Mysimba is indicated, as an adjunct to a reduced-calorie diet and increased physical activity, for the management of weight in adult patients (≥18 years) with an initial Body Mass Index (BMI) of
- ≥ 30 kg/m2 (obese), or
- ≥ 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of one or more weight-related co morbidities (e.g., type 2 diabetes, dyslipidaemia, or controlled hypertension)
Treatment with Mysimba should be discontinued after 16 weeks if patients have not lost at least 5% of their initial body weight.
Mysimba is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions to:
HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2;
Tel: +353 1 6764971; Fax: +353 1 6762517;
Website: www.hpra.ie; e-mail: email@example.com
Adverse events should also be reported to Orexigen®: 1-800-902-210 or Mysimba@druginfo.com.
For more information on Mysimba, including efficacy, safety and tolerability, please review the SmPC which is available here:
For all other queries, please contact our Irish office at Tel: +353 (0)1 2057760, Fax: +353 (0)1 2698919 or firstname.lastname@example.org
Mysimba SPC available at www.medicines.ie