Krispofun Cysto (Powder) Instructions for Use

Marketing Authorization Holder

Artelar, LLC (Russia)

Manufactured By

VTF, LLC (Russia)

Dosage Form

Krispofun Cysto

Powder: sachet-bags 5 g 10 pcs.

Dosage Form, Packaging, and Product Composition

Powder for oral administration with an average mass of 5 g.

¹ % of the recommended daily consumption level according to TR TS 022/2011 “Food products in terms of its labeling” (Appendix 2).
² % of the adequate consumption 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 consumption level according to “Unified sanitary-epidemiological and hygienic requirements for goods subject to sanitary-epidemiological surveillance (control)”.

Composition glucose, potassium citrate, magnesium citrate, Inulin, Blueberry shoots extract, acidity regulator (citric acid), L-aspartic acid (vit. C), anti-caking agent (amorphous silicon dioxide), Extract of Phyllanthus niruri, Red beet juice powder, sweetener (sucralose).

Nutritional value (10 g of powder): carbohydrates – 6 g, dietary fiber – 0.6 g.
Energy value (10 g of powder): 110 kJ/25 kcal.

5 g – sachet-bags (10) – cardboard packs.

Therapeutic Category

Dietary supplement for maintaining the function of the urinary system

Indications

• Krispofun Cysto is a dietary supplement (BAA) intended to be used as an additional source of potassium, magnesium, vitamin C, inulin, and tannins.
• The product is specifically formulated to support the normal function of the urinary system.
• It contributes to the alkalinization of urine, which can help create a less favorable environment for certain types of urinary crystals.
• The components are selected to assist in maintaining a healthy mineral balance in the urine, which is important for overall urinary tract health.

Contraindications

• Individual intolerance to any of the components of the dietary supplement. A careful review of the composition is necessary before the first use to identify potential allergens or intolerances.
• Pregnancy and breastfeeding. Due to the lack of sufficient clinical data on the safety of the product’s components for the fetus, newborn, and infant, use during these periods is not recommended without explicit medical supervision.
• Severe renal impairment (e.g., acute or chronic renal failure). The high potassium content can be dangerous if the kidneys are unable to excrete it properly, leading to a risk of hyperkalemia.
• Conditions associated with hyperkalemia (elevated blood potassium levels) or hypermagnesemia (elevated blood magnesium levels). The supplement directly contributes to the intake of these minerals and can exacerbate such conditions.
• Patients with severe or decompensated heart failure and those using potassium-sparing diuretics or ACE inhibitors should avoid use without prior consultation with a physician due to the increased risk of electrolyte imbalances.

Dosage Regimen

The recommended dose for adults is two sachet-bags (10 g of powder total) per day. This constitutes one full daily dose.

The contents of the sachet-bags should be dissolved in 150-200 ml (approximately 5-7 oz) of cool or room temperature water. Stir thoroughly until the powder is completely dissolved. The resulting solution is for oral administration.

The prepared solution should be consumed once daily with a meal. Adherence to the recommended dosage is crucial to avoid potential adverse effects associated with excessive intake of the active components.

The duration of use is recommended to be 1 month. If there is a need for a repeated course, it is imperative to consult a healthcare professional.

Adverse Reactions

Adverse reactions are rare when the product is used at the recommended dosage; however, in cases of individual hypersensitivity or excessive consumption, the following may occur:

From the gastrointestinal tract: nausea, discomfort or pain in the epigastric region, diarrhea, or constipation. These effects may be related to the citrate components or the dietary fiber (inulin) content.

Allergic reactions: In predisposed individuals, skin rash, itching, urticaria, and redness may occur. These are manifestations of individual intolerance to one or more components of the supplement, such as plant extracts or other ingredients.

Electrolyte imbalances: With prolonged use exceeding the recommended dose, especially in individuals with impaired renal function, there is a potential risk of developing hyperkalemia (symptoms may include muscle weakness, paresthesia, irregular heartbeat) or hypermagnesemia (symptoms may include nausea, vomiting, low blood pressure, bradycardia).

If any of the described or other undesirable reactions occur, discontinue use of the supplement immediately and seek medical advice.

Drug Interactions

The potassium and magnesium citrate components of Krispofun Cysto can significantly interact with several classes of medications.

Potassium-sparing diuretics (e.g., spironolactone, eplerenone, amiloride, triamterene), Angiotensin-Converting Enzyme (ACE) inhibitors (e.g., lisinopril, enalapril), Angiotensin II Receptor Blockers (ARBs) (e.g., losartan, valsartan), and certain non-steroidal anti-inflammatory drugs (NSAIDs) can reduce the renal excretion of potassium. Concurrent use with this potassium-rich supplement significantly increases the risk of severe hyperkalemia, a potentially life-threatening condition.

Concomitant use with cardiac glycosides (e.g., digoxin) requires extreme caution. Hyperkalemia can potentiate the toxic effects of digoxin on the heart, while hypokalemia (which the supplement aims to prevent) can increase the drug’s toxicity; therefore, any shift in potassium balance is dangerous.

The magnesium content may reduce the absorption and, consequently, the effectiveness of oral tetracycline antibiotics (e.g., tetracycline, doxycycline), bisphosphonates (e.g., alendronate), and fluoroquinolones (e.g., ciprofloxacin, levofloxacin). To avoid this interaction, it is recommended to take these medications at least 2 hours before or 4-6 hours after consuming Krispofun Cysto.

Due to the potential for alkalinization of urine, this supplement may alter the excretion of other medications that are weak acids or bases, potentially affecting their plasma concentration and efficacy.

It is critically important to inform your physician about all medications you are taking, including prescription, over-the-counter, and other dietary supplements, before starting Krispofun Cysto.

Overdose

In case of a single significant overdose, the most likely and dangerous consequence is the development of acute hyperkalemia. Symptoms may include muscle weakness (starting in the legs), paresthesia (tingling sensation), flaccid paralysis, bradycardia (slow heart rate), and other cardiac arrhythmias that can be life-threatening.

Overdose may also lead to hypermagnesemia, manifesting as nausea, vomiting, facial flushing, urinary retention, severe hypotension, respiratory depression, and complete heart block.

If an overdose is suspected, immediate medical attention must be sought. Do not induce vomiting. Treatment is symptomatic and supportive and must be carried out in a medical facility. It may include ECG monitoring, administration of calcium gluconate or chloride to antagonize the cardiac effects of hyperkalemia, use of insulin with glucose to shift potassium into cells, and in severe cases, hemodialysis.

To prevent overdose, strictly adhere to the recommended dosage and do not use the product for longer than the recommended period without consulting a doctor.

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.