In the U.S.—

• Antihypertensive

Valsartan ( val-SAR-tan) and Hydrochlorothiazide ( hye-droe-klor-oh-THYE-a-zide)

This combination medicine belongs to the class of medicines called high blood pressure medicines (antihypertensives). It is used to treat high blood pressure (hypertension).

High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

Valsartan works by blocking a substance in the body that causes blood vessels to tighten. As a result, valsartan relaxes blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart. Hydrochlorothiazide helps reduce the amount of salt and water in the body by acting on the kidneys to increase the flow of urine; this also helps to lower blood pressure.

This combination may also be used for other conditions as determined by your doctor.

This medicine is available only with your doctor's prescription, in the following dosage form(s):

Oral
• Tablets (U.S.)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For valsartan and hydrochlorothiazide, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to valsartan, sulfonamides (sulfa drugs), bumetanide, furosemide, acetazolamide, dichlorphenamide, or methazolamide or to hydrochlorothiazide or any of the other thiazide diuretics (water pills). Also tell your health care professional if you are allergic to any other substances, such as foods, sulfites or other preservatives, or dyes.

Pregnancy—Use of valsartan during pregnancy, especially after the first three months, can cause low blood pressure, kidney failure, too much potassium, or death in newborns. Additionally, when hydrochlorothiazide is used during pregnancy, it may cause jaundice, blood problems, and other side effects in the newborn baby. Therefore, it is important that you check with your doctor immediately if you think that you may be pregnant .

Breast-feeding—It is not known whether valsartan passes into breast milk. However, it does pass into the milk of lactating rats. Hydrochlorothiazide does pass into breast milk. Be sure that you discuss this with your doctor if you decide to breast feed while taking these medicines.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of valsartan and hydrochlorothiazide combination in children with use in other age groups.

Older adults—Elderly patients may be more sensitive than younger adults to the effects of this medicine.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

• Diabetes mellitus (sugar diabetes)—Hydrochlorothiazide may raise blood sugar levels

• Fluid or electrolyte (e.g., potassium, chloride, sodium) imbalance (due to excessive perspiration, vomiting, diarrhea, etc.)—The side effects of valsartan and hydrochlorothiazide may be increased

• Gout—Hydrochlorothiazide may increase the amount of uric acid in the body, which may activate or aggravate this condition

• Heart failure, severe—Lowering of blood pressure by these medicines may make this condition worse

• Kidney disease or
• Liver disease—These conditions may be aggravated by valsartan and hydrochlorothiazide

This medicine works best if there is a constant amount in the blood. To help keep this amount constant, do not miss any doses and take the medicine at the same time each day.

In addition to the use of the medicine your doctor has prescribed, treatment for your high blood pressure may include weight control and care in the types of foods you eat, especially foods high in sodium. Your doctor will tell you which of these is most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that this medicine will not cure your high blood pressure but it does help control it. Therefore, you must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life . If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

Dosing—

The dose of these medicines will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The number of tablets that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are taking valsartan and hydrochlorothiazide .

• For oral dosage form (tablets):
  • For high blood pressure:
    • Adults—1 tablet once a day. Your doctor may increase your dose if needed.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the medicine from freezing. Do not refrigerate.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

It is important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Check with your doctor immediately if you think that you may be pregnant. Valsartan and hydrochlorothiazide may cause birth defects or other problems in the baby if taken during pregnancy.

Check with your doctor immediately if lightheadedness or fainting occurs while you are taking this medicine. A dosage adjustment or change in medication may be necessary.

For diabetic patients:

• Hydrochlorothiazide may raise blood sugar levels. Check with your doctor if any changes in your blood sugar levels occur.

Do not take other medicines unless they have been discussed with your doctor. This especially includes potassium supplements or salt substitutes that contain potassium, since they may alter your blood potassium levels, or over-the-counter (nonprescription) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may tend to increase your blood pressure.

Dizziness, lightheadedness, or fainting may occur with this medicine. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you experience these effects.

Check with your doctor right away if you become sick while taking this medicine, especially with severe or continuing nausea and vomiting or diarrhea. These conditions may cause you to lose too much water and lead to low blood pressure.

Dizziness, lightheadedness, or fainting may also occur if you exercise or if the weather is hot. Heavy sweating can cause loss of too much water and result in low blood pressure. Use extra care during exercise or hot weather.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine.

Avoid alcoholic beverages until you have discussed their use with your doctor. Alcohol may make the low blood pressure effect worse and/or increase the possibility of dizziness or fainting.

Hydrochlorothiazide may cause your skin to be more sensitive to sunlight than it is normally. Be sure to wear protective clothing and a hat or apply a product to the skin that prevents sunburn before going outside.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Rare
  • Itching, pain, redness, or swelling of eye or eyelid, watering of eyes, troubled breathing or wheezing, severe skin rash or hives, and flushing ;  chills, fever, and sore throat;  bloating or pain of the stomach, fever, nausea, and vomiting;  fainting;  yellow eyes or skin 
  
  

• Symptoms of fluid and electrolyte imbalance
  • Confusion;  convulsions (seizures);  dizziness or lightheadedness;  diminished urine output;  drowsiness or sluggishness;  dry mouth;  fast heartbeat;  muscle cramps or pain;  muscle fatigue ;  nausea and vomiting;  restlessness;  thirst;  weakness  
  
  

Check with your doctor as soon as possible if any of the following side effects occur:

• Less common
  • Cold or flu-like symptoms;  dizziness ;  fatigue;  sore throat, difficulty swallowing, tender or swollen lymph nodes in the neck 
  
  

• Rare
  • Abdominal pain;  rash;  sudden occurrence of joint pain, usually in the ankle, knee, or great toe; joint stiffness, or swelling 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• Less common
  • Cough;  diarrhea (mild);  headache 
  
  

• Rare
  • Anxiety;  heartbeat sensations;  redness of face or neck;  increased sensitivity to sunlight;  reduced sexual performance or drive ;  increased sweating 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.