carisoprodol/aspirin - oral, Soma Compound (cont.)

SIDE EFFECTS: Stomach upset, headache, drowsiness, dizziness, lightheadedness, or flushing may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.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: fainting, hearing problems (e.g., ringing in the ears), fast heartbeat, difficult/painful swallowing.Sometimes carisoprodol may cause a very rare but serious reaction that occurs within minutes or hours of the first dose of this medication. Stop taking this medication and seek immediate medical attention if any of these symptoms occur: unable to move arms/legs, shaky/unsteady movement, loss of balance, joint pain, mental/mood changes (e.g., agitation, confusion, unexplained mood swings), vision problems (e.g., blurred vision, double vision, loss of vision), extreme weakness.Tell your doctor immediately if any of these rare but very serious side effects occur: black/bloody/tarry stools, easy bruising/bleeding, persistent nausea/vomiting, severe stomach/abdominal pain, change in amount/color of urine, vomit that looks like coffee grounds.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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.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 this medication, tell your doctor or pharmacist if you are allergic to carisoprodol or aspirin; or to related medications such as meprobamate, tybamate, NSAIDs such as ibuprofen or naproxen, or other salicylates such as salsalate; or if you have any other allergies.This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), bleeding/clotting problems (e.g., coagulopathy, bleeding peptic ulcers), certain genetic blood disorder (porphyria).Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma, certain genetic conditions (G6PD deficiency, pyruvate kinase deficiency), gout, growths in the nose (nasal polyps), personal/family history of regular use/abuse of drugs/alcohol, heart problems (e.g., fast/irregular heartbeat, heart failure), high blood pressure, kidney disease, liver disease, stomach/intestine/esophagus problems (e.g., bleeding, heartburn, ulcers).This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.To avoid dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.This medicine may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Limit alcohol and stop smoking. Consult your doctor or pharmacist for more information.This medication contains aspirin. Children and teenagers should not take aspirin if they have chickenpox, flu, or any undiagnosed illness without first consulting a doctor about Reye's syndrome, a rare but serious illness.This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details.This drug may pass into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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