País: União Europeia
Língua: inglês
Origem: EMA (European Medicines Agency)
bupropion hydrochloride, naltrexone hydrochloride
Orexigen Therapeutics Ireland Limited
A08AA
naltrexone, bupropion
Antiobesity preparations, excl. diet products
Obesity; Overweight
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.
Revision: 25
Authorised
2015-03-26
37 B. PACKAGE LEAFLET 38 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT MYSIMBA 8 MG/90 MG PROLONGED-RELEASE TABLETS naltrexone hydrochloride/bupropion hydrochloride This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. -If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Mysimba is and what it is used for 2. What you need to know before you take Mysimba 3. How to take Mysimba 4. Possible side effects 5. How to store Mysimba 6. Contents of the pack and other information 1. WHAT MYSIMBA IS AND WHAT IT IS USED FOR Mysimba contains 2 active substances: naltrexone hydrochloride and bupropion hydrochloride and is used in obese or overweight adults to manage weight together with a reduced calorie diet and physical exercise. This medicine works on areas on the brain involved in the control of food intake and energy expenditure. Obesity in adults over 18 years of age is defined as a body mass index of greater than or equal to 30 and overweight in adults over 18 years of age is defined as a body mass index greater than or equal to 27 and less than 30. The body mass index is calculated as the measured body weight (kg) divided by the measured height squared (m 2 ). Mysimba is approved for use in patients with an initial body mass index of 30 or greater; it can also be given to those with a body mass index between 27 and 30 if they have additio Leia o documento completo
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 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. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Mysimba 8 mg/90 mg prolonged-release tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 8 mg naltrexone hydrochloride, equivalent to 7.2 mg of naltrexone, and 90 mg bupropion hydrochloride, equivalent to 78 mg of bupropion. Excipient with known effect: Each prolonged-release tablet contains 73.2 mg of lactose (see section 4.4). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Prolonged-release tablet. Blue, biconvex, round tablet of 12-12.2 mm diameter debossed with “NB-890” on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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/m 2 (obese), or • ≥ 27 kg/m 2 to < 30 kg/m 2 (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 (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Upon initiating treatment, the dose should be escalated over a 4-week period as follows: • Week 1: One tablet in the morning • Week 2: One tablet in the morning and one tablet in the evening • Week 3: Two tablets in the morning and one tablet in the evening • Week 4 and onwards: Two tablets in the morning and two tablets in the evening The maximum recommended daily dose of Mysimba is two tablets taken twice daily for a total dose of 32 mg naltrexone hydrochloride and 360 mg bupropion hydrochloride. The nee Leia o documento completo