This medicine is a calcium channel blocker, angiotensin II receptor blocker, and thiazide diuretic combination used to treat high blood pressure. It may also be used to treat other conditions as determined by your doctor.
Follow the directions for using this medicine provided by your doctor. AN ADDITIONAL PATIENT INFORMATION LEAFLET is available with this medicine. Ask your doctor, nurse, or pharmacist any questions that you may have about this information. This medicine may be taken on an empty stomach or with food. WHEN YOU FIRST START TAKING THIS MEDICINE, it may cause an increase in urine or in frequency of urination. To prevent 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 this medicine. STORE THIS MEDICINE at room temperature between 59 and 86 degrees F (15 and 30 degrees C), away from heat, moisture, and light. KEEP THIS MEDICINE out of the reach of children and away from pets. Take this medicine regularly to receive the most benefit from it. Taking this medicine at the same time each day will help you to remember. CONTINUE TO TAKE THIS MEDICINE even if you feel well. Do not miss any doses. IF YOU MISS A DOSE OF THIS MEDICINE, 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.
WARNING: This medicine may cause birth defects or fetal or newborn death if you take it while you are pregnant. If you think you may be pregnant, contact your doctor right away. If you are planning to become pregnant, talk with your doctor about other treatment options. Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE if you are also taking dofetilide or ketanserin. DO NOT TAKE THIS MEDICINE if you are also taking aliskiren and you have either diabetes or kidney problems. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking adrenocorticotropic hormone (ACTH), aliskiren, angiotensin-converting enzyme (ACE) inhibitors (eg, ramipril), aspirin, barbiturates (eg, phenobarbital), carbamazepine, clarithromycin, cholestyramine, cobicistat, colestipol, conivaptan, corticosteroids (eg, prednisone), cyclophosphamide, cyclosporine, diazoxide, digoxin, diuretics (eg, furosemide), insulin or other diabetes medicines (eg, glipizide, metformin), itraconazole, ketoconazole, lithium, methotrexate, narcotic pain relievers (eg, morphine), nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, celecoxib, ibuprofen, naproxen), potassium supplements, potassium-sparing diuretics (eg, amiloride, spironolactone, triamterene), protease inhibitors (eg, ritonavir, telaprevir), rifamycins (eg, rifampin), sildenafil, simvastatin, telithromycin, or other medicines for high blood pressure or heart problems. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including dehydration, low blood volume, high or low blood electrolyte levels (eg, sodium, magnesium, potassium, calcium), allergies, pregnancy or if you are able to become pregnant, or breast-feeding. Tell your doctor if you have a history of gallbladder or liver problems; kidney problems (eg, renal artery stenosis); asthma; gout or high blood levels of uric acid; lupus; parathyroid gland problems; low blood pressure; blood vessel problems; heart problems (eg, heart failure, angina, narrowing of heart blood vessels); high blood cholesterol or lipid levels; diabetes; swelling or fluid retention; stroke; heart attack; kidney transplant; or angioedema (eg, swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; hoarseness), including angioedema caused by treatment with another angiotensin II receptor blocker (eg, losartan) or an ACE inhibitor (eg, ramipril). Tell your doctor if you drink alcohol, if you are on dialysis, if you will be having surgery, if you have recently had a certain type of nerve surgery (sympathectomy), if you are on a low-salt (sodium) diet, or if you have never taken another medicine for high blood pressure. USE OF THIS MEDICINE IS NOT RECOMMENDED if you are pregnant, if you have severe kidney or liver problems, or if you are unable to urinate. Contact your doctor or pharmacist if you have any questions or concerns about using this medicine.
SIDE EFFECTS that may occur while taking this medicine include dizziness, headache, indigestion, mild back pain, mild sore throat or discomfort when swallowing, muscle spasms, nausea, stuffy nose, tiredness, or upset stomach. If they continue or are bothersome, check with your doctor. THIS MEDICINE 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. THIS MEDICINE CONTAINS A SULFONAMIDE CALLED HYDROCHLOROTHIAZIDE, which can cause certain eye problems (myopia, angle-closure glaucoma). Your risk may be increased if you are allergic to sulfonamide medicines (eg, sulfamethoxazole) or to penicillin antibiotics (eg, amoxicillin). Untreated angle-closure glaucoma can lead to permanent vision loss. If these eye problems occur, symptoms usually occur within hours to weeks of starting this medicine. Contact your doctor immediately if you experience symptoms such as vision changes (eg, decrease in vision) or eye pain. CONTACT YOUR DOCTOR IMMEDIATELY if you experience blurred vision; burning, numbness, or tingling; change in the amount of urine produced; chest, jaw, or arm pain; confusion; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; increased thirst; joint pain, swelling, warmth, or redness (especially of the big toe joint); mental or mood changes (eg, depression); red, swollen, blistered, or peeling skin; restlessness; seizures; severe or persistent dry mouth; severe or persistent dizziness or light-headedness; severe or persistent muscle pain, tenderness, or cramps; severe or persistent nausea, vomiting, or stomach or back pain; shortness of breath; sluggishness; sudden, unexplained weight gain; swelling of the feet, ankles, or hands; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, severe or persistent stomach pain, yellowing of the eyes or skin); unusual bruising or bleeding; unusual sweating, tiredness, or weakness; or worsening of angina pain (eg, longer, more often, more severe). AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; or unusual hoarseness. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
IF OVERDOSE IS SUSPECTED, contact your local poison control center or emergency room immediately. Symptoms of overdose may include fainting; flushing; severe or persistent dizziness or light-headedness; symptoms of blood electrolyte problems (eg, confusion; irregular heartbeat; mental or mood changes; muscle pain, weakness, or cramping; seizures; sluggishness); or symptoms of dehydration (eg, drowsiness; dry eyes; fast heartbeat; nausea; restlessness; unusual thirst, tiredness, or weakness; vomiting).
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. DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. IF YOU WILL BE USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, be sure to obtain necessary refills before your supply runs out. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.