Description
Mysimba®
(naltrexone HCl 8 mg/bupropion HCl 90 mg)
What is Mysimba®?
Mysimba® is a prescription drug that can be prescribed to treat overweight or obese patients. Mysimba® is a prolonged-release tablet and contains two active substances: naltrexone (8mg) and bupropion (90mg).
Who is Mysimba® for?
Mysimba® (naltrexone 8mg/bupropion 90mg) has been indicated for weight control as a supplement to a calorie-controlled diet and increased physical exercise for adult patients (≥18 years of age) with an initial BMI ≥30 (obese), or a BMI between 27 and 30 (overweight) who are subject to one or more weight-related comorbidities (such as type 2 diabetes, dyslipidemia and/or regulated hypertension).
What does Mysimba® do?
Mysimba® interacts with the brain to help control body weight.
Bupropion stimulates POMC neurons in the hypothalamus to reduce the sensation of hunger. Naltrexone stops this process from being inhibited. Both naltrexone and bupropion interact with the reward system of the brain. This can reduce the urge to eat. The exact neurochemical appetite-suppressing effects of naltrexone/bupropion are not yet fully understood.
Reasons to cease treatment with Mysimba®
- Weight loss of less than 5% of the initial weight in 16 weeks.
- Concerns regarding increased blood pressure, or concerns regarding the safety or tolerability of this drug.
This drug is subject to additional monitoring. This means new safety information can quickly be established. Please contribute to this by reporting any side effects you experience.
Adverse events, warnings and precautions
Like all medicines, Mysimba® can cause side effects, although not everyone gets them. Very common side effects are: Headache, Nausea, Constipation, Vomiting.
To see the full list of adverse events, warnings and precautions see:
- The Insert
- Or the SMPC and the RMM-documents (doctors)
You can report side effects at any time at www.lareb.nl, or by calling 073-64 69 700 on weekdays.
RMM-documentation
You can request additional material from Goodlife Endocrinology BV, available via info@goodlifepharma.com or by phone at +31-(0)85-0646016.
Patient information
Additional risk minimization measures:
Report adverse events
For all your medical questions, reports of any side effects and product quality complaints, please contact Goodlife via +31-(0)85-0646016 or per e-mail via quality@goodlifepharma.com.
Marketing authorisationholder
Orexigen Therapeutics
Ireland Limited 9-10 Fenian
Street, Dublin 2, D02 RX24
Ireland
Product authorisation number EU/1/14/988/001-002
MYS-0449-001 12/25
This page is published as of December 2025