Mysimba
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
08-01-2024
Fachinformation
(SPC)
08-01-2024
Öffentlichen Beurteilungsberichts
(PAR)
15-04-2015
Wirkstoff:
bupropion hydrochloride, naltrexone hydrochloride
Verfügbar ab:
Orexigen Therapeutics Ireland Limited
ATC-Code:
A08AA
INN (Internationale Bezeichnung):
naltrexone, bupropion
Therapiegruppe:
Antiobesity preparations, excl. diet products
Therapiebereich:
Obesity; Overweight
Anwendungsgebiete:
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.
Produktbesonderheiten:
Revision: 25
Berechtigungsstatus:
Authorised
Berechtigungsdatum:
2015-03-26
Gebrauchsinformation
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
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Fachinformation
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
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