17.1 Information for Patients

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

Renal Impairment

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

Suicidality and Depression

Families and caregivers of patients being treated with Campral 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 and Precautions ( ) 5.2

Alcohol Withdrawal

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

Manufactured by: Merck Santé s.a.s. Subsidiary of Merck KGaA, Darmstadt, Germany 37, rue Saint-Romain 69008 LYON FRANCE

Manufactured for: Forest Pharmaceuticals, Inc. Subsidiary of Forest Laboratories, Inc. St. Louis, MO 63045