bull; It is an offence to drive while under the influence of this medicine.
• However, you would not be committing an offence (called 'statutory defence') if:
o The medicine has been prescribed to treat a medical problem and
o You have taken it according to the instructions given by the prescriber and in the information provided with the medicine and
o It was not affecting your ability to drive safely.
4.8 Undesirable effects
Summary of the safety profile
Adverse reactions observed with Elvanse Adult treatment mainly reflect side effects commonly associated with stimulant use. Very common adverse reactions seen in adults include decreased appetite, insomnia, dry mouth and headache.
Tabulated summary of adverse reactions
The following table presents all adverse reactions based on clinical trials and spontaneous reporting.
The following definitions apply to the frequency terminology used hereafter:
Very common (≥ 1/10)
Common (≥ 1/100 to < 1/10)
Uncommon (≥ 1/1,000 to < 1/100)
Rare (≥ 1/10,000 to < 1/1,000)
Very rare (< 1/10,000)
Frequency not known (cannot be estimated from the available data).
An asterisk (*) indicates that additional information on the respective adverse reaction is provided below the table.
System/Organ Class
Adverse Reaction
Children
(6 to 12 years)
Adolescents
(13 to 17 years)
Adults
Immune System Disorders
Anaphylactic reaction
Frequency not known
Frequency not known
Frequency not known
Hypersensitivity
Uncommon
Uncommon
Uncommon
Metabolism and Nutrition Disorders
Decreased appetite
Very common
Very common
Very common
Psychiatric Disorders
*Insomnia
Very common
Very common
Very common
Agitation
Uncommon
Uncommon
Common
Anxiety
Uncommon
Common
Common
Logorrhea
Uncommon
Uncommon
Uncommon
Libido decreased
Not applicable
Not reported
Common
Depression
Uncommon
Common
Uncommon
Tic
Common
Uncommon
Uncommon
Affect lability
Common
Uncommon
Common
Dysphoria
Uncommon
Uncommon
Uncommon
Euphoria
Frequency not known
Uncommon
Uncommon
Psychomotor hyperactivity
Uncommon
Uncommon
Common
Bruxism
Uncommon
Uncommon
Common
Dermatillomania
Uncommon
Uncommon
Uncommon
Psychotic episodes
Frequency not known
Frequency not known
Frequency not known
Mania
Uncommon
Uncommon
Uncommon
Hallucination
Uncommon
Uncommon
Frequency not known
Aggression
Common
Uncommon
Frequency not known
Nervous System Disorders
Headache
Very common
Very common
Very common
Dizziness
Common
Common
Common
Restlessness
Uncommon
Common
Common
Tremor
Uncommon
Common
Common
Somnolence
Common
Common
Uncommon
Seizure
Frequency not known
Frequency not known
Frequency not known
Dyskinesia
Uncommon
Uncommon
Uncommon
Dysgeusia
Uncommon
Uncommon
Uncommon
Eye Disorders
Vision blurred
Uncommon
Frequency not known
Uncommon
Mydriasis
Uncommon
Uncommon
Frequency not known
Cardiac Disorders
Tachycardia
Common
Common
Common
Palpitation
Uncommon
Common
Common
Cardiomyopathy
Frequency not known
Uncommon
Frequency not known
Vascular disorders
Raynaud's phenomenon
Uncommon
Frequency not known
Frequency not known
Respiratory, Thoracic and Med |
