Keepcalm (Tablets) Instructions for Use

Marketing Authorization Holder

Artelar, LLC (Russia)

Manufactured By

VTF, LLC (Russia)

Dosage Form

Keepcalm

Tablets: 30 pcs.

Dosage Form, Packaging, and Product Composition

Tablets mass of 1600 mg.

¹ % of the recommended daily intake level according to TR TS 022/2011 “Food products in terms of their labeling” (Appendix 2).
² % of the adequate intake level according to “Unified sanitary-epidemiological and hygienic requirements for goods subject to sanitary-epidemiological surveillance (control)” (Appendix 5).
* does not exceed the upper permissible intake level according to “Unified sanitary-epidemiological and hygienic requirements for goods subject to sanitary-epidemiological surveillance (control)”.
Information on the nutritional value of the product is determined by calculation based on the average content of the biologically active substance (BAS).

Auxiliary substances : carriers (microcrystalline cellulose, polyvinylpyrrolidone, hypromellose, maltodextrin, stearic acid), anti-caking agents (talc, silicon dioxide amorphous, magnesium stearate, propylene glycol), colorant (titanium dioxide), humectant (propylene glycol), gum arabic, sucrose, modified starch, sodium ascorbate, medium-chain triglycerides, sodium carboxymethylcellulose, croscarmellose sodium, natural colorant carmine (content of coloring substances 50%, carrier (maltodextrin), sodium hydroxide).

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

Therapeutic Category

Dietary supplement for reducing manifestations of menopausal syndrome

Indications

• As a dietary supplement to the diet, it is a source of isoflavones, iridoids (including aucubin), vitamins (B₁, B₂, B₃, B₅, B₆, B₇, B₉, B₁₂, K₁, D₃), calcium and magnesium.
• For women to reduce the severity of psychoemotional and autonomic manifestations associated with the menopausal period, such as irritability, anxiety, mood swings, sleep disturbances, and feelings of hot flashes.
• To help compensate for the deficiency of essential micronutrients that is often observed in women during hormonal changes.

Dosage Regimen

The recommended dosage for adult women is one tablet once a day with meals.

The tablet should be taken with a sufficient amount of water (approximately 150-200 ml). It is not recommended to chew or crush the tablet due to its specific coating and composition.

The duration of continuous use is one month. If necessary, the course can be repeated after consulting a physician. It is important to adhere to the recommended daily intake and not exceed it.

The timing of administration (morning or evening) can be adjusted based on individual tolerance and the manifestation of the calming effect, especially if the product is used to improve sleep quality.

Contraindications

• Individual intolerance to any of the components of the dietary supplement.
• Pregnancy and breastfeeding. The safety of using this complex of active ingredients during these periods has not been established.
• Conditions and diseases associated with hormone-dependent tumors (including a history of breast cancer, ovarian cancer, endometrial cancer).
• Severe liver and kidney dysfunction.
• Children and adolescents under 18 years of age.

Drug Interactions

Before starting to take the dietary supplement, if you are taking any other medications, including over-the-counter ones, you must consult a doctor.

The soy isoflavones contained in the supplement may potentially interact with hormonal drugs, including hormone replacement therapy (HRT) and oral contraceptives, as they have phytoestrogenic activity.

Vitamin K₁ (phytomenadione) may reduce the anticoagulant effect of warfarin and other vitamin K antagonists. Patients taking these drugs should use this supplement with extreme caution and under strict medical supervision with regular monitoring of INR (International Normalized Ratio).

High doses of calcium can interfere with the absorption of tetracycline and quinolone antibiotics, bisphosphonates, and levothyroxine. It is recommended to take these medications at least 2-4 hours apart from taking the Keepcalm tablet.

Motherwort extract may enhance the effect of sedatives, hypnotics, and other drugs that depress the central nervous system.

Adverse Reactions

When used according to the recommended regimen, adverse reactions are rare. However, in some cases, especially at the beginning of use, the following are possible:

From the gastrointestinal tract: nausea, discomfort in the epigastric region, flatulence, or stool disturbances. These symptoms are usually mild and transient.

Allergic reactions: skin rash, itching, urticaria, redness of the skin may occur in individuals with hypersensitivity to the components of the product, including soy, Vitex agnus-castus, or other plant extracts.

Other: in rare cases, headache, drowsiness, or dizziness may occur, which may be associated with the sedative effect of motherwort or individual sensitivity.

If any undesirable reactions occur, you should stop taking the supplement and consult a doctor.

Overdose

Cases of overdose with this dietary supplement have not been described. With a significant single excess of the recommended dose, an increase in the severity of the described adverse reactions is theoretically possible.

In case of accidental intake of a large number of tablets, it is necessary to: immediately rinse the stomach, take enterosorbents (for example, activated charcoal), and seek medical help, showing the doctor the packaging of the product.

Chronic overdose associated with long-term use of doses exceeding the recommended ones is dangerous due to the cumulative effect of fat-soluble vitamins (D₃, K₁) and minerals. This can lead to hypercalcemia (with symptoms such as nausea, vomiting, thirst, polyuria), impaired liver and kidney function.

Symptomatic therapy is indicated; there is no specific antidote.

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.