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ACOMPLIA (RIMONABANT): PATIENT INFORMATION

Acomplia (Rimonabant) 20 mg film-coated tablets

Read all of this leaflet carefully before you start taking this medicine.

  • 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 (Rimonabant) is and what it is 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 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.


    Before you take Rimonabant (Acomplia)

    Do not take Acomplia

  • 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

    Take special care with Acomplia

    Tell your doctor before you start to take this medication

  • 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
  • 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 (Rimonabant) tablets in people under 18 years of age.

    Serious psychiatric events including depression or mood changes have been reported in patients taking Rimonabant (Acomplia) tablets.

    If you experience symptoms of depression (see below) during treatment with Acomplia you should contact your doctor and stop the treatment.

    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, pharmacist, or other healthcare professional if any of the symptoms listed above develop or worsen after treatment has begun.

    Taking other medicines

    The activity of Acomplia (Rimonabant) 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 (antidepressant)

    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 Johnís wort, rifampicin (antibiotic), medicines for weight loss, medicines to improve blood lipids (fats), antidiabetes medicines and medicines to treat epilepsy (e.g. phenobarbital, phenytoin, carbamazepine) or depression.

    Pregnancy and breast-feeding

    Rimonabant should not be taken during pregnancy. Contact your doctor or physician immediately if you become pregnant, think you might be pregnant or are planning to become pregnant while taking Rimonabant (Acomplia).

    Do not take this drug when breast-feeding. Tell your healthcare professional if you are breast-feeding or if you are planning to breast-feed your baby.

    Driving and using machines

    At the recommended dose, Acomplia (Rimonabant) tablets is not expected to reduce your ability to drive and use machines.

    Important information about some of the ingredients of Rimonabant (Acomplia) tablets

    Acomplia tablets include lactose. If you are intolerant to some sugars, contact your doctor before taking this medication.


    How to take Acomplia (Rimonabant)?

    Always take Rimonabant 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.

    Taking Rimonabant (Acomplia) with food and drink

    This medicine should be taken once daily in the morning before breakfast.

    If you take more Acomplia (Rimonabant) tablets than you should

    If you take more Rimonabant (Acomplia) tablets than you should tell a 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.

    If you have any further questions on the use of this product ask your doctor, pharmacist, or other healthcare professional.


    Possible side effects

    Like all medicines, Acomplia (Rimonabant) 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 this drug 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 Rimonabant include: vomiting, upset stomach, nervousness, trouble with sleeping, depression, dizziness, irritability, diarrhoea, itching, anxiety, excessive sweating, fatigue, muscle cramps or spasm, bruising, memory loss, tendon pain and inflammation (tendonitis), back pain (sciatica), altered sensitivity (less sensitivity or abnormal burning or prickling sensation) of the hands and feet, fall, hot flush, 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 Rimonabant (Acomplia) include: tremor, sleepiness (lethargy), night sweats, hiccups, panic symptoms, anger, emotional disorder, restlessness (dysphoria), suicidal thoughts, hypoglycaemia (low blood sugar), aggressiveness or aggressive behaviour.

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

    During post-marketing experience the following side effects have also been reported (frequency not known): disturbance in attention, convulsion, delusion (false belief), rash, paranoia, 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, pharmacist or other healthcare provider.


    How to store Acomplia (Rimonabant)?

    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 medication does not require any special storage conditions.

    Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist or doctor how to dispose of medicines no longer required. These measures will help to protect the environment.


    Further information about Acomplia (Rimonabant) tablets

    What Acomplia contains?

    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, croscarmellose sodium, sodium laurilsulfate, microcrystalline cellulose, magnesium stearate
  • Tablet coating: lactose monohydrate, hypromellose 15 mPa.s, titanium dioxide, macrogol 3000
  • Tablet polishing: carnauba wax

    What Rimonabant (Acomplia) looks like and contents of the pack?

    Acomplia 20 mg is supplied as teardrop-shaped, white film-coated tablets debossed with "20" on one side.

    Acomplia (Rimonabant) 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.

    Manufactured and distributed by Sanofi-Aventis pharmaceutical company and its divisions.

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