Renalis Cysto (Powder) Instructions for Use

Marketing Authorization Holder

Artelar, LLC (Russia)

Manufactured By

VTF, LLC (Russia)

Dosage Form

Renalis Cysto

Powder for oral use: sachet-bags 2 g 14 pcs.

Dosage Form, Packaging, and Product Composition

Powder for oral use with a mass of 2 g.

Composition extract of horsetail herb, extract of cowberry leaves, extract of birch bark, extract of bearberry leaves, extract of cranberry berries, ascorbic acid (vit. C), alpha-tocopherol acetate 50% (D,L-alpha-tocopherol acetate (vit. E), modified starch, maltodextrin, silicon dioxide), carrier (dextrose (glucose) monohydrate), anti-caking agent (amorphous silicon dioxide), natural cranberry flavor (carriers: gum arabic, sugar, maltodextrin, triacetin).

2 g – sachet-bags (14) – cardboard packs.

Therapeutic Category

Dietary supplement for maintaining the function of the urinary system

Indications

• As a dietary supplement to the diet, an additional source of flavonoids, hydroxycinnamic acids, arbutin, and vitamins C and E.
• To help support the normal function of the urinary system and maintain healthy kidney function.
• To contribute to the increase in diuresis (urine volume) and support the body’s natural cleansing processes.
• For providing antioxidant support due to the content of vitamins and plant-derived compounds.

It is important to note that this product is not a medicine and is intended for use as part of a balanced diet and healthy lifestyle. It is not intended to diagnose, treat, cure, or prevent any disease.

Contraindications

• Hypersensitivity (allergy) to any component of the dietary supplement, including the active plant extracts or excipients such as dextrose and flavors.
• Pregnancy and breastfeeding due to the lack of sufficient safety data for use in these populations and the potential for certain plant compounds to affect hormonal balance or pass into breast milk.
• Children and adolescents under 18 years of age, as safety and efficacy have not been established for this age group.
• Patients with severe kidney impairment (e.g., acute glomerulonephritis, renal failure) or those requiring dialysis, as the effects of the supplement have not been studied in these conditions.
• Individuals with known oxalate kidney stones or a history of such, as some herbal components may influence oxalate metabolism.
• Concomitant use with lithium-based medications, as the diuretic effect may alter lithium concentrations in the blood, increasing the risk of toxicity.

Consultation with a healthcare professional is strongly recommended before starting use, especially for individuals with pre-existing medical conditions or those taking other medications.

Dosage Regimen

The recommended dosage for adults is one 2-gram sachet, dissolved in a glass (150-200 ml) of warm or cool water, taken twice daily with meals.

The contents of the sachet should be poured into a glass, filled with water, and stirred thoroughly until the powder is completely dissolved. The resulting solution should be consumed immediately after preparation.

The duration of use is 2-4 weeks. If necessary, the course may be repeated after consultation with a healthcare provider. It is important to adhere to the recommended dosage and not exceed it. The supplement should be used as part of a balanced diet and is not a substitute for a varied and healthy diet.

Concurrent intake of adequate fluids is recommended to support the physiological action of the product. If symptoms persist or worsen, discontinue use and consult a physician.

Adverse Reactions

Renalis Cysto is generally well-tolerated when used at the recommended dosage. However, as with any supplement, allergic reactions are possible, especially in individuals sensitive to any of the herbal ingredients. These may manifest as skin rash, itching, urticaria, or, in rare cases, more severe reactions.

Due to the diuretic properties of the herbal extracts, an increase in urinary frequency is an expected physiological effect and is not typically considered an adverse reaction. Gastrointestinal discomfort, such as mild nausea or stomach upset, may occur, particularly if taken on an empty stomach.

In the event of any unexpected or severe side effects, discontinuation of the product is advised, and a healthcare professional should be consulted. Reporting adverse reactions to your pharmacist or doctor helps improve drug safety monitoring.

Drug Interactions

Due to its composition, Renalis Cysto has the potential to interact with certain medications. The diuretic effect of the plant extracts may potentiate the action of other diuretic drugs (e.g., furosemide, hydrochlorothiazide), potentially leading to excessive fluid and electrolyte loss (such as potassium).

As mentioned in the contraindications, concurrent use with lithium is not recommended, as the increased urine output can reduce the clearance of lithium, raising its blood levels to toxic concentrations. Caution is advised when taking this supplement with anticoagulant or antiplatelet drugs (e.g., warfarin, aspirin, clopidogrel), as some plant compounds, like those in birch bark or bearberry, could theoretically affect blood clotting, though clinical significance is not well-established.

Patients taking medications for diabetes should be aware that the product contains dextrose (glucose), which may have a minor impact on blood sugar levels. It is crucial to inform your doctor or pharmacist about all the products you are using, including this dietary supplement, to avoid potential interactions.

Overdose

Information on acute overdose with Renalis Cysto is limited. Significant exceeding of the recommended dose may lead to an intensification of the described adverse reactions.

This could include severe gastrointestinal disturbances (nausea, vomiting, diarrhea), pronounced diuresis leading to dehydration and electrolyte imbalances (signs may include dizziness, weakness, muscle cramps, or irregular heartbeat), and an increased risk of allergic manifestations.

In case of suspected overdose, discontinue use immediately and ensure adequate fluid intake to prevent dehydration. There is no specific antidote; treatment is symptomatic and supportive. If severe symptoms occur or if a very large quantity has been ingested, seek immediate medical attention or contact a poison control center. Bring the product packaging with you to the medical facility.

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.