VYVANSE 50 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

LISDEXAMFETAMINE DIMESYLATE

Available from:

MEDISON PHARMA LTD

ATC code:

N06BA12

Pharmaceutical form:

CAPSULES

Composition:

LISDEXAMFETAMINE DIMESYLATE 50 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

SHIRE PHARMACEUTICAL CONTRACTS LTD, UK

Therapeutic area:

LISDEXAMFETAMINE

Therapeutic indications:

Vyvanse is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients ages 6 years and above.Vyvanse is indicated for the treatment of Moderate to Severe Binge Eating Disorder (BED) for patient over 18 years.Limitation of Use:Vyvanse is not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of Vyvanse for the treatment of obesity have not been established

Authorization date:

2019-12-31

Patient Information leaflet

Vyvanse-PIL-RUS-D23-F
VYVANSE-PIL-1122-V1
ИНСТРУКЦИЯ ПО ПРИМЕНЕНИЮ ПРЕПАРАТА В
СООТВЕТСТВИИ С "ПОЛОЖЕНИЕМ О
ФАРМАЦЕВТАХ
(ПРЕПАРАТЫ)" - 1986
Лекарство продается только по рецепту
врача
ВИВАНС 30 МГ КАПСУЛЫ
ВИВАНС 50 МГ КАПСУЛЫ
ВИВАНС 70 МГ КАПСУЛЫ
СОСТАВ АКТИВНОГО ВЕЩЕСТВА:
Каждая капсула Виванс 30 содержит 30 мг
лиздексамфетамина димезилата
(Lisdexamfetamine dimesylate).
Каждая капсула Виванс 50 содержит 50 мг
лиздексамфетамина димезилата
(Lisdexamfetamine dimesylate).
Каждая капсула Виванс 70 содержит 70 мг
лиздексамфетамина димезилата
(Lisdexamfetamine dimesylate).
Неактивные вещества и аллергены в
препарате: см. пункт 6 «Дополнительная
информация».
ПРЕЖДЕ ЧЕМ НАЧАТЬ ПРИМЕНЕНИЕ
ПРЕПАРАТА, ВНИМАТЕЛЬНО ПРОЧТИТЕ
ИНСТРУКЦИЮ ДО
КОНЦА. Инструкция содержит краткую
информацию о препарате. Если у вас
есть
дополнительные вопросы, обратитесь к
врачу или фармацевту.
Этот препарат был назначен для
лечения вашего заболевания, и не
следует передавать его
другим людям. Он может повредить им,
даже если вам кажется, что ваши
заболевания
похожи.
Этот препарат не предназначен для
детей в возрасте до 6 лет, страдающих
СДВГ (ADHD),
или пациентов в возрасте до 18 лет,
страдающих компульсивным пе

Summary of Product characteristics

PHYSICIAN’S PRESCRIBING INFORMATION
NAME OF THE MEDICINAL PRODUCT
Vyvanse 30 mg
Vyvanse 50 mg
Vyvanse 70 mg
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient is Lisdexamfetamine Dismesylate.
For the full list of excipients, see section "DESCRIPTION" below.
PHARMACEUTICAL FORM
Capsules
1
INDICATIONS AND USAGE
Vyvanse is a central nervous system (CNS) stimulant indicated for:
•
the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in
patients ages 6 years and
above.
•
the treatment of Moderate to Severe Binge Eating Disorder (BED) for
patients over 18 years.
Limitation of Use:
VYVANSE is not indicated or recommended for weight loss. Use of other
sympathomimetic drugs
for weight loss has been associated with serious cardiovascular
adverse events. The safety and
effectiveness of VYVANSE for the treatment of obesity have not been
established
_[see Warnings and _
_Precautions (5.2)]_
.
2
DOSAGE AND ADMINISTRATION
2.1
PRE-TREATMENT SCREENING
Prior to treating patients with CNS stimulants, including VYVANSE,
assess for the presence of
cardiac disease (e.g., a careful history, family history of sudden
death or ventricular arrhythmia, and
physical exam)
_[see Warnings and Precautions (5.2)]_
.
_ _
To reduce the abuse of CNS stimulants including VYVANSE, assess the
risk of abuse, prior to
WARNING: ABUSE AND DEPENDENCE
CNS STIMULANTS, INCLUDING VYVANSE, OTHER AMPHETAMINE-CONTAINING
PRODUCTS, AND
METHYLPHENIDATE, HAVE A HIGH POTENTIAL FOR ABUSE AND DEPENDENCE.
ASSESS THE RISK OF ABUSE
PRIOR TO PRESCRIBING AND MONITOR FOR SIGNS OF ABUSE AND DEPENDENCE
WHILE ON THERAPY _[SEE _
_WARNINGS AND PRECAUTIONS (5.1), AND DRUG ABUSE AND DEPENDENCE (9.2,
9.3)]. _
prescribing. After prescribing, keep careful prescription records,
educate patients about abuse,
monitor for signs of abuse and overdose, and re-evaluate the need for
VYVANSE use
_[see Warnings _
_and Precautions (5.1), Drug Abuse and Dependence (9.)]_
.
2.2
GENERAL INSTRUCTIONS FOR USE
Take VYVANSE by mouth in the morning with or without food; avoi