17.1 Information for Patients

Physicians are advised to discuss the following issues with patients for whom they prescribe acamprosate calcium.

Renal Impairment

A lower dose is recommended for patients with moderate renal impairment. Acamprosate calcium is contraindicated in patients with severe renal impairment (creatinine clearance of ≤30 mL/min) [see Dosage and Administration (2.1), Contraindications (4.2), Warnings and Precautions (5.1) and Use in Specific Populations (8.6)].

Suicidality and Depression

Families and caregivers of patients being treated with acamprosate calcium should be alerted to the need to monitor patients for the emergence of symptoms of depression or suicidality, and to report such symptoms to the patient's health care provider [see Warnings andPrecautions (5.2)].

Alcohol Withdrawal

Use of acamprosate calcium does not eliminate or diminish withdrawal symptoms [see Warnings and Precautions (5.3)].

Pregnancy and Breast Feeding

• •Advise patients to notify their physician if they become pregnant or intend to become pregnant during therapy.
• •Advise patients to notify their physician if they are breast-feeding.

Relapse to Drinking

• •Advise patients to continue acamprosate calcium therapy as directed, even in the event of relapse and remind them to discuss any renewed drinking with their physicians.
• •Advise patients that acamprosate calcium has been shown to help maintain abstinence only when used as a part of a treatment program that includes counseling and support.

Distributed by:

Glenmark Pharmaceuticals Inc., USA

Elmwood Park, NJ 07407

Questions? 1 (888) 721-7115

www.glenmarkpharma-us.com

Packaged and Distributed by:

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268 USA

Refer to package label for Distributor's NDC Number

May 2025