telmisartan

WARNING: FETAL TOXICITY

Boxed Warning section

• When pregnancy is detected, discontinue telmisartan as soon as possible [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ]. • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ]

1 INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

2 DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

3 DOSAGE FORMS AND STRENGTHS

DOSAGE FORMS & STRENGTHS SECTION

• 20 mg, white to off-white, uncoated round shaped tablets, flat with beveled edges, plain on one side and debossed “036” on other side. • 40 mg, white to off-white, uncoated oval shaped tablets, biconvex with beveled edges, plain on one side and debossed “037” on other side. • 80 mg, white to off-white, uncoated oval shaped tablets, biconvex with beveled edges, plain on one side and debossed “038” on other side.

4 CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Telmisartan is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis or angioedema) to telmisartan or any other component of this product [see Adverse Reactions (6.2) ]. Do not co-administer aliskiren with telmisartan in patients with diabetes. [see Drug interactions(7) ].

5 WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

6 ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

The following adverse reaction is described elsewhere in labeling: • Renal dysfunction upon use with ramipril [see Warnings and Precautions (5.6) ]

7 DRUG INTERACTIONS

DRUG INTERACTIONS SECTION

Aliskiren: Do not co-administer aliskiren with telmisartan in patients with diabetes. Avoid use of aliskiren with telmisartan in patients with renal impairment (GFR

8 USE IN SPECIFIC POPULATIONS

USE IN SPECIFIC POPULATIONS SECTION

10 OVERDOSAGE

OVERDOSAGE SECTION

Limited data are available with regard to overdosage in humans. The most likely manifestation of overdosage with telmisartan tablets would be hypotension, dizziness and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted. Telmisartan is not removed by hemodialysis.

11 DESCRIPTION

DESCRIPTION SECTION

Telmisartan tablets USP is a non-peptide angiotensin II receptor (type AT 1 ) antagonist. Telmisartan is chemically described as 4'-[(1,4'-dimethyl-2'-propyl [2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid. Its empirical formula is C 33 H 30 N 4 O 2 , its molecular weight is 514.63, and its structural formula is: Telmisartan, USP is a white to slightly yellowish solid. It is practically insoluble in water and in the pH range of 3 to 9, sparingly soluble in strong acid (except insoluble in hydrochloric acid), and soluble in strong base. Telmisartan is available as tablets for oral administration, containing 20 mg, 40 mg or 80 mg of telmisartan USP. The tablets contain the following inactive ingredients: magnesium stearate, mannitol, meglumine, povidone, sodium hydroxide and sodium streayl fumarate. Telmisartan tablets, USP are hygroscopic and require protection from moisture.

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

Telmisartan Tablets, USP are supplied as below: 20 mg, white to off-white uncoated round shaped tablets, flat, with beveled edges, plain on one side and debossed “036”on other side. NDC 68788-8441-30 bottle of 30 Tablets NDC 68788-8441-60 bottle of 60 Tablets NDC 68788-8441-0 bottle of 90 Tablets Storage Store at 20 o to 25 o C (68 o to 77 o F) [see USP Controlled Room Temperature]. Dispense in a tightly closed container. Insert the cotton every time back in to the bottle after every consumption

17 PATIENT COUNSELING INFORMATION

INFORMATION FOR PATIENTS SECTION

Advise the patient to read the FDA-approved patient labeling (Patient Information) Pregnancy Advise female patients of childbearing age about the consequences of exposure to telmisartan during pregnancy. Discuss treatment options with women planning to become pregnant. Tell patients to report pregnancies to their physicians as soon as possible [see and ] . Lactation Advise nursing women not to breastfeed during treatment with telmisartan [see ] . Symptomatic Hypotension and Syncope Advise patients that lightheadedness can occur, especially during the first days of therapy, and to report it to their healthcare provider. Inform patients that inadequate fluid intake, excessive perspiration, diarrhea, or vomiting can lead to an excessive fall in blood pressure, with the same consequences of lightheadedness and possible syncope. Advise patients to contact their healthcare provider if syncope occurs [see ] . Potassium Supplements Advise patients not to use potassium supplements or salt substitutes that contain potassium without consulting the prescribing healthcare provider [see ] . Manufactured By: Inventia Healthcare Limited, F1-F1/1-F75/1, Additional Ambernath M.I.D.C., Ambernath (East)-421506, Thane 421506, Maharashtra State, India Distributed by: Ascend Laboratories, LLC Bedminster, NJ 07921. Revised: March 2025 Trademarks are the property of their respective owners. 2011663

