Fosinopril HCTZ 10-12.5mg Tablets

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.

FOSINOPRIL/HYDROCHLOROTHIAZIDE - ORAL

(fos-IN-oh-pril/HYE-droe-KLOR-oh-THYE-a-zide)

COMMON BRAND NAME(S): Monopril HCT

WARNING: This drug can cause serious (possibly fatal) harm to an unborn baby if used during pregnancy. Therefore, it is important to prevent pregnancy while taking this medication. Consult your doctor for more details and to discuss the use of reliable forms of birth control. If you are planning pregnancy, become pregnant, or think you may be pregnant, contact your doctor immediately.

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, fosinopril and hydrochlorothiazide. Fosinopril belongs to a class of drugs known as ACE inhibitors. It works by relaxing blood vessels so that blood can flow more easily. 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. It also helps to relax the blood vessels so that blood can flow more easily.

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 drug may also be used to treat heart failure.

HOW TO USE: Take this medication by mouth with or without food, usually once daily or as directed by your doctor. 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. Dosage is based on your medical condition and response to treatment. Antacids containing aluminum or magnesium can decrease the absorption of fosinopril. If you are taking an antacid that contains aluminum or magnesium, take it at least 2 hours before or 2 hours after taking this product. If you also take certain drugs to lower your cholesterol (bile acid-binding resins such as cholestyramine or colestipol), take fosinopril/hydrochlorothiazide at least 4 hours before or at least 4 to 6 hours after these medications. 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. Tell your doctor if your condition does not improve or if it worsens (for example, your routine blood pressure readings remain high or increase).

SIDE EFFECTS: Dizziness, lightheadedness, or tiredness may occur as your body adjusts to the medication. Dry cough may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. 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. This product may cause a loss of too much body water (dehydration) and salt/minerals. Tell your doctor right away if you have any symptoms of dehydration or mineral loss, including: extreme thirst, very dry mouth, muscle cramps/weakness, fast/slow/irregular heartbeat, confusion, decreased urination. Tell your doctor immediately if any of these unlikely but serious side effects occur: symptoms of a high potassium blood level (such as muscle weakness, slow/irregular heartbeat), toe/joint pain, decrease in vision, eye pain, unusual change in the amount of urine (not including the normal increase in urine when you first start this drug). This drug may rarely cause serious (possibly fatal) liver problems. Tell your doctor immediately if you notice any of the following rare but very serious side effects: yellowing eyes/skin, dark urine, severe stomach/abdominal pain, persistent nausea/vomiting. Tell your doctor immediately if any of these rare but very serious side effects occur: signs of infection (such as fever, persistent sore throat), easy bruising/bleeding, unusual change in the amount of urine (not including the normal increase in urine when you first start this drug). A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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 either fosinopril or hydrochlorothiazide; or to other ACE inhibitors (such as captopril, lisinopril); or to other thiazides (such as chlorothiazide); 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. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a history of an allergic reaction that included swelling of the face/lips/tongue/throat (angioedema), an inability to make urine (anuria). Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease (such as renal artery stenosis), collagen vascular disease (such as lupus, scleroderma), gout, untreated salt imbalance (such as high calcium, high or low potassium, low magnesium), loss of too much body water (dehydration), blood filtering procedures (such as LDL apheresis, dialysis). This drug may make you dizzy. 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. To help prevent dizziness, drink plenty of fluids while taking this medication unless directed otherwise by your doctor. Too much sweating, diarrhea, or vomiting may cause you to feel lightheaded. Report prolonged diarrhea or vomiting to your doctor. Before having surgery, tell your doctor or dentist that you are taking this 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. This product may affect your potassium levels, which could cause side effects. Before using potassium supplements or salt substitutes that contain potassium, consult your doctor or pharmacist. If you have diabetes, this product may affect 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, or signs of low blood sugar such as nervousness, hunger, and shaking. Your doctor may need to adjust your diabetes medication, exercise program, or diet. Older adults may be more sensitive to the side effects of this product, especially dizziness. This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details. (See also Warning section.) Fosinopril and hydrochlorothiazide pass into breast milk, and the effect on a nursing infant is unknown. Discuss the risks and benefits with your doctor before breast-feeding.

DRUG INTERACTIONS: See also How to Use and Precautions sections. Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first. This drug should not be used with the following medication because very serious interactions may occur: dofetilide. If you are currently using the medication listed above, tell your doctor or pharmacist before starting fosinopril/hydrochlorothiazide. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: aliskiren, cisapride, lithium, drugs that may increase the level of potassium in the blood (such as birth control pills containing drospirenone, corticosteroids such as prednisone), gold injections. A very serious reaction may occur if you are getting injections for bee/wasp sting allergy (desensitization) and are also taking fosinopril/hydrochlorothiazide. Make sure all your doctors know which medicines you are using. 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 or worsen your heart failure. Ask your pharmacist for more details. This product may interfere with certain laboratory tests (such as parathyroid, protein-bound iodide, tyramine, phentolamine, and certain digoxin drug level tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe dizziness.

NOTES: Do not share this medication with others. Talk with your doctor about making lifestyle changes 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 from time to time to monitor your progress or check for side effects. Consult your doctor for more details. Have your blood pressure checked regularly while taking this medication. Learn how to check your own blood pressure 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 a temperature of 77 degrees F (25 degrees C) away from light and moisture. Brief storage from 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines 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 for more details about how to safely discard your product.

Information last revised July 2012. Copyright(c) 2012 First Databank, Inc.