VALDOXAN 25MG TABLETS 28`S

Agomelatine is an antidepressant with a unique, novel mechanism of action that distinguishes it from all other antidepressants. It works in two ways: it acts as an agonist (activator) at melatonin MT1 and MT2 receptors (resynchronising circadian rhythms and improving sleep architecture), while simultaneously acting as an antagonist (blocker) at serotonin 5-HT2C receptors (enhancing dopamine and noradrenaline release in the prefrontal cortex without affecting serotonin reuptake).

Because it does not inhibit serotonin reuptake, agomelatine has a distinctive side effect profile — it does not cause the sexual dysfunction, weight gain, or discontinuation syndrome commonly associated with SSRIs and SNRIs.

It is indicated for: the treatment of major depressive disorder (MDD) in adults.

The starting dose is one 25 mg tablet taken once daily at bedtime. After 2 weeks, the dose may be increased to 50 mg (two 25 mg tablets) at bedtime if response is insufficient. Always take at bedtime — agomelatine's melatonergic mechanism is tied to the evening circadian rhythm. Do not take in the morning. Swallow whole with water.

Agomelatine must not be used in: hepatic impairment (Child-Pugh A, B, or C) or transaminases > 3 x ULN at baseline; patients taking strong CYP1A2 inhibitors (fluvoxamine, ciprofloxacin); known hypersensitivity to agomelatine or excipients; lactose intolerance (contains lactose); patients under 18 (not indicated); or patients with dementia.

•       Strong CYP1A2 inhibitors (fluvoxamine, ciprofloxacin): CONTRAINDICATED — dramatically increase agomelatine plasma levels and hepatotoxicity risk.

•       Moderate CYP1A2 inhibitors (propranolol, grepafloxacin, enoxacin): use with caution — increased agomelatine exposure.

•       CYP1A2 inducers (rifampicin, carbamazepine, smoking): reduce agomelatine levels — reduced efficacy.

•       Alcohol: ABSOLUTELY CONTRAINDICATED — severe additive hepatotoxicity risk.

Store at room temperature below 30°C. Keep in original blister packaging. Keep out of reach of children. Do not use after expiry date.

Agomelatine has a very different mechanism to SSRIs and SNRIs — rather than simply boosting serotonin, it works with your body's natural melatonin system to restore healthy sleep-wake rhythms while also lifting mood. For patients who have experienced sexual dysfunction, significant weight gain, or discontinuation syndrome with SSRIs, agomelatine can be a very well-tolerated alternative.

Liver function testing before and during treatment is not optional — it is essential for your safety. Keep your blood test appointments. If you develop yellow eyes or skin, dark urine, or pain in the right upper abdomen, stop the tablet and go to your doctor immediately.

Avoid alcohol completely during treatment — even moderate alcohol consumption significantly increases the risk of liver damage with agomelatine.

Agomelatine's unique mechanism results in a distinctive clinical profile: no weight gain, no sexual dysfunction, no discontinuation syndrome (can be stopped without tapering), and no QT prolongation — significant advantages over SSRIs in patients where these effects are problematic.

The mandatory LFT monitoring schedule is: before starting, then at weeks 3, 6, 12, 24. Reinitiation after a gap also requires fresh LFT baseline. The 25 mg dose is the starting dose; 50 mg (2 tablets) is the maximum dose.

Hepatotoxicity risk: estimated at <1% but includes severe outcomes; do not underestimate. Prescribers should document LFT results in records at each monitoring point. Agomelatine is not associated with suicidality — its safety profile in this regard appears favourable compared to some antidepressants.

Why must I always take it at bedtime?

Agomelatine's mechanism is designed to work with your body's evening melatonin surge to resynchronise your sleep-wake cycle and restore healthy sleep architecture. Taking it in the morning or at midday will significantly reduce its effectiveness.

What should I do if I miss a dose?

Take it the following bedtime as usual. Do not double up. If you miss several doses, speak to your doctor before restarting — a fresh liver function test may be required.

Can I drink alcohol while taking Valdoxan?

No, you must completely avoid alcohol. The combination of agomelatine and alcohol significantly increases the risk of serious liver damage. This is one of the most important restrictions with this medicine.

How long before I notice improvement in my depression?

Like most antidepressants, agomelatine takes 2–4 weeks to produce noticeable mood improvement. Sleep quality often improves sooner — within the first 1–2 weeks — which itself can benefit mood and energy levels.

Do I need to taper the dose when stopping?

Unlike SSRIs, agomelatine does not require gradual tapering. It can be stopped without discontinuation syndrome. However, always discuss stopping with your doctor rather than stopping abruptly without advice.