Estrowell^® (Capsules) Instructions for Use

Marketing Authorization Holder

VALEA NT, LLC (Russia)

Manufactured By

Vneshtorg Pharma, LLC (Russia)

Dosage Form

Estrowell®

Capsules: 30 pcs.

Dosage Form, Packaging, and Product Composition

Capsules hard gelatin, yellow-beige color; average weight 520 mg; smell of capsule contents: weak, specific.

Composition dextrose; capsule gelatin (gelatin; food colors E171, E104, E122); extract of soy seeds (Isoflavones soy); extract of griffonia seeds (L-5-Hydroxytryptophan); extract of rhizome with roots of dioscorea; extract of fruits of vitex sacred; tocopheryl acetate (fillers: maltodextrin, starch modified, DL-alpha tocopheryl acetate, silicon dioxide); Indole-3-carbinol; sodium tetraborate; anti-caking agents: silicon dioxide amorphous (E551), magnesium stearate (E470); pyridoxine hydrochloride; phytonadione (fillers: guar gum (E414), sucrose); Folic acid.

* – % of the recommended daily intake level in accordance with TR TS 022/2011 “Food products in terms of its labeling” (Appendix 2).
** – % of the adequate intake level in accordance with “Unified sanitary-epidemiological and hygienic requirements for goods subject to sanitary-epidemiological surveillance (control)” (Chapter II, section 1, Appendix 5).
Content of vitamin B₆, vitamin E and folic acid when taking 2 capsules per day does not exceed the upper permissible intake level.

10 pcs. – blisters (3) – packs cardboard.

Therapeutic Category

Dietary supplement – source of phytoestrogens, vitamins and trace elements

Indications

• Estrowell^® is a dietary supplement indicated as an additional source of phytoestrogens (isoflavones, diosgenin), vitamins B6, E, K1, folic acid, boron, and L-5-Hydroxytryptophan.
• It is intended to be used by women to supplement the diet and may help to reduce the frequency and severity of vasomotor symptoms associated with menopause, such as hot flashes and night sweats, due to its content of soy isoflavones which have a mild estrogen-like activity.
• The supplement may contribute to the maintenance of emotional balance and improvement of mood during the menopausal transition, which is supported by the inclusion of L-5-Hydroxytryptophan, a precursor to serotonin.
• The components, including Vitex agnus-castus extract and Indole-3-carbinol, are traditionally used to help support hormonal balance and promote well-being during premenstrual and menstrual periods.
• The combination of vitamins and plant extracts is aimed at supporting bone health and providing antioxidant protection for cells against oxidative stress, which is particularly relevant during and after menopause.

It is crucial to understand that this product is not a medicine and is not intended to diagnose, treat, cure, or prevent any disease. The use of this supplement should be part of a holistic approach to health that includes a balanced diet and a healthy lifestyle.

Contraindications

• Hypersensitivity or individual intolerance to any of the components of the dietary supplement, including soy, gelatin, or any of the excipients. Patients with known allergies to legumes should exercise caution due to the presence of soy isoflavones.
• Pregnancy and breastfeeding (lactation). The safety of the complex of active ingredients in Estrowell^® for pregnant women, fetuses, and nursing infants has not been established. The phytoestrogen content may potentially interfere with hormonal balance during these critical periods.
• Estrogen-dependent conditions and tumors, such as a history of or suspected breast cancer, endometrial cancer, or ovarian cancer. Phytoestrogens can exert weak estrogenic effects and their use in such conditions is contraindicated unless explicitly approved by an oncologist or gynecologist.
• Endometriosis and uterine fibroids (leiomyoma). Due to the potential estrogenic activity of the components, the supplement may theoretically stimulate the growth of estrogen-sensitive tissues.
• Patients with severe liver or kidney impairment, as the metabolism and excretion of the supplement’s components may be compromised, leading to an increased risk of adverse effects.
• Patients with phenylketonuria should be aware that the product contains a source of phenylalanine (as part of the L-5-Hydroxytryptophan from Griffonia simplicifolia).
• Concomitant use with monoamine oxidase inhibitors (MAOIs) or other serotonergic drugs is contraindicated due to the risk of developing serotonin syndrome from the L-5-Hydroxytryptophan component.

Consultation with a healthcare professional is mandatory before starting use if you have any pre-existing medical conditions or are taking any other medications.

Dosage Regimen

The recommended dosage for adult women is one capsule per day with meals. The capsule should be swallowed whole with a sufficient amount of water (approximately 150-200 ml).

