Acomplia - rimonabant

PLEASE NOTE: MEDICINAL PRODUCT IS NO LONGER AUTHORIZED

What is Acomplia - rimonabant?

ACOMPLIA is a medicine containing the active substance rimonabant. It is available in tablets a

teardrop shape, white in color.

What is Acomplia used for - rimonabant?

ACOMPLIA is used together with diet and exercise to treat adult patients:

• who are obese (very overweight) and with a body mass index greater than or equal to 30 kg / m2;

• or who are overweight (with a body mass index greater than or equal to 27 kg / m2) and in the presence of risk factor (s), such as type 2 diabetes or dyslipidemia (abnormal levels of fat in the blood). The medicine can only be obtained with a prescription.

How is Acomplia used - rimonabant?

One tablet of ACOMPLIA is taken a day, in the morning before breakfast patients must also follow a diet with less calories and increase their level of physical activity. The medicine should not be used by patients with severe liver or kidney problems.

How does Acomplia work - rimonabant?

The active substance in ACOMPLIA, rimonabant, is a cannabinoid receptor antagonist. It works by blocking a specific type of receptor, cannabinoid receptors of type 1 (CB1). These receptors are found in the nervous system and are part of the system used by the body to control food intake. Receptors are also present in adipocytes (fat tissue).

What studies have been carried out on Acomplia - rimonabant?

The effects of ACOMPLIA were first tested in experimental models before being studied in humans.

Four studies were conducted on ACOMPLIA in overweight and obese patients, for a total of about 7, 000 patients, whose weight at the start of the studies was on average between 94 and 104 kg. One study focused on patients with abnormal levels of blood fat and another on patients with type 2 diabetes.

The studies compared the effect of ACOMPLIA with that of a placebo (a dummy treatment) on weight loss over a period between one and two years. One study also looked at how the loss could be maintained during the second year. Four studies were also conducted on ACOMPLIA, compared with placebo, as an aid to smoking cessation in over 7, 000 patients and measuring the effects of the administration of the medicine for 10 weeks (one year in one of the studies) on smoking cessation and on relapses in the following year.

What benefit has Acomplia - rimonabant shown during the studies?

After one year, all patients treated with ACOMPLIA had lost more weight than people receiving placebo: on average, the loss was 4.9 kg more than placebo, except in the study on diabetic patients where the difference in loss of weight was 3.9 kg. The medicine has also reduced the risk of weight recovery.

Smoking cessation studies have not presented consistent results and the effect of ACOMPLIA in this area is difficult to assess. The company has decided to withdraw the smoking cessation application, so ACOMPLIA is not recommended as a smoking cessation aid.

What are the risks associated with Acomplia - rimonabant?

During the studies, the most common side effects seen with ACOMPLIA (affecting more than 1 in 10 patients) were nausea (feeling sick) and upper respiratory tract infections. For the full list of all side effects reported with ACOMPLIA, see the Package Leaflet. ACOMPLIA should not be used in patients who may be hypersensitive (allergic) to rimonabant or to the other ingredients of the medicine, or to breast-feeding women. It should not be used in patients with ongoing severe depression or who have been treated with antidepressants, as it may increase the risk of depression, including suicidal thoughts in a small proportion of patients. Patients experiencing symptoms of depression should consult their doctor and perhaps stop treatment. ACOMPLIA should be used with caution in combination with certain medicines such as ketoconazole or itraconazole (antifungal medicines), ritonavir (used against HIV infection), or telithromycin or clarithromycin (antibiotics).

Why has Acomplia - rimonabant been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that ACOMPLIA demonstrated its effectiveness in reducing the weight of obese or overweight patients with the associated risk factor (s). It decided that the benefits of ACOMPLIA outweigh its risks when used, in addition to diet and exercise, for the treatment of obese and overweight patients with risk factors such as type 2 diabetes or dyslipidemia and has therefore it is recommended to issue the marketing authorization.