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BACLOFEN-INJECTION (cont.)

SIDE EFFECTS: Constipation, dizziness, drowsiness, weakness, headache, trouble sleeping; change in amount or frequency of urine; loss of appetite, change in sexual ability, or changes in pulse may occur. If these effects persist or worsen, notify your doctor. Unlikely but report promptly: fainting, pink urine, mental/mood changes. Very unlikely but report promptly: chest/leg pain, seizures, difficulty speaking, numbness/tingling, fever, vision changes, unsteadiness, swelling. In the unlikely event you have an allergic reaction to this drug, seek immediate medical attention. Symptoms of an allergic reaction include: rash, itching, swelling, severe dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

PRECAUTIONS: Tell your doctor your medical history, including: any allergies, diabetes, seizures, kidney disease, strokes, stomach/intestinal ulcers, mental/mood disorders. Limit alcohol intake, as it may aggravate certain side effects of this drug. Caution is advised when performing tasks requiring alertness (e.g., driving). To avoid dizziness and lightheadedness, get up slowly when rising from a seated or lying position. Caution is advised when this drug is used in the elderly, as they may be more sensitive to the side effects of baclofen. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is not known whether this drug is excreted into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Tell your doctor of all nonprescription and prescription medication you may use, especially drugs causing drowsiness, such as: medicine for sleep, sedatives, tranquilizers, anti-anxiety drugs, narcotic pain relievers (e.g., codeine), psychiatric medicines, anti-seizure drugs, other muscle relaxants, certain antihistamines (e.g., diphenhydramine). Check all nonprescription medicine labels carefully, especially cough-and-cold preparations, since many may contain antihistamines (e.g., diphenhydramine) which can cause drowsiness. Consult your pharmacist if you have any questions. Do not start or stop any medicine without doctor or pharmacist approval.




Report Problems to the Food and Drug Administration

 

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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