nts undergoing dialysis. Lisdexamfetamine and dexamfetamine are not dialysable.
Patients with hepatic impairment
No studies have been conducted in patients with hepatic impairment.
Paediatric population
Elvanse Adult is indicated for adults. For children and adolescents aged 6 to 17 years, another product containing lisdexamfetamine dimesylate is available. Currently available data are described in sections 4.8, 5.1 and 5.2.
Elvanse Adult should not be used in children under the age of 6 years. Safety and efficacy in this age group has not been established.
4.3 Contraindications
Hypersensitivity to sympathomimetic amines or any of the excipients listed in section 6.1.
Concomitant use of monoamine oxidase inhibitors (MAOI) or within 14 days after MAOI treatment (hypertensive crisis may result; see section 4.5).
Hyperthyroidism or thyrotoxicosis.
Agitated states.
Symptomatic cardiovascular disease.
Advanced arteriosclerosis.
Moderate to severe hypertension.
Glaucoma.
4.4 Special warnings and precautions for use
Abuse and dependence
Stimulants including Elvanse Adult have a potential for abuse, misuse, or diversion that physicians should consider when prescribing this product. The risk of misuse may be greater in adults (especially young adults) than in paediatric use. Stimulants should be prescribed cautiously to patients with a history of substance abuse or dependence.
Abuse of amfetamines can lead to tolerance, and psychological dependence with varying degrees of abnormal behaviour. Symptoms of amphetamine abuse may include dermatoses, insomnia, irritability, hyperactivity, emotional lability and psychosis. Withdrawal symptoms such as fatigue and depression have been reported.
Cardiovascular adverse events
Sudden death and pre-existing structural cardiac abnormalities or other serious heart problems
Children and adolescents: Sudden death has been reported in children and adolescents taking CNS stimulants, including those with structural cardiac abnormalities or other serious heart problems. Although some serious heart problems alone carry an increased risk of sudden death, stimulant products generally should not be used in children or adolescents with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug.
Adults: Sudden deaths, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses for ADHD. Although the role of stimulants in these adult cases is unknown, adults have a greater likelihood than children of having serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems. Adults with such abnormalities should also generally not be treated with stimulant drugs.
Hypertension and other cardiovascular conditions
Stimulant medications cause a modest increase in average blood pressure (about 2 - 4 mmHg) and average heart rate (about 3 - 6 bpm), and individuals may have larger increases. While the mean changes alone would not be expected to have short-term consequences, all patients should be monitored for changes in heart rate and blood pressure. Caution is indicated in treating patients whose underlying medical conditions might be compromised by increases in bloo |
