SC 20 Pill: white, round, 7mm

Table 4 displays the number of patients with clinical worsening events in Study 2.

Kaplan-Meier plot of time to clinical worsening is presented in Figure 11.Figure 11. Kaplan-Meier Plot of Time (in Days) to Clinical Worsening of PAH in Study 2Improvements in WHO functional class for PAH were also demonstrated in subjects on sildenafil compared to placebo.

5.2 Worsening Pulmonary Vascular Occlusive Disease

If you notice a sudden decrease or loss of hearing, talk to your doctor right away. It is not possible to determine whether these events are related directly to this class of oral medicines, including sildenafil tablets, or to other diseases or medicines, to other factors, or to a combination of factors.• heart attack, stroke, irregular heartbeats, and death.

What should I do if I accidentally use too much sildenafil?

More than twice as many sildenafil-treated patients (36%) as placebo-treated patients (14%) showed an improvement in at least one functional New York Heart Association (NYHA) class for PAH.Study 3 (Sildenafil monotherapy (1 mg, 5 mg, and 20 mg three times a day))A randomized, double-blind, parallel dose study (Study 3) was planned in 219 patients with PAH. This study was prematurely terminated with 129 subjects enrolled.

Patients were required to have a mPAP greater than or equal to 25 mmHg and a PCWP less than or equal to 15 mmHg at rest via right heart catheterization within 12 weeks before randomization, and a baseline 6-minute walk test distance greater than or equal to 100 meters and less than or equal to 450 meters (mean 345 meters). Patients were randomized to 1 of 3 doses of sildenafil: 1 mg, 5 mg, and 20 mg, three times a day.At baseline patients had PPH (74%) or secondary PAH (26%); WHO functional class II (57%), III (41%), or IV (2%); the mean age was 44 years; and 67% were female. The majority of subjects were Asian (67%), and 28% were Caucasian.The primary efficacy endpoint was the change from baseline at Week 12 (at least 4 hours after the last dose) in the 6- minute walk distance.

How much does Sildenafil (Viagra) cost?

See “What are the ingredients in sildenafil tablets?” at the end of this leaflet.What should I tell my doctor before taking sildenafil tablets?Tell your doctor about all of your medical conditions, including if you• have heart problems such as angina (chest pain), heart failure, irregular heartbeats, or have had a heart attack• have a disease called pulmonary veno-occlusive disease (PVOD)• have high or low blood pressure or blood circulation problems• have an eye problem called retinitis pigmentosa• have or had loss of sight in one or both eyes• have any problem with the shape of your penis or Peyronie’s disease• have any blood cell problems such sickle cell anemia• have a stomach ulcer or any bleeding problems• are pregnant or planning to become pregnant. It is not known if sildenafil tablets could harm your unborn baby.• are breastfeeding. Sildenafil passes into your breast milk, it is not known if it could harm your baby.Tell your doctor about all of the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal products. Sildenafil tablets and certain other medicines can cause side effects if you take them together. The doses of some of your medicines may need to be adjusted while you take sildenafil tablets.Especially tell your doctor if you take• Nitrate medicines.

Erectile dysfunction

See “What is the most important information I should know about sildenafil tablets?”• Riociguat (Adempas). See “What is the most important information I should know about sildenafil tablets?”• Ritonavir (Norvir®) or other medicines used to treat HIV infection• Ketoconazole (Nizoral®)• Itraconazole (Sporanox)• High blood pressure medicineKnow the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.How should I take sildenafil tablets?• Take sildenafil tablets exactly as your doctor tells you.Sildenafil may be prescribed to you as• Sildenafil tablets• Take sildenafil tablet 3 times a day about 4 to 6 hours apart.• Take sildenafil tablets at the same times every day.• If you miss a dose, take it as soon as you remember. If it is close to your next dose, skip the missed dose, and take your next dose at the regular time.• Do not take more than one dose of sildenafil tablets at a time.• Do not change your dose or stop taking sildenafil tablets on your own. Talk to your doctor first.• If you take too much sildenafil, call your doctor or go to the nearest hospital emergency room.What are the possible side effects of sildenafil tablets?• low blood pressure.

