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|Copaxone

Copaxone

Copaxone is used for:

Reducing the frequency of relapses with relapsing-remitting multiple sclerosis.

Copaxone is a polypeptide mixture. How Copaxone works is not fully understood. However, it is thought to act by changing immune processes responsible for the effects of multiple sclerosis.

Do NOT use Copaxone if:

• you are allergic to any ingredient in Copaxone or mannitol

Contact your doctor or health care provider right away if any of these apply to you.

Before using Copaxone :

Some medical conditions may interact with Copaxone . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with Copaxone . However, no specific interactions with Copaxone are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Copaxone may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Copaxone :

Use Copaxone as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Copaxone is usually administered as an injection at your doctor"s office, hospital, or clinic. If you are using Copaxone at home, carefully follow the injection procedures taught to you by your health care provider.
• Copaxone comes with an additional patient leaflet. Read it carefully and reread it each time you get Copaxone refilled.
• If the medicine contains particles or is discolored, or if the vial/container is cracked or damaged in any way, do not use it.
• Copaxone is only to be injected beneath the skin. Do not inject it into a vein.
• Keep this product, as well as syringes and needles, out of the reach of children. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor, nurse, or pharmacist to explain local regulations for proper disposal.
• Copaxone works best if it is given at the same time every day.
• If you miss a dose of Copaxone , use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Copaxone .

Important safety information:

• Copaxone may cause dizziness, drowsiness, or changes in vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Copaxone . Using Copaxone alone, with other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Use Copaxone with extreme caution in CHILDREN; safety and effectiveness have not been confirmed
• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Copaxone during pregnancy. It is unknown if Copaxone is excreted in breast milk. If you are or will be breast-feeding while you are using Copaxone , check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Copaxone :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Anxiety upon injection; back pain; chest tightness; diarrhea; ear pain; fever; flu symptoms or infection (fever, chills, sore throat); flushing; joint pain; loss of appetite; mild redness, pain, itching, or a lump at the injection site; nausea; neck pain; nervousness; pain; painful menstrual flow; rapid eye movement; skin nodules; stomach pain; sweating; swelling of the legs and feet; vomiting; weakness; weight gain.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal thinking; chest pain or tightness; continuing flushing and anxiety long after injection; dizziness; fast heartbeat; memory loss; pounding in the chest; severe pain, redness, or swelling at injection site; sweating; tightness in the throat; tremor.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Store Copaxone in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted for up to 7 days. Protect from light. Keep Copaxone out of the reach of children and away from pets.

General information:

• If you have any questions about this medicine, please talk with your doctor, pharmacist, or other health care provider.
• Copaxone is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Copaxone . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.