SILDENAFIL (Page 8 of 9)

16 HOW SUPPLIED/STORAGE AND HANDLING

Sildenafil tablets, USP are supplied as blue, film-coated, oval biconvex tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil and debossed on the obverse and reverse sides as follows:

25 mg 50 mg 100 mg
Obverse R R R
Reverse 25 50 100
Bottle of 30 NDC 72888-015-30 NDC 72888-016-30 NDC 72888-017-30
Bottle of 100 Not Applicable NDC 72888-016-01 NDC 72888-017-01
Bottle of 500 NDC 72888-015-05 Not Applicable Not Applicable
Bottle of 1000 Not Applicable NDC 72888-016-00 NDC 72888-017-00

Recommended Storage: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information)

Nitrates

Physicians should discuss with patients the contraindication of sildenafil tablets with regular and/or intermittent use of nitric oxide donors, such as organic nitrates or organic nitrites in any form [ see Contraindications (4.1)].

Guanylate Cyclase (GC) Stimulators

Physicians should discuss with patients the contraindication of sildenafil tablets with use of guanylate cyclase stimulators such as riociguat [ see Contraindications (4.3)].

Concomitant Use with Drugs Which Lower Blood Pressure

Physicians should advise patients of the potential for sildenafil tablets to augment the blood pressure lowering effect of alpha-blockers and anti-hypertensive medications. Concomitant administration of sildenafil tablets and an alpha-blocker may lead to symptomatic hypotension in some patients. Therefore, when sildenafil tablets is co-administered with alpha-blockers, patients should be stable on alpha-blocker therapy prior to initiating sildenafil tablets treatment and sildenafil should be initiated at the lowest dose [ see Warnings and Precautions (5.5)].

Cardiovascular Considerations

Physicians should discuss with patients the potential cardiac risk of sexual activity in patients with preexisting cardiovascular risk factors. Patients who experience symptoms (e.g., angina pectoris, dizziness, nausea) upon initiation of sexual activity should be advised to refrain from further activity and should discuss the episode with their physician [ see Warnings and Precautions (5.1)].

Sudden Loss of Vision

Physicians should advise patients to stop use of all PDE5 inhibitors, including sildenafil tablets, and seek medical attention in the event of a sudden loss of vision in one or both eyes. Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including possible permanent loss of vision, that has been reported rarely post-marketing in temporal association with the use of all PDE5 inhibitors. Physicians should discuss with patients the increased risk of NAION in individuals who have already experienced NAION in one eye. Physicians should also discuss with patients the increased risk of NAION among the general population in patients with a “crowded” optic disc, although evidence is insufficient to support screening of prospective users of PDE5 inhibitor, including sildenafil tablets, for this uncommon condition [ see Warnings and Precautions (5.3) and Adverse Reactions (6.2)].

Sudden Hearing Loss

Physicians should advise patients to stop taking PDE5 inhibitors, including sildenafil tablets, and seek prompt medical attention in the event of sudden decrease or loss of hearing. These events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to the intake of PDE5 inhibitors, including sildenafil tablets. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [ see Warnings and Precautions (5.4) and Adverse Reactions (6.2)].

Priapism

Physicians should warn patients that prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently since market approval of sildenafil tablets. In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result [ see Warnings and Precautions (5.2)].

Avoid Use with other PDE5 Inhibitors

Physicians should inform patients not to take sildenafil tablets with other PDE5 inhibitors including REVATIO or other pulmonary arterial hypertension (PAH) treatments containing sildenafil. Sildenafil is also marketed as REVATIO for the treatment of PAH. The safety and efficacy of sildenafil tablets with other PDE5 inhibitors, including REVATIO, have not been studied [ see Warnings and Precautions (5.7)].

Sexually Transmitted Disease

The use of sildenafil tablets offers no protection against sexually transmitted diseases. Counseling of patients about the protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV), may be considered [ see Warnings and Precautions (5.9)].

Distributed by:

Advagen Pharma Ltd.,
666 Plainsboro Road,
Suite 605, Plainsboro,
NJ 08536, USA.

Manufactured by:

Rubicon Research Private Limited

Ambernath, Dist: Thane, 421506,

INDIA.

Patient Information

SILDENAFIL (sil-DEN-a-fil) TABLETS

What is the most important information I should know about sildenafil tablets?

