Cystone®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT CYSTON®

Composition:

Each tablet contains:

Extracts:

Didymocarpus pedicellata (stem-leaved didymocarpus) leaves – 65 mg,
Saxifraga ligulata (tongue saxifrage) roots – 49 mg,
Rubia cordifolia (heart-leaved madder) roots – 16 mg,
Cyperus scariosus (scarious cyperus) rhizomes – 16 mg,
Achyranthes aspera (rough chaff flower) seeds – 16 mg,
Onosma bracteatum (bracteate onosma) aerial parts – 16 mg,
Vernonia cinerea (ash-coloured vernonia) – 16 mg;
Powders: siliceous lime (Hajrulya hood bhasma) – 16 mg; purified mineral resin (Shilajeet purified) – 13 mg;

processed with aqueous extract from: Ocimum basilicum (true basil) herb, Tribulus terrestris (puncture vine) fruits, Mimosa pudica (sensitive plant) seeds, Dolichos biflorus (two-flowered dolichos) seeds, Pavonia odorata (fragrant pavonia), Equisetum arvense (field horsetail), Tectona grandis (teak tree) seeds;
Excipients: microcrystalline cellulose, sodium carboxymethylcellulose, magnesium stearate, crospovidone, colloidal anhydrous silicon dioxide.

Pharmaceutical form. Tablets.

Main physicochemical properties: round, biconvex tablets of light brown color with light and dark speckles.

Pharmacotherapeutic group.
Agents promoting dissolution of urinary calculi. ATC code G04BC.

Pharmacological properties.

The action of the medicinal product is determined by the properties of its constituent components.

Didymocarpus pedicellata contains isopedicine, pedicine, essential oil, and pedicillin. It has strong diuretic properties.

Polygonum aviculare is a diuretic agent that reduces irritation, exerts an astringent effect, promotes dissolution and disintegration of kidney and urinary tract stones by influencing the crystalloidal-colloidal balance; it also has antimicrobial activity.

Rubia cordifolia contains anthraquinone glycosides and ruberythric acid, which can dissolve oxalate stones present in the urinary tract, thus facilitating their elimination. Rubia cordifolia exerts astringent and diuretic effects.

Saxifraga ligulata has antimicrobial activity in the urogenital system.

Scoparia dulcis exhibits spasmolytic and diuretic effects.

Onosma bracteatum has antiseptic, anti-inflammatory, diuretic, and antimicrobial properties, and relieves bladder irritation. It is used for the treatment of urinary tract infections.

Vernonia cinerea is used for bladder spasms and difficult urination.

Silicea acts as a diuretic and promotes the lysis of urinary concretions.

Purified mineral resin is a balanced, general tonic composition of beneficial mineral and organic components. In addition to correcting urinary excretion, it influences digestive processes, absorption, and assimilation of food. It alleviates digestive and metabolic disturbances.

Cystone**®** enhances blood flow to the kidneys and urinary tract, producing diuretic and anti-inflammatory effects. Cystone**®** inhibits the process of stone formation. Suppression of stone formation occurs by reducing the levels of lithogenic substances (e.g., oxalic acid, etc.). Cystone**®** facilitates the elimination of stones through micro-pulverization. Disintegration of stones and crystals occurs due to the effect on mucin, which binds individual particles together.

Cystone**®** has antimicrobial activity, particularly against E. coli and Klebsiella. It also has antispasmodic properties, which help relieve painful urination.

Clinical characteristics.

Indications.

Dissolution of kidney stones caused by oxalates, phosphates, uric acid, and urates.

Prevention of stone formation after surgery.

As an adjunctive agent in urinary tract infections; non-specific urethritis; cystitis; pyelitis.

Attacks occurring during the excretion of uric acid.

Contraindications.

Hypersensitivity to the components of the drug. Acute pain in the urinary tract area. Nephritis, nephroses, nephronephritis.

Interaction with other medicinal products and other forms of interaction.

In experimental studies, Cystone**®** has shown an effect on the bioavailability of sulfamethoxazole, trimethoprim, and norfloxacin. Therefore, when these drugs are used concomitantly, their dosage should be adjusted.

Special precautions for use.

Cystone**®** is not recommended for use in cases of obstruction caused by large calculi (more than 10 mm according to ultrasound findings), or in the presence of large stones that may cause obstruction.

If symptoms such as fever, dysuria, spasms, or hematuria occur during treatment with the drug, consult a physician.

Use during pregnancy or breastfeeding.

Do not use.

Ability to affect reaction rate while driving or operating machinery.

No effect.

Method of Administration and Dosage

Cystone® is for oral use.

Dissolution of kidney stones caused by oxalates, phosphates, uric acid, and urates:

For adults and children aged 14 years and older – 2 tablets, for children aged 12 to 14 years – 1 tablet, 3 times daily for 3–4 months; thereafter, for adults and children aged 14 years and older – 1 tablet, for children aged 12 to 14 years – ½ tablet, 2 times daily, or until stone passage.

For urinary tract infections: for adults and children aged 14 years and older – 2 tablets, for children aged 12 to 14 years – 1 tablet, 3 times daily for 4–6 weeks.

For recurrent urinary tract infections: for adults and children aged 14 years and older – 1 tablet, for children aged 12 to 14 years – ½ tablet, 2 times daily for 6–12 weeks.

For prevention of kidney stone formation: for adults and children aged 14 years and older – 1 tablet, for children aged 12 to 14 years – ½ tablet, 3 times daily for 4–5 months.

Children

The medicinal product is intended for use in children aged 12 years and older.

Overdose

Not reported. An overdose may lead to an intensification of adverse reactions.

Side effects.

Skin and subcutaneous tissue disorders: skin rashes, erythema, urticaria, pruritus.

Gastrointestinal and hepatic disorders: gastrointestinal disturbances and liver-related disorders.

Immune system disorders: hypersensitivity reactions, including angioneurotic edema.

Urinary system disorders: back pain and pain at the end of urination.

Shelf life. 3 years.

Storage conditions.

Store at a temperature not exceeding 30 °C in the original packaging.

Keep out of reach of children.

Packaging.

100 tablets in bottles, placed in a cardboard box.

Availability. Over-the-counter (without prescription).

Manufacturer.

Himalaya Wellness Company.

Manufacturer's address and location of business operations.

Makali, Bangalore–562 162, India.