iastinal Disorders
Dyspnoea
Uncommon
Common
Common
Gastrointestinal Disorders
Dry mouth
Common
Common
Very common
Diarrhoea
Common
Common
Common
Constipation
Common
Uncommon
Common
Upper abdominal pain
Very common
Common
Common
Nausea
Common
Common
Common
Vomiting
Common
Common
Uncommon
Hepatobilary Disorders
*Eosinophilic Hepatitis
Frequency not known
Frequency not known
Frequency not known
Skin and Subcutaneous Tissue Disorders
Hyperhidrosis
Uncommon
Uncommon
Common
Urticaria
Uncommon
Uncommon
Uncommon
Rash
Common
Uncommon
Uncommon
*Angioedema
Frequency not known
Frequency not known
Frequency not known
*Stevens-Johnson Syndrome
Frequency not known
Frequency not known
Frequency not known
Reproductive System and Breast Disorders
Erectile dysfunction
Not applicable
Uncommon
Common
General Disorders and Administration Site Conditions
Chest Pain
Uncommon
Uncommon
Common
Irritability
Common
Common
Common
Fatigue
Common
Common
Common
Feeling jittery
Uncommon
Common
Common
Pyrexia
Common
Common
Uncommon
Investigations
Blood pressure increased
Uncommon
Uncommon
Common
Weight decreased
Very Common
Very Common
Common
Description of selected adverse reactions
Insomnia
Includes insomnia, initial insomnia, middle insomnia, and terminal insomnia.
Eosinophilic hepatitis
No cases were reported in the clinical studies.
Angioedema
No cases were reported in the clinical studies.
Stevens-Johnson syndrome
No cases were reported in the clinical studies.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme.
Website: www.mhra.gov.uk/yellowcard
4.9 Overdose
The prolonged release of dexamfetamine after administration of Elvanse Adult should be considered when treating patients with overdose.
Manifestations of acute overdosage with amfetamines include restlessness, tremor, hyperreflexia, rapid respiration, confusion, aggression, hallucinations, panic states, hyperpyrexia, and rhabdomyolysis. Fatigue and depression usually follow the central nervous system stimulation. Cardiovascular effects include arrhythmias, hypertension or hypotension, and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhoea, and abdominal cramps. Fatal poisoning is usually preceded by convulsions and coma.
Management of acute amfetamine intoxication is largely symptomatic and includes gastric lavage, administration of activated charcoal, administration of a cathartic, and sedation. Acidification of the urine increases amfetamine excretion but is believed to increase risk of acute renal failure if myoglobinuria is present. If acute severe hypertension complicates amfetamine overdosage, administration of intravenous phentolamine has been suggested. However, a gradual drop in blood pressure will usually result when sufficient sedation has been achieved.
Lisdexamfetamine and dexamfetamine are not dialysable.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Pharmac |
