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Valsartan/Hydrochlorothiazide

Valsartan/Hydrochlorothiazide is used for:

Treating high blood pressure. It may also be used for other conditions as determined by your doctor.

Valsartan/Hydrochlorothiazide is a combination angiotensin II receptor blocker and diuretic. The angiotensin II receptor blocker works by relaxing the blood vessels. Exactly how the diuretic works to decrease blood pressure is unknown, but it helps the kidneys to eliminate fluid and sodium from the body.

Do NOT use Valsartan/Hydrochlorothiazide if:

• you are allergic to any ingredient in Valsartan/Hydrochlorothiazide or to any other sulfonamide medicine (eg, sulfamethoxazole)
• you are pregnant
• you have severe kidney problems or are unable to urinate
• you are taking dofetilide or ketanserin

Contact your doctor or health care provider right away if any of these apply to you.

Before using Valsartan/Hydrochlorothiazide :

Some medical conditions may interact with Valsartan/Hydrochlorothiazide . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are planning to become pregnant or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have ever had a severe reaction (eg, swelling of the hands, face, lips, eyes, throat, or tongue; trouble swallowing or breathing; hoarseness) after taking any other angiotensin II receptor blocker or an angiotensin converting enzyme (ACE) inhibitor (eg, captopril)
• if you are dehydrated; have low blood volume; have low blood sodium, chloride, potassium, or magnesium levels; or have high blood calcium levels
• if you have asthma; diabetes; gout; heart problems (eg, congestive heart failure); liver, gall bladder, or kidney problems; high blood cholesterol or lipid levels; or systemic lupus erythematosus
• if you have recently had nerve surgery

Some MEDICINES MAY INTERACT with Valsartan/Hydrochlorothiazide . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Dofetilide or ketanserin because the risk of irregular heartbeat may be increased
• Adrenocorticotropic hormone (ACTH), barbiturates (eg, phenobarbital), corticosteroids (eg, prednisone), diuretics (eg, furosemide), narcotic pain medicines (eg, morphine), or other medicines for high blood pressure because they may increase the risk of Valsartan/Hydrochlorothiazide "s side effects
• Cholestyramine, colestipol, or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen) because they may decrease Valsartan/Hydrochlorothiazide �"s effectiveness
• Diazoxide, digoxin, lithium, nondepolarizing muscle relaxants (eg, tubocurarine), potassium, or potassium-sparing diuretics (eg, spironolactone) because risk of their side effects and toxic effects may be increased by Valsartan/Hydrochlorothiazide
• Diabetes medicine (eg, glipizide, metformin), insulin, or pressor amines (eg, norepinephrine) because their effectiveness may be decreased by Valsartan/Hydrochlorothiazide

This may not be a complete list of all interactions that may occur. Ask your health care provider if Valsartan/Hydrochlorothiazide may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Valsartan/Hydrochlorothiazide :

Use Valsartan/Hydrochlorothiazide as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Valsartan/Hydrochlorothiazide . Talk to your pharmacist if you have questions about this information.
• Valsartan/Hydrochlorothiazide may be taken with or without food.
• Drinking extra fluids while you are taking Valsartan/Hydrochlorothiazide is recommended. Check with your doctor for instructions.
• Valsartan/Hydrochlorothiazide may increase the amount of urine or cause you to urinate more often when you first start taking it. To keep this from disturbing your sleep, try to take your dose before 6 pm.
• If you take cholestyramine or colestipol, ask your doctor or pharmacist how to take it with Valsartan/Hydrochlorothiazide .
• Continue to take Valsartan/Hydrochlorothiazide even if you feel well. Do not miss any doses.
• If you miss a dose of Valsartan/Hydrochlorothiazide , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Valsartan/Hydrochlorothiazide .

Important safety information:

• Valsartan/Hydrochlorothiazide may cause drowsiness, dizziness, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Valsartan/Hydrochlorothiazide with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Valsartan/Hydrochlorothiazide may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
• Report any lightheadedness or fainting to your doctor immediately. Your risk of lightheadedness or fainting may be increased if you experience diarrhea, vomiting, excessive sweating, if you do not drink enough fluids, or if you are on a low-salt diet.
• Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel �"normal."� Tell your doctor if you develop any new symptoms.
• Valsartan/Hydrochlorothiazide may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Valsartan/Hydrochlorothiazide . Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
• Tell your doctor or dentist that you take Valsartan/Hydrochlorothiazide before you receive any medical or dental care, emergency care, or surgery.
• If you have high blood pressure, do not use nonprescription products that contain stimulants. These products may include diet pills or cold medicines. Contact your doctor if you have any questions or concerns.
• Your doctor may have also prescribed a potassium supplement for you. If so, follow the dosing carefully. Do not start taking additional potassium on your own or change your diet to include more potassium without first checking with your doctor.
• Check with your doctor before you use a salt substitute or a product that has potassium in it.
• Diabetes patients - Valsartan/Hydrochlorothiazide may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Valsartan/Hydrochlorothiazide may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
• Valsartan/Hydrochlorothiazide may interfere with certain lab tests, including parathyroid function tests. Be sure your doctor and lab personnel know you are taking this medicine.
• Lab tests, including kidney function, blood pressure, and blood electrolytes, may be performed while you use Valsartan/Hydrochlorothiazide . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Valsartan/Hydrochlorothiazide with caution in the ELDERLY; they may be more sensitive to its effects.
• Valsartan/Hydrochlorothiazide should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Valsartan/Hydrochlorothiazide may cause birth defects or fetal death if you take it while you are pregnant. If you think you may be pregnant, contact your doctor right away. Valsartan/Hydrochlorothiazide is found in breast milk. Do not breast-feed while taking Valsartan/Hydrochlorothiazide .

Possible side effects of Valsartan/Hydrochlorothiazide :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; headache.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; confusion; decrease in sexual ability; decreased urination; depression; drowsiness; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; hoarseness; muscle pain, tenderness, or cramps; red, swollen, blistered, or peeling skin; restlessness; seizures; severe or persistent dry mouth; shortness of breath; swelling of the arms or legs; unusual bruising or bleeding; unusual thirst, tiredness, or weakness; vomiting; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include confusion; fainting; fast, slow, or irregular heartbeat; severe or unusual dizziness.

Store Valsartan/Hydrochlorothiazide at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Valsartan/Hydrochlorothiazide out of the reach of children and away from pets.

General information:

• If you have any questions about Valsartan/Hydrochlorothiazide , please talk with your doctor, pharmacist, or other health care provider.
• Valsartan/Hydrochlorothiazide is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Valsartan/Hydrochlorothiazide . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.