INSTRUCTION FOR MEDICAL USE Cystone®
Registration number П N008949
Commercial product name Cystone®
Generic drug name
- PHARMACEUTICAL DOSAGE FORM
Tablets
- PREPARATION FORMULA
Each tablet contains:
Active ingredients:
Dry extracts *: Didymocarpus pedicellata flowers 65,0 мг; Saxifraga ligulata culms 49,0 мг; Indian madder culms 16,0 мг; Cyperus scariosus rootstocks 16,0 мг; Achyranthes aspera seeds 16,0 мг; Onosma bracteatum Wall aboveground portion 16,0 мг; Vernonia cinerea intact plant 16,0 мг. Powders*: Lime silicate 16,0 мг; Shilajit (purified) 13,0 мг. - Excipients
magnesium stearate 2.0 mg; microcrystalline cellulose 38.0 mg; carmellose sodium 22.0 mg; crospovidone 6.0 mg; colloidal silicon dioxide 9.0 mg
- Notes
*Steam-treated aqueous extract (1:10) from a mixture of the following plant raw materials, taken in equal amounts: Oсimum basilicum aboveground portion, Dolichos biflorus seeds, Tribulus terrestris fruits, Mimosa pudica seeds, Pavonia odorata intact plant, Equisetum arvense intact plant, Tectona grandis seeds.
- Names of source plants in Latin:
Didymocarpus pedicellata R.Br., Saxifraga ligulata Wall., Rubia cordifolia L., Cyperus scariosus R.Br., Achyranthes aspera L., Onosma bracteatum Wall., Vernonia cinerea (L. Less.), Oсimum basilicum L., Dolichos biflorus L., Tribulus terrestris L., Mimosa pudica L., Pavonia odorata Willd., Equisetum arvense L., Tectona grandis L.f.
- Description:
Round biconvex tablets of light brown color interspersed with lighter and darker color spots.
- Pharmacotherapeutic group:
Nephrolithiasis treatment agent of a plant origin.
- ATC Code
G04BC.
- Pharmacodynamics:
The complex of biologically active ingredients that are included in Cyston® agent has a diuretic, antispasmodic, litholytic, antimicrobial and anti-inflammatory effect.
- Фармакокинетика:
There are no data on the pharmacokinetics of the multicomponent agent of plant origin Cyston® in the tablet pharmaceutical form. The agent activity is stipulated by the mutually reinforcing combined action of its components, which is typical for the plant medicines. As far as it is impossible to designate the agent activity to any single compound in full, the pharmacokinetic studies of multicomponent agents of plant origin, including Cyston® tablets, are unrealizable.
- RECOMMENDED INDICATIONS
complex therapy of urolithiasis, crystalluria, urinary tract infections.
- CONTRAINDICATIONS
Hypersensitivity to the agent components. Acute pain in the kidneys and urinary tract. Age under 18.
It is not recommended to use the agent if the calculi are more than 9 mm in diameter due to the threat of obstruction.
- INTAKE DURING PREGNANCY AND LACTATION
The agent intake is not recommended during the pregnancy and lactation (due to insufficient research data of effectiveness and safety of the agent in these conditions). If it is necessary to use the agent during lactation, the latter should be discontinued.
- DOSAGE AND INTAKE METHODS
Peroral after the meals.
The use of Cyston® is recommended against the background of increased fluid consumption up to 2-2.5 liters per day.
Adults: a complex therapy of urolithiasis and crystalluria: 2 tablets BID for 4-6 months or until the calculi come out from the urinary bladder;
recurrence prevention after the surgical removal, extracorporeal lithotripsy, or a spontaneous stone coming out: 2 tablets BID for the first month, then 1 tablet BID for 4-5 months;
a complex therapy of urinary tract infections (cystitis, urethritis, pyelonephritis and others): 2 tablets BID, the duration of the therapy course is 2-3 weeks or until the normalization of clinical symptoms and laboratory tests.
The therapy courses can be prolonged depending on the disease severity on the doctor's recommendation.- SIDE EFFECTS
Allergic reactions.
If any of the listed in the instructions side effects are aggravated, or you notice any other unlisted in the instructions side effects, please inform your doctor.- OVERDOSE
No cases of overdose have been identified till the present moment, therefore, the overdose symptoms have not been described. To avoid overdose, please strictly follow the instructions for use. The treatment in case of accidental overdose with Cyston® is symptomatic.
- INTERACTION WITH OTHER MEDICINAL PRODUCTS
The co-administration with antibiotics increases the therapy effectiveness.
Cyston® increases the bioavailability of norfloxacin. By the co-administration with co-trioxazole in an experiment on animals, Cyston® delayed the absorption of sulfamethoxazole, statistically significantly increasing its bioavailability, as well as accelerated the absorption of trimethoprim without significant affect to its bioavailability. When using these agents simultaneously with Cyston®, their dose may need to be adjusted.
Special warnings
Since the therapeutic effect of Cyston® develops gradually, it is necessary to stop taking it in case of acute pain in the kidneys and urinary tract and consult a doctor.
The agent use for urolithiasis requires adherence to a diet with a restriction of nutrients, promoting the formation of salt crystals or stones in the urinary tract, and taking into account the peculiarities of metabolism and acid-base urine reaction.
The use for urolithiasis and crystalluria does not depend on the calculi composition and urine pH. The agent is effective in oxalate, urate, phosphate urolithiasis.
By the discontinuation of Cyston® tablets the withdrawal effect is not observed. The elderly patients and patients with renal insufficiency do not require dose adjustment. The special measures are not required when one or more doses are missed. In case the patient misses one or more doses, the agent should be continued according to the prescribed in the instruction regimen without doubling the dose.
No special precautions are required when disposing of unused medicine.- PHARMACEUTICAL FORM
Tablets; 100 tablets in a high density polyethylene plastic vial with a screw cap. The vial neck is additionally tightened with aluminum foil applied by the company's trademark. Each vial with instructions for use is placed in a cardboard box.
- RECOMMENDATIONS FOR STORAGE
In a dry place at a temperature of 10°C to 30°C.
Keep out of the reach of children.- EXPIRATION DATE
3 years. Do not use after the expiration date.
- DISPENSING RULES
Without recipes.
Effects on ability to drive and use machines. The agent does not affect the performance of potentially hazardous activities that require special attention and quick reactions (driving and other vehicles, works with moving mechanisms, the dispatcher/operator work, etc.).
The name and address of the manufacturing site of the drug manufacturer: Himalaya Drag Co., Makali, Bengaluru 562 162, India.
Name, address of the organization authorized by the holder or owner of the product registration certificate for medical use to accept claims from the consumer/exclusive distributor: ZAO TRANSATLANTIC INTERNATIONAL, Russia.
119590, Moscow, 1 Olof Palme st. Tel. (495) 775-39-38; Fax: (495) 514-10-54/67.