Approved Uses 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: 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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