Perindopril and amlodipine (Oral)

Perindopril and amlodipine is a combination of medicines used to treat high blood pressure (hypertension). High blood pressure increases the workload of the heart and arteries. If it persists for a long time, the heart and arteries may not work properly. This can harm the blood vessels in the brain, heart, and kidneys, leading to a stroke, heart failure, or kidney failure. Lowering blood pressure can lower the risk of strokes and heart attacks.

Perindopril is an angiotensin-converting enzyme (ACE) inhibitor. It operates by blocking a substance in the body that causes blood vessels to tighten. This helps relax the blood vessels and lower blood pressure.

Amlodipine is a calcium channel blocker (CCB). It influences how calcium moves into the cells of the heart and blood vessels. This also helps relax the blood vessels and lower blood pressure. Lower blood pressure increases the amount of blood and oxygen supplied to the heart.

This medicine is available only with your doctor's prescription.

It is very important that your doctor checks your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to prevent pregnancy. If you think you have become pregnant while using this medicine, tell your doctor right away.

You should not use this medicine together with sacubitril. Do not use this medicine and sacubitril/valsartan (Entresto®) within 36 hours of each other.

This medicine may cause serious allergic reactions, including anaphylaxis. This can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, lips, tongue, or throat while you are using this medicine.

Check with your doctor right away if you have severe stomach pain (with or without nausea or vomiting). This could be a symptom of a condition called intestinal angioedema.

This medicine may cause angina (chest pain) or a heart attack in certain patients with severe heart or blood vessel disease. Check with your doctor right away if you are having chest pain or discomfort, fast or irregular heartbeat, nausea or vomiting, pain or discomfort in the arms, jaw, back, or neck, shortness of breath, or sweating.

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position or if you have been taking a diuretic (water pill). Do not drive or do anything else that could be dangerous if you are dizzy. If you feel dizzy, lie down to avoid fainting. Then sit for a few moments before standing to prevent the dizziness from returning.

Check with your doctor right away if you have bloody urine, decrease in frequency or amount of urine, increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, troubled breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Before having any type of surgery (including dental surgery) or emergency treatment, tell the doctor or dentist in charge that you are taking this medicine.

Hyperkalemia (high potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you have the following symptoms: abdominal or stomach pain, confusion, difficulty with breathing, irregular heartbeat, nausea, vomiting, nervousness, numbness or tingling in the hands, feet, or lips, shortness of breath, or weakness or heaviness of the legs. Ask your doctor before you use any medicine, supplement, or salt substitute that contains potassium.

This medicine may be less effective in black patients. Black patients also have an increased risk of swelling of the hands, arms, face, mouth, or throat. Talk with your doctor if you have concerns about this.

Do not take other medicines unless they have been discussed with your doctor. This especially includes prescription or nonprescription (over-the-counter [OTC]) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine compared to the benefits it will provide. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your health care professional know about any other allergies you may have, such as allergies to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There have not been enough studies to determine how the combination of perindopril and amlodipine affects children. Safety and effectiveness have not been established.

Geriatric

Current studies have not shown specific problems in older adults that would limit the use of the perindopril and amlodipine combination. However, older patients are more likely to experience unwanted effects (like dizziness or rash) or age-related liver problems, which may require careful monitoring and possible dose adjustments for patients taking this medicine.

Breast Feeding

There are no sufficient studies in women to determine the risk to infants from using this medicine while breastfeeding. Weigh the potential benefits against the potential risks before taking this medicine while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines might be used together even if an interaction could occur. Your doctor may adjust the dose or take other precautions if you are taking this medicine. It is very important for your healthcare professional to know if you are taking any of the following medicines. The following interactions are significant but may not include all possible interactions.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to prescribe this medication or may alter your other medications.

• Aliskiren
• Sacubitril

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some situations. If both medicines are prescribed together, your doctor may change the dose or frequency of use for one or both medicines.

• Abametapir
• Alteplase, Recombinant
• Amiloride
• Aspirin
• Atazanavir
• Azathioprine
• Azilsartan
• Azilsartan Medoxomil
• Candesartan
• Canrenoate
• Ceritinib
• Clarithromycin
• Clopidogrel
• Conivaptan
• Cyclosporine
• Dantrolene
• Darunavir
• Digoxin
• Domperidone
• Droperidol
• Epirubicin
• Eplerenone
• Eprosartan
• Erythromycin
• Everolimus
• Fedratinib
• Fexinidazole
• Fosnetupitant
• Furosemide
• Irbesartan
• Itraconazole
• Lacosamide
• Lithium
• Losartan
• Mavacamten
• Melphalan
• Mercaptopurine
• Netupitant
• Olmesartan
• Omaveloxolone
• Phenobarbital
• Piperaquine
• Potassium
• Potassium Citrate
• Potassium Phosphate
• Primidone
• Rifampin
• Ritonavir
• Simvastatin
• Sirolimus
• Spironolactone
• Tacrolimus
• Tegafur
• Telaprevir
• Telmisartan
• Triamterene
• Trimethoprim
• Valsartan

Using this medicine with any of the following medicines may increase the risk of certain side effects, but taking both might be the best treatment option for you. If both medicines are prescribed together, your doctor may adjust the dose or frequency of use for one or both medicines.

