Fosinopril-Hydrochlorothiazide

This drug can cause serious (possibly fatal) harm to an unborn baby if used during pregnancy. 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 right away.

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 for heart failure.

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.

Take this medication by mouth with or without food as directed by your doctor, usually once daily. If you take this drug too close to bedtime, you may need to wake up to urinate. 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.

The 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. Keep 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 get better or if it gets worse (your blood pressure readings remain high or increase).

Dizziness, lightheadedness, or tiredness may occur as your body adjusts to the medication. Dry cough may also occur. If any of these effects last or get worse, 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.

Remember that this medication has been prescribed because your doctor 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 dehydration and electrolyte imbalance. Tell your doctor right away if you have any symptoms of dehydration or electrolyte imbalance, including unusual dry mouth/thirst, muscle cramps/weakness, slow/fast/irregular heartbeat, or confusion.

Tell your doctor right away if you have any serious side effects, including: fainting, toe/joint pain, decrease in vision, eye pain, easy bruising/bleeding, signs of kidney problems (such as change in the amount of urine).

This drug may rarely cause serious (possibly fatal) liver problems. Get medical help right away if you have any symptoms of liver damage, including: nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine.

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 or at MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

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

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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: a history of an allergic reaction that included swelling of the face/lips/tongue/throat (angioedema), liver disease, kidney disease (such as renal artery stenosis), lupus, gout, untreated salt imbalance (such as high calcium, high or low potassium, low magnesium), dehydration, blood filtering procedures (such as LDL apheresis, dialysis), skin cancer.

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Severe sweating, diarrhea, or vomiting may cause dehydration and cause you to feel lightheaded. Tell your doctor if you have severe diarrhea or vomiting. To prevent dehydration, drink plenty of fluids unless your doctor tells you not to.

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

This medication may make you more sensitive to the sun. It may also increase your risk for skin cancer, especially if you take it for a long time. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned, have skin blisters/redness, or notice new or changed moles/skin lesions.

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. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination, or signs of low blood sugar such as sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. 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 drug, especially dizziness and change in the amount of urine (kidney problems).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using this product. Fosinopril may harm an unborn baby. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication. (See also Warning section.)

Fosinopril and hydrochlorothiazide pass into breast milk. Consult your doctor before breastfeeding.

See also How to Use and Precautions sections.

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 are: aliskiren, dofetilide, certain drugs that weaken the immune system/increase the risk of infection (such as everolimus, sirolimus), lithium, drugs that may increase the level of potassium in the blood (such as ARBs including losartan/valsartan, birth control pills containing drospirenone), gold injections, sacubitril.

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.

Some products have ingredients that could raise your blood pressure or worsen your heart failure. Tell your pharmacist what products you are using, and ask how to use them safely (especially cough-and-cold products, diet aids, or NSAIDs such as ibuprofen/naproxen).

This medication may interfere with certain lab tests (such as parathyroid, protein-bound iodide, tyramine, phentolamine, and certain digoxin drug level tests), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

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).

Lab and/or medical tests (such as kidney/liver function, blood mineral levels such as potassium, skin exams) should be done while you are taking this medication. Keep all medical and lab appointments. 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.

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. Take your next dose at the regular time. Do not double the dose to catch up.

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.