and fever.
– Seizures – rare
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 flashes (symptoms may include a sudden feeling of warmth in the upper body), indigestion, changes in color vision, blurred vision, visual disturbances, nasal congestion, and dizziness.
Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, bloodshot eyes/redness, eye pain, seeing flashes of light or seeing light as very bright, sensitivity to light, watery eyes, palpitations, fast heartbeat, high blood pressure, low blood pressure, muscle pain, sleepiness, reduced sensation, vertigo, ringing in the ears, dry mouth, blocked or blocked sinuses, inflammation of the mucous membrane of the nose (symptoms include rhinitis, sneezing and nasal congestion), pain in the upper part of the stomach, gastroesophageal reflux disease(symptoms include heartburn), presence of blood in the urine, pain in the arms or legs, nosebleeds, feeling warm and feeling tired.
Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, temporarily reduced blood flow to parts of the brain, a feeling of tightness in the throat, numb mouth, bleeding in the back of the eye, double vision, decreased visual acuity, abnormal sensation in the eye, swelling of the eye or eyelid, small dots or spots in the field of vision, seeing a halo around light sources, dilated pupils, discoloration of the whites of the eyes, bleeding in the penis, blood in the semen, dry nose, swelling inside the nose, irritability and sudden reduction or loss of hearing.
After the medicine has been marketed and used by patients, rare cases of unstable angina (a type of heart problem) and sudden death have been reported. It is worth noting that most – but not all – of the men who experienced these symptoms had heart problems before taking this medication. It is impossible to say whether these events were due to VIAGRA.
How to store VIAGRA
Keep this medicine out of the sight and reach of children.
Store at a maximum of 30 °C.
Use before the expiry date stated on the carton and printed packaging after EXP.
The expiration date is the last day of the specified month.
Store in the original packaging. Moisture sensitive.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active ingredient is sildenafil. Each tablet contains 25 mg of sildenafil (in the form of citrate salt).
- Other ingredients are:
- Tablet core: microcrystalline cellulose, calcium phosphate (anhydrate), croscarmellose sodium (see section 2 “VIAGRA contains sodium”), magnesium stearate
- Film coating: hypromellose, titanium dioxide (E171), lactose monohydrate (see section 2 “VIAGRA contains lactose”), triacetin, indigo carmine aluminum lake (E132)
Appearance and package sizes of the medicine
VIAGRA tablets are blue and rounded-diamond-shaped. They are marked “PFIZER” on one side and “VGR 25”, on the other side. The tablets are supplied in pressure packs containing 2, 4, 8, or 12 tablets. Some pack sizes may not be marketed in your country.
Marketing Authorization Holder is Upjohn EESV, Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, The Netherlands.
VIAGRA is manufactured by Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Pocé-Sur-Cisse, France.