Tadalafil (Page 12 of 14)

16.1 How Supplied

Tadalafil tablets, USP are supplied as follows:

2.5 mg light yellow, oval-shaped, film-coated tablets, debossed with ‘08’ on one side and plain on the other side.

Carton of 30 tablets (2 blister cards of 15 tablets) NDC 0480-2308-65

5 mg pale yellow, oval-shaped, film-coated tablets, debossed with ‘09’ on one side and plain on the other side.

Carton of 30 tablets (2 blister cards of 15 tablets) NDC 0480-2309-65

Bottles of 30 NDC 0480-2309-56

10 mg pale yellow, oval-shaped, film-coated tablets, debossed with ‘10’ on one side and plain on the other side.

Bottles of 30 NDC 0480-2310-56

20 mg pale yellow, oval-shaped, film-coated tablets, debossed with ‘11’ on one side and plain on the other side.

Bottles of 30 NDC 0480-2311-56

16.2 Storage

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep out of reach of children.

17 PATIENT COUNSELING INFORMATION

“See FDA-approved patient labeling (Patient Information)”

17.1 Nitrates

Physicians should discuss with patients the contraindication of tadalafil tablets with regular and/or intermittent use of organic nitrates. Patients should be counseled that concomitant use of tadalafil tablets with nitrates could cause blood pressure to suddenly drop to an unsafe level, resulting in dizziness, syncope, or even heart attack or stroke.

Physicians should discuss with patients the appropriate action in the event that they experience anginal chest pain requiring nitroglycerin following intake of tadalafil tablets. In such a patient, who has taken tadalafil tablets, where nitrate administration is deemed medically necessary for a life-threatening situation, at least 48 hours should have elapsed after the last dose of tadalafil tablets before nitrate administration is considered. In such circumstances, nitrates should still only be administered under close medical supervision with appropriate hemodynamic monitoring. Therefore, patients who experience anginal chest pain after taking tadalafil tablets should seek immediate medical attention [see Contraindications (4.1) and Warnings and Precautions (5.1)].

17.2 Guanylate Cyclase (GC) Stimulators

Physicians should discuss with patients the contraindication of tadalafil tablets with any use of a GC stimulator, such as riociguat, for pulmonary arterial hypertension. Patients should be counseled that the concomitant use of tadalafil tablets with GC stimulators may cause blood pressure to drop to an unsafe level.

17.3 Cardiovascular Considerations

Physicians should consider the potential cardiac risk of sexual activity in patients with preexisting cardiovascular disease. Physicians should advise patients who experience symptoms upon initiation of sexual activity to refrain from further sexual activity and seek immediate medical attention [see Warnings and Precautions (5.1)].

17.4 Concomitant Use with Drugs Which Lower Blood Pressure

Physicians should discuss with patients the potential for tadalafil tablets to augment the blood-pressure-lowering effect of alpha-blockers, and antihypertensive medications [see Warnings and Precautions (5.6), Drug Interactions (7.1), and Clinical Pharmacology (12.2)].

17.5 Potential for Drug Interactions When Taking Tadalafil Tablets for Once Daily Use

Physicians should discuss with patients the clinical implications of continuous exposure to tadalafil when prescribing tadalafil tablets for once daily use, especially the potential for interactions with medications (e.g., nitrates, alpha- blockers, antihypertensives and potent inhibitors of cytochrome P450 3A4) and with substantial consumption of alcohol [see Dosage and Administration (2.7), Warnings and Precautions (5.6), Drug Interactions (7.1, 7.2), Clinical Pharmacology (12.2), and Clinical Studies (14.2)].

17.6 Priapism

There have been rare reports of prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) for this class of compounds. Priapism, if not treated promptly, can result in irreversible damage to the erectile tissue. Physicians should advise patients who have an erection lasting greater than 4 hours, whether painful or not, to seek emergency medical attention.

17.7 Sudden Loss of Vision

Physicians should advise patients to stop use of all PDE5 inhibitors, including tadalafil 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 postmarketing 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 inhibitors, including tadalafil tablets, for this uncommon condition [see Warnings and Precautions (5.4) and Adverse Reactions (6.2)].

17.8 Sudden Hearing Loss

Physicians should advise patients to stop taking PDE5 inhibitors, including tadalafil 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 tadalafil tablets. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [see Adverse Reactions (6.1, 6.2)].

17.9 Alcohol

Patients should be made aware that both alcohol and tadalafil tablets, a PDE5 inhibitor, act as mild vasodilators. When mild vasodilators are taken in combination, blood-pressure-lowering effects of each individual compound may be increased. Therefore, physicians should inform patients that substantial consumption of alcohol (e.g., 5 units or greater) in combination with tadalafil tablets can increase the potential for orthostatic signs and symptoms, including increase in heart rate, decrease in standing blood pressure, dizziness, and headache [see Warnings and Precautions (5.9), Drug Interactions (7.1), and Clinical Pharmacology (12.2)].

17.10 Sexually Transmitted Disease

The use of tadalafil tablets offers no protection against sexually transmitted diseases. Counseling of patients about the protective measures necessary to guard against sexually transmitted diseases, including Human Immunodeficiency Virus (HIV) should be considered.

17.11 Recommended Administration

Physicians should instruct patients on the appropriate administration of tadalafil tablets to allow optimal use.

For tadalafil tablets for use as needed in men with ED, patients should be instructed to take one tablet at least
30 minutes before anticipated sexual activity. In most patients, the ability to have sexual intercourse is improved for up to 36 hours.

For tadalafil tablets for once daily use in men with ED or ED/BPH, patients should be instructed to take one tablet at approximately the same time every day without regard for the timing of sexual activity. Tadalafil is effective at improving erectile function over the course of therapy.

For tadalafil tablets for once daily use in men with BPH, patients should be instructed to take one tablet at approximately the same time every day.

Brands listed are the trademarks of their respective owners.

Manufactured In India By:

Watson Pharma Private Ltd.

Verna, Salcette Goa 403 722 INDIA

Manufactured For:

Teva Pharmaceuticals

Parsippany, NJ 07054

Rev. A 10/2022

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