DutoprolMgTablet

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

METOPROLOL EXTENDED-RELEASE/HYDROCHLOROTHIAZIDE – ORAL

(met-oh-PRO-lol/HYE-droe-KLOR-oh-THYE-a-zide)

COMMON BRAND NAME(S): Dutoprol

WARNING: Do not stop taking this medication without consulting your doctor. Some conditions may become worse when you suddenly stop this drug. Some people who have suddenly stopped taking similar drugs have had chest pain, heart attack, and irregular heartbeat. If your doctor decides you should no longer use this drug, he or she may direct you to gradually decrease your dose over 1 to 2 weeks.

When gradually stopping this medication, it is recommended that you temporarily limit physical activity to decrease strain on the heart. Get medical help right away if you develop chest pain/tightness/pressure, chest pain spreading to the jaw/neck/arm, unusual sweating, trouble breathing, or fast/irregular heartbeat.

USES: This medication is used to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. This product contains 2 medications: metoprolol and hydrochlorothiazide. Metoprolol belongs to a class of drugs known as beta blockers. It works by keeping certain natural chemicals such as epinephrine from acting on the heart and blood vessels. This effect lowers the heart rate, blood pressure, and strain on the heart. Hydrochlorothiazide is a “water pill” (diuretic) and causes your body to get rid of extra salt and water. This effect may increase the amount of urine you make when you first start the medication.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This medication may also be used for heart failure.

HOW TO USE: See also Warning section.

Take this medication by mouth with or without food as directed by your doctor, usually once daily. The dosage is based on your medical condition and response to treatment.

Do not crush or chew extended-release tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.

If you take this drug too close to bedtime, you may need to wake up to urinate. Therefore, it is best to take this medication at least 4 hours before your bedtime. Consult your doctor or pharmacist if you have questions about when to take this medication.

To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor’s instructions carefully.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

It may take several weeks before you get the full benefit of this medication. It is important to continue taking this medication even if you feel well. Most people with high blood pressure do not feel sick.

If you also take certain drugs to lower your cholesterol (bile acid-binding resins such as cholestyramine or colestipol), take this product at least 4 hours before or at least 4 to 6 hours after these medications.

Tell your doctor if your condition does not improve or if it worsens (your blood pressure readings remain high or increase).

SIDE EFFECTS: See also Warning and Precautions sections.

Dizziness, lightheadedness, drowsiness, slow heartbeat, tiredness, and diarrhea may occur. Some people may have decreased sexual ability. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

This product may reduce blood flow to your hands and feet, causing them to feel cold. Smoking may worsen this effect. Dress warmly and avoid tobacco use.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

The hydrochlorothiazide in this product may cause your body to lose too much water and salt (dehydration). Tell your doctor promptly if you notice any symptoms of dehydration, such as unusual decreased urination, unusual dry mouth/thirst, fast heartbeat, dizziness/lightheadedness, muscle cramps/weakness, confusion, fainting, seizures.

Tell your doctor right away if you have any serious side effects, including: very slow/irregular heartbeat, mental/mood changes (such as depression, mood swings), toe/joint pain, trouble breathing, blue fingers/toes, decrease in vision, eye pain.

Although this medication may be used to treat heart failure, some people may rarely develop new or worsening symptoms of heart failure. Tell your doctor right away if you experience any of these serious side effects: swelling ankles/feet, severe tiredness, shortness of breath, unexplained/sudden weight gain.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US –

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this product, tell your doctor or pharmacist if you are allergic to metoprolol or hydrochlorothiazide; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: certain types of heart rhythm problems (such as a slow heartbeat, second- or third-degree atrioventricular block, sick sinus syndrome), blood circulation problems (such as Raynaud’s disease, peripheral vascular disease), breathing problems (such as asthma, chronic bronchitis, emphysema), liver disease, kidney disease (such as anuria), lupus, serious allergic reactions including those needing treatment with epinephrine, gout, a certain muscle/nerve disease (myasthenia gravis).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Severe sweating, diarrhea, or vomiting can increase the risk for a serious loss of body water (dehydration). Drink plenty of fluids while taking this medication unless your doctor directs you otherwise. Report prolonged diarrhea or vomiting to your doctor.

This medication may reduce the potassium levels in your blood. Ask your doctor about adding potassium to your diet. Your doctor may prescribe a potassium supplement.

If you have diabetes, this product may prevent the fast/pounding heartbeat you would usually feel when your blood sugar level falls too low (hypoglycemia). Other symptoms of low blood sugar, such as dizziness and sweating, are unaffected by this drug. This product may also make it harder to control your blood sugar levels. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor immediately if you have symptoms of high blood sugar such as increased thirst/urination. Your doctor may need to adjust your diabetes medication.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially dizziness.

During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor.

This medication passes into breast milk, but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: See also How To Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

Some products that may interact with this drug include: cisapride, dofetilide, fingolimod, lithium.

Other medications can affect the removal of metoprolol from your body, which may affect how this product works. Examples include lumefantrine, quinidine, propafenone, SSRI antidepressants (such as fluoxetine, paroxetine), St. John’s wort, among others.

Check the labels on all your medicines (such as cough-and-cold products, diet aids, or NSAIDs such as ibuprofen, naproxen) because they may contain ingredients that could increase your blood pressure/heart rate or worsen your heart failure. Ask your pharmacist for more details.

This medication may interfere with certain laboratory tests (including parathyroid, tyramine, and phentolamine), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe dizziness, fainting, very slow heartbeat, trouble breathing.

NOTES: Do not share this medication with others.

Talk with your doctor about making changes to your lifestyle that may help this medication work better (such as stress reduction programs, exercise, and dietary changes).

Laboratory and/or medical tests (such as kidney/liver function, blood mineral levels such as potassium) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Have your blood pressure and heart rate checked regularly while taking this medication. Learn how to monitor your own blood pressure and heart rate at home, and share the results with your doctor.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised December 2013. Copyright(c) 2013 First Databank, Inc.