Prestalia

Prestalia is a prescription medication used to treat high blood pressure.

It is a single product containing 2 medications: perindopril and amlodipine. Perindopril belongs to a group of drugs called angiotensin-converting enzyme (ACE) inhibitors, which relax blood vessels to lower blood pressure and make the heart more efficient. Amlodipine belongs to a group of drugs called calcium channel blockers, which help relax blood vessels. This makes it easier for the heart to pump blood.

This medication comes in tablet form and is usually taken once daily.

Common side effects of Prestalia include swelling of the hands, legs, and feet, cough, and headache.

Prestalia can also cause dizziness. Do not drive or operate heavy machinery until you know how Prestalia affects you.

Prestalia is a prescription medication used to treat high blood pressure.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Prestalia. See the “Prestalia Precautions” section.

Common side effects of Prestalia include:

• swelling of the hands, legs, and feet
• cough
• headache
• dizziness

This is not a complete list of Prestalia side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• potassium supplements
• potassium-sparing diuretics such as spironolactone (Aldactone), triamterene (Dyrenium), amiloride (Midamor)
• lithium (Eskalith, Lithobid)
• injectable gold
• other medications for high blood pressure such as furosemide (Lasix), hydrochlorothiazide, torsemide (Demadex)
• non-steroidal anti-inflammatory drugs such as celecoxib (Celebrex), diclofenac (Cambia, Cataflam, Flector, Voltaren, Zipsor and others), etodolac (Lodine), ibuprofen (Advil, Motrin, Nuprin), indomethacin (Indocin, Indocin SR), ketoprofen (Orudis, Actron, Oruvail), ketorolac (Toradol), meloxicam (Mobic), nabumetone (Relafen), naproxen (Naprosyn), naproxen sodium (Aleve, Anaprox, Naprelan), oxaprozin (Daypro),piroxicam (Feldene)

This is not a complete list of Prestalia drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Prestalia including the following:

• anaphylactoid reactions, including swelling of the head, neck, face, or intestines
• myocardial infarction

Do not take Prestalia if you:

• are allergic to Prestalia or to any of its ingredients
• have a history of allergy or sensitivity to amlodipine or any angiotensin-converting enzyme (ACE) inhibitor

Do not use Prestalia with aliskiren in patients with diabetes.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Prestalia, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Prestalia, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Prestalia or to any of its ingredients
• have diabetes
• have heart problems
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X - are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Prestalia falls into category D. It has been shown that use of Prestalia in pregnant women caused some babies to be born with problems. However, in some serious situations, the benefit of using this medication may be greater than the risk of harm to the baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Prestalia crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Prestalia.

Take Prestalia exactly as prescribed.

This medication comes in tablet form and is usually taken once daily.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take 2 doses of Prestalia at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• how you respond to this medication

The recommended initial dose of Prestalia for the treatment of high blood pressure is 3.5 mg perindopril/2.5 mg amlodipine once daily. The dose should be adjusted according to blood pressure goals and response to medication.

If you take too much Prestalia, call your healthcare provider or local Poison Control Center or seek emergency medical attention right away.

If Prestalia is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if an overdose is suspected, seek emergency medical attention.

• Store Prestalia at room temperature between 15°C and 30°C (59°F and 86°F). Protect this medication from exposure to moisture.
• Keep this and all medications out of the reach of children.

WARNING: FETAL TOXICITY

When pregnancy is detected, discontinue Prestalia as soon as possible.

Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.