Micardis HCT

Serious side effects have been reported with Micardis-HCT. See the “Drug Precautions” section.

Common side effects of Micardis-HCT include the following:

• sinus pain and congestion
• back pain
• diarrhea
• frequent urination (having to pee often)
• dizziness

This is not a complete list of side effects. Ask your doctor or pharmacist for more information.

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 the FDA at 1-800-FDA-1088.

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

• aliskiren (Tekturna)
• digoxin (Lanoxin)
• lithium (Eskalith, Lithobid)
• other medicines for high blood pressure
• NSAIDs (such as aspirin, ibuprofen, naproxen, others)
• corticosteroids (such as prednisone, hydrocortisone, others)
• angiotensin-converting enzyme (ACE) blockers such as benazepril (Lotensin), enalapril (Vasotec), lisinopril (Prinivil, Zestril
• angiotensin II receptor blockers such as losartan (Cozaar),  olmesartan (Benicar), valsartan (Diovan)

This is not a complete list of Micardis-HCT drug interactions.  Ask your doctor or pharmacist for more information.

Before taking Micardis-HCT, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to telmisartan, hydrochlorothiazide or to any of its ingredients
• have liver problems
• have kidney problems
• have heart problems
• have diabetes
• have gout
• have lupus 
• are pregnant or breastfeeding

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

If you are having surgery, including dental surgery, tell the doctor or dentist that you are taking telmisartan/hydrochlorothiazide.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The usual recommended dose for Micardis-HCT (telmisartan/hydrochlorothiazide) for the treatment of high blood pressure is 80 mg/12.5 mg. This medication may be titrated up to a max dose of 160 mg/25 mg.

Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take this medicine with or without food.

Your blood pressure will need to be checked often.

Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking this medication, which can lead to severely low blood pressure or a serious electrolyte imbalance.

If you need surgery or medical tests, tell the surgeon ahead of time that you are using hydrochlorothiazide and telmisartan.

It may take up to 4 weeks for this medication to control your blood pressure. Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Store at room temperature away from moisture and heat. Keep each tablet in its blister pack until you are ready to take it. Gently push the tablet through the foil to remove it.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Telmisartan and hydrochlorothiazide combination is used to treat high blood pressure (hypertension). 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. A lower blood pressure can reduce the risk of strokes and heart attacks.

Telmisartan is an angiotensin II receptor blocker (ARB). It works by blocking a substance in the body that causes the blood vessels to tighten. As a result, telmisartan relaxes the blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart.

Hydrochlorothiazide is a thiazide diuretic (water pill). It reduces the amount of water in the body by increasing the flow of urine, which helps lower the blood pressure.

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

• It is used to treat high blood pressure.
• It may be given to you for other reasons. Talk with the doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of fluid and electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, very bad dizziness or passing out, fast heartbeat, more thirst, seizures, feeling very tired or weak, not hungry, unable to pass urine or change in the amount of urine produced, dry mouth, dry eyes, or very bad upset stomach or throwing up.
• Chest pain.
• Trouble passing urine.
• Pain when passing urine.
• This medicine can cause certain eye problems. If left untreated, this can lead to lasting eyesight loss. If eye problems happen, signs like change in eyesight or eye pain most often happen within hours to weeks of starting this medicine. Call your doctor right away if you have these signs.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Telmisartan
Limited data are available with regard to overdosage of telmisartan in humans. The most likely manifestations of overdosage with telmisartan are hypotension, dizziness, and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted. Telmisartan is not removed by hemodialysis.

Hydrochlorothiazide
The most common signs and symptoms observed in patients with a hydrochlorothiazide overdose are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias. The degree to which hydrochlorothiazide is removed by hemodialysis has not been established. The oral LD50 of hydrochlorothiazide is greater than 10 g/kg in both mice and rats.

Telmisartan and Hydrochlorothiazide
In controlled clinical trials with more than 2500 hypertensive patients, 1017 patients were exposed to telmisartan (20 mg to 160 mg) and concomitant hydrochlorothiazide (6.25 mg to 25 mg). These trials included one factorial trial (Study 1) with combinations of telmisartan (20 mg, 40 mg, 80 mg, 160 mg, or placebo) and hydrochlorothiazide (6.25 mg, 12.5 mg, 25 mg, and placebo). The factorial trial randomized 818 patients, including 493 (60%) males; 596 (73%) Non-Black and 222 (27%) Blacks; and 143 (18%) ≥65 years of age (median age was 53 years old). The mean supine blood pressure at baseline for the total population was 154/101 mmHg.

The combination of telmisartan and hydrochlorothiazide resulted in additive placebo-adjusted decreases in systolic and diastolic blood pressures at trough of 16-21/9-11 mmHg for doses between 40 mg/12.5 mg and 80 mg/25 mg, compared with 9-13/7-8 mmHg for telmisartan 40 mg to 80 mg monotherapy and 4/4 mmHg for hydrochlorothiazide 12.5 mg monotherapy. The antihypertensive effect was independent of age or gender. There was essentially no change in heart rate in patients treated with the combination of telmisartan and hydrochlorothiazide in the placebo-controlled trial.

Four other studies of hypertensive patients of at least six months’ duration allowed add-on of hydrochlorothiazide for patients who either were not adequately controlled on the randomized telmisartan monotherapy dose or had not achieved adequate blood pressure response after completing the up-titration of telmisartan. In active-controlled studies, the addition of 12.5 mg hydrochlorothiazide to titrated doses of telmisartan in patients who did not achieve or maintain adequate response with telmisartan monotherapy further reduced systolic and diastolic blood pressures.