Fosinopril Sodium (fos-IN-oh-pril SOE-dee-um), Hydrochlorothiazide (hye-droe-klor-oh-THYE-a-zide)

Treats high blood pressure (hypertension). This medicine is a combination of an ACE inhibitor and a thiazide diuretic.

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Swallow the tablet whole. Do not crush, break, or chew it.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine together with aliskiren if you have diabetes.
• Some medicines can affect how fosinopril/hydrochlorothiazide works. Tell your doctor if you are using any of the following:
  • Cholestyramine, colestipol, gold, lithium, methenamine, norepinephrine
  • Antacid medicines (including aluminum hydroxide, magnesium hydroxide, and simethicone)
  • Diuretic (water pills)
  • Insulin or oral diabetes medicine
  • Muscle relaxants
  • NSAIDs (including aspirin, celecoxib, diclofenac, ibuprofen, naproxen)
  • Steroid medicines (including cortisone, prednisone)
• Ask your doctor before you use any medicine, supplement, or salt substitute that contains potassium.
• Alcohol, narcotic pain medicine, or sleeping pills may cause you to feel more lightheaded, dizzy, or faint when used with this medicine.

Warnings While Using This Medicine:

• This medicine is not safe to take during pregnancy, especially in your second or third trimester. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Tell your doctor if you are breastfeeding, or if you have kidney disease (including patients on dialysis), liver disease, heart disease, heart failure, diabetes, gout, collagen-vascular disease (including lupus or scleroderma), or a history of asthma or allergies, or if you have had surgery of the nerves.
• This medicine may cause the following problems:
  • Angioedema (severe swelling), including head, neck, and intestinal swelling
  • Low blood pressure
  • Liver problems
  • Kidney problems
  • High cholesterol, fats, and uric acid in the blood
  • Increased risk of skin cancer
• This medicine could lower your blood pressure too much and cause you to feel dizzy or lightheaded. This is more likely to happen when you first use the medicine or if you become dehydrated. Stand or sit up slowly if you are dizzy.
• Drink plenty of fluids if you exercise, sweat more than usual, or have diarrhea or vomiting while you are using this medicine.
• Do not stop using this medicine without asking your doctor, even if you feel well. This medicine will not cure your high blood pressure, but it will help keep it in the normal range. You may have to take blood pressure medicine for the rest of your life.
• Tell any doctor or dentist who treats you that you are using this medicine, especially before you have any type of surgery or medical tests.
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• This medicine may make your skin more sensitive to sunlight. Wear sunscreen. Do not use sunlamps or tanning beds.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate
• Chest pain, fast, slow, or uneven heartbeat
• Confusion, numbness or tingling in your hands, feet, or lips
• Dark urine or pale stools, loss of appetite, stomach pain, yellow skin or eyes
• Dry mouth, increased thirst, muscle cramps, nausea, vomiting
• Fever, chills, cough, sore throat, body aches
• Lightheadedness, fainting
• Sores, reddish patch or irritated area, shiny bump, pink growth, or white, yellow or waxy scar-like area on the skin
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Headache

If you notice other side effects that you think are caused by this medicine, tell your doctor

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