Mysimba

What is Mysimba?

Mysimba (substance names: naltrexone and bupropion) is an orally administered drug used to help adults suffering from obesity lose weight and keep it off. This drug works on areas in the brain involved in the regulation of food intake and energy expenditure. Mysimba was developed by the pharmaceutical company Goodlife and is only available by prescription.

Naltrexone and Bupropion

Naltrexone and bupropion are the substance names of the medicine used in Mysimba. A modified-release tablet contains 8 mg naltrexone (hydrochloride) and 90 mg bupropion (hydrochloride). Naltrexone reduces food cravings, and bupropion acts on the brain's reward system to reduce appetite.

Mysimba Price

The price of Mysimba is determined by the pharmacist.

Who is Mysimba suitable for?

Mysimba is prescribed to adult patients with an initial BMI (Body Mass Index) of: ≥ 30 BMI (obesity), or ≥ 27 BMI to < 30 BMI (overweight) who have at least one weight-related comorbidity, such as diabetes, high blood pressure, high cholesterol, osteoarthritis, or sleep apnea. Treatment with Mysimba should be discontinued if at least 5% of the initial body weight has not been lost after 16 weeks of using the daily dose of 3.0 mg.

Mysimba Prescription

Mysimba is only available with a doctor's prescription if the client meets the indications described above.

The substances contained in Mysimba

The active substances in this medicine are 8 mg naltrexone and 90 mg bupropion. Other substances in this medicine are: microcrystalline cellulose, hydroxypropyl cellulose, anhydrous lactose, lactose monohydrate, cysteine hydrochloride, crospovidone type A, magnesium stearate, hypromellose, disodium edetate, colloidal silicon dioxide, and indigo carmine aluminum lake.

Mysimba Reimbursement by Health Insurer

The medication Mysimba can be reimbursed from the basic package for the treatment of a small group of people with overweight. Reimbursement only applies to people with a Body Mass Index (BMI) of 30 or higher, or 27 or higher with a weight-related condition, who have already participated in a combined lifestyle intervention (GLI) for at least 1 year and have not achieved sufficient weight loss through it.

Mysimba Dosage

Dosing schedule for adult use

The dosage of Mysimba is 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg. The dosing schedule for adult use is shown below. You gradually build up the dosage over 5 weeks from 0.6 mg to the maximum dosage of 3.0 mg.

• Week 1 – 1 tablet, in the morning
• Week 2 – 1 tablet, in the morning and evening
• Week 3 – 2 tablets in the morning and 1 tablet in the evening
• Week 4 – 2 tablets, in the morning and evening The maximum allowed dosage is 2 tablets twice daily. Always use this medicine exactly as your doctor has told you. The dosing schedule has been set up to minimize the chance of side effects when starting Mysimba. Because you slowly increase the dosage, your body can adapt to the medication, and you have less chance of developing side effects. If you experience side effects, your doctor can adjust the dosing schedule in consultation with you.

When should you not use Mysimba?

You should not use Mysimba in the following cases:

• during pregnancy or breastfeeding;
• in case of uncontrolled or excessively high blood pressure;
• in case of epilepsy or a history of seizures;
• in case of a central nervous system tumor;
• in case of a mental disorder;
• in case of severe liver failure;
• in the end-stage of kidney failure;
• in case of an allergy to any of the substances in Mysimba;
• if you are older than 75 years. Furthermore, there are medicines that should not be used together with Mysimba, namely certain antidepressants, antipsychotics, chronic use of sleeping pills, 1st generation antihistamines, antimalarial drugs, opioids, quinolones, theophylline, corticosteroids, and certain diabetes medications.

Storage Advice

Keep out of the sight and reach of children. Do not use this medicine after the expiry date. This can be found on the box and the strip after EXP. There will be a month and a year. The last day of that month is the expiry date. Store below 30°C. Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. They will then be destroyed in a responsible manner and will not end up in the environment.

Have you forgotten to use Mysimba?

If you forget to take a dose, skip it and take the next tablet(s) at the usual time. Do not take a double dose to make up for a forgotten dose.

Have you taken too much of this medicine?

If you have taken too many tablets, you have a greater chance of a seizure or other side effects as described below. Do not delay, contact your doctor immediately or the emergency department of the nearest hospital.

Are you using any other medicines?

If you are using other medicines besides Mysimba, or have recently done so, or if there is a possibility that you will use other medicines in the near future? Then tell your doctor.

If you stop taking Mysimba

You should take Mysimba for at least 16 weeks for the full effect. Do not stop taking Mysimba before you have discussed it with your doctor. You should gradually reduce the use of Mysimba as you built it up.

Mysimba Side Effects

As with all medication, the use of Mysimba can cause side effects. The dosage is therefore gradually built up to minimize the chance of side effects. The most common side effects of Mysimba are:

• headache
• dizziness
• fatigue
• nausea
• diarrhea
• constipation
• vomiting Most side effects are mild and will disappear once you are on a continuous dosage. It also helps to adhere to certain eating and drinking advice. Your coach will discuss this with you. A complete list of side effects can be found in the package leaflet inside the Mysimba packaging. The medicinal product Mysimba has obtained marketing authorization in the EU. The use of the medicinal product may have side effects. The side effects are listed in the package leaflet. If you have questions about side effects or experience (too many) side effects, please contact your doctor, pharmacist, or coach. You can also report side effects directly via the Netherlands Pharmacovigilance Centre Lareb, website www.lareb.nl. By reporting side effects, you can help us obtain more information about the safety of this medicinal product.