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This document provides essential safety and warning information regarding the use of this medication. Please review the details carefully and consult your healthcare provider if you have any questions or concerns.

• Suicidal Thoughts and Behavior: Although not frequent, individuals taking acamprosate in clinical trials reported higher rates of suicidal thoughts and behaviors compared to those receiving a placebo. Such thoughts often emerged during alcohol relapse. It is crucial to maintain close communication with your healthcare team throughout your alcohol recovery journey. Promptly report any signs of mood deterioration or thoughts of self-harm. Inform family members and loved ones about your treatment so they can observe and report any behavioral changes to your healthcare provider if necessary.

• Kidney Function Concerns: Acamprosate is eliminated from the body by the kidneys. If your kidneys do not function properly, the medication may accumulate in your system. Individuals with mild kidney impairment might need to take half the standard dose. Those with severe kidney issues should avoid using acamprosate.

• Effectiveness for Alcohol Withdrawal: Studies indicate that acamprosate may not be effective for alleviating alcohol withdrawal symptoms. It is intended for use after cessation of alcohol consumption and completion of the initial withdrawal phase. However, treatment with acamprosate can continue if a relapse occurs. Regular consultations with your healthcare team are important to receive ongoing support and resources necessary for sustaining recovery.

Contraindications: This medication should not be used in the presence of certain conditions, as it may pose significant health risks. Consult your healthcare provider if any of the following apply to you:

• Severe kidney problems

Common side effects:

• Diarrhea
• Nausea
• Vomiting
• Gas
• Stomach pain
• Headaches
• Drowsiness
• Dizziness
• Tiredness
• Changes in weight
• Changes in appetite
• Changes in sexual desire
• Trouble sleeping
• Nervousness
• Anxiety
• Physical weakness
• Dry mouth

Serious side effects:

• Mental or mood changes (such as depression or suicidal thoughts)
• Signs of kidney problems (like changes in urine output)
• Fainting
• Rapid heartbeat
• Vision or hearing alterations
• Persistent stomach pain
• Black stools
• Vomit resembling coffee grounds
• Seizures
• Allergic reaction (rash, itching, swelling of face, tongue, or throat, severe dizziness, difficulty breathing)

Acamprosate is primarily excreted unchanged through the kidneys and does not undergo liver metabolism. This characteristic reduces the likelihood of interactions with other medications that are metabolized by liver enzymes. Studies have shown that acamprosate does not induce or inhibit major cytochrome P450 enzymes, including CYP1A2, 2C9, 2C19, 2D6, 2E1, and 3A4. Consequently, it does not significantly affect the metabolism of drugs processed by these enzymes.

When taken alongside alcohol, Diazepam, or Disulfiram, acamprosate does not alter the pharmacokinetics of these substances, indicating no significant interactions. However, co-administration with Naltrexone has been observed to increase acamprosate's peak plasma concentration (Cmax) by 33% and its overall exposure (AUC) by 25%. Despite this increase, no dosage adjustment is typically necessary when acamprosate and naltrexone are used together.

While acamprosate has a low potential for drug interactions, it is important to inform your healthcare provider about all medications, supplements, and herbal products you are currently using. This ensures the safe and effective use of acamprosate in your treatment plan.