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ACOMPLIA (RIMONABANT): WARNINGS AND PRECAUTIONS

Depressive disorders

Depressive disorders or mood alterations with depressive symptoms have been reported in up to 10%, and suicidal ideation in up to 1%, of patients receiving rimonabant. In patients with current suicidal ideations and/or with a history of suicidal ideation and depressive disorder rimonabant should not be used unless the benefits of treatment are considered to outweigh these risks in an individual patient. Obesity is a condition that can be associated with depressive disorders. Depressive disorders can be associated with an increased risk of suicidal thoughts, self harm and suicide.

The prescriber should carefully investigate if the patient has had a depressive disorder in the past in order to evaluate the potential risks with Rimonabant (Acomplia) treatment.

Depressive reactions may occur in patients who have no obvious risk factors, apart from obesity itself. In postmarketing experience, more than half of the patients who develop such reactions appear to do so within 1 month of starting treatment, approximately 80% appear to do so within 3 months. Patients should be actively monitored for signs and symptoms of psychiatric disorders, particularly depression following the start of treatment. If depression is diagnosed during rimonabant therapy, rimonabant treatment must be stopped. The patient should be monitored and treated appropriately.

Patients, especially those with a history of depressive disorders/mood alterations, (and relatives or other relevant persons) should be alerted about the need to monitor for the emergence of such symptoms and to seek medical advice immediately if these occur.

Other psychiatric conditions

Therapy with Acomplia (Rimonabant) tablets is not recommended in patients with uncontrolled psychiatric illness. If psychiatric illness is diagnosed during rimonabant therapy, treatment must be stopped.

Seizures

Rimonabant (Acomplia) tablets has not been studied in patients being treated for epilepsy. In clinical trials no difference in the incidence of seizures was seen in patients receiving rimonabant or placebo. Rimonabant, however, should be used with caution in these patients.

Hepatic impairment

Rimonabant is metabolised by the liver, thus caution is advised in patients with moderate hepatic impairment. The pharmacokinetics and safety of rimonabant have not been studied in patients with severe hepatic impairment; its use in these patients is not recommended.

Renal impairment

There are limited data in patients with moderate renal impairment and no data in patients with severe renal impairment. Acomplia should not be used in patients with severe renal impairment.

Elderly

The efficacy and safety of Acomplia (Rimonabant) treatment in patients over 75 years of age has not sufficiently been established. Rimonabant should be used with caution in this population.

Race

The clinical effect (weight loss) of rimonabant in Black patients was lower than in Caucasians. This could be caused by a higher rimonabant clearance than in Caucasians resulting in a lower exposure.

Diabetic patients

Due to the effect of Rimonabant (Acomplia) on the blood glucose level, when rimonabant is administered in diabetic patients, hypoglyceamia can occur. Monitoring of blood glucose level is recommended in these patients.

Drug Interactions

Acomplia (Rimonabant) tablets should be used with caution in combination with potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, ritonavir, clarithromycin, telithromycin, nefazodone).

Lactose

Since Rimonabant (Acomplia) tablets contain lactose, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption, should not take this drug.

Patients should be instructed not to increase their dose of Acomplia.

Patients who had a cardiovascular event (myocardial infarction, stroke, etc.) less than 6 months ago were excluded in the studies for rimonabant.

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