Consumer Information for: VALSARTAN HCT

BEFORE you use VALSARTAN HCT talk to your doctor, nurse, or pharmacist if you:

• Are allergic to any drug used to lower blood pressure, including angiotensin converting enzyme (ACE) inhibitors, or penicillin.
• Have narrowing of an artery or a heart valve.
• Have heart failure.
• Have diabetes, liver or kidney disease.
• Have lupus or gout.
• Are on dialysis.
• Are dehydrated or suffer from excessive vomiting, diarrhea, or sweating.
• Are taking a salt substitute that contains potassium, potassium supplements, or a potassium-sparing diuretic (a specific kind of “water pill”).
• Are on a low-salt diet.
• Are less than 18 years old.
• Suffer from severe liver disease with destruction of the small bile ducts within the liver (biliary cirrhosis) leading to the builds up bile in the liver (cholestasis);
• Ever had swelling mainly of the face and throat while taking other drugs (including an ACE-inhibitor). If you get those symptoms, stop taking VALSARTAN HCT and contact your doctor straight away. You should never take VALSARTAN HCT again.
• Have low levels of potassium in your blood (with or without symptoms such as muscle weakness, muscle spasms, abnormal heart rhythm).
• Have low levels of sodium in your blood (with or without symptoms such as tiredness, confusion, muscle twitching, convulsions).
• Have high levels of calcium in your blood (with or without symptoms such as nausea, vomiting, constipation, stomach pain, frequent urination, thirst, muscle weakness and twitching).
• Have high levels of uric acid in the blood.
• Are suffering from allergy or asthma
• Have high levels of cholesterol or triglycerides in your blood.
• Are suffering from vomiting or diarrhea, or taking high doses of a diuretic (water pill).
• Are taking a medicine that contains aliskiren, such RASILEZ, used to lower high blood pressure. The combination with VALSARTAN HCT is not recommended.
• Are taking an angiotensin converting enzyme (ACE) inhibitor.
• Have had skin cancer or have a family history of skin cancer.
• Have a greater chance of developing skin cancer because you have light-coloured skin, get sunburned easily, or are taking drugs to suppress your immune system.

Risk of skin cancer:

• VALSARTAN HCT contains hydrochlorothiazide. Treatment with hydrochlorothiazide may increase the risk of developing non-melanoma skin cancer. The risk is higher if you have been taking VALSARTAN HCT for many years (more than 3) or at a high dose.
• While taking VALSARTAN HCT:
• Make sure to regularly check your skin for any new lesions. Check areas that are most exposed to the sun, such as the face, ears, hands, shoulders, upper chest and back.
• Limit your exposure to the sun and to indoor tanning. Always use sunscreen (SPF-30 or higher) and wear protective clothing when going outside.
• Talk to your doctor immediately if you get more sensitive to the sun or UV light or if you develop an unexpected skin lesion (such as a lump, bump, sore, or patch) during the treatment.

Hydrochlorothiazide in VALSARTAN HCT can cause Sudden Eye Disorders:

• Myopia: sudden nearsightedness or blurred vision.
• Glaucoma: an increased pressure in your eyes, eye pain. Untreated, it may lead to permanent vision loss.

These eye disorders are related and can develop within hours to weeks of starting VALSARTAN HCT.

You may become sensitive to the sun while taking VALSARTAN HCT. Exposure to sunlight should be minimized until you know how you respond.

You should have regular blood tests before and during treatment with VALSARTAN HCT. These will monitor the amount of electrolytes (such as potassium, sodium, calcium or magnesium) in your blood and may also monitor your kidney function

You are pregnant, breast-feeding or thinking of becoming pregnant?

Taking VALSARTAN HCT during pregnancy can cause injury and even death to your baby. This medicine should not be used during pregnancy. If you are planning to become pregnant while taking VALSARTAN HCT, contact immediately your doctor.

It is also advisable not to take VALSARTAN HCT during breastfeeding. The diuretic component of VALSARTAN HCT passes into the breast milk and may also reduce your milk supply. If you are breast-feeding, avoid using VALSARTAN HCT unless recommended by your doctor.

Similar medicines were associated with serious harm to fetuses when they were taken during pregnancy. It is therefore important to tell your doctor immediately if you think you may have become pregnant, or planning to become pregnant. Your doctor will discuss with you the potential risk of taking VALSARTAN HCT during pregnancy.

Driving and using machines: Before you perform tasks which may require special attention, wait until you know how you respond to VALSARTAN HCT. Dizziness, lightheadedness, or fainting can especially occur after the first dose and when the dose is increased.