Instructions for use Cystinol Akut film-coated tablets blister pack No. 30
Composition
active ingredient: 1 tablet contains dry extract of bearberry leaves (Arctostaphylos uva-ursi) (3.5-5.5:1) 238.7-297.5 mg, which corresponds to 70 mg of hydroquinone derivatives, calculated as anhydrous arbutin; extractant: ethanol 60% (v/v);
Excipients: microcrystalline cellulose; long-chain partial glyceride; hypromellose; lactose monohydrate; macrogol 6000; magnesium stearate; colloidal silicon dioxide; quinoline yellow (E 104); indigo carmine (E 132); aluminum hydroxide, titanium dioxide (E 171).
Dosage form
The tablets are coated.
Main physicochemical properties: light green glossy tablets, coated with an oval shell.
Pharmacotherapeutic group
Drugs used in urology. ATX code G04B P01.
Pharmacological properties
Pharmacodynamics.
In vitro, preparations of bearberry leaves have antibacterial effects against Proteus vulgaris, E. coli, Ureaplasma urealyticum, Mycoplasma hominis, Staphylococcus aureus, Pseudomonas aeruginosa, Klebsiella pneumoniae, Enterococcus faecalis, Streptococcus strains, and also against Candida albicans.
The antibacterial effect is mainly associated with the aglycones of hydroquinone, which are released from arbutin or from products resulting from the excretion of arbutin. When hydroquinone is released from conjugates (hydroquinone glucuronide and sulfate), the enzymatic activity of microorganisms that cause urinary tract infections is blocked.
At the same time, the extract of common bearberry leaves, due to the presence of tannins, reduces the adhesion of bacteria to host cells.
Pharmacokinetics.
Arbutin from the leaves of the mountain ash (prodrug) is adsorbed in the small intestine and undergoes fermentation, and is also metabolized in the liver. As a result, hydroquinone conjugates are converted by a second-pass reaction into hydroquinone glucuronide and sulfate. These non-toxic compounds are water-soluble and excreted in the urine.
In metabolism studies in healthy volunteers (Cystinol Akut, film-coated tablets), more than 70% of the administered dose of arbutin was excreted in the urine as conjugated hydroquinone within 24 hours. Recovery of the active substance in the form of free hydroquinone was less than 0.5% of the administered dose of arbutin.
Microbiological studies with E. coli have shown that fermentation of the conjugates occurs with a wide range of intrabacterial interactions and is independent of urine pH. In addition, the antiseptic effect increases only in the area where bacteria are present.
Indication
Inflammatory diseases of the lower urinary tract.
Contraindication
Hypersensitivity to bearberry leaves or to other components of the drug.
Interaction with other medicinal products and other types of interactions
Cystinol Akut, film-coated tablets, contain an extract of bearberry leaves, so they should not be used together with drugs that increase urine acidity, as it is impossible to exclude a decrease in the antibacterial effect of bearberry leaves.
Application features
If there is blood in the urine, in case of a high fever, or if the complaints persist for more than 5 days, you should consult a doctor.
Patients with hereditary galactose intolerance, lactase deficiency and glucose-galactose malabsorption should not take this medicine.
Use during pregnancy or breastfeeding
Do not use during pregnancy or breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
Does not affect.
Method of administration and doses
Adults and children over 12 years of age should take 2 tablets 3 times a day. The tablets should be swallowed with plenty of liquid, preferably water, after meals.
Unless otherwise prescribed by a doctor, a medicine containing arbutin should not be used for longer than 1 week and more than 5 times a year.
Children
Do not use in children under 12 years of age.
Overdose
Symptoms: when using the drug in doses higher than recommended, digestive tract disorders may occur in the form of vomiting, nausea, hematuria, and liver damage.
Treatment: immediately stop taking the drug and consult a doctor. Therapy is symptomatic.
Side effects
Side effects are rated by frequency of occurrence as follows: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1000, < 1/100), rare (≥ 1/10,000, < 1/1000), very rare (< 1/10,000), unknown (cannot be estimated from the available data).
Very rarely, patients with stomach sensitivity may complain of digestive symptoms (nausea, vomiting, abdominal pain, diarrhea).
Nervous system: dizziness.
In rare cases, allergic reactions may occur, such as: rash, itching.
If side effects occur, treatment should be discontinued and a doctor should be consulted who will assess their severity.
The doctor should decide on further action as necessary.
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 ºC.
Keep out of reach of children.
Packaging
15 tablets in a blister, 2 blisters in a cardboard box; 20 tablets in a blister, 2 or 3 or 5 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
Shaper & Brümmer GmbH & Co. KG.
Location of the manufacturer and address of its place of business.
Bahnhofstrasse 35,
38259 Salzgitter, Germany.
