Vivacia Red Clover 1000 mg (Tablets) Instructions for Use

Marketing Authorization Holder

Artelar, LLC (Russia)

Manufactured By

Maryvery, Limited (UK)

Dosage Form

Vivacia Red Clover 1000 mg

Tablets: 60 pcs.

Dosage Form, Packaging, and Product Composition

Tablets mass of 250 mg.

* extract of the above-ground part of red clover (Trifolium pretense L.) from 83.5 mg of extract 12:1 (contains by standard 6.7% isoflavones).

Auxiliary substances : volume-forming agent (microcrystalline cellulose (MCC)), volume-forming agent (dicalcium phosphate), anti-caking agent (magnesium stearate, silicon dioxide).

^# recommended norm of consumption.

Energy value (100 g): 293.95 kJ/70.25 kcal.

60 pcs. – bottles (1).

Therapeutic Category

Dietary supplement for alleviation of symptoms of climacteric condition

Indications

• This dietary supplement is indicated for use as a source of isoflavones to help alleviate the symptoms associated with the climacteric (menopausal) period in women.
• It may be used to support the reduction in the frequency and severity of vasomotor symptoms, such as hot flashes and night sweats.
• It is intended to provide general well-being support during the hormonal changes of menopause.

It is important to remember that this is a dietary supplement and not a medicine; therefore, it is not intended to diagnose, treat, cure, or prevent any disease.

Dosage Regimen

The recommended adult dosage is one tablet (1000 mg) once daily, taken with a meal and a full glass of water.

The tablet should be swallowed whole and not chewed or crushed. For optimal absorption, it is advised to take the supplement at approximately the same time each day.

The duration of use should be discussed with a healthcare provider. Continuous use for a period of several weeks may be necessary to observe the full beneficial effects. Do not exceed the recommended daily dose.

If you miss a dose, take it as soon as you remember, but if it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not take a double dose to make up for a forgotten one.

Contraindications

• Hypersensitivity or allergy to red clover (Trifolium pratense), any other plants of the Fabaceae family, or to any of the auxiliary ingredients listed in the composition.
• Pregnancy and breastfeeding. The safety of red clover isoflavones during pregnancy and lactation has not been established. Due to the potential for hormonal activity, use is contraindicated.
• Estrogen-dependent conditions, such as a history of, or suspected, breast cancer, endometrial cancer, ovarian cancer, or endometriosis, as the isoflavones may exert estrogen-like effects.
• Bleeding disorders or in patients taking anticoagulant/antiplatelet medications, as red clover contains coumarin derivatives which may affect blood coagulation.
• Use in children and adolescents under the age of 18 is contraindicated due to a lack of safety and efficacy data in this population.

Adverse Reactions

Vivacia Red Clover is generally well-tolerated when taken at the recommended dosage; however, some individuals may experience adverse reactions.

Commonly reported adverse reactions are typically mild and may include headache, nausea, muscle aches, and vaginal spotting or bleeding in some women. These effects often subside with continued use.

Less frequently, allergic skin reactions, such as rash or hives, may occur. In rare cases, due to the coumarin content, there is a theoretical risk of increased bleeding tendency.

If any adverse reaction is severe, persistent, or causes concern, discontinue use immediately and consult a healthcare professional. Report any suspected adverse reactions to your pharmacist or doctor.

Drug Interactions

Red clover may interact with several classes of medications, potentially altering their effects. Concurrent use with the following drugs requires caution and should only be undertaken under medical supervision.

Hormonal Therapies: Red clover may interfere with the action of estrogens (used in hormone replacement therapy or oral contraceptives) and tamoxifen. It is not recommended to use this supplement concurrently with these medications.

Anticoagulants and Antiplatelets: Due to its coumarin content, red clover may potentiate the effects of drugs like warfarin, clopidogrel, aspirin, and other NSAIDs, increasing the risk of bleeding and bruising.

Medications Metabolized by Liver Enzymes: Red clover might affect the activity of cytochrome P450 enzymes, potentially altering the blood levels of drugs metabolized by this system, such as certain statins, calcium channel blockers, and some antidepressants.

Inform your doctor or pharmacist about all the products you are using, including prescription, over-the-counter medicines, and other herbal supplements, before starting Vivacia Red Clover.

Overdose

There are no well-documented reports of serious overdose with red clover supplements. However, taking doses significantly higher than recommended may increase the risk and severity of the adverse reactions described.

Symptoms of overdose may include severe nausea, vomiting, headache, muscle weakness, and signs of increased bleeding (e.g., unexplained bruising, bleeding gums, blood in stool).

In case of suspected overdose, discontinue use immediately and seek medical attention or contact a Poison Control Center without delay. Provide the medical personnel with the product packaging. Treatment is expected to be supportive and symptomatic.

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.