Acomplia
rimonabant
Medicinal product no longer authorised
(rimonabant)
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If any of the side effects get serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.
You are advised to share the information in this leaflet with relatives or other relevant persons.
What ACOMPLIA is and what it is used for
Before you take ACOMPLIA
How to take ACOMPLIA
Possible side effects
5 How to store ACOMPLIA
6. Further information
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 obese or overweight patients with additional risk factors such as diabetes or high levels of fatty substances in the blood called lipids (dyslipidaemia; mainly cholesterol and triglycerides) as adjunct to diet and exercise.
if you currently suffer from depression
if you are currently being treated for depression
if you are allergic (hypersensitive) to rimonabant, or any of the other ingredients of ACOMPLIA
if you are breast-feeding
.
Tell your doctor before you start to take this medicine
if you have previously suffered from depression or have had suicidal thoughts
if you have impaired liver function
if you have severely impaired renal function
if you have diabetes (see section 4)
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.
Serious psychiatric events including depression or mood changes have been reported in patients taking ACOMPLIA (see section POSSIBLE SIDE EFFECTS).
If you experience symptoms of depression (see below) during treatment with ACOMPLIA you should contact your doctor and stop the treatment.
Medicinal product no longer authorised
Signs and symptoms associated with depression could be:
Sadness, depressed mood; loss of interest in previously pleasurable activities; agitation; irritability; slowed, inhibited actions; poor concentration; anxiety; difficulty in sleeping (insomnia); thoughts or words about death or suicide.
You should inform your doctor if any of the symptoms listed above develop or worsen after treatment has begun.
The activity of ACOMPLIA is increased by simultaneous use of some drugs (so-called CYP3A4 inhibitors) such as:
itraconazole (antifungal medicine)
ketoconazole (antifungal medicine)
ritonavir (medicine for the treatment of HIV infections)
telithromycin (antibiotic)
clarithromycin (antibiotic)
nefazodone (anti-depressor)
Please inform 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, carbamazepine) or depression.
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-feeding. Tell your doctor if you are breast-feeding or if you are planning to breast-feed your baby.
At the recommended dose, ACOMPLIA is not expected to reduce your ability to drive and use machines.
ACOMPLIA tablets include lactose. If you are intolerant to some sugars, contact your doctor before taking this medicine.
Always take ACOMPLIA exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose is one 20 mg 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.
ACOMPLIA should be taken once daily in the morning before breakfast.
If you take more ACOMPLIA than you should tell a doctor or pharmacist.
Medicinal product no longer authorised
Take it as soon as you remember but do not take a double dose to make up for any forgotten dose.
If you have any further questions on the use of this product ask your doctor or your pharmacist.
Like all medicines, ACOMPLIA can cause side effects, although not everybody gets them Very common side effects, that affect more than 1 per 10, that 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 than1 per 10, that have occurred in patients on ACOMPLIA include:
upset stomach, vomiting, trouble with sleeping, nervousness, depression, irritability, dizziness, diarrhoea, anxiety, itching, excessive sweating, muscle cramps or spasm, fatigue, bruising, tendon pain and inflammation (tendonitis), memory loss, back pain (sciatica), altered sensitivity (less sensitivity or abnormal burning or prickling sensation) of the hands and feet, hot flush, fall, influenza, and joint
sprain.
Uncommon side effects, that affect less than 1 per 100 but more than1 per 1000, that have occurred in patients on ACOMPLIA include:
Sleepiness (lethargy), tremor, night sweats, panic symptoms, hiccups, anger, restlessness (dysphoria), emotional disorder, suicidal thoughts, aggressiveness or aggressive behaviour, hypoglycaemia (low blood sugar).
Rare side effects, that affect less than 1 per 1000, that have occurred in patients on ACOMPLIA include: hallucinations.
During post-marketing experience the following side effects have also been reported (frequency not known):
Convulsion, disturbance in attention, delusion (false belief), paranoia, rash, headache and stomach pain.
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.
Keep out of the 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
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Medicinal product no longer authorised
The active substance is rimonabant. One film-coated tablet contains 20 mg rimonabant. The other ingredients are:
Tablet core: maize starch, lactose monohydrate, povidone K 30 (E1201), croscarmellose sodium (E468), sodium laurilsulfate (E487), microcrystalline cellulose (E460), magnesium stearate Tablet coating: lactose monohydrate, hypromellose 15 mPa.s (E464), titanium dioxide (E171), macrogol 3000
Tablet polishing: carnauba wax (E903)
ACOMPLIA 20 mg is supplied as teardrop-shaped, white film-coated tablets debossed with “20”on one side.
ACOMPLIA is available in blister packs of 14, 28, 30, 56, 84, 90 and 98 tablets, in perforated unit dose blister packs containing 70 x 1 tablets, and in white plastic bottles containing 28, 98 and 500 tablets.
Not all pack sizes may be marketed.
sanofi-aventis
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Sanofi Winthrop Industrie
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