MICARDIS Telmisartan Tablets - Hypertension Medication

WARNING: AVOID USE IN PREGNANCY
See full prescribing information for complete boxed warning.
When used in pregnancy, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. When pregnancy is detected, MICARDIS tablets should be discontinued as soon as possible.

Patient Information

Read this Patient Information before you start taking MICARDIS 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 MICARDIS tablets?

MICARDIS is not for pregnant women. Taking MICARDIS tablets during your pregnancy can cause injury and even death to your unborn baby. If you get pregnant, stop taking MICARDIS tablets and call your doctor right away. If you plan to become pregnant, talk to your doctor about other ways to lower your blood pressure.

What other important safety information should I know about MICARDIS tablets?

You may experience sleepiness, dizziness, lightheadedness, or fainting when taking medicines such as MICARDIS tablets. Use caution when engaging in activities such as driving a car or operating appliances or machinery.

What is MICARDIS?

MICARDIS is a prescription medicine used:

to treat high blood pressure (hypertension)
in certain high risk people aged 55 years and older to help lower their risk of having certain cardiovascular problems such as stroke, heart attack, or death

It is not known if MICARDIS is safe and effective in children.

Who should not take MICARDIS?

You should not take MICARDIS tablets if you are allergic (hypersensitive) to the active ingredient (telmisartan) or any of the other ingredients listed at the end of this leaflet.

What should I tell my doctor before taking MICARDIS tablets?

Before you take MICARDIS tablets, tell your doctor if you:

have liver problems
have kidney problems
have heart problems
have any other medical conditions
are pregnant or are planning to become pregnant. See "What is the most important information I should know about MICARDIS tablets?"
are breast-feeding or plan to breast-feed. It is not known if MICARDIS passes into your breast milk. You and your doctor should decide if you will take MICARDIS tablets or breast-feed. You should not do both. Talk with your doctor about the best way to feed your baby if you take MICARDIS tablets.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

MICARDIS may affect the way other medicines work, and other medicines may affect how MICARDIS works. Especially tell your doctor if you take:

digoxin (Lanoxin^®, Lanoxicaps^®)
lithium (Eskalith^®, Lithobid^®)
medicines used to treat pain and arthritis, called non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors
ramipril (Altace^®) or 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 MICARDIS tablets?

Take MICARDIS tablets exactly as your doctor tells you to take it.
Your doctor will tell you how much MICARDIS to take and when to take it.
Do not change your dose unless your doctor tells you to.
Take MICARDIS one time each day at the same time.
Take MICARDIS 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 MICARDIS, 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 MICARDIS. Talk with your doctor if you do not understand the instructions.

What are the possible side effects of MICARDIS tablets?

MICARDIS 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 MICARDIS 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 MICARDIS 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
blistering of the skin or rash

The most common side effects of MICARDIS tablets include:

sinus pain and congestion (sinusitis)
back pain
diarrhea

These are not all the possible side effects with MICARDIS 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 MICARDIS tablets?

Store MICARDIS tablets between 59°F to 86°F (15°C to 30°C).
Do not remove MICARDIS tablets from blisters until right before you take them.

Keep MICARDIS tablets and all medicines out of the reach of children.

General information about MICARDIS tablets

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

This medication guide summarizes the most important information about MICARDIS tablets. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about MICARDIS tablets that is written for health professionals.

For more information, call Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257, or (TTY) 1-800-459-9906.

What are the ingredients in MICARDIS tablets?

Active Ingredient: telmisartan

Inactive Ingredients: sodium hydroxide, meglumine, povidone, sorbitol, and magnesium stearate

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. MICARDIS tablets can help your blood vessels relax so your blood pressure is lower. 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).

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)

Distributed by:

Boehringer Ingelheim Pharmaceuticals, Inc.
Ridgefield, CT 06877 USA

Licensed from: Boehringer Ingelheim International GmbH, Ingelheim, Germany

Revised: April 2011 MC/CBS/4-11 MC94028CONS

*Co-pay assistance and patient education.

INDICATIONS

MICARDIS is a prescription medicine used to treat high blood pressure (hypertension).

Additionally, MICARDIS 80 mg is used in certain high-risk people aged 55 years and older who are ACE-intolerant to help lower their risk of having certain cardiovascular problems such as stroke, heart attack, or death.

IMPORTANT SAFETY INFORMATION

MICARDIS is not for pregnant women. Taking MICARDIS during pregnancy can cause injury and even death to your unborn baby. If you become pregnant, stop taking MICARDIS and call your doctor right away.

If you plan to become pregnant or breastfeed, talk to your doctor about other ways to lower your blood pressure.

Do not take MICARDIS if you are allergic (hypersensitive) to the active ingredient (telmisartan) or any other ingredient in this medicine.

Serious allergic reactions may occur. Tell your doctor right away if you have signs of allergic reaction such as swelling of face, tongue or throat, difficulty breathing, or skin rash.

Before taking MICARDIS, tell your doctor about any medical conditions you have, including any liver, kidney, or heart problems, and if you are pregnant or breast feeding. Tell your doctor about all other medications and supplements you are taking.

You may experience sleepiness, dizziness, lightheadedness, or fainting when taking medicines like MICARDIS. Use caution when driving a car or operating machinery or appliances.

MICARDIS can cause serious side effects including injury to your unborn child, low blood pressure, kidney problems and high potassium in your blood.

Other side effects include sinus pain, back pain, and diarrhea.

Other rare but serious side effects may occur.

Please see full Prescribing Information, including Boxed WARNING, for MICARDIS.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.