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- WARNINGS AND PRECAUTIONS
Do not use more of it and do not use it more often than your doctor ordered.
Introduction: Sexual Health, Gender, and the Visibility Gap
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco. If too much is used, the chance of side effects is increased. This medicine comes with a patient information leaflet. Read and follow these instructions carefully before you start using sildenafil and each time you get a refill of your medicine. Ask your doctor if you have any questions. You may take this medicine with or without food. Place the film on top of your tongue. It will dissolve in your mouth and can be swallowed with saliva without using water or other liquids. Shake the bottle well for at least 10 seconds before each use. Remove the cap by pushing it down and twisting it counter-clockwise. Push the plunger of the syringe, then insert the tip into the bottle while holding the bottle upright on a flat surface. Slowly pull back the plunger until the required dose. If you see air bubbles in the syringe, repeat the steps. Place the tip of the syringe into you or your child's mouth and point it towards the cheek. This medicine usually begins to work for erectile dysfunction within 30 minutes after taking it. It continues to work for up to 4 hours, although its action is usually less after 2 hours. Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way. The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so. The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine. For treatment of erectile dysfunction:For oral dosage form (tablets):Adults up to 65 years of age—50 milligrams (mg) as a single dose no more than once a day, 1 hour before sexual intercourse. Alternatively, the medicine may be taken 30 minutes to 4 hours before sexual intercourse. Your doctor may adjust your dose if needed.Adults 65 years of age and older—25 mg as a single dose no more than once a day, 1 hour before sexual intercourse. Your doctor may adjust your dose if needed.Children—Use is not recommended.For oral dosage form (film):Adults up to 65 years of age—50 milligrams (mg) as a single dose no more than once a day, 1 hour before sexual intercourse. Your doctor may adjust your dose as needed.Adults 65 years of age and older—25 mg as a single dose no more than once a day, 1 hour before sexual intercourse. Your doctor may adjust your dose as needed.Children—Use is not recommended. For oral dosage form (tablets):Adults up to 65 years of age—50 milligrams (mg) as a single dose no more than once a day, 1 hour before sexual intercourse. Your doctor may adjust your dose if needed.Children—Use is not recommended.
12.3 Pharmacokinetics
It is not known if the medicine is safe for use in these patients. The effects may be increased because of slower removal of the medicine from the body. Sickle-cell anemia (blood disorder)—Sildenafil should be used with caution in these patients as problems with prolonged erection of the penis may occur. Pulmonary arterial hypertension (high blood pressure in the lungs) or Pulmonary veno-occlusive disease or PVOD (a type of lung disease)—Use with caution. Use sildenafil exactly as directed by your doctor. Adults up to 65 years of age—50 milligrams (mg) as a single dose no more than once a day, 1 hour before sexual intercourse. Your doctor may adjust your dose if needed. Adults 65 years of age and older—25 mg as a single dose no more than once a day, 1 hour before sexual intercourse. For oral dosage form (film):Adults up to 65 years of age—50 milligrams (mg) as a single dose no more than once a day, 1 hour before sexual intercourse. Your doctor may adjust your dose as needed. For treatment of pulmonary arterial hypertension:For oral dosage forms (suspension or tablets):Adults—20 milligrams (mg) 3 times a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 80 mg 3 times a day.Children 1 year of age and older weighing 45 kilograms (kg) or more—20 mg 3 times a day. However the dose is usually not more than 40 mg 3 times a day.Children 1 year of age and older weighing 20 to 45 kg—20 mg 3 times a day.Children 1 year of age and older weighing 20 kg or less—10 mg 3 times a day.Children younger than 1 year of age—Use and dose must be determined by your doctor. For oral dosage forms (suspension or tablets):Adults—20 milligrams (mg) 3 times a day. Adults—20 milligrams (mg) 3 times a day. However, the dose is usually not more than 80 mg 3 times a day. Children 1 year of age and older weighing 45 kilograms (kg) or more—20 mg 3 times a day. However the dose is usually not more than 40 mg 3 times a day. Children 1 year of age and older weighing 20 to 45 kg—20 mg 3 times a day. Children 1 year of age and older weighing 20 kg or less—10 mg 3 times a day. Children younger than 1 year of age—Use and dose must be determined by your doctor. For oral dosage forms (suspension or tablets): If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed.
5. Viagra® comes in different doses.
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially: Abnormal penis, including a curved penis or birth defects of the penis—Chance of problems occurring may be increased and this medicine should be used with caution in these patients. Arrhythmia (irregular heartbeat, within the last 6 months) or Blood vessel problems (eg, aortic stenosis, idiopathic subaortic stenosis) or Heart attack (within the last 6 months) or Retinitis pigmentosa (an inherited eye disorder) or Stroke (within the last 6 months)—Should not be used in patients with these conditions. Crowded disc or low cup to disc ratio in the eye (an eye disorder) or Hyperlipidemia (high fats in the blood) or Non-arteritic anterior ischemic optic neuropathy or NAION (serious eye condition), history of or Retinitis pigmentosa (an inherited eye disorder) or Smoking—May increase the chance for a serious side effect in the eye called NAION. Stomach ulcer, or history of or—Chance of problems occurring may be increased. Ask your healthcare professional how you should dispose of any medicine you do not use. Store mixed oral liquid in the refrigerator. Throw away any unused mixed Revatio® oral liquid after 60 days. It is important that you tell all of your doctors that you take sildenafil. If you need emergency medical care for a heart problem, it is important that your doctor knows when you last took sildenafil. Do not use this medicine if you are also using a nitrate medicine, often used to treat angina or high blood pressure. Some illegal ("street") drugs called "poppers" (such as amyl nitrate, butyl nitrate, or nitrite). Do not use this medicine if you also use riociguat (Adempas®).
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The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take. Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. If you will be taking this medicine for pulmonary arterial hypertension, your doctor will want to check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. If you take sildenafil for pulmonary arterial hypertension, do not take Viagra®, Vibrique™ or other PDE5 inhibitors, including tadalafil (Cialis®) or vardenafil (Levitra®). If you take too much sildenafil or take it together with these medicines, the chance for side effects will be higher. It is important to tell your doctor about any heart problems you have now or may have had in the past. This medicine can cause serious side effects in patients with heart problems. If you experience a prolonged or painful erection for 4 hours or more, contact your doctor immediately. This condition may require prompt medical treatment to prevent serious and permanent damage to your penis. If you experience a sudden loss of vision in one or both eyes, contact your doctor immediately. Check with your doctor right away if you have a sudden decrease in hearing or loss of hearing, which may be accompanied by dizziness and ringing in the ears. If you already use medicine for high blood pressure (hypertension), sildenafil could make your blood pressure go too low. Call your doctor right away if you have blurred vision, confusion, dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly, sweating, or unusual tiredness or weakness.