What’s the difference between sildenafil and Viagra?

Low blood pressure may cause you to feel faint or dizzy. Lie down if you feel faint or dizzy.• more shortness of breath than usual. Tell your doctor if you get more short of breath after you start sildenafil tablets. More shortness of breath than usual may be due to your underlying medical condition.• decreased eyesight or loss of sight in one or both eyes (NAION). If you notice a sudden decrease or loss of eyesight, talk to your doctor right away.• sudden decrease or loss of hearing. Similar increases in walk distance (mean increase of 38-41 meters) were observed in the 5 and 20 mg dose groups.

• Sildenafil tablets may have different appearances depending on manufacturer.
• Consult a healthcare professional if unsure about dosing or interactions.
• Sildenafil should be used responsibly to prevent dependence.
• Some users experience a slight tingling sensation after ingestion.
• Generic sildenafil is usually less expensive but equally effective.
• Always buy from trusted sources to avoid counterfeit medication.
• Sildenafil can be used in combination with other ED treatments if advised.
• Certain medical conditions may contraindicate sildenafil use.
• The tablets are commonly available in blister packs for safety.
• Avoid combining sildenafil with grapefruit juice, which can affect metabolism.
• Keep a record of all medications and their effects during treatment.

These increases were significantly better than those observed in the 1 mg dose group (Figure 12).Figure 12.

Stronger erections, better sex

Table 4 displays the number of patients with clinical worsening events in Study 2. Kaplan-Meier plot of time to clinical worsening is presented in Figure 11.Figure 11. Kaplan-Meier Plot of Time (in Days) to Clinical Worsening of PAH in Study 2Improvements in WHO functional class for PAH were also demonstrated in subjects on sildenafil compared to placebo. More than twice as many sildenafil-treated patients (36%) as placebo-treated patients (14%) showed an improvement in at least one functional New York Heart Association (NYHA) class for PAH.Study 3 (Sildenafil monotherapy (1 mg, 5 mg, and 20 mg three times a day))A randomized, double-blind, parallel dose study (Study 3) was planned in 219 patients with PAH. This study was prematurely terminated with 129 subjects enrolled.

How should I store sildenafil?

Patients were required to have a mPAP greater than or equal to 25 mmHg and a PCWP less than or equal to 15 mmHg at rest via right heart catheterization within 12 weeks before randomization, and a baseline 6-minute walk test distance greater than or equal to 100 meters and less than or equal to 450 meters (mean 345 meters). Patients were randomized to 1 of 3 doses of sildenafil: 1 mg, 5 mg, and 20 mg, three times a day.At baseline patients had PPH (74%) or secondary PAH (26%); WHO functional class II (57%), III (41%), or IV (2%); the mean age was 44 years; and 67% were female. The majority of subjects were Asian (67%), and 28% were Caucasian.The primary efficacy endpoint was the change from baseline at Week 12 (at least 4 hours after the last dose) in the 6- minute walk distance. Similar increases in walk distance (mean increase of 38-41 meters) were observed in the 5 and 20 mg dose groups. These increases were significantly better than those observed in the 1 mg dose group (Figure 12).Figure 12.

What are the serious side effects of sildenafil?

