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|Micardis Plus

TELMISARTAN AND HYDROCHLOROTHIAZIDE (Systemic)

Some commonly used brand names are:

In the U.S.—

• Micardis HCT

In Canada—

• Micardis Plus

Category

• Antihypertensive

Description

Telmisartan and Hydrochlorothiazide((tel-mi-SAR-tan) and (hi-dro-clo-ro-THYE-a-zide). ) This 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, in the following dosage form:

• Oral
• Tablets (U.S. and Canada)

Before Using This Medicine

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 telmisartan and hydrochlorothiazide, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to telmisartan. Tell your doctor if you have ever had any unusual or allergic reaction to hydralazine, sulfonamides (sulfa drugs), bumetanide, furosemide, acetazolamide, dichlorphenamide, or methazolamide or to hydrochlorothiazide or any of the other thiazide diuretics (water pills). Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Use of telmisartan during pregnancy, especially during the second and third trimesters (after the first 3 months) can cause low blood pressure, severe kidney failure, or possibly death in the newborn. Therefore, it is important that you check with your doctor immediately if you think that you may have become pregnant. When hydrochlorothiazide is used during pregnancy, it may cause side effects including jaundice, blood problems, and low potassium in the newborn infant. Be sure that you have discussed this with your doctor before taking this medicine.

Breast-feeding—It is not known whether telmisartan passes into breast milk. However, telmisartan passes into the milk of lactating rats. Because this medicine may cause serious side effects, breast-feeding is generally not recommended while you are taking it.

Children—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.

Older adults—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.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking telmisartan and hydrochlorothiazide combination , it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Alcohol or
• Barbiturates (e.g., Phenobarbital, Fiorinal) or
• Narcotic pain medicine (e.g., morphine, codeine, Oxycontin)—May cause blood pressure to decrease when standing up from a sitting or lying position.

• Diuretics (e.g., Bumex, Diamox, Lasix)—Telmisartan and hydrochlorothiazide with diuretics may cause blood pressure to become too low.

• Lithium (e.g., Eskalith, Lithobid)—Risk of lithium overdose, even at usual doses, lithium level may be increased.

Other medical problems—The presence of other medical problems may affect the use of telmisartan and hydrochlorothiazide. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy or
• Asthma, bronchial—May have an increased risk of allergic reaction to hydrochlorothiazide
• Congestive heart failure (severe)—May worsen condition and cause kidney problems
• Dehydration (fluid and electrolyte loss due to excessive perspiration, vomiting, diarrhea, long-term diuretic therapy, dialysis, or dietary salt restriction) or
• Sympathectomy—Blood pressure-lowering effects may be increased
• Type 2 diabetes mellitus—May require a dosage adjustment of diabetes medicine
• Systemic lupus erythematosis—Hydrochlorothiazide may cause this condition to become active or worse
• A blockage in the gallbladder or bile ducts, or
• Liver disease— Blood levels of telmisartan may be higher in patients with this condition. If hydrochlorothiazide causes loss of too much water from the body, problems can become much worse
• No urination, or
• Kidney disease—Use of telmisartan and hydrochlorothiazide may cause kidney or urinary problems to become worse.

Proper Use of This Medicine

Dosing—Take this medicine only as directed by your doctor. Do not take more of it and do not take it more often than your doctor ordered. This medication also works best when there is constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at the same time each day.

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.

The dose of telmisartan and hydrochlorothiazide 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 telmisartan and hydrochlorothiazide. If your dose is different, do not change it unless your doctor tells you to do so.

The number of tablets that you take depends on the strength of the medicine.

• 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—To store this medicine:

• Do not remove tablets from blisters until immediately before taking.
• Keep out of the reach of children.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

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.

Side Effects of This Medicine

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.

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome.

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

Developed: 02/21/2002
Revised: 06/13/2002

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