→Appendix 1: agomelatine
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▶Common or very common Abdominal pain. anxiety. back
pain. constipation. diarrhoea. dizziness. drowsiness.
fatigue. headaches. nausea. sleep disorders. vomiting.
weight changes
▶Uncommon Aggression. confusion. hyperhidrosis. mood
altered. movement disorders. paraesthesia. skin reactions
. suicidal tendencies. tinnitus. vision blurred
▶Rare or very rare Angioedema. face oedema. hallucination
. hepatic disorders. urinary retention
SIDE-EFFECTS, FURTHER INFORMATION The use of
antidepressants has been linked with suicidal thoughts
and behaviour; children, young adults, and patients with a
history of suicidal behaviour are particularly at risk. Where
necessary patients should be monitored for suicidal
behaviour, self-harm, or hostility, particularly at the
beginning of treatment or if the dose is changed.
Akathisia. anxiety. appetite increased.
arrhythmia. asthenia. behaviour abnormal. blood
disorder. confusion. constipation. dizziness. drowsiness.
dry mouth. dysuria. hallucination. headache.
hyperhidrosis. insomnia. jaundice. nausea. paraesthesia.
peripheral neuritis. postural hypotension (more common
in elderly). reflexes increased. skin reactions. suicidal
tendencies. tremor. vision blurred. vomiting. weight
increased
SIDE-EFFECTS, FURTHER INFORMATION Risk of postural
hypotension and hypertensive responses. Discontinue if
palpitations or frequent headaches occur.
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Manufacturer advises avoid.
Increased risk of neonatal malformations—
manufacturer advises avoid unless there are compelling
Nervous system
reasons.
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Avoid—present in milk in animal studies.
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Manufacturer advises caution if
transaminases are elevated; avoid in hepatic impairment
or if transaminases exceed 3 times the upper limit of
normal.
In general, manufacturers advise
avoid.
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Caution in moderate to severe
impairment.
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Test liver function before
treatment and after 3, 6, 12 and 24 weeks of treatment,
and then regularly thereafter when clinically indicated
(restart monitoring schedule if dose increased);
discontinue if serum transaminases exceed 3 times the
upper limit of reference range or symptoms of liver
disorder.
Monitor blood pressure (risk
of postural hypotension and hypertensive responses).
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