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It is given in patients who have already had a heart attack or severe chest pain, in patients with other blood circulation problems that could lead to a stroke or heart attack, or in patients who have been treated with a procedure called angioplasty.

A heart attack or stroke may occur when a blood vessel in the heart or brain is blocked by a blood clot. Prasugrel reduces the chance that a harmful blood clot will form by preventing certain cells in the blood from clumping or sticking together. This effect of prasugrel may also increase the chance of serious bleeding in some people .

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 prasugrel in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of prasugrel in the elderly. Because of prasugrel`s toxicity, use in elderly patients 75 years of age and older is not recommended .

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.

• Citalopram


• Escitalopram


• Fluoxetine


• Fluvoxamine


• Nefazodone


• Paroxetine


• Sertraline


• Warfarin

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:

• Bleeding (e.g., head, stomach, or bowel bleeding), active or


• Stroke, history of or


• Transient ischemic attack (TIA) or "mini-stroke", history ofa€”Should not be used in patients with these conditions.

• Liver disease, severe or


• Low body weight (less than 60 kilograms [kg] or 132 pounds [lbs[) or


• Stomach or bowel bleeding, recurrent or


• Stomach ulcer or


• Surgery or other procedures (e.g., CABG [heart bypass surgery], coronary angiography, PCI), recent or


• Trauma, recenta€”Use with caution. May increase risks for more serious side effects.

Proper Use

Take this medicine exactly as directed by your doctor . Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

You may take this medicine with or without food.

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 prevention of heart attacks or strokes:
    
    
    
    • Adults weighing 60 kilograms (kg) and abovea€”At first, 60 milligrams (mg) taken as a single loading dose, and then 10 mg once a day. You may take this medicine with aspirin (75 to 325 mg) once a day.
    
    
    • Adults weighing less than 60 kilograms (kg)a€”At first, 60 milligrams (mg) taken as a single loading dose, and then 5 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.

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.

Precautions

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.

Tell all medical doctors, dentists, nurses, and pharmacists you go to that you are taking this medicine. Prasugrel may increase the risk of serious bleeding during an operation or some kinds of dental work. Treatment may have to be stopped about 7 days before the operation or dental work is done.

Check with your doctor right away if you have the following symptoms: change in mental status, dark or bloody urine, difficulty with speaking, fever, pale color of the skin, pinpoint red spots on the skin, seizures, weakness, yellow eyes or skin . These maybe symptoms of a serious condition called thrombotic thrombocytopenic purpura (TTP).

Do not stop taking this medicine without checking with your doctor first. Your doctor may want you to gradually reduce the amount you are using before stopping it completely.

Do not take other medicines unless they have been discussed with your doctor . This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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

• Blurred vision


• Dizziness


• Headache


• Nervousness


• Pounding in the ears


• Slow or fast heartbeat

Less common

• Black, tarry stools


• Bloating or swelling of the face, arms, hands, lower legs, or feet


• Chest pain or discomfort


• Chills


• Cough


• Difficult or labored breathing


• Fainting


• Fever


• Irregular heartbeat


• Lightheadedness, dizziness, or fainting


• Painful or difficult urination


• Rapid weight gain


• Shortness of breath


• Sore throat


• Sores, ulcers, or white spots on the lips or in the mouth


• Swollen glands


• Tightness in the chest


• Tingling of the hands or feet


• Unusual bleeding or bruising


• Unusual tiredness or weakness


• Unusual weight gain or loss


• Wheezing

Incidence not known

• Change in mental status


• Dark or bloody urine


• Difficulty with speaking


• Fever


• Pale color of the skin


• Pinpoint red spots on the skin


• Seizures


• Weakness


• Yellow eyes or 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:

Less common

• Back pain


• Diarrhea


• Nausea


• Pain in the arms or legs


• 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.