Lisdexamfetamine Aristo 10mg/mL oral solution

देश: माल्टा

भाषा: अंग्रेज़ी

स्रोत: Malta Medicines Authority

थमां उपलब्ध:

Aristo Pharma GmbH Wallenroder Straße 8–10, 13435, Berlin, Germany

ए.टी.सी कोड:

N06BA12

INN (इंटरनेशनल नाम):

Lisdexamfetamine dimesylate 10 mg/ml

फार्मास्यूटिकल फॉर्म:

ORAL SOLUTION

रचना:

Lisdexamfetamine dimesylate 10 mg/ml

प्रिस्क्रिप्शन प्रकार:

POM

चिकित्सीय क्षेत्र:

PSYCHOANALEPTICS

प्राधिकरण का दर्जा:

Authorised

प्राधिकरण की तारीख:

2024-02-13

सूचना पत्रक

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PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE USER
LISDEXAMFETAMINE ARISTO 10 MG/ML ORAL SOLUTION
lisdexamfetamine dimesylate
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.
THE LEAFLET IS IN SECTIONS:
-
Sections 1 to 6 are for parents and carers (sometimes called ‘your
guardians’).
-
The last section is a special section for a child or young person to
read.
However, all sections are written as though the child or young person
taking the medicine is reading
them.
WHAT IS IN THIS LEAFLET
1.
What Lisdexamfetamine Aristo
is and what it is used for
2.
What you need to know before you take Lisdexamfetamine Aristo
3.
How to take Lisdexamfetamine Aristo
4.
Possible side effects
5.
How to store Lisdexamfetamine Aristo
6.
Contents of the pack and other information
1.
WHAT LISDEXAMFETAMINE ARISTO IS AND WHAT IT IS USED FOR
WHAT LISDEXAMFETAMINE ARISTO IS
Lisdexamfetamine Aristo contains the active substance lisdexamfetamine
dimesylate which helps with
your brain activity. It helps improve your attention, helps you
concentrate and makes you less
impulsive. This medicine is a long acting medicine which works
gradually over a 13-hour time period.
WHAT LISDEXAMFETAMINE ARISTO IS USED FOR
Lisdexamfetamine Aristo is a treatment for ‘attention deficit
hyperactivity disorder’ (ADHD). It is
used:
-
in children and young people between the ages of 6 and 18 who have
previously taken a
methylphenidate treatment that inadequately treated their ADHD. You
may continue to take this
medicine into adulthood if you

उत्पाद विशेषताएं

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Lisdexamfetamine Aristo 10 mg/mL oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of oral solution contains 10 mg lisdexamfetamine dimesylate,
equivalent to 2.95 mg of
dexamfetamine.
Excipient(s) with known effect
Lisdexamfetamine Aristo contains 1 mg sodium methyl
parahydroxybenzoate (E219), 0.1 mg sodium
propyl parahydroxybenzoate (E217) and 100 mg propylene glycol (E1520)
per ml of oral solution.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution
Clear and colorless to slightly yellow solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is indicated as part of a comprehensive
treatment programme for attention
deficit/hyperactivity disorder (ADHD) in children aged 6 years and
over when response to previous
methylphenidate treatment is considered clinically inadequate.
Treatment must be under the supervision of a specialist in childhood
and/or adolescent behavioural
disorders. Diagnosis should be made according to DSM criteria or the
guidelines in ICD and should be
based on a complete history and evaluation of the patient. Diagnosis
cannot be made solely on the
presence of one or more symptoms.
The specific aetiology of this syndrome is unknown, and there is no
single diagnostic test. Adequate
diagnosis requires the use of medical and specialised psychological,
educational, and social resources.
A comprehensive treatment programme typically includes psychological,
educational and social
measures as well as pharmacotherapy and is aimed at stabilising
children with a behavioural syndrome
characterised by symptoms which may include chronic history of short
attention span, distractibility,
emotional lability, impulsivity, moderate to severe hyperactivity,
minor neurological signs and
abnormal EEG. Learning may or may not be impaired.
Lisdexamfetamine Aristo is not indicated in all children with ADHD and
the decision to use the drug
must be