Advanced Consumer Information

Micardis HCT

Generic Name: telmisartan and hydrochlorothiazide (Oral route)

tel-mi-SAR-tan, hye-droe-klor-oh-THYE-a-zide

Oral routeTablet

When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. When pregnancy is detected, hydrochlorothiazide/telmisartan tablets should be discontinued as soon as possible .

Drugs that act directly on the renin-angiotensin system can cause injury or death to the developing fetus when used during the second and third trimesters. Stop therapy as soon as possible when pregnancy is detected .

Commonly used brand name(s):

In the U.S.

Micardis HCT

Available Dosage Forms:

Tablet

Therapeutic Class: Angiotensin II Receptor Antagonist/Thiazide Combination

Pharmacologic Class: Angiotensin II Receptor Antagonist

Chemical Class: Thiazide

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Uses For Micardis HCT

Telmisartan and HydrochlorothiazideThis combination is used to treat high blood pressure (hypertension).Telmisartan belongs to the class of medicines called angiotensin II inhibitors. Telmisartan works by blocking the action of a substance in the body that causes blood vessels to tighten. As a result, telmisartan relaxes blood vessels. This lowers blood pressure. Hydrochlorothiazide is a type of medicine known as a thiazide diuretic and helps reduce the amount of water in the body by acting on the kidneys to increase the flow of urine. However, the mechanism by which hydrochlorothiazide decreases blood pressure is not fully understood.

High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

This medicine is available only with your doctor's prescription.

Before Using Micardis HCT

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of telmisartan and hydrochlorothiazide in children with use in other age groups.

Geriatric

This medicine has been tested in patients 65 years of age or older and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
1st Trimester	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
2nd Trimester	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.
3rd Trimester	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Dofetilide

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acetyldigoxin
Arsenic Trioxide
Deslanoside
Digitalis
Digitoxin
Digoxin
Droperidol
Flecainide
Ketanserin
Levomethadyl
Lithium
Metildigoxin
Ouabain
Proscillaridin
Sotalol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Aceclofenac
Acemetacin
Alacepril
Alclofenac
Apazone
Benazepril
Benoxaprofen
Bepridil
Bromfenac
Bufexamac
Calcium Carbonate
Captopril
Carbamazepine
Carprofen
Celecoxib
Chlorpropamide
Cholestyramine
Cilazapril
Clometacin
Clonixin
Cyclophosphamide
Delapril
Dexketoprofen
Diclofenac
Diflunisal
Digoxin
Dipyrone
Droxicam
Enalaprilat
Enalapril Maleate
Etodolac
Etofenamate
Felbinac
Fenbufen
Fenoprofen
Fentiazac
Floctafenine
Flufenamic Acid
Flurbiprofen
Fosinopril
Ginkgo
Glipizide
Gossypol
Ibuprofen
Imidapril
Indomethacin
Indoprofen
Isoxicam
Ketoprofen
Ketorolac
Licorice
Lisinopril
Lornoxicam
Meclofenamate
Mefenamic Acid
Meloxicam
Moexipril
Nabumetone
Naproxen
Niflumic Acid
Nimesulide
Oxaprozin
Oxyphenbutazone
Pentopril
Perindopril
Phenylbutazone
Pirazolac
Piroxicam
Pirprofen
Propyphenazone
Proquazone
Quinapril
Ramipril
Rofecoxib
Spirapril
Sulindac
Suprofen
Temocapril
Tenidap
Tenoxicam
Tiaprofenic Acid
Ticrynafen
Tolmetin
Topiramate
Trandolapril
Valdecoxib
Zofenopril
Zomepirac

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of Micardis HCT

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

In addition to the use of the medicine your doctor has prescribed, treatment for your high blood pressure may include weight control and care in the types of foods you eat, especially foods high in sodium. Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed. Remember that this medicine will not cure your high blood pressure but it does help control it. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

You may take this medicine with or without food.

For oral dosage form (tablets):
- For high blood pressure:
  - Adults—Take one tablet once a day. Your doctor may increase your dose if needed.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Do not remove tablets from blisters until immediately before taking.

Precautions While Using Micardis HCT

It is important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Check with your doctor immediately if you think that you may be pregnant. Telmisartan may cause birth defects or other problems in the baby if the medicine is taken during pregnancy.

Do not take other medicines unless they have been discussed with your doctor. This especially includes nonprescription medicines, such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may increase your blood pressure.

This medicine may cause some people to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.

Check with your doctor right away if you become sick while taking this medicine, especially with severe or continuing nausea and vomiting or diarrhea. These conditions may cause you to lose too much water and lead to low blood pressure.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. This is more likely to occur in the morning. Getting up slowly may help. When you get up from lying down, sit on the edge of the bed with your feet dangling for 1 or 2 minutes. Then stand up slowly. If the problem continues or gets worse, check with your doctor.

Dizziness, lightheadedness, or fainting also may occur if you exercise or if the weather is hot. Heavy sweating can cause loss of too much water and result in low blood pressure. Use extra care during exercise or hot weather.

This medicine may increase blood sugar levels and require an adjustment to dosages of diabetes medicines. Blood sugar levels should be monitored carefully. Notify your doctor of consistent changes in blood sugar levels.

Micardis HCT Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less Common

Hypokalemia, such as convulsions, decreased urine, dry mouth, irregular heartbeat, increased thirst, loss of appetite, mood changes, muscle pain or cramps, nausea or vomiting, numbness or tingling in hands, feet, or lips, shortness of breath, unusual tiredness or weakness
hypotension, such as blurred vision, confusion, dizziness, faintness, or lightheadedness when getting up from a lying or sitting position, sudden sweating, unusual tiredness or weakness
tachycardia such as fainting, fast, pounding, or irregular heartbeat, or pulse palpitations
urinary tract infection , such as difficulty in urinating, frequent urge to urinate, painful urination

Rare

Angioedema, such as large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

Dizziness
upper respiratory tract infection, such as cough, runny or stuffy nose, sore throat

Less Common

Abdominal pain
back pain
bronchitis, such as cough producing mucus, difficulty breathing, shortness of breath, chest tightness
cough
diarrhea
dyspepsia, such as acid or sour stomach, belching, heartburn, indigestion, or stomach discomfort upset or pain
fatigue
headache
influenza-like symptoms, such as chills, cough, diarrhea, fever, general feeling of discomfort or illness, headache, joint pain, loss of appetite, muscle aches and pains, nausea, runny nose, shivering, sore throat, sweating, trouble sleeping, unusual tiredness or weakness, vomiting
nausea
pain
pharyngitis, such as dryness or soreness of throat, fever, hoarseness, tender, swollen glands in neck, trouble in swallowing, or voice changes
rash
sinusitis, such as pain or tenderness around eyes and cheekbones, fever, stuffy or runny nose, headache, cough
vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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