Mean Change from Baseline in Six Minute Walk (meters) by Visit to Week 12 – ITT Population Sildenafil Protocol A1481244Study 4 (Sildenafil added to bosentan therapy – lack of effect on exercise capacity)A randomized, double-blind, placebo controlled study was conducted in 103 patients with PAH who were on bosentan therapy for a minimum of three months. The PAH patients included those with primary PAH, and PAH associated with CTD. Patients were randomized to placebo or sildenafil (20 mg three times a day) in combination with bosentan (62.5-125 mg twice a day). The primary efficacy endpoint was the change from baseline at Week 12 in 6MWD. The results indicate that there is no significant difference in mean change from baseline on 6MWD observed between sildenafil 20 mg plus bosentan and bosentan alone . Mean Change from Baseline in Six Minute Walk (meters) by Visit to Week 12 – ITT Population Sildenafil Protocol A1481244Study 4 (Sildenafil added to bosentan therapy – lack of effect on exercise capacity)A randomized, double-blind, placebo controlled study was conducted in 103 patients with PAH who were on bosentan therapy for a minimum of three months. The PAH patients included those with primary PAH, and PAH associated with CTD. Patients were randomized to placebo or sildenafil (20 mg three times a day) in combination with bosentan (62.5-125 mg twice a day). The primary efficacy endpoint was the change from baseline at Week 12 in 6MWD. The results indicate that there is no significant difference in mean change from baseline on 6MWD observed between sildenafil 20 mg plus bosentan and bosentan alone . Studies of Adults with Pulmonary Arterial Hypertension Study 1 (Sildenafil monotherapy (20 mg, 40 mg, and 80 mg three times a day)) Study 2 (Sildenafil co-administered with epoprostenol) Kaplan-Meier Plot of Time (in Days) to Clinical Worsening of PAH in Study 2 16 HOW SUPPLIED/STORAGE AND HANDLING Sildenafil tablets, USP are supplied as white to off-white, film-coated, round tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil as follows:Recommended Storage for Sildenafil Tablets, USP: Store at controlled room temperature 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature]. Sildenafil tablets, USP are supplied as white to off-white, film-coated, round tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil as follows: Recommended Storage for Sildenafil Tablets, USP: Store at controlled room temperature 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature]. 17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information).Inform patients of contraindication of sildenafil tablets 20 mg with regular and/or intermittent use of organic nitrates.Inform patients that sildenafil is also marketed as VIAGRA for erectile dysfunction.

Advise patients taking sildenafil tablets 20 mg not to take VIAGRA or other PDE-5 inhibitors.Advise patients to seek immediate medical attention for a sudden loss of vision in one or both eyes while taking sildenafil tablets 20 mg. Such an event may be a sign of NAION.Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking sildenafil tablets 20 mg. These events may be accompanied by tinnitus and dizziness.VIAGRA® is registered trademark of Pfizer Inc. All other trademarks herein are the property of their respective owners.Manufactured for:Macleods Pharma USA, Inc.Plainsboro, NJ 08536Manufactured by:Macleods Pharmaceutical Ltd.Baddi, Himachal Pradesh, IndiaRevised: February 2018PM01596108PATIENT INFORMATIONSildenafil (sil-DEN-a-fil) TabletsRead this Patient Information before you start taking sildenafil tablets and each time 150mg sildenafil for sale you get a refill. This information does not take the place of talking with your doctor about your medical condition or treatment. If you have any questions about sildenafil tablets, ask your doctor or pharmacist.What is the most important information I should know about sildenafil tablets?Never take sildenafil tablets with any nitrate or guanylate cyclase stimulator medicines. Your blood pressure could drop quickly to an unsafe level. Nitrate medicines include:• Medicines that treat chest pain (angina)• Nitroglycerin in any form including tablets, patches, sprays, and ointments• Isosorbide mononitrate or dinitrate• Street drugs called “poppers” (amyl nitrate or nitrite)Guanylate cyclase stimulators include:• Riociguat (Adempas)Ask your doctor or pharmacist if you are not sure if you are taking a nitrate or a guanylate cyclase stimulator medicine.What are sildenafil tablets?Sildenafil tablets are a prescription medicine used in adults to treat pulmonary arterial hypertension (PAH).

Your heart has to work hard to pump blood into your lungs.Sildenafil tablets improve the ability to exercise and can slow down worsening changes in your physical condition.• Sildenafil tablets are not for use in children• Adding sildenafil tablets to another medication used to treat PAH, bosentan (Tracleer®), does not result in improvement in your ability to exercise.Sildenafil tablets 20 mg contain the same medicine as VIAGRA® (sildenafil), which is used to treat erectile dysfunction (impotence).

