Telmisartan (Page 5 of 6)

14 CLINICAL STUDIES

14.1 Hypertension

The antihypertensive effects of telmisartan have been demonstrated in six principal placebo-controlled clinical trials, studying a range of 20 mg to 160 mg; one of these examined the antihypertensive effects of telmisartan and hydrochlorothiazide in combination. The studies involved a total of 1,773 patients with mild to moderate hypertension (diastolic blood pressure of 95 to 114 mmHg), 1,031 of whom were treated with telmisartan. Following once daily administration of telmisartan, the magnitude of blood pressure reduction from baseline after placebo subtraction was approximately (SBP/DBP) 6 to 8/6 mmHg for 20 mg, 9 to 13/6 to 8 mmHg for 40 mg, and 12 to 13/7 to 8 mmHg for 80 mg. Larger doses (up to 160 mg) did not appear to cause a further decrease in blood pressure.

Upon initiation of antihypertensive treatment with telmisartan, blood pressure was reduced after the first dose, with a maximal reduction by about 4 weeks. With cessation of treatment with telmisartan tablets, blood pressure gradually returned to baseline values over a period of several days to one week. During long-term studies (without placebo control) the effect of telmisartan appeared to be maintained for up to at least one year. The antihypertensive effect of telmisartan is not influenced by patient age, gender, weight, or body mass index. Blood pressure response in black patients (usually a low-renin population) is noticeably less than that in Caucasian patients. This has been true for most, but not all, angiotensin II antagonists and ACE inhibitors.

In a controlled study, the addition of telmisartan to hydrochlorothiazide produced an additional dose-related reduction in blood pressure that was similar in magnitude to the reduction achieved with telmisartan monotherapy. Hydrochlorothiazide also had an added blood pressure effect when added to telmisartan.

The onset of antihypertensive activity occurs within 3 hours after administration of a single oral dose. At doses of 20 mg, 40 mg, and 80 mg, the antihypertensive effect of once daily administration of telmisartan is maintained for the full 24-hour dose interval. With automated ambulatory blood pressure monitoring and conventional blood pressure measurements, the 24-hour trough-to-peak ratio for 40 mg to 80 mg doses of telmisartan was 70% to 100% for both systolic and diastolic blood pressure. The incidence of symptomatic orthostasis after the first dose in all controlled trials was low (0.04%).

There were no changes in the heart rate of patients treated with telmisartan in controlled trials.

There are no trials of telmisartan demonstrating reductions in cardiovascular risk in patients with hypertension, but at least one pharmacologically similar drug has demonstrated such benefits.

16 HOW SUPPLIED/STORAGE AND HANDLING

Telmisartan tablets USP, 20 mg, are supplied as white to off-white, round shaped uncoated tablets, debossed with ‘AN’ on one side and ‘291’ on the other side. They are available as follows:

Bottles of 30: NDC 65162-291-03

Bottles of 90: NDC 65162-291-09

Bottles of 500: NDC 65162-291-50

Carton of 30 tablets (3 x 10 unit-dose) NDC 65162-291-63

Telmisartan tablets USP, 40 mg, are supplied as white to off-white, modified capsule shaped uncoated tablets, debossed with ‘AN’ on one side and ‘292’ on the other side. They are available as follows:

Bottles of 30: NDC 65162-292-03

Bottles of 90: NDC 65162-292-09

Bottles of 500: NDC 65162-292-50

Bottles of 1000: NDC 65162-292-11

Carton of 30 tablets (3 x 10 unit-dose) NDC 65162-292-63

Telmisartan tablets USP, 80 mg, are supplied as white to off-white, modified capsule shaped uncoated tablets, debossed with ‘AN293’ on one side and plain on the other side. They are available as follows:

Bottles of 30: NDC 65162-293-03

Bottles of 90: NDC 65162-293-09

Bottles of 500: NDC 65162-293-50

Bottles of 1000: NDC 65162-293-11

Carton of 30 tablets (3 x 10 unit-dose) NDC 65162-293-63

Storage

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Tablets should not be removed from blisters or bottles until immediately before administration.

17 PATIENT COUNSELING INFORMATION

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 Warnings and Precautions (5.1) and Use in Specific Populations (8.1)].

Lactation

Advise nursing women not to breastfeed during treatment with telmisartan [see Use in Specific Populations (8.2)].

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 Warnings and Precautions (5.2)].

Potassium Supplements

Advise patients not to use potassium supplements or salt substitutes that contain potassium without consulting the prescribing healthcare provider [see Warnings and Precautions (5.3)].

Manufactured by:

Amneal Pharmaceuticals Pvt. Ltd.

Ahmedabad 382220, INDIA

Distributed by:

Amneal Pharmaceuticals LLC

Bridgewater, NJ 08807

Rev. 02-2018-01

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 tablets, tell your doctor right away.

What are telmisartan tablets?

Telmisartan tablets are a prescription medicine used:

• to treat high blood pressure (hypertension)

It is not known if telmisartan tablets are 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 tablets 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 (Lithobid^® , 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.
• Read the “How to Open the Blister” at the end of this leaflet before you use telmisartan tablets. Talk with your doctor if you do not understand the instructions.

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:

• take water pills (diuretics)
• are on a low-salt diet
• get dialysis treatments
• have heart problems
• 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:

• swelling in your feet, ankles, or hands
• 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 between 68° to 77°F (20° to 25°C).
• Do not remove telmisartan tablets from blisters or bottles until right before you take them.

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 Amneal Pharmaceuticals at 1-877-835-5472.

What are the ingredients in telmisartan tablets?

Active Ingredient: telmisartan, USP

Inactive Ingredients: magnesium stearate, mannitol, meglumine, povidone, sodium hydroxide and talc.

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.

How to open the blister:

1. Tear (You may also use scissors to tear the blister apart)
   
2. Peel (Peel off the paper layer from the aluminum foil)
   
3. Push (Push the tablet through the foil)

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

Trademarks are the property of their respective owners.

Manufactured by:

Amneal Pharmaceuticals Pvt. Ltd.

Ahmedabad 382220, INDIA

Distributed by:

Amneal Pharmaceuticals LLC

Bridgewater, NJ 08807

Rev. 02-2018-01