These highlights do not include all the information needed to use TADALAFIL TABLETS safely and effectively. See full prescribing information for TADALAFIL TABLETS. TADALAFIL tablets, for oral use Initial U.S. Approval: 2003

1 INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

2 DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Do not split tadalafil tablets; entire dose should be taken.

3 DOSAGE FORMS AND STRENGTHS

DOSAGE FORMS & STRENGTHS SECTION

2.5 mg tablets: Yellow colored, round shaped, biconvex, film-coated tablets, debossed with “2½” on one side and plain on other side. 5 mg tablets: Yellow colored, oval shaped, biconvex, film-coated tablets, debossed with “5” on one side and “S” on other side. 10 mg tablets: Yellow colored, oval shaped, biconvex, film-coated tablets, debossed with “10” on one side and “S” on other side. 20 mg tablets: Yellow colored, oval shaped, biconvex, film-coated tablets, debossed with “20” on one side and “S” on other side.

4 CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

5 WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

Evaluation of erectile dysfunction and BPH should include an appropriate medical assessment to identify potential underlying causes, as well as treatment options. Before prescribing tadalafil, it is important to note the following:

6 ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

7 DRUG INTERACTIONS

DRUG INTERACTIONS SECTION

8 USE IN SPECIFIC POPULATIONS

USE IN SPECIFIC POPULATIONS SECTION

10 OVERDOSAGE

OVERDOSAGE SECTION

Single doses up to 500 mg have been given to healthy subjects, and multiple daily doses up to 100 mg have been given to patients. Adverse events were similar to those seen at lower doses. In cases of overdose, standard supportive measures should be adopted as required. Hemodialysis contributes negligibly to tadalafil elimination.

11 DESCRIPTION

DESCRIPTION SECTION

Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the molecular formula C 22 H 19 N 3 O 4 representing a molecular weight of 389.41. The structural formula is: The chemical designation is pyrazino[1’,2’:1,6]pyrido[3,4-b]indole-1,4-dione,6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-,(6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil tablets, USP are available as round shaped (2.5 mg) and oval shaped (5 mg, 10 mg, and 20 mg) tablets for oral administration. Each tadalafil tablet, USP contains 2.5 mg, 5 mg, 10 mg, or 20 mg of tadalafil, USP and the following inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer, polyethylene glycol, talc, titanium dioxide, and yellow iron oxide.

12 CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

13 NONCLINICAL TOXICOLOGY

NONCLINICAL TOXICOLOGY SECTION

14 CLINICAL STUDIES

CLINICAL STUDIES SECTION

16 HOW SUPPLIED/STORAGE AND HANDLING

HOW SUPPLIED SECTION

16.1 How Supplied Tadalafil tablets, USP are supplied as follows: 10 mg tablets are yellow colored, oval shaped, biconvex, film-coated tablets, debossed with “10” on one side and “S” on other side. They are supplied in the following package sizes: NDC 63629-8157-1: 30 Tablets in a Bottle NDC 63629-8157-2: 10 Tablets in a Bottle NDC 63629-8157-3: 60 Tablets in a Bottle NDC 63629-8157-4: 90 Tablets in a Bottle NDC 63629-8157-5: 20 Tablets in a Bottle NDC 63629-8157-6: 6 Tablets in a Bottle 16.2 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

