Prestalia contains a combination of amlodipine and perindopril. Amlodipine is a calcium channel blocker. Amlodipine relaxes (widens) blood vessels and improves blood flow.

Perindopril is an ACE inhibitor. ACE stands for angiotensin converting enzyme. Perindopril also widens blood vessels and also prevents the body from retaining water.

Prestalia is used to treat high blood pressure (hypertension).

Do not use Prestalia if you are pregnant. If you become pregnant, stop taking this medicine and tell your doctor right away.

You should not use Prestalia if you have ever had angioedema. Do not take this medicine within 36 hours before or after taking medicine that contains sacubitril (such as Entresto).

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

Take Prestalia exactly as prescribed by your doctor. 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 Prestalia with or without food. Take the medicine at the same time each day.

Vomiting, diarrhea, or heavy sweating can cause you to become dehydrated. Drink plenty of water each day while you are taking this medicine.

Your blood pressure will need to be checked often, and you may also need frequent blood tests.

If you need surgery, tell your surgeon you currently use this medicine. You may need to stop for a short time.

Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking Prestalia. This can lead to very low blood pressure, electrolyte disorders, or kidney failure.

Keep using this medicine 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.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Hypertension:

Initial dose: Amlodipine 2.5 mg-Perindopril 3.5 mg orally once a day

Maximum dose: Amlodipine 10 mg-Perindopril 14 mg orally once a day

Comments:
-Wait 7 to 14 days between titration steps.
-May be used as initial therapy if multiple drugs are likely needed to achieve blood pressure goals.
-In patients greater than 65 years old, monitor blood pressure up to 2 weeks following titrations at doses above amlodipine 5 mg-perindopril 7 mg.

You should not use Prestalia if you are allergic to amlodipine or perindopril, or if:

• you have had angioedema (hives or severe swelling of deep skin tissues sometimes caused by allergic reaction);

• you recently took a heart medicine called sacubitril ; or

• you are allergic to any other ACE inhibitor, such as captopril, enalapril, lisinopril, moexipril, quinapril, ramipril, Accupril, Prinivil, Mavik, Vasotec, and many others.

Do not take Prestalia within 36 hours before or after taking medicine that contains sacubitril (such as Entresto).

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

You may also need to avoid taking Prestalia with aliskiren if you have kidney disease.

Tell your doctor if you have ever had:

• heart disease or a heart attack;

• high levels of potassium in your blood;

• kidney disease (or if you are on dialysis);

• liver disease; or

• if you are on a low-salt diet.

Do not use if you are pregnant. If you become pregnant, stop taking this medicine and tell your doctor right away. Perindopril can cause injury or death to the unborn baby if you take the medicine during your second or third trimester.

You should not breast-feed while you are using Prestalia.

Take the medicine as soon as you can, but skip the missed dose if you are more than 12 hours late for the dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Drinking alcohol with this medicine can cause side effects.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Do not use salt substitutes or potassium supplements while taking Prestalia, unless your doctor has told you to.

Get emergency medical help if you have signs of an allergic reaction to Prestalia: hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat. You may be more likely to have an allergic reaction if you are African-American.

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;

• little or no urinating;

• new or worsened chest pain;

• jaundice (yellowing of the skin or eyes); or

• high potassiumnausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement.

Common Prestalia side effects may include:

• cough;

• headache, dizziness; or

• swelling in your hands or feet.

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.

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 interact with amlodipine and perindopril, especially:

• a diuretic or "water pill";

• heart or blood pressure medication; or

• NSAIDs (nonsteroidal anti-inflammatory drugs)aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

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