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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, showing 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 20
mg. daily.
Active ingredients
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)
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.
Do not take Acomplia:
- If you are (hypersensitive) allergic to rimonabant, or any
of the other ingredients of Acomplia.
- If you are breast-feeding
AKE SPECIAL CARE WITH ACOMPLIA
Tell your doctor before you take this medicine:
- f 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.
Cncommon 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.
are side effects, that affect less than 1 per 1000, that have
occurred in patients on Acomplia
include:
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.
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