A French Pharmaceutical Company, Sanofi-Synthelabo, produced Rimonabant (Acomplia® and Zimulti). Rimonabant is a new drug designed for treatment of obesity that has the possibility of use with various other ailments. In the United Kingdom this diet drug was publicly approved on June 28th 2006, several European and other countries around the world have also given approval for use of the drug. Hopefully this will lead to FDA approval in the United States, but there are no guarantees as the FDA has strict policies concerning new medications available to the market, and a recent application did not receive FDA approval.

Acomplia (Rimonabant or Zimulti) offers some hope to people living with obesity, particularly when previous treatments have had little affect or unbearable side effects. This medication does not present without potential side effects for the user but might offer more benefits than other products. Rimonabant works differently to other weight loss medication, and has potential benefits that do not appear in other diet drugs. Increases levels of HDL (good cholesterol) have appeared in studies of the product indicating a simultaneous reduction in triglycerides (bad cholesterol). It has also been suggested that Rimonabant could be used for aiding smoking cessation although this has not been officially approved to date.

PRODUCT INFORMATION

Rimonabant is the active substance, with 20mg of rimonabant in each film-coated tablet of Acomplia. Other ingredients included are: Tablet Core: lactose monohydrate, maize starch, croscarmellose sodium (E468), povidone K30 (E1201), sodium laurilsulfate (E487), magnesium stearate, miceocrystalline cellulose (E 460).

Tablet coat: hypromellose 15 mPa.s (E 464), macrogol 3000, lactose monohydrate, titanium dioxide (E171).

Tablet polish: carnauba wax (E 903)

ACOMPLIA  AND ITS USES

Rimonabant, the active ingredient of Acomplia, works by blocking certain receptors present in the brain and fat cells called CB1 receptors. It is indicated for the treatment of obesity and body weight management in addition to proper diet and exercise.

BEFORE YOU TRY ACOMPLIA (contra-indications)

Acomplia is contra-indicated if you are allergic to rimonabant, or any of the active ingredients contained in Acomplia.

PREGNANCY AND BREAST-FEEDING

Acomplia is contra-indicated during pregnancy. Immediately contact your doctor if you think you might have fallen pregnant or if you plan to become pregnant or do become pregnant while using Acomplia.
Do not take Acomplia while breast-feeding and inform your doctor if you are planning to, or breast feeding your baby while using Acomplia.

PRECAUTIONS TO TAKE PRIOR THE USE OF ACOMPLIA

Inform your doctor prior to the use of this medication.
Do not use Acomplia if you have impaired liver function, seriously impaired renal function or if you are receiving treatment for epilepsy. If you are under the age of 18 years as there is no knowledge of people under the age of 18 years using Acomplia.

TAKING OF OTHER MEDICINES

Acomplia’s activity is increased with simultaneous use of certain drugs such as (CYP3A4 inhibitors), see following list:

ritonavir (medication for treatment of HIV infection)

itraconazole (antifungal medicine)

telithromycin (antibiotic)

ketaconazole (antifungal medicine)

nefazodone (anti-depressant)

clarithromycin (antibiotic)

Please inform your doctor or pharmacist should you be presently or have recently used any of the

medicines mentioned above or any other medication, including any product obtained without prescription i.e. St. John’s Wort, medication for weight loss, rifampicin (antibiotic), medication for improvement of blood lipids (fats), medicines for treatment of epilepsy (e.g. phenytoin carbamazeptine), antidiabetes medication and Phenobarbital, or any medication for depression.

DRIVING AND THE OPERATION OF MACHINERY

If taken in the recommended dosage, Acomplia is not anticipated to reduce any ability to drive or use machinery.

IMPORTANT INFORMATION REGARDING CERTAIN INGREDIENTS CONTAINED IN ACOMPLIA

Acomplia tablets include lactose and if you have intolerance to certain sugars, you should consult with your doctor prior to using this product.

USE OF ACOMPLIA

Always use this product precisely as your doctor instructs. Always check with your doctor or pharmacist if you are uncertain. Normal dosage is one 20mg tablet, taken once daily before breakfast in the morning. The tablet should be swallowed whole.

It is recommended that a reduced calorie diet and a physical exercise program be commenced and combined with the use of Acomplia to obtain the best results. Your doctor can recommend a suitable diet and the amount and type of physical activity needed to suit your  overall health.

If you accidentally take more Acomplia than prescribed you should inform your doctor or pharmacist.
Should you forget to a dose of Acomplia in the morning, take it immediately that you remember but do not double the dose to compensate for the forgotten dose.

SIDE EFFECTS

Obesity in the population is rapidly increasing, and affects every age group. As lifestyles become more and more sedentary health problems are rising especially so for weight related illness. Side effects involved with taking medication must also be examined and possible side effects that the taking of Acomplia may lead to include (though not everyone suffers them): Dizziness, nausea, mood swings,  infections, metabolic and nutritional disorders: anorexia, vomiting, decrease in appetite, disorders of the nervous system, disturbance in attention span, gastrointestinal disorder, dry mouth, trouble sleeping, depression, diarrhea, irritability, anxiety, itching, muscle spasm, excessive sweating, fatigue, bruising, tendon pain or inflammation (tendonitis), back pain (sciatica), memory loss, altered sensitivity in the hands and feet, hot flushes, influenza, joint sprains and falling.

There have been some reports that the side effects appear to subside as soon as there has been an adjustment to the drug. Acomplia’s side effects may be less severe than those experienced with other weight loss medication.  However its proven effectiveness for weight loss and its tested capacity to regulate blood pressure, cholesterol and blood sugar levels could be of great benefit to its users. Some concern regarding the side effects of Acomplia on one’s mental well being may cause the FDA to take some time before approval for it to be sold in the USA.

The Information given Above should Never take the place of advice given by your personal physician.

CLINICAL STUDIES

A group of patients, in a clinical study, were treated for twelve months with a daily dose of 20mg of rimonabant (Acomplia or Zimulti), and lost an average of 20lbs verses a placebo group who lost only 5 lbs. Approximately 75% lost more than 5% of their original body weight and approximately 44% lost over 10% of original body weight. This study took into consideration cardiovascular risk and found noteworthy benefits including a 23% rise in "Good Cholesterol" levels (HDL-cholesterol - an elevated level appears to guard against heart attack.) An average reduction of 15% was found in triglycerides (the chemical make-up in which the majority of fats associated with cholesterol are present in the body.)

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