17 PATIENT COUNSELING INFORMATION

INFORMATION FOR PATIENTS SECTION

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

Patient Information

SPL PATIENT PACKAGE INSERT SECTION

Dispense with Patient Information available at https://www.sunpharma.com/usa/products Tadalafil (ta-DAL-a-fil) Tablets, USP Read this important information before you start taking tadalafil tablets and each time you get a refill. There may be new information. You may also find it helpful to share this information with your partner. This information does not take the place of talking with your healthcare provider. You and your healthcare provider should talk about tadalafil tablets when you start taking it and at regular checkups. If you do not understand the information, or have questions, talk with your healthcare provider or pharmacist. What Is The Most Important Information I Should Know About Tadalafil Tablets? Tadalafil tablets can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. You could get dizzy, faint, or have a heart attack or stroke. Never taketadalafil tablets with any nitrate or guanylate cyclase stimulator medicines. Do not take tadalafil tablets if you take any medicines called “nitrates.” Nitrates are commonly used to treat angina. Angina is a symptom of heart disease and can cause pain in your chest, jaw, or down your arm. Medicines called nitrates include nitroglycerin that is found in tablets, sprays, ointments, pastes, or patches. Nitrates can also be found in other medicines such as isosorbide dinitrate or isosorbide mononitrate. Some recreational drugs called “poppers” also contain nitrates, such as amyl nitrite and butyl nitrite. Do not take tadalafil 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. Ask your healthcare provider or pharmacist if you are not sure if any of your medicines are nitrates or guanylate cyclase stimulators, such as riociguat. (See “Who Should Not Take Tadalafil Tablets?” ) Tell all of your healthcare providers that you take tadalafil 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 tadalafil tablets. After taking a single tablet, some of the active ingredient of tadalafil tablets remains in your body for more than 2 days. The active ingredient can remain longer if you have problems with your kidneys or liver, or you are taking certain other medications (see “Can Other Medicines Affect Tadalafil 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. See also “What Are The Possible Side Effects Of Tadalafil Tablets?” What Are Tadalafil Tablets? Tadalafil tablets are a prescription medicine taken by mouth for the treatment of: men with erectile dysfunction (ED) men with symptoms of benign prostatic hyperplasia (BPH) men with both ED and BPH Tadalafil Tablets for the Treatment of ED ED is a condition where the penis does not fill with enough blood to harden and expand when a man is sexually excited, or when he cannot keep an erection. A man who has trouble getting or keeping an erection should see his healthcare provider for help if the condition bothers him. Tadalafil tablets help increase blood flow to the penis and may help men with ED get and keep an erection satisfactory for sexual activity. Once a man has completed sexual activity, blood flow to his penis decreases, and his erection goes away. Some form of sexual stimulation is needed for an erection to happen with tadalafil tablets. Tadalafil tablets do not: cure ED increase a man’s sexual desire protect a man or his partner from sexually transmitted diseases, including HIV. Speak to your healthcare provider about ways to guard against sexually transmitted diseases. serve as a male form of birth control Tadalafil tablets are only for men over the age of 18, including men with diabetes or who have undergone prostatectomy. Tadalafil Tablets for the Treatment of Symptoms of BPH BPH is a condition that happens in men, where the prostate gland enlarges which can cause urinary symptoms. Tadalafil Tablets for the Treatment of ED and Symptoms of BPH ED and symptoms of BPH may happen in the same person and at the same time. Men who have both ED and symptoms of BPH may take tadalafil tablets for the treatment of both conditions. Tadalafil tablets are not for women or children. Tadalafil tablets must be used only under a healthcare provider’s care. Who Should Not Take Tadalafil Tablets? Do not take tadalafil tablets if you: take any medicines called “nitrates”. use recreational drugs called “poppers” like amyl nitrite and butyl nitrite. (See “What Is The Most Important Information I Should Know About Tadalafil Tablets?”) take any medicines called guanylate cyclase stimulators, such as riociguat. are allergic to tadalafil tablets or ADCIRCA®*, or any of its ingredients. See the end of this leaflet for a complete list of ingredients in tadalafil tablets. Symptoms of an allergic reaction may include: rash hives swelling of the lips, tongue, or throat difficulty breathing or swallowing Call your healthcare provider or get help right away if you have any of the symptoms of an allergic reaction listed above. What Should I Tell My Healthcare Provider Before Taking Tadalafil Tablets? Tadalafil tablets are not right for everyone. Only your healthcare provider and you can decide if tadalafil tablets are right for you. Before taking tadalafil tablets, tell your healthcare provider about all your medical problems,including if you: have heart problems such as angina, heart failure, irregular heartbeats, or have had a heart attack. Ask your healthcare provider if it is safe for you to have sexual activity. You should not take tadalafil tablets if your healthcare provider has told you not to have sexual activity because of your health problems. have pulmonary hypertension have low blood pressure or have high blood pressure that is not controlled have had a stroke have liver problems have kidney problems or require dialysis have retinitis pigmentosa, a rare genetic (runs in families) eye disease have ever had severe vision loss, including a condition called NAION have stomach ulcers have a bleeding problem have a deformed penis shape or Peyronie’s disease have had an erection that lasted more than 4 hours have blood cell problems such as sickle cell anemia, multiple myeloma, or leukemia Can Other Medicines Affect Tadalafil Tablets? Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Tadalafil tablets and other medicines may affect each other. Always check with your healthcare provider before starting or stopping any medicines. 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 Tadalafil Tablets?”) medicines called guanylate cyclase stimulators, such as riociguat (Adempas®*), used to treat pulmonary hypertension medicines called alpha blockers. These include 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. If tadalafil tablets are taken with certain alpha blockers, your blood pressure could suddenly drop. You could get dizzy or faint. other medicines to treat high blood pressure (hypertension) medicines called HIV protease inhibitors, such as ritonavir (Norvir®*, Kaletra®*) some types of oral antifungals such as ketoconazole (Nizoral®*), itraconazole (Sporanox®*) some types of antibiotics such as cl...

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tadalafil Tablets 10 mg