• Sildenafil tablets are not intended for recreational use or performance enhancement.
• Always follow a healthcare provider’s instructions for safe use.
• Sildenafil’s effects last for a few hours, depending on individual factors.
• The medication is taken as needed, not as a daily supplement.
• Only use sildenafil under medical supervision if you have heart disease.
• Do not take sildenafil if you are allergic to sildenafil citrate.
• The drug helps improve quality of life for men with ED.
• Sildenafil may cause temporary visual disturbances, like a blue tint.
• Proper hydration can help minimize side effects.
• Certain genetic conditions may affect sildenafil's effectiveness.
• Regular medical reviews ensure safe long-term use of sildenafil.

Do not take sildenafil tablets 20 mg with VIAGRA or other PDE-5 inhibitors.Who should not take sildenafil tablets?Do not take sildenafil tablets if you:• take nitrate medicines. See “What is the most important information I should know about sildenafil tablets?”• take guanylate cyclase stimulator medicines. See “What is the most important information I should know about sildenafil tablets?”• are allergic to sildenafil or any other ingredient in sildenafil tablets.

8.6 Renal Impairment

Studies of Adults with Pulmonary Arterial Hypertension Study 1 (Sildenafil monotherapy (20 mg, 40 mg, and 80 mg three times a day)) Study 2 (Sildenafil co-administered with epoprostenol) Kaplan-Meier Plot of Time (in Days) to Clinical Worsening of PAH in Study 2 16 HOW SUPPLIED/STORAGE AND HANDLING Sildenafil tablets, USP are supplied as white to off-white, film-coated, round tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil as follows:Recommended Storage for Sildenafil Tablets, USP: Store at controlled room temperature 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature]. Sildenafil tablets, USP are supplied as white to off-white, film-coated, round tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil as follows: Recommended Storage for Sildenafil Tablets, USP: Store at controlled room temperature 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature]. 17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information).Inform patients of contraindication of sildenafil tablets 20 mg with regular and/or intermittent use of organic nitrates.Inform patients that sildenafil is also marketed as VIAGRA for erectile dysfunction. Advise patients taking sildenafil tablets 20 mg not to take VIAGRA or other PDE-5 inhibitors.Advise patients to seek immediate medical attention for a sudden loss of vision in one or both eyes while taking sildenafil tablets 20 mg. Such an event may be a sign of NAION.Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking sildenafil tablets 20 mg.

Patient resources

These events may be accompanied by tinnitus and dizziness.VIAGRA® is registered trademark of Pfizer Inc. All other trademarks herein are the property of their respective owners.Manufactured for:Macleods Pharma USA, Inc.Plainsboro, NJ 08536Manufactured by:Macleods Pharmaceutical Ltd.Baddi, Himachal Pradesh, IndiaRevised: February 2018PM01596108PATIENT INFORMATIONSildenafil (sil-DEN-a-fil) TabletsRead this Patient Information before you start taking sildenafil tablets and each time 150mg sildenafil for sale you get a refill. This information does not take the place of talking with your doctor about your medical condition or treatment. If you have any questions about sildenafil tablets, ask your doctor or pharmacist.What is the most important information I should know about sildenafil tablets?Never take sildenafil tablets with any nitrate or guanylate cyclase stimulator medicines. Your blood pressure could drop quickly to an unsafe level.

