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It is not known if SILDENAFIL CITRATE TABLETS is safe and effective in women or children under 18 years of age.

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It is not known if sildenafil tablets are safe and effective in women or children under 18 years of age. Do not take sildenafil 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 tablets and REVATIO, or any of the ingredients in sildenafil tablets. See the end of this leaflet for a complete list of ingredients in sildenafil tablets. What should I tell my healthcare provider before taking sildenafil tablets? Before you take sildenafil 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 • sildenafil 25 mg tablets 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 take*, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Other Interactions

Sildenafil tablets may affect the way other medicines work, and other medicines may affect the way sildenafil tablets works causing side effects. Especially tell your healthcare provider if you take any of the following: • medicines called nitrates (see “What is the most important information I should know about sildenafil tablets?”) • medicines called guanylate cyclase stimulators, such as riociguat (Adempas) • medicines called alpha blockers such as Hytrin (terazosin HCl), Flomax (tamsulosin HCl), Cardura (doxazosin mesylate), Minipress (prazosin HCl), Uroxatral (alfuzosin HCl), Jalyn (dutasteride and tamsulosin HCl), or Rapaflo (silodosin). In some patients, the use of sildenafil tablets with alpha-blockers can lead to a drop in blood pressure or to fainting. • medicines called HIV protease inhibitors, such as ritonavir (Norvir), indinavir sulfate (Crixivan), saquinavir (Fortovase or Invirase) or atazanavir sulfate (Reyataz) • some types of oral antifungal medicines, such as ketoconazole (Nizoral), and itraconazole (Sporanox) • some types of antibiotics, such as clarithromycin (Biaxin), telithromycin (Ketek), or erythromycin • other medicines that treat high blood pressure • Sildenafil tablets contain sildenafil, which is the same medicine found in another drug called REVATIO. Sildenafil tablets should not be used with REVATIO or with other PAH treatments containing sildenafil or any other PDE5 inhibitors (such as Adcirca [tadalafil]). Who should not take SILDENAFIL CITRATE TABLETS?

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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.

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These are not all the possible side effects of sildenafil tablets. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800- FDA-1088. Store sildenafil tablets at room temperature between 68°F to 77°F (20°C to 25°C).

Does sildenafil interact with other medicines (drug interactions)?

Keep sildenafil tablets and all medicines out of the reach of children. General information about the safe and effective use of sildenafil tablets. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. This Patient Information leaflet summarizes the most important information about sildenafil tablets. You can ask your healthcare provider or pharmacist for information about sildenafil tablets that is written for health professionals. 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?

  • Sildenafil tablets LP 100 mg is approved by the FDA for ED treatment.
  • The medication can improve erectile response in men with ED.
  • Follow prescribed dosage instructions carefully for safety.

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

Drug Label Information

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. 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. 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.

  • The medication may cause flushing and upset stomach in some users.
  • Use with caution in elderly patients due to increased sensitivity.
  • Monitor blood pressure regularly if prescribed for cardiovascular issues.

SILDENAFIL CITRATE TABLETS may affect the way other medicines work, and other medicines may affect the way SILDENAFIL CITRATE TABLETS works causing side effects.

5.4 Epistaxis

Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine. • Take sildenafil tablets exactly as your healthcare provider tells you to take it. • Your healthcare provider will tell you how much sildenafil tablets to take and when to take it. • Your healthcare provider may change your dose if needed.

Are you currently using Sildenafil (Viagra, Revatio)?

• Take sildenafil tablets about 1 hour before sexual activity. You may take sildenafil tablets between 30 minutes to 4 hours before sexual activity if needed. • Sildenafil tablets can be taken with or without food. If you take sildenafil tablets after a high fat meal (such as a cheeseburger sildenafil citrate tablets 200mg and french fries), sildenafil tablets may take a little longer to start working • Do not take sildenafil tablets more than 1 time a day. • If you accidentally take too much sildenafil tablets, call your doctor or go to the nearest hospital emergency room right away. Especially tell your healthcare provider if you take any of the following: medicines called nitrates (see "What is the most important information I should know about SILDENAFIL CITRATE TABLETS?") medicines called guanylate cyclase stimulators, such as riociguat (Adempas) medicines called alpha blockers such as Hytrin (terazosin HCl), Flomax (tamsulosin HCl), Cardura (doxazosin mesylate), Minipress (prazosin HCl), Uroxatral (alfuzosin HCl), Jalyn (dutasteride and tamsulosin HCl), or Rapaflo (silodosin).

8.6 Patients with Hepatic Impairment

What are the possible side effects of sildenafil tablets? Sildenafil tablets can cause serious side effects. • an erection that will not go away (priapism). If it is not treated right away, priapism can permanently damage your penis. • sudden vision loss in one or both eyes.

Identification & Billing

Stop taking sildenafil tablets and call your healthcare provider right away if you have sudden vision loss in one or both eyes. If you have these symptoms, stop taking sildenafil tablets and contact a doctor right away. The most common side effects of sildenafil tablets are: • abnormal vision, such as changes in color vision (such as having a blue color tinge) and blurred vision In addition, heart attack, stroke, irregular heartbeats and death have happened rarely in men taking sildenafil tablets. It is not known if sildenafil tablets caused these problems. Tell your healthcare provider if you have any side effect that bothers you or does not go away. In some patients, the use of SILDENAFIL CITRATE TABLETS with alpha-blockers can lead to a drop in blood pressure or to fainting.

Contraindication Reason Alternative Action
Use of Nitrates Severe hypotension risk Avoid co-administration
Severe Cardiovascular Disease Increased risk of adverse events Medical consultation required
Hypersensitivity to Sildenafil or excipients Allergic reaction Discontinue use and notify healthcare provider
Concurrent use of Guanylate Cyclase Stimulators Risk of significant hypotension Seek medical advice before use

medicines called HIV protease inhibitors, such as ritonavir (Norvir), indinavir sulfate (Crixivan), saquinavir (Fortovase or Invirase) or atazanavir sulfate (Reyataz) some types of oral antifungal medicines, such as ketoconazole (Nizoral), and itraconazole (Sporanox) some types of antibiotics, such as clarithromycin (Biaxin), telithromycin (Ketek), or erythromycin other medicines that treat high blood pressure SILDENAFIL CITRATE TABLETS contains sildenafil, which is the same medicine found in another drug called SILDENAFIL TABLETS.

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

For more information, call Cipla Ltd. at 1-866-604-3268. What are the ingredients in sildenafil tablets? This Patient Information has been approved by the U.S. Food and Drug Administration.

Sildenafil Tablets for ED

*The other brands listed are trademarks of their respective owners. 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. Do not take SILDENAFIL CITRATE TABLETS if you take any other medicines called "nitrates." 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.