Alkapress Plus 10 / 160 mg ( amlodipine + valsartan ) 14 film-coated tablets 

Indications:

Amlodipine is a calcium channel blocker. Valsartan is an angiotensin II receptor antagonist.

Amlodipine and valsartan is a combination medicine used to treat high blood pressure (hypertension). Lowering blood pressure may lower your risk of a stroke or heart attack.

Amlodipine and valsartan is usually given after other blood pressure medicines have been tried without success.

Amlodipine and valsartan may also be used for purposes not listed in this medication guide.

Important Information
Do not use if you are pregnant. If you become pregnant, stop taking amlodipine and valsartan and tell your doctor right away.

If you have diabetes, do not use amlodipine and valsartan together with any medication that contains aliskiren (a blood pressure medicine).

Before taking this medicine
You should not use this medicine if you are allergic to amlodipine (Norvasc) or valsartan (Diovan).

If you have diabetes, do not use amlodipine and valsartan together with any medication that contains aliskiren (a blood pressure medicine).

You may also need to avoid taking amlodipine and valsartan with aliskiren if you have kidney disease.

Tell your doctor if you have ever had:

heart problems;

a heart attack;

kidney disease;

liver disease; or

if you are on a low-salt diet.

Do not use if you are pregnant. Stop using the medicine and tell your doctor right away if you become pregnant. Amlodipine and valsartan can cause injury or death to the unborn baby if you take the medicine during your second or third trimester.

You should not breastfeed while using this medicine.

Amlodipine and valsartan is not approved for use by anyone younger than 18 years old.

How should I take amlodipine and valsartan?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take this medication with or without food.

Your blood pressure will need to be checked often. Your kidney function may also need to be checked.

You may have very low blood pressure while taking this medication. Call your doctor if you are sick with vomiting or diarrhea, or if you are sweating more than usual.

If you need surgery, tell the surgeon ahead of time that you are using amlodipine and valsartan.

It may take up to 4 weeks for this medication to control your blood pressure. Keep using amlodipine and valsartan as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medicine for the rest of your life.

Blood pressure medication is only part of a complete treatment program that may also include diet, exercise, regular blood pressure checks, lifestyle changes, and other medications. Follow your doctor's instructions very carefully.

Use all medications as directed by your doctor. Do not change your doses or stop taking any of your medications without your doctor's advice.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking amlodipine and valsartan?
Do not use potassium supplements or salt substitutes, unless your doctor has told you to.

Drinking alcohol with amlodipine and valsartan can cause side effects.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Amlodipine and valsartan side effects
Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

a light-headed feeling, like you might pass out;

swelling in your hands or feet, rapid weight gain; or

high potassium level--nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement.

Common side effects include:

swelling in your hands or feet;

dizziness; or

cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Amlodipine and valsartan dosing information
Usual Adult Dose for Hypertension:

Initial therapy: Amlodipine 5 mg-Valsartan 160 mg orally once a day

Add-on/Replacement therapy: Amlodipine 5 to 10 mg-Valsartan 160 to 320 mg orally once a day

Comments:
-May increase dose after 1 to 2 weeks of therapy.
-A patient who experiences dose-limiting adverse reactions on either component alone may be switched to this drug containing a lower dose of that component in combination with the other. If blood pressure remains uncontrolled after 3 to 4 weeks, may titrate up to a maximum of amlodipine 10 mg-valsartan 320 mg orally once a day.

What other drugs will affect amlodipine and valsartan?
Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your current medicines. Many drugs can affect amlodipine and valsartan, especially:

cyclosporine;

lithium;

simvastatin or other cholesterol medication;

an antibiotic or antifungal medicine;

heart or blood pressure medication, including a diuretic ("water pill"); or

NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), and others.

This list is not complete and many other drugs may affect amlodipine and valsartan. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Further information
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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