Cystone^® (Tablets) Instructions for Use

Marketing Authorization Holder

Himalaya Wellness Company (India)

ATC Code

G04BC (Drugs for the treatment of nephrourolithiasis)

Dosage Form

Cystone®

Tablets: 100 pcs.

Dosage Form, Packaging, and Composition

Tablets of light brown color with inclusions of lighter and darker color, round, biconvex.

Excipients: magnesium stearate, microcrystalline cellulose, sodium carboxymethylcellulose, crospovidone, colloidal silicon dioxide (aerosil).

100 pcs. – plastic bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Herbal preparation with diuretic, litholytic, and anti-inflammatory action

Pharmacotherapeutic Group

Nephrolithiasis treatment of plant origin

Pharmacological Action

A combined herbal preparation. It has diuretic, antispasmodic, litholytic, antimicrobial, and anti-inflammatory action.

The drug regulates the crystal-colloid balance in dysmetabolic nephropathy, reduces the concentration in urine of elements that promote stone formation (oxalic acid, calcium, hydroxyproline). It increases the level of elements that inhibit the process of stone formation (sodium, magnesium, potassium). By acting on mucin, the drug promotes the disintegration of stones, leading to their demineralization.

It prevents the accumulation of particles around the stone nucleus, which prevents its further growth.

By stimulating diuresis and relaxing the smooth muscles of the urinary tract, Cystone^® promotes the excretion of oxalate and phosphate salts, uric acid, and small stones from the urinary tract.

Cystone^® has a bacteriostatic and bactericidal effect, especially against Klebsiella spp., Pseudomonas aeruginosa, Escherichia coli and other gram-negative bacteria.

The litholytic effect of the drug does not depend on the pH of urine.

Pharmacokinetics

The therapeutic effect of Cystone^® is due to the combined action of its components, therefore, conducting kinetic observations is not possible.

Indications

As part of complex therapy

• Urolithiasis;
• Crystalluria;
• Urinary tract infections (cystitis, pyelonephritis);
• Gout.

ICD codes

Dosage Regimen

In complex therapy of urolithiasis, the drug is prescribed 2 tablets 2 times/day for 4-6 months or until the stones are passed.

In complex therapy of urinary tract infections, the drug is prescribed 2 tablets 2 times/day until the process is eliminated.

For preventing recurrence after surgical removal or passage of stones – 2 tablets 2 times/day for 1 month, then 1 tablet 2 times/day for 4-5 months.

Adverse Reactions

Possible allergic reactions.

Contraindications

• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

Use in pregnant women for cystitis is not contraindicated.

Special Precautions

It should be taken into account that the effect of Cystone^® develops gradually.

It is not recommended to use the drug for acute pain in the urinary tract area.

If acute pain occurs during treatment, the drug should be discontinued.

Overdose

No information on overdose of Cystone^® is available.

Drug Interactions

Drug interaction of Cystone^® has not been described.

Storage Conditions

The drug should be stored in a dry place, out of the reach of children, at a temperature between 10°C (50°F) and 30°C (86°F).

Shelf Life

Shelf life – 3 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

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.