VIAGRA 100 MG. * 4 TABLETS

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. The action of VIAGRA is to help the penis enlargement of the blood vessels, which facilitates blood circulation in the face of sexual arousal. VIAGRA will only help you get an erection if you are sexually stimulated.

VIAGRA is a treatment for elderly men with erectile dysfunction, sometimes called impotence. This means that the man can not gain or retain a stable penis erection necessary for sexual act.

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 because the combination may cause a potentially dangerous drop in your blood pressure. Tell your doctor if you are taking any of these medicines that are often given to relieve angina (or “chest pain”). If you are not sure, ask your doctor or pharmacist.
– If you use any of the medicines known as nitric oxide donors such as amyl nitrite (“poppers”), as the combination may also lead to a potentially dangerous drop in your blood pressure.
– If you’re taking rhizoguan. This medicine is used to treat pulmonary arterial hypertension (ie, eye contactblood 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 enhance the blood pressure lowering effect of this drug. If you are taking a rhizogue or are not sure, tell 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 some rare inherited eye diseases (such as pigment retinitis).
– If you have ever had loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking VIAGRA:
– If you have sickle cell anemia (red blood cell anomaly), leukemia (cancer of the blood), multiple myeloma (bone marrow cancer) .
– If you have deformity of the penis or Peyroni’s disease.
– If you have heart problems. Your doctor should check carefully whether your heart can undergo extra work such as having sex.
– If you currently have a stomach ulcer or problems with blood clotting (such as haemophilia).
– If you experience sudden decrease or loss of vision, stop taking VIAGRA and contact your doctor immediately.

VIAGRA should not be used concomitantly with other oral or topical treatments for erectile dysfunction.
You should not use VIAGRA with sildenafil-containing pulmonary arterial hypertension medicines (PAH) or with other PDE5 inhibitors.
You should not take VIAGRA unless you have erectile dysfunction.
You should not take VIAGRA if you are a woman.
Special warnings for patients with kidney or liver problems
You should tell your doctor if you have kidney or liver problems. Your doctor may decide to prescribe a lower dose.

Children and adolescents
VIAGRA should not be used in subjects below 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 interact with some medicines, especially those used to treat chest pain. In case of urgency you should tell your doctor, pharmacist or nurse that you have taken VIAGRA and when you have taken it. Do not take VIAGRA with other medicines unless your doctor has allowed you.

You should not take VIAGRA if you are taking medicines called nitrates because the combination of these medicines can cause a potentially dangerous drop in your blood pressure. Always tell your doctor, pharmacist or nurse if you are taking any of these medicines that are often given to relieve angina (or “chest pain”).

You should not use VIAGRA if you are using any of the medicines known as nitric oxide donors such as “poppers”, as the combination may also lead to a potentially dangerous drop in your blood pressure.

Tell your doctor or pharmacist if you are already taking rhizogen.

If you are taking medicines known as protease inhibitors used to treat HIV, your doctor will probably prescribe the lowest dose (25 mg) of VIAGRA.

Some patients who are on alpha-blocker therapy to treat high blood pressure or prostate enlargement may experience dizziness or fainting, which may be caused by lowering blood pressure when sitting or standing upright. Some patients have experienced these symptoms when taking VIAGRA with alpha-blockers. This is most likely to happen during the first 4 hours after taking VIAGRA. You should have a regular daily dose of alpha-blocker before taking VIAGRA to reduce the risk of these symptoms occurring. Your doctor may prescribe a lower starting dose (25 mg) of VIAGRA.

VIAGRA with food, drink, and alcohol
VIAGRA can be taken with or without food.
However, you may notice that VIAGRA starts to work slower if you take it with a heavy meal.

Drinking alcohol may temporarily break your ability to achieve an erection. To get the most out of your medicine, we advise you not to drink too much alcohol before taking VIAGRA.

Pregnancy, breast-feeding and fertility
VIAGRA is not indicated for use in women.

Driving and using machines
VIAGRA can cause dizziness and affect vision. You should know your individual reaction to VIAGRA before driving or using machines.

VIAGRA contains lactose
Contact your doctor before taking VIAGRA if he or she has told you that you have an intolerance to some sugars, such as lactose.

3. How to take VIAGRA?
Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. The recommended starting dose is 50 mg.

You should not take VIAGRA more than once a day.

Do not take VIAGRA film-coated tablets in combination with VIAGRA orodispersible tablets.

VIAGRA should be taken about an hour before your planned sexual intercourse. Drink the tablet whole with a glass of water.

