DOSAGE FORMS AND STRENGTHS

Your doctor may adjust your dose if needed.

7.4 Ritonavir and other CYP3A4 inhibitors

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.

What should I know about sildenafil before taking it?

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.

Sildenafil Citrate

Call your doctor right away sildenafil 10mg 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. This medicine does not protect you against sexually transmitted diseases (including HIV or AIDS). Use protective measures and ask your doctor if you have any questions about this. Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements. 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.

5.4 Hearing Loss

If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took SILDENAFIL CITRATE TABLETS. Stop sexual activity and get medical help right away if you get symptoms such as chest pain, dizziness, or nausea during sex. Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease. Ask your doctor if your heart is healthy enough to handle the extra strain of having sex. SILDENAFIL CITRATE TABLETS does not protect you or your partner from getting sexually transmitted diseases, including HIV—the virus that causes AIDS. 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. Ask your healthcare professional how you should dispose of any medicine you do not use.

Is generic medication less effective than brand-name medication?

SILDENAFIL CITRATE TABLETS is a prescription medicine used to treat erectile dysfunction (ED). SILDENAFIL CITRATE TABLETS helps a man with erectile dysfunction get and keep an erection only when he is sexually excited (stimulated). SILDENAFIL CITRATE TABLETS is not for use in women or children. It is not known if SILDENAFIL CITRATE TABLETS is safe and effective in women or children under 18 years of age. Who should not take SILDENAFIL CITRATE TABLETS? 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.

Side Effects

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.

Incidence not known

Do not keep outdated medicine or medicine no longer needed. 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.

Does sildenafil interact with foods or drinks?

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®). If you will be taking this medicine for pulmonary arterial hypertension, your doctor will want to check your progress at regular visits. 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®). If you will be taking this medicine for pulmonary arterial hypertension, your doctor will want to check your progress at regular visits.

• Sildenafil 100mg is generally intended for adult males with diagnosed ED.
• It is not suitable for individuals with severe liver or kidney impairment.
• Use under medical supervision ensures proper dosing and reduces risks.

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.

5.7 Combination with other PDE5 Inhibitors or Other Erectile Dysfunction Therapies

Do not take SILDENAFIL CITRATE TABLETS if you: take medicines called nitrates (such as nitroglycerin) use street drugs called "poppers" such as amyl nitrate or amyl nitrite, and butyl nitrate take any medicines called guanylate cyclase stimulators such as riociguat (Adempas) are allergic to sildenafil, as contained in SILDENAFIL CITRATE TABLETS and REVATIO, or any of the ingredients in SILDENAFIL CITRATE TABLETS. See the end of this leaflet for a complete list of ingredients in SILDENAFIL CITRATE TABLETS. What should I tell my healthcare provider before taking SILDENAFIL CITRATE TABLETS? Before you take SILDENAFIL CITRATE TABLETS, tell your healthcare provider if you: have or have had heart problems such as a heart attack, irregular heartbeat, angina, chest pain, narrowing of the aortic valve or heart failure have had heart surgery within the last 6 months have low blood pressure, or high blood pressure that is not controlled have had an erection that lasted for more than 4 hours have problems with your blood cells such as sickle cell anemia, multiple myeloma, or leukemia have retinitis pigmentosa, a rare genetic (runs in families) eye disease have ever had severe vision loss, including an eye problem called non-arteritic anterior ischemic optic neuropathy (NAION) have kidney problems or are having kidney dialysis Tell your healthcare provider about all the medicines you take1, including prescription and over-the-counter medicines, vitamins, and herbal supplements. SILDENAFIL CITRATE TABLETS may affect the way other medicines work, and other medicines may affect the way SILDENAFIL CITRATE TABLETS works causing side effects. If you already use medicine for high blood pressure (hypertension), sildenafil could make your blood pressure go too low. Call your doctor right away sildenafil 10mg 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. This medicine does not protect you against sexually transmitted diseases (including HIV or AIDS). Use protective measures and ask your doctor if you have any questions about this. Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements. Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Check with your doctor immediately if any of the following side effects occur: burning feeling in the chest or stomach burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings decrease in amount of urine or the frequency of urination dizziness or lightheadedness, especially when getting up suddenly from a lying or sitting position dryness, redness, scaling, or peeling of the skin increase in the size of the pupil redness, burning, or swelling of the eyes redness, itching, or tearing of the eyes seeing shades of colors differently than before swelling of the face, hands, feet, or lower legs unusual feeling of burning or stinging of the skin Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: pain or tenderness around the eyes and cheekbones diarrhea or stomach cramps (severe or continuing) numbness or tingling of the hands, legs, or feet redness, soreness, swelling, or bleeding of the gums sensation of motion, usually whirling, either of one's self or of one's surroundings sexual problems in men (continuing), including failure to experience a sexual orgasm sores in the mouth and on the lips Other side effects not listed may also occur in some patients.