Do not exceed the recommended daily dose. The duration of the course of intake is one month. If necessary, the course can be repeated after a consultation with a doctor. The supplement is intended for continuous use, and effects may be noticed after several weeks of consistent use as the active components accumulate in the body.

For optimal absorption and to minimize potential gastrointestinal discomfort, it is advised to take the capsule at the same time each day, preferably during the largest meal. If a dose is missed, it should be taken as soon as remembered on the same day; however, a double dose should not be taken to make up for a forgotten one.

Drug Interactions

Estrowell^® contains active botanical and nutrient components that may interact with certain medications. Concurrent use with prescription drugs requires careful medical supervision.

The L-5-Hydroxytryptophan (5-HTP) component may lead to serious interactions. It is absolutely contraindicated with monoamine oxidase inhibitors (MAOIs) due to the high risk of a hypertensive crisis and serotonin syndrome. Caution is also required when taking it with other serotonergic drugs, including selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, tramadol, triptans, and St. John’s Wort, as this may potentiate the risk of serotonin syndrome, characterized by agitation, confusion, tachycardia, and hyperthermia.

Soy isoflavones possess weak phytoestrogenic activity and may theoretically interfere with the action of tamoxifen and other selective estrogen receptor modulators (SERMs). They may also potentially alter the effects of hormone replacement therapy (HRT) and oral contraceptives, although clinical data are conflicting. Patients on thyroid hormone replacement therapy (e.g., levothyroxine) should be monitored, as isoflavones may slightly reduce its absorption.

Vitamin K1 (phytonadione) can antagonize the effect of warfarin and other vitamin K antagonist anticoagulants, potentially reducing their anticoagulant efficacy and increasing the risk of thrombosis. Patients on such therapy should avoid using this supplement or have their INR monitored very closely if use is deemed necessary.

Vitamin B6 (pyridoxine) at high doses can reduce the efficacy of levodopa in Parkinson’s disease patients (this is not relevant for the combination of levodopa with carbidopa). It may also potentially decrease serum levels of certain anticonvulsants like phenobarbital and phenytoin.

Always inform your healthcare provider about all the dietary supplements and medications you are taking.

Adverse Reactions

Estrowell^® is generally well-tolerated when used at the recommended dosage; however, as with any dietary supplement, adverse reactions are possible, though not everyone experiences them.

The most commonly reported adverse reactions are gastrointestinal in nature and may include mild and transient symptoms such as nausea, abdominal discomfort, bloating, or changes in bowel habits. These effects often subside as the body adjusts to the supplement.

Due to the soy isoflavone content, individuals with sensitivity may experience allergic reactions, ranging from mild skin rashes and itching to more severe manifestations. The L-5-Hydroxytryptophan component may cause drowsiness, dizziness, dry mouth, or vivid dreams, especially at the beginning of the course. Patients should exercise caution when driving or operating machinery until their response to the supplement is known.

In rare cases, components like Vitex agnus-castus may cause headache, acne, or menstrual cycle irregularities. If any adverse reactions persist or worsen, or if you experience any symptoms that may suggest an allergic reaction (such as difficulty breathing, swelling of the face, lips, tongue, or throat, severe dizziness), discontinue use immediately and seek medical attention. It is important to report any suspected adverse reactions to your healthcare provider.

Overdose

In case of accidental ingestion of a significantly higher than the recommended dose, the risk of adverse effects increases. Symptoms of acute overdose are likely to be an extension of the adverse reactions described and may include severe gastrointestinal distress (nausea, vomiting, diarrhea), pronounced drowsiness, dizziness, and headache due to the L-5-Hydroxytryptophan content.

Chronic excessive intake of certain components can lead to more serious consequences. Vitamin B6 (pyridoxine) in very high doses (typically exceeding 1000 mg per day for long periods) is known to cause sensory neuropathy, ataxia, and skin lesions. Although the dose in this supplement is low, cumulative intake from multiple sources must be considered. High doses of boron can cause nausea, vomiting, weakness, and in severe cases, affect the kidneys.

There is no specific antidote for an overdose of Estrowell^®. Treatment is symptomatic and supportive. In case of suspected overdose, discontinue the supplement immediately, ensure adequate hydration, and consult a doctor or contact a poison control center immediately. Gastric lavage or administration of activated charcoal may be considered if the overdose was very recent. Always provide the medical professional with the product packaging.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.