Sildenafil 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 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 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 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 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 tablets does not protect you or your partner from getting sexually transmitted diseases, including HIV—the virus that causes AIDS.

What are sildenafil tablets?

Sildenafil tablets are prescription medicine used to treat erectile dysfunction (ED). You will not get an erection just by taking this medicine. Sildenafil tablets helps a man with erectile dysfunction get and keep an erection only when he is sexually excited (stimulated).

Sildenafil tablets are not for use in women or children.

It is not known if sildenafil tablets are safe and effective in women or children under 18 years of age.

Who should not take sildenafil tablets?

Do not take s ildenafil 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 s ildenafil 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 pulmonary hypertension
  • have had a stroke
  • have low blood pressure, or high blood pressure that is not controlled
  • have a deformed penis shape
  • 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 bleeding problems
  • have or have had stomach ulcers
  • have liver problems
  • have kidney problems or are having kidney dialysis
  • have any other medical conditions

Tell your healthcare provider about all the medicines you take * , including prescription and over-the-counter medicines, vitamins, and herbal supplements.

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 s ildenafil 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). Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. 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 itraconozale (Sporanox)
  • some types of antibiotics, such as clarithromycin (Biaxin), telithromycin (Ketek), or erythromycin
  • other medicines that treat high blood pressure
  • other medicines or treatments for ED
  • Sildenafil tablets contain sildenafil, which is the same medicine found in another drug called REVATIO. REVATIO is used to treat a rare disease called pulmonary arterial hypertension (PAH). Sildenafil tablets should not be used with REVATIO or with other PAH treatments containing sildenafil or any other PDE5 inhibitors (such as Adcirca [tadalafil]).

Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure. Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

How should I take sildenafil tablets?

  • 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.
  • 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 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.

What are the possible side effects of sildenafil tablets?

Sildenafil tablets can cause serious side effects. Rarely reported side effects include:

  • an erection that will not go away (priapism). If you have an erection that lasts more than 4 hours, get medical help right away. If it is not treated right away, priapism can permanently damage your penis.
  • sudden vision loss in one or both eyes. Sudden vision loss in one or both eyes can be a sign of a serious eye problem called non-arteritic anterior ischemic optic neuropathy (NAION). It is uncertain whether PDE5 inhibitors directly cause the vision loss. Stop taking sildenafil tablets and call your healthcare provider right away if you have sudden vision loss in one or both eyes.
  • sudden hearing decrease or hearing loss. Some people may also have ringing in their ears (tinnitus) or dizziness. If you have these symptoms, stop taking sildenafil tablets and contact a doctor right away.

The most common side effects of sildenafil tablets are:

  • headache
  • flushing
  • upset stomach
  • abnormal vision, such as changes in color vision (such as having a blue color tinge) and blurred vision
  • stuffy or runny nose
  • back pain
  • muscle pain
  • nausea
  • dizziness
  • rash

In addition, heart attack, stroke, irregular heartbeats and death have happened rarely in men taking sildenafil tablets. Most, but not all, of these men had heart problems before 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.

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 Rubicon Research Private Limited, Ambernath at 00-91-251-6619500 or FDA at 1-800-FDA-1088.

How should I store sildenafil tablets?

  • Store sildenafil tablets at room temperature between 68°F to 77°F (20°C to 25°C).

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. Do not use sildenafil tablets for a condition for which it was not prescribed. Do not give sildenafil tablets to other people, even if they have the same symptoms that you have. It may harm them.

This Patient Information leaflet summarizes the most important information about sildenafil tablets. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about sildenafil tablets that is written for health professionals.

What are the ingredients in sildenafil tablets?

Active ingredient: Sildenafil citrate

Inactive ingredients: crospovidone, hydrophobic colloidal silica, hypromellose, lactose monohydrate, magnesium stearate VG, microcrystalline cellulose, titanium dioxide, triacetin and FD&C Blue# 2/ Indigo Carmine Aluminium.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Distributed by:

Advagen Pharma Ltd.,
666 Plainsboro Road,
Suite 605, Plainsboro, NJ 08536, USA.

Manufactured by:

Rubicon Research Private Limited

Ambernath, Dist: Thane, 421506,

INDIA.

Rev.00,10/21

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