PLEASE NOTE: MEDICINAL PRODUCT NO LONGER AUTHORIZED
What is Acomplia - rimonabant?
ACOMPLIA is a medicine that contains 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 have risk factor (s) such as type 2 diabetes or dyslipidaemia (abnormal levels of fat in the blood). The medicine can only be obtained with a prescription.
How is Acomplia used - rimonabant?
One ACOMPLIA tablet is taken per day, in the morning before breakfast patients should also follow a diet with fewer 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 - rimonabant work?
The active substance in ACOMPLIA, rimonabant, is a cannabinoid receptor antagonist. It works by blocking a specific type of receptors, cannabinoid type 1 (CB1) receptors. These receptors are found in the nervous system and are part of the system used by the body to control food intake. The receptors are also present in adipocytes (fat tissue).
How has Acomplia - rimonabant been studied?
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, involving a total of approximately 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 to 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 of one to two years. One study also looked at how the loss could be maintained during the second. Four studies were also conducted on ACOMPLIA, compared with placebo, as a smoking cessation aid in over 7,000 patients and measuring the effects of administering the medicine for 10 weeks (one year in one of the studies) on smoking cessation and on the 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 who received a placebo: on average the loss was 4.9 kg more than placebo, except in the diabetic patient study where the difference in weight loss weight was 3.9 kg. The medicine also reduced the risk of weight regain.
Studies on smoking cessation 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 side effects reported with ACOMPLIA, see the Package Leaflet. ACOMPLIA must not be used in patients who may be hypersensitive (allergic) to rimonabant or the other ingredients of the medicine, or in women who are breastfeeding. 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 physician and perhaps discontinue treatment. ACOMPLIA should be used with caution in combination with certain medicines such as ketoconazole or itraconazole (antifungal medicines), ritonavir (used for 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 has been shown to be effective in reducing the weight of obese or overweight patients with associated risk factor (s). It decided that ACOMPLIA's benefits are greater than its risks when it is used, in addition to diet and exercise, to treat obese and overweight patients with risk factors such as type 2 diabetes or dyslipidaemia and has therefore it is recommended to issue the marketing authorization.
More information about Acomplia - rimonabant
On 19 June 2006, the European Commission granted sanofi-aventis a "Marketing Authorization" for ACOMPLIA, valid throughout the European Union.
For the full version of the ACOMPLIA evaluation (EPAR), click here.
Last update of this summary: 10-2007
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