IMPORTANT SAFETY INFORMATION
IMPORTANT SAFETY
INFORMATION AND INDICATIONS
What is the most important information I should know about EXFORGE end EXFORGE HCT?
- EXFORGE and EXFORGE HCT can cause harm or death to an unborn baby. Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant.
- If you get pregnant while taking EXFORGE or EXFORGE HCT, tell your doctor right away.
- EXFORGE and EXFORGE HCT can cause harm or death to an unborn baby. Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant.
- If you get pregnant while taking EXFORGE or EXFORGE HCT, tell your doctor right away.
Do not take EXFORGE HCT if you have low or no urine output (anuria), have allergic reactions to certain drugs known as sulfonamides, if you are allergic to any of its ingredients, or if you have diabetes and take a medicine that contains aliskiren.
INDICATIONS
EXFORGE and EXFORGE HCT are prescription medications for the treatment of high blood pressure.
EXFORGE contains two prescription medicines: amlodipine, a calcium channel blocker (CCB), and valsartan, an angiotensin receptor blocker (ARB). EXFORGE may be used when any one of the following medicines to lower your high blood pressure is not enough: a dihydropyridine CCB or an ARB. It may also be used as the first medicine to lower high blood pressure if your doctor decides you are likely to need more than one medicine.
EXFORGE HCT contains three prescription medicines: amlodipine, valsartan, and hydrochlorothiazide (HCTZ), a diuretic, or “water pill.” EXFORGE HCT may be used to lower blood pressure in adults when any two of the following medicines to lower high blood pressure have been tried first: a CCB, an ARB, and a diuretic.
Serious side effects could occur with EXFORGE and EXFORGE HCT such as:
- Harm to an unborn baby causing injury and even death
- Low blood pressure (hypotension). Lie down if you feel faint or dizzy and call your doctor right away.
- Worsening chest pain (angina) or heart attack, particularly in patients who already have severe heart disease. Get emergency help if you get worse chest pain or chest pain that does not go away.
- Kidney problems. Call your doctor if you have swelling in your feet, ankles, or hands or unexplained weight gain.
- Changes in blood test results in people with congestive heart failure.
- Allergic reactions.
- Skin rash with EXFORGE HCT. Call your doctor right away if you get an unusual rash.
- Eye problems with EXFORGE HCT. Call your doctor right away if you have eye pain or decrease in vision.
- Harm to an unborn baby causing injury and even death
- Low blood pressure (hypotension). Lie down if you feel faint or dizzy and call your doctor right away.
- Worsening chest pain (angina) or heart attack, particularly in patients who already have severe heart disease. Get emergency help if you get worse chest pain or chest pain that does not go away.
- Kidney problems. Call your doctor if you have swelling in your feet, ankles, or hands or unexplained weight gain.
- Changes in blood test results in people with congestive heart failure.
- Allergic reactions.
- Skin rash with EXFORGE HCT. Call your doctor right away if you get an unusual rash.
- Eye problems with EXFORGE HCT. Call your doctor right away if you have eye pain or decrease in vision.
Tell your doctor about any of the following signs and symptoms of fluid and electrolyte problems with EXFORGE HCT: dry mouth, thirst, weakness, lack of energy (lethargy), drowsiness, restlessness, confusion, seizures, muscle pains or cramps, muscle fatigue, low blood pressure, very low urine output, fast heartbeat, or nausea and vomiting.
Tell your doctor about all your medical conditions, including if you are pregnant or plan to become pregnant, have a heart condition, have liver or kidney problems, are vomiting or having a lot of diarrhea, have or have had gallstones, have lupus, or are breastfeeding or plan to breastfeed. It is not known whether EXFORGE or EXFORGE HCT affects your breastfed baby or milk production. Do not breastfeed while you are taking EXFORGE or EXFORGE HCT.
Tell your doctor if you have low levels of potassium or magnesium or if you have high levels of calcium in your blood. Tell your doctor if you have ever had a reaction called angioedema to another blood pressure medicine. Angioedema causes swelling of the face, lips, tongue and/or throat, and may cause difficulty breathing.
Tell all your doctors and dentist you are taking EXFORGE or EXFORGE HCT if you are going to have surgery or go for kidney dialysis.
Tell your doctor about all the medicines you take including prescription and nonprescription medicine, vitamins, and herbal supplements. If you are taking EXFORGE or EXFORGE HCT, especially tell your doctor if you take other medicines for high blood pressure or a heart problem; water pills (diuretics); potassium supplements or a salt substitute containing potassium; aspirin; non-steroidal anti-inflammatory drugs (NSAIDs, like ibuprofen or naproxen); medicines for fungal skin infections or bacterial infections; certain antibiotics (rifamycin group); a drug used to protect against transplant rejection (cyclosporine); an antiretrovirol drug used to treat HIV/AIDS infection (ritonavir); or lithium.
If you are taking EXFORGE HCT, also tell your doctor if you take diabetes medicine including insulin; narcotic pain medicines; sleeping pills and anti-seizure medicines called barbiturates; steroids; cholesterol lowering medicine; muscle relaxants, cancer medicines, or alcohol.
The most common side effects that occur more frequently with EXFORGE than placebo (sugar pill) are swelling of the hands, ankles, or feet; nasal congestion or sore throat; head or chest cold; and dizziness.
The most common side effects with EXFORGE HCT include dizziness; swelling (edema) of the hands, ankles, or feet; indigestion; tiredness; muscle spasms; back pain; nausea; and nasal congestion or sore throat.
Protect your skin from the sun and undergo regular skin cancer screening, as one of the medicines in EXFORGE HCT may cause non-melanoma skin cancer.
INDICATIONS
EXFORGE and EXFORGE HCT are prescription medications the treatment of high blood pressure.
EXFORGE contains two prescription medicines: amlodipine, calcium channel blocker (CCB), and valsartan, an angiotensin receptor blocker (ARB). EXFORGE may be used when any one of the following medicines to lower your high blood pressure is not enough: a dihydropyridine CCB or an ARB. It may also be used as the first medicine to lower high blood pressure if your doctor decides you are likely to need more than one medicine.
EXFORGE HCT contains three prescription medicines: amlodipine, valsartan, and hydrochlorothiaside (HCTZ), a diuretic, or “water pill”. EXFORGE HCT may be used to lower blood pressure in adults when any two of the following medicines to lower high blood pressure have been tried first: a CCB, an ARB, and a diuretic.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088.
Please see full and , including IMPORTANT WARNING, for EXFORGE.
Please see full and , including IMPORTANT WARNING, for EXFORGE HCT.
