Product Information: Acomplia (Rimonabant)

Product Information
The latest breakthrough for obesity and smoking cessation

Acomplia contains Rimonabant, the long awaited breakthrough drug by Sanofi for the treatment of obesity and smoking cessation.

Acomplia represents one of the latest and indeed a most novel method for controlling body weight. Acomplia operates by being a cannabinoid receptor antagonist. This means that Acomplia prevents the normal action of endogenous cannabinoid in the brain from stimulating the so-called CB1 receptors. It would appear that these receptors stimulate appetite and therefore when they are subdued so is the need to eat.

The clinical trials that have been run over the past few years are impressive and have shown that these receptor sites may be responsible for more than just appetite, because the results show that Acomplia also aids people to stop smoking and even improves cardiovascular factors such as cholesterol ratios.

With specific regard to weight loss, the human trials have shown an average weight loss of 10% of bodyweight, most importantly that weight has remained off even up to 2-years later. Also importantly, it would appear that the majority of weight is actually lost from the difficult to lose area around the waist. The average figures from the trials show a loss of fat of 20 lbs (9 Kg) and 3 inches (8 cm) diameter taken off the waist.

Additional trials have been undertaken to help smokers kick the habit. Even here Acomplia has been successful, showing that persons using Acomplia have double the chance of quitting smoking for good, and perhaps importantly also helping those smokers from not gaining any weight once they stop smoking, as it is often the case that smokers trying to quit substitute their cigarettes with food etc.

On top of that, Acomplia has also been shown to improve HDL - good cholesterol - and triglyceride levels, show

ing benefit for diabetes and heart conditions.

Meanwhile, Acomplia has shown few and minor side effects in the clinical trials, some of which have been conducted continuously for 2-years. Side effects noted in the studies were mainly mild and transient consisting (in order of frequency) of nausea, dizziness, diarrhoea, vomiting, hypoglycaemia and anxiety.

The most beneficial doses noted in the trials have been 20mg daily.

Perhaps it is no wonder that Acomplia is expected to be a blockbuster drug now it is available in Europe.

Manufacturers Insert

ACOMPLIA (RIMONABANT)

The active substance is rimonabant. Each film-coated tablet of Acomplia contains 20mg of rimonabant. The other ingredients are: Tablet Core: maize starch, lactose monohydrate, povidone K30 (E1201), croscarmellose sodium (E468), sodium laurilsulfate (E487), miceocrystalline cellulose (E 460), magnesium stearate.

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

Tablet polishing: carnauba wax (E 903)

WHAT ACOMPLIA IS AND WHAT IS IT USED FOR
The active ingredient of Acomplia is rimonabant. It works by blocking specific receptors in the brain and fat tissues called CB1 receptors. Acomplia is indicated in the treatment of obesity and management of body weight as adjunct to diet and exercise.

BEFORE YOU TAKE ACOMPLIA
Do not take Acomplia:

• If you are (hypersensitive) allergic to rimonabant, or any of the other ingredients of Acomplia.
• If you are breast-feeding

TAKE SPECIAL CARE WITH ACOMPLIA
Tell your doctor before you take this medicine:

• If you have impaired liver
• If you have severely impaired renal function
• If you are currently being treated for epilepsy
• If you are less than 18 years of age. There is no information available on the use of Acomplia in people under 18 years of age.

TAKING OTHER MEDICINES
The activity of Acomplia is increased by simultaneous use of some drugs (so-called CYP3A4 inhibitors) such as:

• itraconazole (antifungal medicine)
• ketaconazole (antifungal medicine)
• ritonavir (medicine for the treatment of HIV infections)
• telithromycin (antibiotic)
• clarithromycin (antibiotic)
• nefazodone (anti-depressor)

Please tell your doctor or pharmacist if you are taking or have recently taken the above mentioned medicines or any other medicines, including those obtained without a prescription such as St. John’s wort, rifampicin (antibiotic), medicines for weight loss, medicines to improve blood lipids (fats), antidiabetes medicines and medicines to treat epilepsy (e.g. phenytoin, Phenobarbital, carbamazeptine) or depression

DRIVING AND USING MACHINES
At the recommended dose, Acomplia is not expected to reduce your ability to drive and use machines.

PREGNANCY AND BREAST-FEEDING
Acomplia should not be taken during pregnancy. Contact your doctor immediately if you become pregnant, think you might be pregnant or are planning to become pregnant while taking Acomplia.

Do not take this medicine when breast-feeing. Tell your doctor if you are breast-feeding or if you are planning to breast-feed your baby.

IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS OF ACOMPLIA
Acomplia tablets include lactose. If you are intolerant to some sugars, contact your doctor before taking this medicine.

HOW TO TAKE ACOMPLIA
Always take Acomplia exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

The usual dose is one 20mg tablet to be taken once daily in the morning before breakfast. Swallow the tablet whole.

You need to start and continue a reduced calorie diet and a physical activity program to get best results. Your doctor should recommend the type of diet and the level of physical activity required, that suits your specific condition and overall health.

Taking Acomplia with food and drink
Acomplia should be taken once daily in the morning before breakfast.

If you take more Acomplia than you should
Tell your doctor or pharmacist.

If you forget to take Acomplia
Take it as soon as you remember but do not take a double dose to make up for any forgotten dose.

POSSIBLE SIDE EFFECTS
Like all medicines, Acomplia can cause side effects, although not everybody gets them.
Very common side effects, that affect more than 1 per 10, have occurred in patients on Acomplia include:

* nausea and upper respiratory tract infection

Common side effects, that affect more than 1 per 100 but less than 1 per 10, that have occurred in patients on Acomplia include:

* upset stomach, vomiting, trouble with sleeping, depression, irritability, dizziness, diarrhea, anxiety, itching, excessive sweating, muscle cramps or spasm, fatigue, bruising, tendon pain and inflammation (tendonitis), memory loss, back pain (sciatica), altered sensitivity of the hands and feet, hot flush, fall, influenza, and joint sprain.

Uncommon side effects, that affects less than 1 per 100 but more than 1 per 1000, that have occurred in patients on Acomplia include: sleepiness (lethargy), night sweats, panic symptoms, hiccups, anger, restlessness (dysphoria), emotional disorder.

Rare side effects, that affect less than 1 per 1000, that have occurred in patients on Acomplia include hallucinations.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

STORING ACOMPLIA
Keep out of reach and sight of children. Do not use Acomplia after the expiry date which is stated on the outer packaging after EXP. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions.