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The following information outlines crucial safety warnings and precautions for the use of baclofen. It is essential to review these details thoroughly and consult your healthcare provider if you have any questions or concerns.

• Withdrawal Symptoms: Abrupt discontinuation of baclofen, especially after long-term use, can lead to severe withdrawal symptoms, including tremors, muscle stiffness, or seizures. It is important to consult your healthcare provider to create a plan for gradually reducing your dosage. This precaution is particularly important for newborns whose mothers took baclofen during pregnancy.

• Extreme Sleepiness or Dizziness: Baclofen may cause significant drowsiness and dizziness, impacting your cognitive abilities such as thinking, concentration, and focus. To avoid exacerbating these effects, refrain from consuming alcohol or using other medications that induce drowsiness while on baclofen. Additionally, avoid engaging in activities that require alertness, such as driving or operating heavy machinery, until you are aware of how baclofen affects you. This risk is heightened when combined with alcohol, illicit drugs, other drowsy-inducing medications, and in individuals over the age of 65.

• Worsening of Other Health Conditions: Inform your healthcare team of all existing medical conditions prior to starting baclofen, as it may exacerbate symptoms of certain illnesses. This includes mental health disorders (e.g., schizophrenia), high blood pressure related to spinal cord injuries (autonomic dysreflexia), seizures, and conditions where muscle tone is necessary for maintaining posture or balance.

• Pregnancy Precaution: If you are pregnant, it is crucial to discuss the use of baclofen with your healthcare provider. Although human studies are lacking, animal studies suggest potential birth defects. Moreover, infants born to mothers who used baclofen during pregnancy may experience withdrawal symptoms post-birth. Therefore, baclofen should only be considered during pregnancy if the potential benefits justify the potential risks.

Please ensure to discuss any concerns or questions with your healthcare provider to ensure safe usage of baclofen.

When taking this medication, some individuals may experience common side effects which are generally mild and should not cause alarm. These include drowsiness, dizziness, and weakness, affecting up to 63%, 15%, and 15% of users respectively. Other mild effects may include nausea (up to 12%), headaches, tiredness, trouble sleeping, and increased urination. Constipation and a metallic taste in the mouth have also been noted. If these side effects persist or worsen, it is advisable to consult your healthcare provider for guidance.

In rare instances, more serious side effects may occur, and they require prompt medical attention. These include mental or mood changes such as confusion, depression, or hallucinations. Additionally, extreme sleepiness should be addressed urgently. Although a severe allergic reaction is rare, symptoms like rash, itching or swelling of the face, tongue, or throat, severe dizziness, and trouble breathing necessitate immediate medical help.

This summary covers potential side effects, but it's important to monitor your health and communicate with your healthcare provider about any unexpected reactions.

When taking Baclofen, it's important to inform your doctor or pharmacist about any other medications you are using, including over-the-counter drugs, vitamins, and supplements, as Baclofen can interact with several substances. Be especially cautious with products that cause drowsiness, such as opioid pain or cough medications (e.g., codeine, hydrocodone), alcohol, cannabis, sleep or anxiety medications (e.g., alprazolam, lorazepam, zolpidem), other muscle relaxants (e.g., carisoprodol, cyclobenzaprine), and antihistamines (e.g., cetirizine, diphenhydramine).

Additionally, Baclofen may interact with a wide range of prescription medications, including, but not limited to, alfentanil, bromazepam, buprenorphine, cannabidiol, donepezil, fentanyl, gabapentin, ketamine, methadone, morphine, oxycodone, pregabalin, tramadol, and trazodone. If combining Baclofen with any of these medications, your doctor might need to adjust the dosage or frequency of use to minimize the risk of adverse effects. Always check the labels of other medications, especially those for allergy or cold symptoms, to ensure they do not contain ingredients that could cause drowsiness. Consult your pharmacist for advice on how to safely use these products together.