Renalis (Capsules) Instructions for Use

Marketing Authorization Holder

Artelar, LLC (Russia)

Manufactured By

Pharm-Pro, LLC (Russia)

Dosage Form

Renalis

Capsules: 30 pcs.

Dosage Form, Packaging, and Product Composition

Capsules weighing 200 mg.

Auxiliary substances : gelatin capsule (gelatin, titanium dioxide (dye)), microcrystalline cellulose (carrier) – 93 mg, calcium stearate (anti-caking agent) – 1.5 mg, silicon dioxide (anti-caking agent) – 1.5 mg.

15 pcs. – blisters (2) – carton packs.

Therapeutic Category

Dietary supplement for maintaining the function of the urinary system

Indications

• Renalis capsules are indicated as a dietary supplement to the diet to provide comprehensive support for the health of the urinary system.
• They are used to help maintain normal kidney function and promote diuresis.
• The supplement contributes to creating unfavorable conditions for the development of pathogenic microflora in the urinary tract, thereby supporting a healthy state.
• It is recommended to support the body’s defense mechanisms and to help normalize the physiological processes of urination.

Contraindications

• Hypersensitivity or individual intolerance to any of the components of the dietary supplement, including plant extracts and auxiliary substances.
• Pregnancy and breastfeeding due to the lack of sufficient clinical data on safety during these periods. The effects of the contained arbutin and other active compounds on fetal development or the infant are not fully established.
• Severe impairment of kidney or liver function (e.g., acute glomerulonephritis, renal failure, severe hepatitis), as the effect of the supplement on these conditions has not been studied and its use may exacerbate the disease.
• Children and adolescents under 18 years of age, as safety and efficacy for this age group have not been established.
• Concomitant use with drugs that require strict pH control of urine or that may interact with the components of the supplement (e.g., certain diuretics, lithium preparations, anticoagulants).

Dosage Regimen

The recommended dose for adults is one capsule twice daily, taken 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 continuous use should not exceed four weeks. A repeated course of use is possible after consultation with a healthcare professional to assess the advisability and necessity of further use.

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.

Adverse Reactions

Renalis is generally well-tolerated when used at the recommended dosage. However, as with any bioactive supplement, adverse reactions are possible, primarily associated with individual sensitivity.

From the gastrointestinal tract: rarely – nausea, discomfort in the epigastric region, stool disturbances (diarrhea or constipation). These symptoms are usually mild and transient.

Allergic reactions: in rare cases, in individuals with hypersensitivity, skin reactions such as rash, itching, urticaria, and erythema may occur. In very rare cases, more severe systemic allergic reactions, including angioedema, are theoretically possible.

If any undesirable effects occur, including those not listed in this instruction, you should discontinue use of the supplement and consult a doctor.

Drug Interactions

Due to the presence of active plant components, Renalis may potentially interact with certain medications.

The arbutin contained in the lingonberry leaf extract is metabolized to hydroquinone, which has an antiseptic effect in the urinary tract. This may theoretically potentiate the effect of urinary antiseptics (e.g., nitrofurantoin, norfloxacin) or, conversely, lead to antagonism with other agents.

Given the diuretic properties of the components, the supplement may enhance the effect of diuretic drugs (e.g., furosemide, hydrochlorothiazide), which may increase the risk of electrolyte imbalance (loss of potassium, sodium) and dehydration. Monitoring by a physician is advisable.

Caution should be exercised when used concomitantly with lithium preparations, as increased diuresis can reduce the clearance of lithium and increase its concentration in the blood plasma, increasing the risk of toxicity.

There is a theoretical possibility of interaction with anticoagulants (e.g., warfarin) due to the content of vitamin K and other compounds in plant extracts that may affect blood clotting. Monitoring of INR (International Normalized Ratio) is recommended when starting or discontinuing the supplement.

Before using Renalis, inform your doctor about all medications you are taking, including prescription, over-the-counter, and other herbal supplements.

Overdose

Cases of overdose with Renalis capsules have not been reported. However, taking a dose significantly exceeding the recommended one may increase the risk of adverse reactions.

Symptoms of overdose may include severe nausea, vomiting, diarrhea, abdominal pain, and increased diuresis, which can lead to dehydration and electrolyte disturbances.

In case of suspected overdose, immediately discontinue use of the supplement and seek medical attention. Treatment is symptomatic and supportive. Gastric lavage and intake of activated charcoal may be considered if a large number of capsules have been ingested recently. It is important to ensure adequate hydration and correct electrolyte balance if necessary.

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.