INSPAGO 25 MG (AGOMELATINE) — FILM-COATED TABLETS

Medical Product Description | Antidepressant | Prescription Medicine

Product Overview

Inspago 25 mg contains agomelatine, an antidepressant used for the treatment of major depressive episodes in adults. It acts on melatonin receptors and serotonin receptors in the brain, helping regulate circadian rhythms and influencing neurotransmission associated with mood.

Agomelatine may help improve depressive symptoms, sleep patterns, and overall daily functioning in appropriately selected patients. Because of the risk of liver injury, treatment requires liver function testing before initiation and at specified intervals during therapy.

Active ingredient: Agomelatine 25 mg per film-coated tablet.
Dosage form: Oral film-coated tablets.
Pack size: 21 tablets.
Therapeutic class: Antidepressant; melatonin receptor agonist and serotonin 5-HT₂C receptor antagonist.
Indication: Treatment of major depressive episodes in adults.

Indications and Potential Benefits

When prescribed by a qualified healthcare professional, agomelatine may help:

Manage depression: Reduce symptoms associated with major depressive episodes, including persistent low mood and loss of interest or pleasure.
Support sleep–wake regulation: Help regulate circadian rhythms that may be disrupted in people experiencing depression.
Improve daily functioning: Support improvements in energy, motivation, and daily activities as depressive symptoms improve.
Support sustained recovery: Help maintain improvement when used for the duration recommended by the treating physician.

The response to treatment varies between individuals. Agomelatine is not a sleeping tablet and should not be used solely to treat insomnia without an appropriate medical assessment.

Mechanism of Action

Agomelatine works through two main mechanisms:

Melatonin receptor agonism: Stimulates MT₁ and MT₂ receptors, helping regulate the body's internal biological clock and sleep–wake cycle.
Serotonin receptor antagonism: Blocks 5-HT₂C receptors, which is thought to increase noradrenaline and dopamine activity in certain areas of the brain.

Together, these actions contribute to its antidepressant effects and may help improve sleep–wake rhythm disturbances associated with depression.

Dosage and Directions for Use

Recommended adult dose: One 25 mg tablet once daily at bedtime.
Dose adjustment: If symptoms have not improved after two weeks, the physician may consider increasing the dose to 50 mg once daily, taken as two 25 mg tablets together at bedtime.
Administration: Swallow the tablet with water. It may be taken with or without food.
Treatment duration: Treatment is generally continued for at least six months, as directed by the treating physician.
Discontinuation: Dose tapering is generally not required when stopping agomelatine; however, treatment should be discontinued under medical guidance.

Essential monitoring: Liver function tests must be performed before starting treatment and approximately 3, 6, 12, and 24 weeks after initiation. Testing should also be repeated according to clinical circumstances and after a dose increase. Treatment must not be started if liver transaminases exceed three times the upper limit of normal.

Possible Side Effects

Potential adverse effects of agomelatine include:

Common effects: Headache, dizziness, sleepiness, nausea, and back pain.
Sleep-related effects: Insomnia or other changes in sleep patterns.
Gastrointestinal effects: Abdominal discomfort, constipation, or diarrhoea.
Liver-related effects: Increased liver enzymes; less commonly, hepatitis, jaundice, or serious liver injury.
Other effects: Fatigue, sweating, itching, and, occasionally, anxiety or restlessness.

Seek immediate medical attention if symptoms of liver injury occur, including dark urine, pale stools, yellowing of the skin or eyes, persistent unexplained fatigue, or pain in the upper-right abdomen. Report new or worsening suicidal thoughts, severe mood changes, or unusual behavioural changes promptly to a healthcare professional.

Warnings and Precautions

Liver safety is a key consideration when using agomelatine.

Liver disease: Contraindicated in patients with active liver disease or hepatic impairment, including cirrhosis.
Liver monitoring: Baseline and scheduled follow-up liver function tests are essential. Treatment should be stopped if transaminases exceed three times the upper limit of normal or if signs of possible liver injury develop.
Alcohol consumption: Avoid excessive alcohol consumption because of the risk of liver injury.
Older adults: Agomelatine is not recommended for patients aged 75 years or older because efficacy has not been established in this age group.
Pregnancy and breastfeeding: Consult a physician before use.
Children and adolescents: Not recommended for patients under 18 years of age because safety and efficacy have not been established.
Bipolar disorder: Patients with a history of mania or hypomania require careful medical assessment.

Drug interactions

Agomelatine is contraindicated with potent CYP1A2 inhibitors, particularly:

Fluvoxamine.
Ciprofloxacin.

Other medicines that affect liver function or agomelatine metabolism may also require review. Inform the prescribing physician about all prescription medicines, over-the-counter products, and herbal supplements being used.

Storage

Store according to the conditions stated on the original package.
Keep out of the reach and sight of children.
Do not use after the expiry date.
Do not use tablets from damaged packaging.

References

The following authoritative sources provide prescribing, safety, and clinical information:

European Medicines Agency (EMA) — Valdoxan: Official product information and safety guidance. (.europa.eu)
Electronic Medicines Compendium (eMC) — Agomelatine 25 mg: Summary of Product Characteristics. (.org.uk)
European Medicines Agency — Agomelatine and the risk of liver injury. (.europa.eu)

Patient Disclaimer

This information is provided for educational purposes only and is not intended to replace professional medical advice, diagnosis, or treatment. Inspago 25 mg (agomelatine) should be used only under the supervision of a qualified healthcare professional. Liver function testing is essential before and during treatment. Do not start, stop, or change the dose without consulting your physician. Always read the approved patient leaflet before use. This product information does not establish that the medicine is appropriate for every patient and is not intended to diagnose, treat, cure, or prevent any disease without appropriate medical assessment.