d malignant hyperpyrexia can occur, sometimes with fatal outcomes (see section 4.3).
Serotonergic drugs
Serotonin syndrome has rarely occurred in association with the use of amphetamines such as Elvanse Adult, when given in conjunction with serotonergic drugs, including selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs). It has also been reported in association with overdose of amphetamines, including Elvanse Adult (see section 4.9).
Agents whose effects may be reduced by amfetamines
Antihypertensives: Amfetamines may decrease the effectiveness of guanethidine or other antihypertensive medications.
Agents whose effects may be potentiated by amfetamines
Amfetamines potentiate the analgesic effect of narcotic analgesics.
Agents that may reduce the effects of amfetamines
Chlorpromazine: Chlorpromazine blocks dopamine and norepinephrine receptors, thus inhibiting the central stimulant effects of amfetamines.
Haloperidol: Haloperidol blocks dopamine receptors, thus inhibiting the central stimulant effects of amfetamines.
Lithium carbonate: The anorectic and stimulatory effects of amfetamines may be inhibited by lithium carbonate.
Use with alcohol
There are limited data on the possible interaction with alcohol.
Drug/laboratory test interactions
Amfetamines can cause a significant elevation in plasma corticosteroid levels. This increase is greatest in the evening. Amfetamine may interfere with urinary steroid determinations.
4.6 Fertility, pregnancy and lactation
Pregnancy
There are no adequate and well controlled studies of Elvanse Adult in pregnant women. Dexamfetamine, the active metabolite of lisdexamfetamine, crosses the placenta.
Lisdexamfetamine dimesylate had no effect on embryofoetal development or survival when administered orally to pregnant rats and rabbits (see section 5.3).
Administration of lisdexamfetamine dimesylate to juvenile rats was associated with reductions in growth measurements at clinically relevant exposures.
The physician should discuss Elvanse Adult treatment in the context of potential pregnancy or lactation with female patients of child-bearing potential. Elvanse Adult should only be used during pregnancy if the potential benefit justifies the potential risk to the foetus.
Breast-feeding
Amfetamines are excreted in human milk. Elvanse Adult should not be used during breast-feeding.
Fertility
Amfetamine has shown no harmful effects on fertility in a rat study (see section 5.3). The effect of Elvanse Adult on human fertility has not been investigated.
4.7 Effects on ability to drive and use machines
Elvanse Adult can cause dizziness, drowsiness and visual disturbances including difficulties with accommodation, diplopia and blurred vision. These could have a moderate influence on the ability to drive and use machines.
Patients should be warned of these possible effects and advised that if affected, they should avoid potentially hazardous activities such as driving or operating machinery.
This medicine can impair cognitive function and can affect a patient's ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. When prescribing this medicine, patients should be told:
• The medicine is likely to affect your ability to drive.
• Do not drive until you know how the medicine affects you.
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