Product Details

What you need to know before you take Mysimba

Do not take Mysimba: – if you are allergic to naltrexone, to bupropion or to any of the other ingredients of this medicine (listed in section 6); – if you have an abnormally high blood pressure (hypertension) that is not controlled using a medicinal product; 8 – if you have a condition that causes fits (seizures) or if you have a history of fits; – if you have a brain tumour; – if you are usually a heavy drinker and you have just stopped drinking alcohol, or are going to stop while you are taking Mysimba; – if you have recently stopped taking sedatives or medicines to treat anxiety (especially benzodiazepines), or if you are going to stop them while you are taking Mysimba; – if you have or have had a bipolar disorder (extreme mood swings); – if you are using any other medicines which contain bupropion or naltrexone; – if you have an eating disorder or had one in the past (for example, bulimia or anorexia nervosa); – if you are currently dependent on chronic opiates or opiate agonists (for example methadone), or you are going through acute withdrawal (cold turkey); – if you are taking medicines for depression or Parkinson’s disease called monoamine oxidase inhibitors (MAOIs) or have taken them in the last 14 days; – if you have severe liver disease; – if you have endstage kidney disease. Warnings and precautions Talk to your doctor or pharmacist before taking Mysimba. This is important because some conditions make it more likely that you could have side effects (see also section 4). If you feel depressed, contemplate suicide, have a history of attempting suicide, panick attacks or any other mental health problems, you should inform your doctor before taking this medicine.

Fits (seizures) Mysimba has been shown to cause fits (seizures) in up to 1 in 1,000 patients (see also section 4). You should inform your doctor before taking this medicine: • if you have had a serious head injury or head trauma; • if you regularly drink alcohol (see “Mysimba with alcohol”); • if you regularly use medicines to help you to sleep (sedatives); • if you are currently dependent on or addicted to cocaine or other stimulating products; • if you have diabetes for which you use insulin or oral medicines that may cause low sugar levels in your blood (hypoglycaemia); or • if you are taking medicines that may increase the risk of fits (see “Other medicines and Mysimba”). If you have a fit (seizure), you should stop taking Mysimba and consult your doctor immediately. Hypersensitivity reactions You should stop taking Mysimba immediately and consult your doctor if you are experiencing any symptoms of an allergic reaction such as swelling of the throat, tongue, lips, or face, difficulty swallowing or breathing, dizziness, fever, rash, pain in the joints or in the muscles, itching or hives after taking this medicine (see also section 4). Serious skin reactions, including Stevens-Johnson syndrome and acute generalised exanthematous pustulosis (AGEP), have been reported in association with Mysimba treatment. Stop using Mysimba and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4. You should talk to your doctor, especially if: • you have high blood pressure before taking Mysimba, because it can become worse. You will have your blood pressure and heart rate measured before you start taking Mysimba and while you are taking it. If your blood pressure or heart rate increases significantly, you may need to stop taking Mysimba. • you have uncontrolled coronary artery disease (a heart disease caused by poor blood flow in the blood vessels of the heart) with symptoms such as angina (characterised by chest pain) or a recent heart attack.

• you already have or have had a condition affecting the circulation of blood in the brain (cerebrovascular disease). • you have any liver problems before you start Mysimba. • you have any kidney problems before you start Mysimba. • if you have a history of mania (feeling elated or over-excited, which causes unusual behaviour). you are taking medicines for depression, the use of these medicines together with Mysimba can lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Mysimba” in this section and section 4.) Brugada syndrome – if you have a condition called Brugada syndrome (a rare hereditary syndrome that affects the heart rhythm) or if cardiac arrest or sudden death occurred in your family. Older People Use caution when taking Mysimba, if you are 65 years or older. Mysimba is not recommended if you are over 75 years. Children and adolescents No studies have been conducted in children and adolescents under the age of 18. Therefore Mysimba should not be used in children and adolescents below 18 years. Other medicines and Mysimba Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Do not take Mysimba with: • Monoamine oxidase inhibitors (medicines to treat depression or Parkinson’s disease) such as phenelzine, selegiline, or rasagiline. You must stop taking these medicines for at least 14 days before starting Mysimba (see “Do not take Mysimba”). • Opiates and opiate-containing medicines for example to treat cough and cold (such as mixtures containing dextromethorphan or codeine), opiate addiction (such as methadone), pain (for example, morphine and codeine), diarrhoea (for example, paregoric). You must have stopped taking any opiate medicines at least 7-10 days before starting Mysimba. Your doctor may carry out a blood test to ensure that your body has cleared these medicines before starting your treatment. Naltrexone blocks the effects of opiates; if you take higher doses of opiates to overcome these effects of naltrexone, you may suffer from an acute opiate intoxication which may be life threatening. After you stop treatment with Mysimba you may be more sensitive to low doses of opiates (see “Do not take Mysimba”).