Prior authorization

Nitrate medicines include:• Medicines that treat chest pain (angina)• Nitroglycerin in any form including tablets, patches, sprays, and ointments• Isosorbide mononitrate or dinitrate• Street drugs called “poppers” (amyl nitrate or nitrite)Guanylate cyclase stimulators include:• Riociguat (Adempas)Ask your doctor or pharmacist if you are not sure if you are taking a nitrate or a guanylate cyclase stimulator medicine.What are sildenafil tablets?Sildenafil tablets are a prescription medicine used in adults to treat pulmonary arterial hypertension (PAH). Your heart has to work hard to pump blood into your lungs.Sildenafil tablets improve the ability to exercise and can slow down worsening changes in your physical condition.• Sildenafil tablets are not for use in children• Adding sildenafil tablets to another medication used to treat PAH, bosentan (Tracleer®), does not result in improvement in your ability to exercise.Sildenafil tablets 20 mg contain the same medicine as VIAGRA® (sildenafil), which is used to treat erectile dysfunction (impotence). Do not take sildenafil tablets 20 mg with VIAGRA or other PDE-5 inhibitors.Who should not take sildenafil tablets?Do not take sildenafil tablets if you:• take nitrate medicines. See “What is the most important information I should know about sildenafil tablets?”• take guanylate cyclase stimulator medicines. See “What is the most important information I should know about sildenafil tablets?”• are allergic to sildenafil or any other ingredient in sildenafil tablets. See “What are the ingredients in sildenafil tablets?” at the end of this leaflet.What should I tell my doctor before taking sildenafil tablets?Tell your doctor about all of your medical conditions, including if you• have heart problems such as angina (chest pain), heart failure, irregular heartbeats, or have had a heart attack• have a disease called pulmonary veno-occlusive disease (PVOD)• have high or low blood pressure or blood circulation problems• have an eye problem called retinitis pigmentosa• have or had loss of sight in one or both eyes• have any problem with the shape of your penis or Peyronie’s disease• have any blood cell problems such sickle cell anemia• have a stomach ulcer or any bleeding problems• are pregnant or planning to become pregnant. It is not known if sildenafil tablets could harm your unborn baby.• are breastfeeding. Sildenafil passes into your breast milk, it is not known if it could harm your baby.Tell your doctor about all of the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal products. Sildenafil tablets and certain other medicines can cause side effects if you take them together. The doses of some of your medicines may need to be adjusted while you take sildenafil tablets.Especially tell your doctor if you take• Nitrate medicines. See “What is the most important information I should know about sildenafil tablets?”• Riociguat (Adempas). See “What is the most important information I should know about sildenafil tablets?”• Ritonavir (Norvir®) or other medicines used to treat HIV infection• Ketoconazole (Nizoral®)• Itraconazole (Sporanox)• High blood pressure medicineKnow the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.How should I take sildenafil tablets?• Take sildenafil tablets exactly as your doctor tells you.Sildenafil may be prescribed to you as• Sildenafil tablets• Take sildenafil tablet 3 times a day about 4 to 6 hours apart.• Take sildenafil tablets at the same times every day.• If you miss a dose, take it as soon as you remember. If it is close to your next dose, skip the missed dose, and take your next dose at the regular time.• Do not take more than one dose of sildenafil tablets at a time.• Do not change your dose or stop taking sildenafil tablets on your own. Talk to your doctor first.• If you take too much sildenafil, call your doctor or go to the nearest hospital emergency room.What are the possible side effects of sildenafil tablets?• low blood pressure. Low blood pressure may cause you to feel faint or dizzy. Lie down if you feel faint or dizzy.• more shortness of breath than usual.

• Sildenafil tablets are often stored in their original packaging to avoid contamination.
• Use only the amount prescribed; more does not mean better results.
• Sildenafil helps improve erectile function but doesn’t increase libido.
• The tablets are designed for rapid and effective absorption.
• Always inform your doctor about existing health conditions before use.
• Some brands of sildenafil are marketed as "white tablets" for easy recognition.
• The medication can cause a mild increase in blood flow to other body parts.
• Avoid caffeine or heavy meals before taking sildenafil for better results.
• The safety and efficacy of sildenafil are supported by numerous clinical trials.
• Never take expired sildenafil tablets, as their safety can’t be guaranteed.
• Regular blood pressure checks are recommended when using sildenafil long-term.

Tell your doctor if you get more short of breath after you start sildenafil tablets.

What other information should I know?

More shortness of breath than usual may be due to your underlying medical condition.• decreased eyesight or loss of sight in one or both eyes (NAION). If you notice a sudden decrease or loss of eyesight, talk to your doctor right away.• sudden decrease or loss of hearing. If you notice a sudden decrease or loss of hearing, talk to your doctor right away. It is not possible to determine whether these events are related directly to this class of oral medicines, including sildenafil tablets, or to other diseases or medicines, to other factors, or to a combination of factors.• heart attack, stroke, irregular heartbeats, and death.