Amlodipine Besylate, Valsartan Oral tablet

What is this medicine?

AMLODIPINE; VALSARTAN (am LOE di peen; val SAR tan) is a combination of a calcium channel blocker and an angiotensin II antagonist. This medicine is used to treat high blood pressure.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• heart failure, recent heart attack, or other heart problems

• kidney disease

• liver disease

• an unusual or allergic reaction to amlodipine, valsartan, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take with or without food. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Patients over 65 years old may have a stronger reaction and need a smaller dose.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

• ACE inhibitors like captopril, enalapril, or lisinopril

• aliskiren

• angiotensin II blockers (ARBs) like candesartan, losartan, or telmisartan

• cyclosporine

• heparin

• lithium

• NSAIDS, medicines for pain and inflammation, like ibuprofen or naproxen

• potassium supplements

• rifampin

• ritonavir

• salt substitutes

• sildenafil

• simvastatin

• some diuretics like amiloride, spironolactone, triamterene

• tacrolimus

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. Check your blood pressure as directed. Ask your doctor or health care professional what your blood pressure should be and when you should contact him or her.

Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

If you are going to have surgery, tell your prescriber or health care professional that you are taking this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• chest pain

• confusion

• fast, irregular heartbeat

• feeling faint or lightheaded, falls

• low blood pressure

• swelling of the hands, ankles, or feet

• trouble passing urine or change in the amount of urine

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):

• change in sex drive or performance

• cough

• diarrhea

• flushing of face, skin

• headache

• nausea, vomiting

• stomach gas, pain

• weak or tired

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from moisture. Throw away any unused medicine after the expiration date.