SPL PATIENT PACKAGE INSERT SECTION

SPL PATIENT PACKAGE INSERT SECTION

Patient Information Telmisartan (TEL-mi-SAR-tan) Tablets, USP Read this Patient Information before you start taking telmisartan tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment. What is the most important information I should know about telmisartan tablets? Telmisartan tablets can cause harm or death to an unborn baby. Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant. If you get pregnant while taking telmisartan, tell your doctor right away. What is telmisartan tablet? Telmisartan tablet is a prescription medicine used: • to treat high blood pressure (hypertension) It is not known if telmisartan tablet is safe and effective in children. Who should not take telmisartan tablets? You should not take telmisartan tablets if you are allergic (hypersensitive) to the active ingredient (telmisartan) or any of the other ingredients listed at the end of this leaflet. For patients with diabetes, if you are taking telmisartan you should not take aliskiren. What should I tell my doctor before taking telmisartan tablets? Before you take telmisartan tablets, tell your doctor if you: • are pregnant or are planning to become pregnant. See “What is the most important information I should know about telmisartan tablets?” • are breast-feeding or plan to breast-feed. It is not known if telmisartan passes into your breast milk. You and your doctor should decide if you will take telmisartan tablets or breast-feed. You should not do both. Talk with your doctor about the best way to feed your baby if you take telmisartan tablets. • have liver problems • have kidney problems • have heart problems • have any other medical conditions Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. For patients with diabetes, if you are taking telmisartan tablets you should not take aliskiren. Telmisartan tablets may affect the way other medicines work, and other medicines may affect how telmisartan tablets works. Especially tell your doctor if you take: • aliskiren • digoxin (Lanoxin ® ) • lithium (Lithobidp ® , lithium carbonate, lithium citrate) • aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) • other medicines used to treat your high blood pressure or heart problem • water pills (diuretic) Know the medicines you take. Keep a list of them and show it to your doctor or pharmacist when you get a new medicine. How should I take telmisartan tablets? • Take telmisartan tablets exactly as your doctor tells you to take it. • Your doctor will tell you how much telmisartan tablets to take and when to take it. • Do not change your dose unless your doctor tells you to. • Take telmisartan tablets one time each day at the same time. • Take telmisartan tablets with or without food. • If you miss a dose, take it as soon as you remember. If it is close to your next dose, do not take the missed dose. Take the next dose at your regular time. • If you take too much telmisartan tablets, call your doctor, or go to the nearest hospital emergency room right away. What are the possible side effects of telmisartan tablets? Telmisartan tablets may cause serious side effects, including: • Injury or death to your unborn baby. See “What is the most important information I should know about telmisartan tablets?” • Low blood pressure (hypotension) is most likely to happen if you also: o take water pills (diuretics) o are on a low-salt diet o get dialysis treatments o have heart problems o get sick with vomiting or diarrhea If you feel faint or dizzy, lie down and call your doctor right away. • Kidney problems, which may get worse if you already have kidney disease. You may have changes in your kidney test results, and you may need a lower dose of telmisartan tablets. Call your doctor if you get: o swelling in your feet, ankles, or hands o unexplained weight gain Call your doctor right away if you get any of the symptoms listed above. • High potassium in the blood (hyperkalemia) . Your doctor may check your potassium levels as needed. Rare, serious allergic reactions may happen. Tell your doctor right away if you get any of these symptoms: • swelling of the face, tongue, throat • difficulty breathing • skin rash The most common side effects of telmisartan tablets include: • sinus pain and congestion (sinusitis) • back pain • diarrhea These are not all the possible side effects with telmisartan tablets. Tell your doctor if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store telmisartan tablets? • Store telmisartan tablets at room temperature 20 o to 25 o C (68 o to 77 o F). Keep telmisartan tablets and all medicines out of the reach of children. General information about telmisartan tablets Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use telmisartan tablets for a condition for which it was not prescribed. Do not give telmisartan tablets to other people, even if they have the same condition you have. It may harm them. This Patient Information leaflet summarizes the most important information about telmisartan tablets. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about telmisartan tablets that is written for health professionals. For more information, call Ascend Laboratories, LLC at 1-877-272-7901 What are the ingredients in telmisartan tablets? Active Ingredient: telmisartan Inactive Ingredients : magnesium stearate, mannitol, meglumine, povidone, sodium hydroxide and sodium streayl fumarate. What is High Blood Pressure (Hypertension)? Blood pressure is the force in your blood vessels when your heart beats and when your heart rests. You have high blood pressure when the force is too much. Telmisartan tablets can help your blood vessels relax so your blood pressure is lower. Medicines that lower your blood pressure lower your chance of having a stroke or heart attack. High blood pressure makes the heart work harder to pump blood throughout the body and causes damage to the blood vessels. If high blood pressure is not treated, it can lead to stroke, heart attack, heart failure, kidney failure, and vision problems. What is Cardiovascular Risk? Patients older than 55 years of age who have been diagnosed with blood vessel disease in the heart, legs, or brain (coronary, peripheral, or cerebral vascular disease) or diabetes with end organ damage (for example: kidney, heart, and brain) are at higher risk of cardiovascular events (for example: death from cardiovascular causes, stroke, and/or heart attack). This Patient Information has been approved by the U.S. Food and Drug Administration. Manufactured By: Inventia Healthcare Limited, F1-F1/1-F75/1, Additional Ambernath M.I.D.C., Ambernath (East)-421506, Thane 421506, Maharashtra State, India Distributed by: Ascend Laboratories, LLC Bedminster, NJ 07921. Revised: March 2025 Trademarks are the property of their respective owners. Repackaged By: Preferred Pharmaceuticals Inc.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Telmisartan tablets, USP 20 mg 30 Tablets NDC : 68788-8441 Repackaged By: Preferred Pharmaceuticals Inc.