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FondaparinuxMedical AlertYour condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada). WarningPeople using this medication may bleed near the spinal cord after certain spinal procedures. Bleeding in this area can cause paralysis that lasts a long time or could become permanent. Talk with your doctor about the benefits and risks before any spinal procedure. Your doctor may direct you to stop this medication for a certain amount of time before and after the procedure. Carefully follow your doctor's directions. The risk of bleeding may be higher if you have a deformed spine, or have had spinal procedures/surgery before (such as epidural catheter placement, difficult epidural/spinal puncture), or are taking other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, "blood thinners" such as warfarin/rivaroxaban, nonsteroidal anti-inflammatory drugs-NSAIDs such as ibuprofen). Tell your doctor right away if you notice symptoms such as back pain, leg numbness/tingling/weakness, loss of control of the bowels or bladder (incontinence). PrecautionsSee also Warning section. Before using fondaparinux, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as dry natural rubber/latex in the needle cover on the prefilled syringe), which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using fondaparinux, tell your doctor or pharmacist your medical history, especially of: infection in the heart (bacterial endocarditis), current serious bleeding (such as bleeding ulcer), low platelet count because of antiplatelet antibody, bleeding/blood problems (such as low blood count/platelets), a past blood-clotting problem because of heparin (heparin-induced thrombocytopenia), a certain eye problem (diabetic retinopathy), high blood pressure, kidney disease, seizures, stomach/intestinal problems (such as recent ulcers, colitis), stroke, recent spinal procedures or puncture, spine problems (such as spinal deformity), recent surgery (especially on the eye, brain, or spine), low body weight (less than 50 kilograms/110 pounds). Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Limit alcohol while taking this drug because it may increase the risk of stomach bleeding. To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports. Older adults may be more sensitive to the side effects of this drug, especially bleeding. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. If you become pregnant or think you may be pregnant, tell your doctor right away. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding. Side EffectsPain, bruising, redness, and swelling at the injection site may occur. Headache, nausea, vomiting, swelling of the hands/feet, or fever may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor 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 right away if you have any serious side effects, including: easy bleeding/bruising, dark urine, yellow eyes/skin. This medication may rarely cause serious bleeding. (See also Warning section.) Tell your doctor right away if you have any signs of serious bleeding, including: shortness of breath, coughing up blood, chest pain, cold/blue fingers or toes, unusual dizziness, fainting, fast/irregular heartbeat, joint/muscle pain, mental/mood changes (such as confusion), numbness/tingling, severe stomach/abdominal pain, bloody/black/tarry stools, red/pinkish urine, vomit that looks like coffee grounds. Get medical help right away if you have any very serious side effects, including: headache that is severe or doesn't go away, vision problems, weakness on one side of the body, trouble speaking, seizures, difficulty moving. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. |