Agnes – natural support for hormonal balance

Agnes by Fortex is a natural food supplement designed to alleviate the symptoms of premenstrual syndrome (PMS) and maintain hormonal balance in women. The basis of the product is a standardized extract of Vitex agnus castus, a plant traditionally used for women's health. Agnes helps reduce such unpleasant symptoms of PMS as mood swings, breast tenderness and irritability, providing gentle and natural regulation of hormone levels.

The product contains only one active ingredient – ​​vitex extract, which makes it a safe and well-tolerated option for women who prefer natural remedies. Thanks to its balanced composition and convenient tablet form, Agnes helps support the female body without unnecessary stress, helping to improve well-being throughout the menstrual cycle.

Indications

Treatment of major depressive episodes in adults.

Clinical efficacy and safety

The efficacy and safety of agomelatine in the treatment of major depressive episodes were investigated in a clinical program involving 7900 patients.

In six short-term, double-blind, placebo-controlled studies evaluating the efficacy of agomelatine in the treatment of major depressive episodes in adults, agomelatine at doses of 25-50 mg demonstrated statistically significant efficacy compared with placebo at the end of treatment (6-8 weeks). Changes from baseline in the primary endpoint were observed as assessed by the Hamilton Rating Scale for Depression (HAMD-17).

Method of administration and dosage

Directions for use

• For oral use.
• Agnesti film-coated tablets can be taken with or without food.

Dosage

• The recommended dose is 25 mg once daily, before bedtime.

If after 2 weeks of therapy the improvement of the clinical condition is insufficient, the dose can be increased to 50 mg once a day, i.e. 2 tablets of 25 mg, which should be taken simultaneously before bedtime.

When deciding on dose increase, the increased risk of transaminase elevation should be taken into account. Dose increase to 50 mg should be performed on an individual patient basis after benefit/risk assessment with mandatory liver function tests.

Contraindications

• Hypersensitivity to the active substance or any excipient of the drug.
• Impaired liver function (liver cirrhosis or active phase of liver disease) or an increase in transaminase levels more than 3 times the upper limit of normal (see sections “Method of administration and dosage” and “Features of use”).
• Use in combination with potent CYP1A2 inhibitors (fluvoxamine, ciprofloxacin) (see section “Interaction with other medicinal products and other forms of interaction”).

Side effects

Agomelatine has been used in clinical trials in over 8,000 patients with depression. Adverse reactions generally occurred during the first 2 weeks of treatment and were mild to moderate in severity. The most common adverse reactions were headache, nausea and dizziness. These adverse reactions were usually transient and did not usually lead to discontinuation of therapy.