Product Summary

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IMPORTANT: 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. ANAGRELIDE - ORAL (an-AG-re-lide) COMMON BRAND NAME(S): Agrylin

USES: Anagrelide is used to treat a certain blood disorder (thrombocythemia), which is caused by your bone marrow making too many platelets. Platelets are a blood cell that the body uses to form blood clots. Too many platelets can cause problems with your circulation, including unwanted blood clots and bleeding problems. This drug reduces the number of platelets in the bloodstream by blocking their production.

HOW TO USE: This medicine may come with a Patient Information Leaflet. Read it carefully if available. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. Take this medication by mouth with or without food, usually 2 or 4 times a day or as directed by your doctor. Children or people with liver problems may start out by taking only 1 dose each day. Your doctor will adjust your dose, usually once a week, to find the best dose for you that keeps your blood counts closer to normal. The dosage is based on your medical condition and response to therapy. You should not take more than 2.5 milligrams in a single dose or more than a total of 10 milligrams in a day. Use this medication regularly in order to get the most benefit from it. To help you remember, take it at the same times each day. It is important to continue taking this medication even if you feel well. People with high platelets may not feel sick. Do not stop taking this medication without consulting your doctor. Stopping anagrelide will cause your platelets to go back up. Your doctor will check your blood counts regularly to monitor your progress and adjust your dose.

SIDE EFFECTS: Headache, diarrhea, weakness, nausea, and dizziness may occur. If any of these effects persist or worsen, contact your doctor or pharmacist promptly. To avoid dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. Remember that your doctor has prescribed this medication because he or she 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 immediately if any of these unlikely but serious side effects occur: unusual bleeding/bruising, black stools, swelling of the ankles/feet, rapid/difficult breathing, fainting, stomach/abdominal pain, unusual tiredness, change in the amount of urine, pink/bloody urine, vomit that looks like coffee grounds. Seek immediate medical attention if any of these rare but very serious side effects occur: chest/jaw/left arm pain, confusion/mental changes, fast/irregular/pounding heartbeat, slurred speech, vision changes, weakness on one side of the body. A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking anagrelide, tell your doctor or pharmacist if you are allergic to it; 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. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe liver disease. Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (e.g., heart attack, heart failure, irregular heartbeat), lung problems, kidney problems, liver problems. This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages. Before having surgery, tell your doctor or dentist that you are using this medication. This medication is not recommended for use during pregnancy because of possible harm to the unborn baby. Discuss the risk and benefits with your doctor. If you become pregnant or think you may be pregnant, inform your doctor immediately. Consult your doctor for more details and to discuss reliable forms of birth control. This drug may pass into breast milk and could have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: 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: sucralfate. Only take aspirin if your doctor approves of it. Aspirin can increase the risk of bleeding when used with anagrelide, especially if you already have a high risk for bleeding. However, if your doctor has directed you to take low-dose aspirin to prevent blood clots, or for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Discuss the risks and benefits with your doctor or pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: unusual bleeding/bruising, fast heartbeat, vomiting.

NOTES: Do not share this medication with others. Laboratory and/or medical tests (e.g., complete blood counts, kidney and liver function tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Keep all medicines 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 for more details about how to safely discard your product. MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information, call MedicAlert at 1-800-854-1166 (USA) or 1-800-668-1507 (Canada). Information last revised January 2012. Copyright(c) 2012 First Databank, Inc.

Anagrelide 0.5mg Capsule