Melitor 25mg 28 tablets — Made in Ireland — Free Delivery

Melitor® tablets are used to treat major depressive episodes in adults.

The active substance is agomelatine (one tablet contains 25 mg of agomelatine).

Excipients: lactose, monohydrate; corn starch; povidone; sodium starch glycolate (type A); stearic acid; magnesium stearate; silicon dioxide colloidal anhydrous; hypromellose; iron oxide yellow (E 172) glycerin; macrogol 6000; titanium dioxide (E 171).

For oral use.

Melitor® film-coated tablets can be taken with or without food.

The recommended dose is 25 mg once daily at bedtime.

If two weeks after the start of therapy, there is not enough improvement in the clinical condition, the dose can be increased to 50 mg 1 time per day, that is, two 25 mg tablets, which must be taken simultaneously at bedtime.

When deciding to increase the dose, the increased risk of elevated transaminase levels should be taken into account. Increasing the dose to 50 mg should be carried out on an individual basis for each patient after assessing the benefit / risk ratio with mandatory liver tests.

All patients should have liver tests performed prior to initiation of treatment. Treatment should not be started if transaminase levels are 3 times the upper limit of normal.

During treatment, it is necessary to periodically monitor the level of transaminases: after 3 weeks, 6 weeks (completion of the acute phase), after 12 weeks and 24 weeks (completion of the maintenance phase) and further if clinically indicated. Treatment should be discontinued if the level of transaminases exceeds three times the upper limit of normal.

When increasing the dose, liver tests should be performed again at the same frequency as at the beginning of treatment.

Duration of Treatment: Patients with depression should be treated for at least 6 months to ensure that their symptoms disappear.

Switching from antidepressant therapy of the group of selective serotonin reuptake inhibitors / serotonin and norepinephrine reuptake inhibitors (SSRIs / SNRIs) to agomelatine. Patients may experience withdrawal symptoms after discontinuation of SSRI/SNRI antidepressants. In order to avoid these symptoms, it is necessary to take into account the recommendations for discontinuation of treatment, which are contained in the instructions for medical use of the medicinal product that the patient is using. Therapy with agomelatine can be started immediately in parallel with a dose reduction of the antidepressant.

Termination of treatment: in the event of a decision to discontinue treatment, there is no need for a gradual dose reduction.

In order to prevent any risks, it is desirable to avoid the use of Melitor® during pregnancy.

It is not known whether agomelatine/metabolites pass into breast milk. Available pharmacodynamic/toxicological data from animal studies have shown that agomelatine/metabolites pass into breast milk. A risk to neonates/infants cannot be excluded. The decision to discontinue breastfeeding or discontinue/withhold treatment with Melitor® should be made taking into account the benefits of breastfeeding for the child and the benefits of treatment for the mother.

Animal reproduction studies have shown no effect of agomelatine on fertility.