VYVANSE 70 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 70 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-1122-V1
Vyvanse-PIL-ENG-D26-F
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
VYVANSE 30 MG CAPSULES
VYVANSE 50 MG CAPSULES
VYVANSE 70 MG CAPSULES
ACTIVE INGREDIENT AND QUANTITY:
Each capsule of Vyvanse 30 contains: lisdexamfetamine dimesylate 30 mg
Each capsule of Vyvanse 50 contains: lisdexamfetamine dimesylate 50 mg
Each capsule of Vyvanse 70 contains: lisdexamfetamine dimesylate 70 mg
Inactive ingredients and allergens – See section 6 “Additional
information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet
contains concise information about this medicine. If you have any
further questions, consult
your doctor or pharmacist.
This medicine has been prescribed for your treatment. Do not pass it
on to others. It may
harm them, even if it seems to you that their medical condition is
similar to yours.
The medicine is not intended for children under the age of 6 years who
have ADHD or
patients under 18 years old with binge eating disorder (BED).
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Vyvanse is used for the treatment of Attention Deficit Hyperactivity
Disorder (ADHD).
Vyvanse can help increase attention and decrease impulsiveness and
hyperactivity in
patients with ADHD.
Vyvanse is intended for treating moderate to severe binge eating
disorder. It may reduce the
number of binge eating days in BED patients.
Vyvanse is not intended for weight loss. It is not known if Vyvanse is
safe and effective for the
treatment of obesity.
Vyvanse is intended only for patients over the age of 6 years who have
ADHD and for
patients over the age of 18 years with BED.
THERAPEUTIC GROUP: CNS stimulant.
It is not known if Vyvanse is safe and effective in children with ADHD
under 6 years old or in
patients with BED under 18 years old.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You or your child is sensitive (allergic) to the active ingredient
(lisdexamfetamine
dime

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