Tell your doctor if you are taking any of the following medicines, as your doctor will closely monitor you for side effects: • Medicines that may, when used alone or in combination with naltrexone/bupropion, increase the risk of fits such as: o medicines for depression and other mental health problems; o steroids (except drops, creams, or lotions for eye and skin conditions or inhalers for breathing disorders such as asthma); o medicines used to prevent malaria; o quinolones (antibiotics such as ciprofloxacine to treat infections); o tramadol (a painkiller belonging to the class of opiates); o theophylline (used in the treatment of asthma); o antihistamines (medicines to treat hayfever, itch, and other allergic reactions) that cause sleepiness (such as chlorphenamine); o medicines to lower sugar levels in your blood (such as insulin, sulphonylureas such as glyburide or glibenclamide, and meglitinides such as nateglinide or repaglinide); o medicines to help you to sleep (sedatives such as diazepam). • Medicines to treat depression (such as amitriptyline, desipramine, imipramine, venlafaxine, paroxetine, fluoxetine, citalopram, escitalopram) or other mental health problems (such as 10 risperidone, haloperidol, thioridazine). Mysimba may interact with some medicines used for treatment of depression and you may experience a so-called serotonin syndrome. Symptoms are mental status changes (e.g. agitation, hallucinations, coma), and other effects, such as body temperature above 38°C, increase in heart rate, unstable blood pressure, and exaggeration of reflexes, muscular rigidity, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea) (see section 4.) • Some medicines used to treat high blood pressure (beta-blockers such as metoprolol, and clonidine, a centrally acting antihypertensive); • Some medicines used to treat irregular heart rhythm (such as propafenone,flecainide); • Some medicines used to treat cancer (such as cyclophospamide, ifosphamide, tamoxifen); • Some medicines for Parkinson’s disease (such as levodopa, amantadine or orphenadrine); • Ticlopidine or clopidogrel, mainly used in the treatment of heart disease or stroke; • Medicines used in the treatment of HIV infection and AIDS, such as efavirenz and ritonavir; • Medicines used to treat epilepsy such as valproate, carbamazepine, phenytoin orphenobarbital.

Your doctor will closely monitor you for side effects and/or may need to adjust the dose of the other medicines or Mysimba. Mysimba may make other medicines less effective when taken at the same time: • If you take digoxin for your heart If this applies to you, tell your doctor. Your doctor may consider adjusting the dose of digoxin. Mysimba with alcohol Excessive use of alcohol while being treated with Mysimba might increase the risk for fits (seizures), mental disorder events or might reduce alcohol tolerance. Your doctor may suggest you do not drink alcohol while you are taking Mysimba, or try to drink as little as possible. If you do drink a lot now, do not just stop suddenly, because that may put you at risk of having a fit. Pregnancy and breast-feeding Mysimba should not be used during pregnancy, or in women currently planning to become pregnant, or while breast-feeding. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Driving and using machines Ask your doctor for advice before you drive and operate machines since Mysimba might make you feel dizzy and sleepy which may weaken your ability to concentrate and react. Do not drive, use any tools or machines, or perform dangerous activities until you know how this medicine affects you. If you experience fainting, muscle weakness or fits during treatment, do not drive or use machines. In case of doubt, check with your doctor, who might consider to interrupt the treatment depending on your situation. Mysimba contains lactose (a type of sugar) If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.