2.1 Dosage Information

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Check with your doctor immediately if any of the following side effects occur: burning feeling in the chest or stomach burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings decrease in amount of urine or the frequency of urination dizziness or lightheadedness, especially when getting up suddenly from a lying or sitting position dryness, redness, scaling, or peeling of the skin increase in the size of the pupil redness, burning, or swelling of the eyes redness, itching, or tearing of the eyes seeing shades of colors differently than before swelling of the face, hands, feet, or lower legs unusual feeling of burning or stinging of the skin Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Effective treatments, trusted by over 500,000 men

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: pain or tenderness around the eyes and cheekbones diarrhea or stomach cramps (severe or continuing) numbness or tingling of the hands, legs, or feet redness, soreness, swelling, or bleeding of the gums sensation of motion, usually whirling, either of one's self or of one's surroundings sexual problems in men (continuing), including failure to experience a sexual orgasm sores in the mouth and on the lips Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. SILDENAFIL CITRATE- sildenafil citrate tablet, film coated Greenstone LLC What is the most important information I should know about SILDENAFIL CITRATE TABLETS?

More common

SILDENAFIL CITRATE TABLETS can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. Do not take SILDENAFIL CITRATE TABLETS if you take any other medicines called "nitrates." Nitrates are used to treat chest pain (angina). A sudden drop in blood pressure can cause you to feel dizzy, faint, or have a heart attack or stroke. Do not take SILDENAFIL CITRATE TABLETS if you take medicines called guanylate cyclase stimulators which include: Riociguat (Adempas®) a medicine that treats pulmonary arterial hypertension and chronic-thromboembolic pulmonary hypertension. Tell all your healthcare providers that you take SILDENAFIL CITRATE TABLETS. If you notice any other effects, check with your healthcare professional.

• Sildenafil is available in many countries but must be obtained through proper medical channels.
• Using counterfeit or unregulated versions can pose serious health risks.
• Always check for proper branding and packaging when purchasing.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. SILDENAFIL CITRATE- sildenafil citrate tablet, film coated Greenstone LLC What is the most important information I should know about SILDENAFIL CITRATE TABLETS? SILDENAFIL CITRATE TABLETS can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines.

7.1 Nitrates

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.

Related treatment guides

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.

What are the most common side effects of sildenafil?

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. Do not take SILDENAFIL CITRATE TABLETS if you take any other medicines called "nitrates." Nitrates are used to treat chest pain (angina). A sudden drop in blood pressure can cause you to feel dizzy, faint, or have a heart attack or stroke. Do not take SILDENAFIL CITRATE TABLETS if you take medicines called guanylate cyclase stimulators which include: Riociguat (Adempas®) a medicine that treats pulmonary arterial hypertension and chronic-thromboembolic pulmonary hypertension. Tell all your healthcare providers that you take SILDENAFIL CITRATE TABLETS. If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took SILDENAFIL CITRATE TABLETS. Stop sexual activity and get medical help right away if you get symptoms such as chest pain, dizziness, or nausea during sex. Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease. Ask your doctor if your heart is healthy enough to handle the extra strain of having sex. SILDENAFIL CITRATE TABLETS does not protect you or your partner from getting sexually transmitted diseases, including HIV—the virus that causes AIDS. SILDENAFIL CITRATE TABLETS is a prescription medicine used to treat erectile dysfunction (ED). SILDENAFIL CITRATE TABLETS helps a man with erectile dysfunction get and keep an erection only when he is sexually excited (stimulated).

SILDENAFIL CITRATE TABLETS is not for use in women or children. It is not known if SILDENAFIL CITRATE TABLETS is safe and effective in women or children under 18 years of age. Who should not take SILDENAFIL CITRATE TABLETS? Do not take SILDENAFIL CITRATE TABLETS if you: take medicines called nitrates (such as nitroglycerin) use street drugs called "poppers" such as amyl nitrate or amyl nitrite, and butyl nitrate take any medicines called guanylate cyclase stimulators such as riociguat (Adempas) are allergic to sildenafil, as contained in SILDENAFIL CITRATE TABLETS and REVATIO, or any of the ingredients in SILDENAFIL CITRATE TABLETS. See the end of this leaflet for a complete list of ingredients in SILDENAFIL CITRATE TABLETS. What should I tell my healthcare provider before taking SILDENAFIL CITRATE TABLETS? Before you take SILDENAFIL CITRATE TABLETS, tell your healthcare provider if you: have or have had heart problems such as a heart attack, irregular heartbeat, angina, chest pain, narrowing of the aortic valve or heart failure have had heart surgery within the last 6 months have low blood pressure, or high blood pressure that is not controlled have had an erection that lasted for more than 4 hours have problems with your blood cells such as sickle cell anemia, multiple myeloma, or leukemia have retinitis pigmentosa, a rare genetic (runs in families) eye disease have ever had severe vision loss, including an eye problem called non-arteritic anterior ischemic optic neuropathy (NAION) have kidney problems or are having kidney dialysis Tell your healthcare provider about all the medicines you take1, including prescription and over-the-counter medicines, vitamins, and herbal supplements. SILDENAFIL CITRATE TABLETS may affect the way other medicines work, and other medicines may affect the way SILDENAFIL CITRATE TABLETS works causing side effects.