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

VIAGRA will only help you get an erection in sexual stimulation. The time for which the effect of VIAGRA occurs is different in individual individuals but is usually between half an hour and one hour. If you take VIAGRA during a meal, the effect may be slower.

If VIAGRA does not help you get an erection or if your erection does not last long enough to have sexual intercourse, you should 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.
You should not take more tablets than your doctor told you to take.
Contact your doctor if you take 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 with VIAGRA are usually mild to moderate and short-lived.

If you get any of the following serious side effects, stop taking VIAGRA and seek medical advice immediately:
• Allergic reaction – it occurs uncommonly (it may affect up to 1 in 100 people)
Symptoms include sudden wheezing, difficulty in breathing or dizziness, swelling of the eyelids, face, lips or throat.
• Breast pain – they occur uncommonly

If they occur during or after intercourse:
– Take a half-seated position and try to relax.
– Do not use nitrates to affect the chest pain.
• Prolonged and sometimes painful erections – these occur rarely (may affect up to 1 in 1,000 people)

If you have an erection that lasts for more than 4 hours, you should contact a doctor immediately.
• Sudden decrease or loss of vision – rarely occurring
• Serious skin reactions – they rarely occur

Symptoms may include severe scaling and swelling of the skin, blistering in the mouth, genital organs and around the eyes , fever.
• Seizures or seizures – rarely occurring Other side effects:

Very common (may affect more than 1 in 10 people) : headache.
Common (may affect up to 1 in 10 people): nausea, flushing, hot flushes (symptoms include a sudden sensation of upper body heat), digestive disorders, changes in color differentiation, blurred vision, nose obstruction and dizziness.
Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, redness of the eyes / red eyes, eye pain, seeing light rays, increased light sensation, light sensitivity, tearing, high blood pressure, low blood pressure, muscle pain, drowsiness, reduced touching sensation, vertigo, tinnitus, dry mouth, stuffy or stuffy sinus, inflammation of the lining of the nose (symptoms include runny nose, sneezing and stuffy nose), pain in the upper abdominal, gastro-oesophageal reflux disease (symptoms include burning behind the sternum due to the return of gastric acid to the esophagus), blood in the urine, pain in the arms or legsbleeding from the nose, a sensation of heat and a feeling of fatigue.
Rare (may affect up to 1 in 1,000 people): loss of consciousness, stroke, heart attack, irregular heartbeat, temporary reduction of blood flow to parts of the brain, feeling of tightening in the throat, numbness of the mouth, bleeding in the back eye vision, double vision, reduced visual acuity, abnormal eye sensation, swelling of the eye or eyelid, vision of small particles or spots, vision of haloes around light sources, enlarged pupil of the eye, discoloration of the white part of the eye, bleeding from the penis, the presence of blood in the semen fluid, dry nose, swelling of the inside of the nose, irritability and sudden decrease or loss of hearing.
Post-marketing experience has reported rare cases of unstable angina (heart disease) and sudden death. It should be noted that most but not all of the men who received the reported side effects had heart problems prior to taking the drug. It is not possible to determine whether these incidents were directly related to VIAGRA.

Tell
your doctor If you get any side effects, talk to your doctor, pharmacist or nurse. This includes all possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. As you report side effects, you can contribute to getting more information on the safety of this medicine.

5. How to store VIAGRA
Keep out of the reach and sight 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 refers to the last day of that month. Store in the original package in order to protect from moisture.

Do not dispose of medicines in the sewage system or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Package Contents and Additional Information

What VIAGRA contains:

The active ingredient is sildenafil. Each tablet contains 100 mg sildenafil (as citrate salt).
The other ingredients are:
– Tablet core: microcrystalline cellulose, calcium hydrogen phosphate (anhydrous), croscarmellose sodium, magnesium stearate.
– Film coating: Hypromellose, Titanium dioxide (E171), Lactose monohydrate, Triacetin, Indigo-carmine aluminum lacquer (E132).

What VIAGRA looks like and contents of the pack
VIAGRA film-coated tablets are blue in color and have a diamond-shaped shape. They are marked “PFIZER” on one side and “VGR 100” on the other. The tablets are supplied in blister packs containing 2, 4, 8, 12 or 24 tablets. Some packages may not be sold in your country.

Marketing Authorization Holder and Manufacturer

The owner of the VIAGRA is Pfizer Limited, Sandwich, Kent, CT13 9NJ, UK

The manufacturer of VIAGRA is Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Poce-sur-Cisse, France.