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High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure . Hypertension may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled .

Perindopril works by blocking an enzyme in the body that is necessary to produce a substance that causes blood vessels to tighten. As a result, the blood vessels relax. This lowers blood pressure and increases the supply of blood and oxygen to the heart .

In addition, perindopril is used in patients with coronary artery disease to prevent heart attacks .

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

This product is available in the following dosage forms:

• Tablet

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

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.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of perindopril in the pediatric population. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of perindopril in the elderly. However, elderly patients may be more sensitive to some side effects with this medicine than younger adults .

Pregnancy

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amiloride


• Azathioprine


• Canrenoate


• Eplerenone


• Potassium


• Spironolactone


• Triamterene

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aceclofenac


• Acemetacin


• Alclofenac


• Aliskiren


• Apazone


• Azosemide


• Bemetizide


• Bendroflumethiazide


• Benoxaprofen


• Benzthiazide


• Bromfenac


• Bufexamac


• Bumetanide


• Bupivacaine


• Buthiazide


• Capsaicin


• Carprofen


• Celecoxib


• Chlorothiazide


• Chlorthalidone


• Clometacin


• Clonixin


• Clopamide


• Cyclopenthiazide


• Cyclothiazide


• Dexketoprofen


• Diclofenac


• Diflunisal


• Dipyrone


• Droxicam


• Ethacrynic Acid


• Etodolac


• Etofenamate


• Felbinac


• Fenbufen


• Fenoprofen


• Fentiazac


• Floctafenine


• Flufenamic Acid


• Flurbiprofen


• Furosemide


• Gold Sodium Thiomalate


• Hydrochlorothiazide


• Hydroflumethiazide


• Ibuprofen


• Indapamide


• Indomethacin


• Indoprofen


• Isoxicam


• Ketoprofen


• Ketorolac


• Lithium


• Lornoxicam


• Meclofenamate


• Mefenamic Acid


• Meloxicam


• Methyclothiazide


• Metolazone


• Nabumetone


• Naproxen


• Niflumic Acid


• Nimesulide


• Oxaprozin


• Oxyphenbutazone


• Phenylbutazone


• Pirazolac


• Piretanide


• Piroxicam


• Pirprofen


• Polythiazide


• Propyphenazone


• Proquazone


• Quinethazone


• Rofecoxib


• Sulindac


• Suprofen


• Tenidap


• Tenoxicam


• Tiaprofenic Acid


• Tolmetin


• Torsemide


• Trichlormethiazide


• Valdecoxib


• Xipamide


• Zomepirac

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Angioedema, history ofa€”Perindopril may increase the risk of this condition occurring again .

• Congestive heart failure (severe) or


• Dehydration or


• Diarrhea or


• Hyponatremia (low sodium in the blood) or


• Kidney diseasea€”These conditions may cause the blood pressure to fall too low with perindopril .

Proper Use

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

Many patients who have high blood pressure will not notice any signs of the problem . In fact, many may feel normal . It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well .

Remember that this medicine will not cure your high blood pressure but it does help control it. Therefore, you must continue to take it as directed if you expect to lower your blood pressure and keep it down . You may 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, stroke, or kidney disease.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor`s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  
  
  
  • For high blood pressure:
    
    
    
    • Adultsa€”At first, 4 milligrams (mg) once a day. Then, your doctor may increase your dose to 16 mg per day taken as a single dose or divided in two doses.
    
    
    • Childrena€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  
  
  
  
  • For coronary artery disease:
    
    
    
    • Adultsa€”At first, 4 milligrams (mg) once a day for two weeks. Then, your doctor may increase your dose to 8 mg once a day.
    
    
    • Childrena€”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.

Storage

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

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions

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

Using this medicine while you are pregnant can harm your unborn baby . If you think you have become pregnant while using this medicine, tell your doctor right away .

Stop using this medicine and call your doctor right away if you have swelling of the face, arms, legs, eyes, lips, or tongue, problems with swallowing or breathing, or hoarseness. These are symptoms of a condition called angioedema .

Stop using this medicine and call your doctor right away if you have severe stomach pain. This could be a symptom of a condition called intestinal angioedema .

You may experience lightheadedness during the first few days with this medicine. If this becomes severe and you faint, stop using this medicine and talk to your doctor right away .

Tell your doctor immediately if you have any signs of infection such as chills, sore throat, or fever. These may be symptoms of an immune system condition called neutropenia .

If your symptoms do not improve within a few days or if they become worse, check with your doctor .

This medicine may increase the amount of potassium in your blood . Do not use salt substitutes containing potassium without first checking with your doctor .

Check with your doctor right away if you have symptoms of jaundice (yellow skin or eyes) because these may be signs of a serious liver condition .

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests .

Side Effects

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

• Body aches or pain


• Chills


• Cough


• Difficulty in breathing


• Ear congestion


• Fever


• Headache


• Loss of voice


• Nasal congestion


• Runny nose


• Sneezing


• Sore throat


• Unusual tiredness or weakness

Less common

• Abdominal pain


• Bladder pain


• Bloody or cloudy urine


• Change in hearing


• Chest pain


• Cold, flu-like symptoms


• Congestion


• Difficult, burning, or painful urination


• Dryness of throat


• Earache or pain in ear


• Ear drainage


• Electrocardiogram (ECG) changes


• Frequent urge to urinate


• Hoarseness


• Lower back or side pain


• Swelling


• Tender, swollen glands in neck


• Trouble in swallowing


• Voice changes


• Vomiting

Rare

• Blurred vision


• Confusion


• Decreased urination


• Dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly


• Dry mouth


• Increase in heart rate


• Irregular heartbeat


• Muscle cramps or pain


• Numbness, tingling, pain, or weakness in hands or feet


• Rapid breathing


• Seizures


• Sunken eyes


• Sweating


• Thirst


• Trembling


• Weakness and heaviness of legs


• Wrinkled skin

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:

More common

• Back pain


• Lack or loss of strength


• Pain or tenderness around eyes and cheekbones


• Shortness of breath or troubled breathing


• Stuffy nose


• Tightness of chest or wheezing

Less common

• Abnormal ejaculation


• Absent, missed, or irregular menstrual periods


• Acid or sour stomach


• Arm pain


• Belching


• Bloated


• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• Continuing ringing or buzzing or other unexplained noise in ears


• Decreased sexual performance or desire


• Diarrhea


• Difficulty in moving


• Discouragement


• Excess air or gas in stomach or intestines


• Excessive muscle tone


• Feeling sad or empty


• Full feeling


• Hearing loss


• Heartburn


• Indigestion


• Injury


• Irritability


• Joint pain


• Lack of appetite


• Leg pain


• Loss of interest or pleasure


• Muscle aching


• Muscle stiffness


• Muscle tension or tightness


• Nausea


• Neck pain


• Nervousness


• Pain, swelling, or redness in joints


• Passing gas


• Rash


• Sleepiness or unusual drowsiness


• Stomach discomfort, upset, or pain


• Stopping of menstrual bleeding


• Swollen joints


• Trouble concentrating


• Trouble sleeping

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.