Agomelatine-Citric Acid (VALOMEL agomelatine (as agomelatine-citric acid) 25 mg tablet blister pack)
What to know about Agomelatine-Citric Acid — also sold as VALOMEL agomelatine (as agomelatine-citric acid) 25 mg tablet blister pack: uses, side effects, interactions, and safety considerations for people taking it or caring for someone who is.
Agomelatine-Citric Acid (brand names: VALOMEL agomelatine (as agomelatine-citric acid) 25 mg tablet blister pack) is classified as Low risk (2 risk points) by AllMeds. It is a S4 medication under the TGA in Australia. Melatonergic antidepressant formulation with sedating effects and potential for impaired cognition affecting workplace safety.
Key Takeaways
- TGA Schedule: S4 in Australia
- Risk level: Low (2 points)
- CNS depressant: May cause sedation, impair driving, and affect work capacity
Scheduling and Classification
| Jurisdiction | Classification | Status |
|---|---|---|
| Australia (TGA) | S4 | Not PBS listed |
Risk Profile
Melatonergic antidepressant formulation with sedating effects and potential for impaired cognition affecting workplace safety.
How Agomelatine-Citric Acid is regulated
Agomelatine-Citric Acid is overseen by medicines regulators in each country. The rules below explain how it's scheduled, what oversight applies, and what to discuss with your doctor or pharmacist before starting, changing, or stopping this medication.
Work capacity impact: As a CNS depressant, Agomelatine-Citric Acid may impair driving, operating machinery, and cognitive function. Work capacity certificates should reflect any medication-related restrictions.
Australia TGA / PBS / State Schemes
Classified as S4 under the Therapeutic Goods Administration (TGA).
United Kingdom NICE / MHRA / FPM
NICE guidelines recommend certain antidepressants (amitriptyline, duloxetine) for chronic pain management. For personal injury claims, antidepressant prescribing should be assessed for injury relatedness.
UK drug driving laws (Section 5A Road Traffic Act 2006) set specific limits for prescription drugs that cause impairment. Employers and occupational health advisors should assess fitness to work.
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Important: This page is general health information, not personal medical advice. If you have questions about your medication — including starting it, stopping it, changing the dose, or combining it with something else — speak with your doctor or pharmacist. For an emergency or suspected overdose, call your local emergency number or poison information service immediately. Information is drawn from regulator and clinical guideline sources (TGA, FDA, MHRA, NICE, PBS, CDC); see our methodology for details.