Contraindications1 – Do not prescribe Mysimba if your patient has:
- Uncontrolled hypertension
- Severe hepatic impairment or end stage renal failure
- Current seizure disorder, history of seizures or known CNS tumour
- Ongoing acute alcohol or benzodiazepine or opioid withdrawal
- Current or previous diagnosis of bulimia or anorexia nervosa
- History of bipolar disorder
Is currently treated with:
- Bupropion or naltrexone
- Opioid agonists
- Monoamine oxidase inhibitors (MAOI) within the last 14 days
Do not initiate/continue treatment if there are concerns with the safety or tolerability of Mysimba treatment.
Additionally, treatment with Mysimba should be discontinued after 16 weeks or at the annual assessment if the patient has not lost or maintained a loss of at least 5% of their initial body weight (Section 4.1 and 4.2 of the SmPC).
MAOI=monoamine oxidase inhibitor.
Increased risk of adverse reactions1
Treatment should only be initiated or maintained after full evaluation of the possible benefits and risks and review of Section 4.4 of the SmPC
- Controlled hypertension (potential increased blood pressure risk)
- Angina or recent history of myocardial infarction
- Mild hepatic impairment (dose adjustment necessary)
- Moderate hepatic impairment (treatment not recommended)
- Moderate or severe renal impairment (dose adjustment necessary). If diabetic or elderly patient or at risk for renal insufficiency, assess eGFR prior to initiating treatment)
- Depression or history of suicidal thoughts/suicidal attempt
- History of mania
- Risk factors for seizures – such as: history of head trauma, episodes of hypoglycaemia from diabetes treatment, concomitant medication that could lower the seizure threshold such as: antipsychotics, antidepressants, antimalarials, tramadol, theophylline, systemic steroids, quinolones, or sedating antihistamines
Do not initiate/continue treatment if there are concerns with the safety or tolerability of Mysimba treatment.
Additionally, treatment with Mysimba should be discontinued after 16 weeks or at the annual assessment if the patient has not lost or maintained a loss of at least 5% of their initial body weight (Section 4.1 and 4.2 of the SmPC).
Mysimba is subject to additional monitoring1 and each patients’ suitability should be assessed with consideration of potential contraindications.
Please refer to the Mysimba Physician Prescribing Checklist on this website or on www.medicines.ie (Ireland) or https://medicinesauthority.gov.mt/rmm (Malta).
References
- Mysimba 8 mg/90 mg prolonged-release tablets Summary of Product Characteristics available on medicines.ie or www.ema.europa.eu ..
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions
IE-MYS-213(1), MYS-0454-001 01/26 DOP: January 2026
The information on this website is intended for Healthcare Professionals who reside in Ireland and Malta only.
Healthcare professionals who reside in Ireland are asked to report any suspected adverse events to: HPRA Pharmacovigilance via www.hpra.ie;
Adverse events should also be reported to Orexigen: +353 1800 849 099 or Currax.Ml@primevigilance.com.
Healthcare professionals who reside in Malta are asked to report any suspected adverse events to: the Malta Medicines Authority via http://medicinesauthority.gov.mt/adrportal or Vivian Corporation Ltd. via pv@viviancorp.com.
Adverse events should also be reported to Orexigen: +356 800 62176 or Currax.Ml@primevigilance.com.