^Principal Display Panel - Mg/ Mg Tablet Blister Card Carton
NDC 0597-0044-37
Micardis ®HCT (telmisartan/ hydrochlorothiazide tablets)
80 mg/12.5 mg
Rx only
30 tablets - 3 blister cards of 10 tablets each. Each tablet contains 80 mg of telmisartan and 12.5 mg of hydrochlorothiazide.
Dosage: Read accompanying prescribing information.
Keep out of reach of children.
Important: Moisture sensitive tablets - do not remove from blisters until immediately before administration.
Boehringer Ingelheim
^Patient Information Micardis® Hct (my-car-dis Hct) (telmisartan And Hydrochlorothiazide Tablets)
Read this Patient Information before you start taking MICARDIS HCT 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 HCT tablets?
MICARDIS HCT 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 MICARDIS HCT, tell your doctor right away.
What is MICARDIS HCT?
MICARDIS HCT is a prescription medicine used to treat high blood pressure (hypertension). MICARDIS HCT contains:
Your doctor may prescribe other medicines for you to take along with MICARDIS HCT to treat your high blood pressure.
It is not known if MICARDIS HCT is safe and effective in children.
Do not take MICARDIS HCT tablets if you:
What should I tell my doctor before using MICARDIS HCT tablets?
Before you take MICARDIS HCT tablets, tell your doctor if you:
Tell your doctor about all the medicines you take,including prescription and non-prescription medicines, vitamins, and herbal supplements. Also, tell your doctor if you drink alcohol.
MICARDIS HCT may affect the way other medicines work, and other medicines may affect how MICARDIS HCT works. Especially tell your doctor if you take:
Ask your doctor if you are not sure if you are taking one of the medicines listed above.
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 HCT tablets?
What are the possible side effects of MICARDIS HCT tablets?
MICARDIS HCT tablets may cause serious side effects,including:
The most common side effects of MICARDIS HCT tablets include:
These are not all the possible side effects with MICARDIS HCT 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 HCT tablets?
Keep MICARDIS HCT tablets and all medicines out of the reach of children.
General information about MICARDIS HCT tablets:
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use MICARDIS HCT tablets for a condition for which it was not prescribed. Do not give MICARDIS HCT 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 MICARDIS HCT tablets. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about MICARDIS HCT tablets that is written for health professionals.
For current prescribing information, scan the code or call Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257.
What are the ingredients in MICARDIS HCT tablets?
Active Ingredients: telmisartan and hydrochlorothiazide
Inactive Ingredients: sodium hydroxide, meglumine, povidone, sorbitol, magnesium stearate, lactose monohydrate, microcrystalline cellulose, maize starch, and sodium starch glycolate
The 40 mg/12.5 mg and 80 mg/12.5 mg tablets also contain: ferric oxide red.
The 80 mg/25 mg tablets also contain: ferric oxide yellow.
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. 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 through the body and causes damage to the blood vessels. MICARDIS HCT tablets can help your blood vessels relax so your blood pressure is lower.
How to open the blister:
This Patient Information has been approved by the U.S. Food and Drug Administration.
Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA
Licensed from: Boehringer Ingelheim International GmbH Ingelheim, Germany
Copyright © 2022 Boehringer Ingelheim International GmbH ALL RIGHTS RESERVED
MICARDIS ®is a registered trademark of and used under license from Boehringer Ingelheim International GmbH.
Boehringer Ingelheim Pharmaceuticals, Inc. either owns or uses the ONTARGET ®trademark under license.
The other brands listed are trademarks of their respective owners and are not trademarks of Boehringer Ingelheim Pharmaceuticals, Inc.
Revised: December 2022
COL10674AL272022 SPL10694A
^Principal Display Panel - Mg/ Mg Tablet Blister Card Carton
NDC 0597-0043-37
Micardis ®HCT (telmisartan/ hydrochlorothiazide tablets)
40 mg/12.5 mg
Rx only
30 tablets - 3 blister cards of 10 tablets each. Each tablet contains 40 mg of telmisartan and 12.5 mg of hydrochlorothiazide.
Dosage: Read accompanying prescribing information.
Keep out of reach of children.
Important: Moisture sensitive tablets - do not remove from blisters until immediately before administration.
Boehringer Ingelheim
^ Patient Counseling Information
Advise the patient to read the FDA-approved patient labeling (Patient Information).
^ Description
MICARDIS HCT tablets are a combination of telmisartan, an orally active angiotensin II antagonist acting on the AT 1receptor subtype, and hydrochlorothiazide, a thiazide diuretic.
Telmisartan, a non-peptide molecule, 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 33H 30N 4O 2, its molecular weight is 514.63, and its structural formula is:
Telmisartan 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.
Hydrochlorothiazide is a white, or practically white, practically odorless, crystalline powder with a molecular weight of 297.74. It is slightly soluble in water, and freely soluble in sodium hydroxide solution. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2 H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C 7H 8ClN 3O 4S 2, and its structural formula is:
MICARDIS HCT tablets are formulated for oral administration in three combinations of 40 mg/12.5 mg, 80 mg/12.5 mg, and 80 mg/25 mg telmisartan and hydrochlorothiazide, respectively. The tablets contain the following inactive ingredients: sodium hydroxide, meglumine, povidone, sorbitol, magnesium stearate, lactose monohydrate, microcrystalline cellulose, maize starch, and sodium starch glycolate. As coloring agents, the 40 mg/12.5 mg and 80 mg/12.5 mg tablets contain ferric oxide red, and the 80 mg/25 mg tablets contain ferric oxide yellow. MICARDIS HCT tablets are hygroscopic and require protection from moisture.
^ How Supplied/storage And Handling
MICARDIS HCT is available in three strengths as biconvex two-layered, oblong-shaped, uncoated tablets containing telmisartan and hydrochlorothiazide:
^Principal Display Panel - Mg/ Mg Tablet Blister Card Carton
NDC 0597-0042-37
Micardis ®HCT (telmisartan/ hydrochlorothiazide tablets)
80 mg/25 mg
Rx only
30 tablets - 3 blister cards of 10 tablets each. Each tablet contains 80 mg of telmisartan and 25 mg of hydrochlorothiazide.
Dosage: Read accompanying prescribing information.
Keep out of reach of children.
Important: Moisture sensitive tablets - do not remove from blisters until immediately before administration.
Boehringer Ingelheim
