Acomplia ® (Sanofi Aventis - Rimonabant) Original EU
N/A
Product Information
The following information is a summary about Acomplia.
It is not intended to replace a doctor's instructions.
How does it work?
Acomplia tablets contain the active ingredient rimonabant, which is a type of medicine called a cannabinoid-1 receptor antagonist. It is used to aid weight loss in people who are obese or overweight.
Rimonabant works by blocking receptors called cannabinoid-1 receptors (CB1). These are found in the brain, fat tissue, digestive system, liver and muscles.
The CB1 receptors are part of a system in the body called the endocannabinoid system. This system has only recently been discovered and explored. It is involved in regulating energy balance, sugar and fat metabolism and body weight.
The CB1 receptors found in a particular area of the brain called the mesolimbic system are involved in controlling our intake of highly palatable, sweet or fatty foods. Overactivation of the CB1 receptors is associated with increased appetite, cravings for food and fat build-up.
Rimonabant blocks CB1 receptors and so reduces cravings for these types of foods and helps decrease appetite and control hunger.
Rimonabant may also increase blood levels of "good fats" called HDL-cholesterol and reduce blood levels of "bad fats" called triglycerides.
Obesity is caused by consuming more energy in food than than the body needs for the amount of physical activity it is doing. This means that reducing hunger and food cravings is only part of the solution to weight loss. It is important to continue to follow a reduced calorie diet and exercise program while taking this medicine. Ask your doctor for advice about this.
What is it used for?
Obesity
Acomplia can be prescribed to aid weight loss in obese people who have a body mass index (BMI) of 30kg/m² or more. It can also be prescribed to overweight people with a BMI of 27kg/m² or more who also have additional risk factors for obesity-related diseases, for example type 2 diabetes or unhealthy levels of fats in the blood (dyslipidaemia, eg high triglyceride levels and low HDL-cholesterol levels). It should be used in combination with a reduced calorie diet and exercise program.
Warning!
Acomplia tablets should be taken once a day, in the morning before breakfast. Do not take more than your doctor has prescribed.
In clinical trials with this medicine, weight loss was only maintained in people who continued treatment. After stopping treatment some people put back on approximately half of the weight they had lost during treatment. It is important to continue to follow a diet and exercise program during and after treatment with this medicine to help you maintain any weight loss. The safety and efficacy of this medicine when used for longer than two years have not yet been studied.
Use with caution in
People over 75 years of age
Moderately decreased liver function
Moderately decreased kidney function
Depression
Epilepsy
People who have had a heart attack or stroke in the last six months (this medicine has not been studied in this group of people).
Not to be used in
Severely decreased liver function
Severely decreased kidney function
Uncontrolled serious psychiatric illness
Uncontrolled depression (also not recommended for people whose depression is controlled with antidepressant medicines)
Pregnancy
Breastfeeding
Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (Acomplia tablets contain lactose).
This medicine is not recommended for children and adolescents under 18 years of age, because its safety and efficacy have not been studied in this age group.
This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.
If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.
Pregnancy and Breastfeeding
Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
The safety of this medicine when used during pregnancy has not been studied and the potential risk for a developing baby is therefore not known. The manufacturer states that this medicine is not recommended for use during pregnancy. If you get pregnant or think you could be pregnant while taking this medicine you should contact your doctor immediately for medical advice.
It is not known if this medicine passes into breast milk. It should not be used by women who are breastfeeding. Seek medical advice from your doctor.
Side effects
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.
Nausea
Infections of the upper airways
Mood changes
Depression
Anxiety
Nervousness
Irritability
Difficulty sleeping (insomnia)
Sleep disorders, eg sleep walking, night sweats
Dizziness
Memory loss
Decreased sensation, eg to touch or pain
Sciatica (back pain)
Hot flushes
Vomiting
Diarrhoea
Fatigue
Itching
Increased sweating
Muscle spasms or cramps
Tendon inflammation (tendonitis)
Feeling unwell, restless or agitated
Hallucinations
The side effects listed above may not include all of the side effects reported by the drug's manufacturer.
For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.
How can this medicine affect other medicines?
It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to ensure that the combination is safe.
The following medicines may increase the blood level of rimonabant and so should be used with caution in combination with Acomplia, because they could increase the risk of its side effects:
clarithromycin
itraconazole
ketoconazole
nefazodone
ritonavir
telithromycin.
The following medicines may decrease the blood level of rimonabant and so could make it less effective:
carbamazepine
phenobarbital
phenytoin
rifampicin
the herbal remedy St John's wort (Hypericum perforatum).
This medicine is not recommended for people who are taking antidepressants, as the effects of this combination have not been studied.
Other medicines containing the same active ingredient
There are currently no other medicines available in the UK that contain rimonabant as the active ingredient.