• Aceclofenac
• Acemetacin
• Amprenavir
• Amtolmetin Guacil
• Aprepitant
• Boceprevir
• Bromfenac
• Bufexamac
• Bumetanide
• Bupivacaine
• Bupivacaine Liposome
• Capsaicin
• Celecoxib
• Choline Salicylate
• Cimetidine
• Ciprofloxacin
• Clofazimine
• Clonixin
• Cobicistat
• Crizotinib
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Diltiazem
• Dipyrone
• Dronedarone
• Droxicam
• Duvelisib
• Ethacrynic Acid
• Etodolac
• Etofenamate
• Etoricoxib
• Etozolin
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Fluconazole
• Flufenamic Acid
• Flurbiprofen
• Fluvoxamine
• Fosamprenavir
• Gold Sodium Thiomalate
• Ibuprofen
• Idelalisib
• Indinavir
• Indomethacin
• Ketoconazole
• Ketoprofen
• Ketorolac
• Letermovir
• Lonafarnib
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Mifepristone
• Morniflumate
• Nabumetone
• Naproxen
• Nefazodone
• Nelfinavir
• Nepafenac
• Nesiritide
• Niflumic Acid
• Nilotinib
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Phenylbutazone
• Piketoprofen
• Piretanide
• Piroxicam
• Posaconazole
• Pranoprofen
• Proglumetacin
• Propionic Acid
• Propyphenazone
• Proquazone
• Ribociclib
• Rifapentine
• Rofecoxib
• Salicylic Acid
• Salsalate
• Saquinavir
• Schisandra sphenanthera
• Sodium Salicylate
• Sulindac
• Telithromycin
• Tenoxicam
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Torsemide
• Troleandomycin
• Tucatinib
• Valdecoxib
• Verapamil
• Voriconazole
• Voxelotor

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at or around mealtime, as interactions may occur. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss how to take your medicine with food, alcohol, or tobacco with your healthcare professional.

Other Medical Problems

Having other medical issues may affect the use of this medicine. Be sure to inform your doctor if you have any other medical conditions, especially:

• Angioedema (swelling of the face, lips, tongue, or throat), history of or
• Diabetes patients who are also taking aliskiren (Tekturna®)—Should not be used in these patients.

• Aortic stenosis (severe heart valve problem) or
• Severe congestive heart failure or
• Severe heart disease—Use with caution as it may worsen side effects.

• Heart failure or
• Severe kidney disease or
• Severe liver disease—Use is not recommended in these patients.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• rapid weight gain
• tingling of the hands or feet
• unusual weight gain or loss

Incidence not known

• Arm, back, or jaw pain
• bloody urine
• blurred vision
• chest pain or discomfort
• chest tightness or heaviness
• confusion
• decreased frequency or amount of urine
• difficult breathing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast or irregular heartbeat
• increased thirst
• irregular heartbeat
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of appetite
• lower back or side pain
• nausea
• nervousness
• numbness or tingling in the hands, feet, or lips
• pain or discomfort in the arms, jaw, back or neck
• stomach pain
• sweating
• unusual tiredness or weakness
• vomiting
• weakness or heaviness of the legs

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Cough
• dizziness
• headache

Incidence not known

• Diarrhea
• rash

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

In the U.S.

• Prestalia

Available Dosage Forms:

• Tablet

Therapeutic Class: Antihypertensive

Pharmacologic Class: Perindopril

Chemical Class: Dihydropyridine

In addition to using this medicine, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium (salt). Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Remember that this medicine will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You might have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, strokes, or kidney disease.

This medicine comes with a patient information insert. Read and follow these instructions carefully. Ask your doctor if you have any questions.

You may take this medicine with or without food.

Dosing

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

• For oral dosage form (tablets):For high blood pressure: Adults—At first, one tablet containing perindopril 3.5 milligrams (mg) and amlodipine 2.5 mg once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than perindopril 14 mg and amlodipine 10 mg per day. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If it is less than 12 hours until your next regular dose, take your next dose at the regular time.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.