Mianserin Remedica (Mianserin Hydrochloride)

Mianserin is a tetracyclic antidepressant used in the treatment of depressive disorders.

• Major depressive disorder: reduction of depressive symptoms and improvement of mood.
• Depressive symptoms in patients with chronic medical conditions: enhancement of motivation and overall wellbeing.
• Depressive symptoms in elderly patients: alleviation of depressive signs with attention to tolerability.

• Mianserin acts as an antagonist at central presynaptic α2‑adrenergic receptors, as well as serotonin 5‑HT2, 5‑HT3 and histamine H1 receptors. By blocking α2‑adrenergic receptors it increases norepinephrine release, while serotonin receptor antagonism enhances serotonergic neurotransmission, together contributing to its antidepressant effect.

Mianserin may cause a range of adverse reactions that vary in frequency and severity.

Common Side Effects

• Drowsiness: feeling unusually sleepy or fatigued.
• Dry mouth: reduced salivation leading to discomfort.
• Weight gain: increase in body weight over time.
• Constipation: difficulty passing stools.

Serious or Rare Side Effects

• Agranulocytosis: severe reduction in white blood cells, increasing infection risk.
• Seizures: occurrence of convulsive episodes.
• Cardiac arrhythmia: irregular heart rhythm that may require medical attention.

When prescribing or dispensing Mianserin, several safety considerations should be observed.

• Monitor blood pressure: watch for orthostatic hypotension, especially at treatment initiation.
• Assess for worsening depression or suicidal thoughts: conduct regular mental health evaluations.
• Avoid abrupt discontinuation: taper the dose to reduce withdrawal symptoms.
• Caution in patients with cardiovascular disease: evaluate cardiac history before use.
• Avoid use with monoamine oxidase inhibitors: ensure a washout period to prevent serotonin syndrome.
• Store at ambient temperature: keep below 25°C in the original packaging, protect from moisture.

Mianserin can interact with several medicines, requiring careful management.

Major Interactions (Avoid)

• Monoamine oxidase inhibitors (MAOIs): risk of severe serotonin syndrome.
• Other serotonergic agents (e.g., SSRIs, SNRIs): increased serotonin toxicity.
• CNS depressants (e.g., benzodiazepines, barbiturates): additive sedation.

Moderate Interactions (Monitor Closely)

• Alcohol: may enhance drowsiness and impair coordination.
• Antihypertensive drugs: potential for additive blood pressure lowering.
• Carbamazepine: may reduce Mianserin plasma levels.
• Warfarin: possible alteration of anticoagulant effect, requiring INR monitoring.