Prestalia 3.5 mg-2.5 mg tablet

Generic name:
Perindopril/amlodipine - oral

Pronunciation
(per-IN-doe-pril/am-LOE-di-peen)

Brand name(s)
Prestalia

This drug can cause serious (possibly fatal) harm to an unborn baby if used during pregnancy. It is important to prevent pregnancy while taking this medication. Consult your doctor for more details and to discuss the use of reliable forms of birth control while taking this medication. If you are planning pregnancy, become pregnant, or think you may be pregnant, tell your doctor right away.

This product is used to treat high blood pressure. It contains 2 medications: perindopril and amlodipine. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Perindopril belongs to a class of drugs known as ACE inhibitors and amlodipine belongs to a class of drugs known as calcium channel blockers. Both of them work by relaxing blood vessels so blood can flow more easily.

Read the Patient Information Leaflet if available from your pharmacist before you start taking this product and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily.

To reduce your risk of side effects, your doctor may direct you to start this product at a low dose and gradually increase your dose. Follow your doctor's instructions carefully.

The dosage is based on your medical condition and response to treatment.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Keep taking this medication even if you feel well. Most people with high blood pressure do not feel sick.

It may take 1 to 2 weeks before you get the full benefit of this drug.

Tell your doctor if your condition does not get better or if it gets worse (your blood pressure readings remain high or increase).

Dizziness or lightheadedness may occur as your body adjusts to the medication. Dry cough, swelling hands/ankles/feet, flushing, or nausea may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• fainting
• fast/irregular/pounding heartbeat
• symptoms of a high potassium blood level (such as muscle weakness, slow/irregular heartbeat)
• signs of kidney problems (such as a change in the amount of urine)

Some people who already have severe heart disease may rarely develop worsening chest pain or a heart attack after starting this medication or increasing the dose. Get medical help right away if you experience:

• worsening chest pain
• symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating)

This product may rarely cause serious (possibly fatal) liver problems. Get medical help right away if you have any symptoms of liver damage, including:

• nausea/vomiting that doesn't stop
• loss of appetite
• stomach/abdominal pain
• yellowing eyes/skin
• dark urine

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also Side Effects section.

Before taking this product, tell your doctor or pharmacist if you are allergic to perindopril; or to amlodipine; or to other ACE inhibitors (such as enalapril, lisinopril); or to other calcium channel blockers (such as nisoldipine, nifedipine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• history of an allergic reaction which included swelling of the face/lips/tongue/throat (angioedema)
• blood filtering procedures (such as LDL apheresis, dialysis)
• high level of potassium in the blood
• a certain structural heart problem (aortic stenosis)
• liver disease
• dehydration

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Severe sweating, diarrhea, or vomiting may cause dehydration and cause you to feel lightheaded. Tell your doctor if you have severe diarrhea or vomiting. To prevent dehydration, drink plenty of fluids unless your doctor tells you not to.

This product may increase your potassium levels. Before using potassium supplements or salt substitutes that contain potassium, consult your doctor or pharmacist.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially dizziness, high potassium levels, and rash.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using this product. Perindopril may harm an unborn baby. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication. (See also Warning section.)

Amlodipine passes into breast milk. It is unknown if perindopril passes into breast milk. Consult your doctor before breastfeeding.

See also Precautions section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• aliskiren
• certain drugs that weaken the immune system/increase the risk of infection (such as everolimus, sirolimus)
• gold injections
• lithium
• drugs that may increase the level of potassium in the blood (such as ARBs including losartan/valsartan, birth control pills containing drospirenone)
• sacubitril

Some products have ingredients that could raise your blood pressure. Tell your pharmacist what products you are using, and ask how to use them safely (especially cough-and-cold products, diet aids, or NSAIDs such as ibuprofen/naproxen).

A very serious reaction may occur if you are getting injections for bee/wasp sting allergy (desensitization) and are also taking this product. Make sure all your doctors know which medicines you are using.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: severe dizziness, fainting, fast/slow heartbeat.

Do not share this medication with others.

Lifestyle changes that may help this medication work better include exercising, stopping smoking, and eating a low-cholesterol/low-fat diet. Consult your doctor for more details.

Lab and/or medical tests (such as kidney function, potassium levels) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Check your blood pressure and pulse (heart rate) regularly while taking this medication. Learn how to check your own blood pressure and pulse at home, and share the results with your doctor.

If you miss a dose, take it as soon as you remember. If it is more than 12 hours after the missed dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.