AFALAZIN

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT AFLAZIN® Aflazin®

Composition:

Active substance: 1 capsule contains 200 mg of dried hibiscus extract (hibisci extractum siccum)*;

Excipients: lactose monohydrate, povidone;

Composition of the hard gelatin capsule: gelatin, titanium dioxide (E 171), tartrazine (E 102), amaranth (E 123), erythrosine (E 127), patent blue V (E 131).

*Extraction solvent: ethanol – water (30:70)

Pharmaceutical form. Capsules.

Main physicochemical properties: hard gelatin capsules No. 0 with burgundy cap and body, containing purple-violet powder with white specks. Presence of compacted columns or lumps, which disintegrate upon pressure, is acceptable.

Pharmacotherapeutic group.

Agents used in urology. ATC code G04BX.

Pharmacological properties.

Pharmacodynamics.

Patented hibiscus extract is a source of organic acids (citric, oxysuccinic, pyrocatechuic, hibiscus), vitamins, polysaccharides, and bioflavonoids, which provide the bacteriostatic effect of the medicinal product Aflazin® against most causative agents of urinary tract infections (Staphylococcus spp., Streptococcus spp., Enterococcus faecalis, Escherichia coli, Enterobacter spp., Candida spp.). It has anti-inflammatory and anti-edematous properties and exhibits anti-adhesive activity, preventing adhesion (attachment) of microorganisms to the walls of the urinary tract, thereby inhibiting their development and proliferation. Prevents the development of dysuric symptoms.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

As part of combination therapy in acute and chronic infections of the urinary bladder (cystitis) and kidneys (pyelonephritis), in asymptomatic bacteriuria, including in pregnant women.

Chronic non-infectious kidney diseases (glomerulonephritis, interstitial nephritis), prevention of urinary tract infections, including after instrumental procedures (endoscopic, radiological, and gynecological examinations).

Prevention of urinary stone formation, including after their removal.

Contraindications.

Individual hypersensitivity to any component of the drug.

Interaction with other medicinal products and other forms of interaction.

Clinically significant interaction of the drug with other medicinal products has not been established. Afalazin® can be used in combination with antibiotics and other antimicrobial agents.

Special precautions for use.

Since the medicinal product contains lactose, it should not be used in patients with rare hereditary forms of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome.

Use during pregnancy or breastfeeding.

Use of the drug during the first trimester of pregnancy is possible only under medical supervision. Use of the drug during pregnancy from the second trimester onwards, as well as during breastfeeding, does not require additional medical consultation.

Ability to influence reaction rate when driving or operating machinery.

Does not affect.

Dosage and Administration.

For adults and children aged 12 years and older: 1 capsule twice daily, independent of food intake. For children aged 6 to 12 years: 1 capsule once daily. Duration of treatment is determined individually by a physician, depending on the severity of the disease. The recommended duration of treatment for acute urinary tract infections and exacerbations of chronic conditions is 4–6 weeks. The recommended course for prophylactic use is 2–4 weeks.

Children.

The drug can be used in children aged 6 years and older.

Overdose.

Cases of poisoning due to drug overdose are unknown.

Side effects.

Allergic reactions to the components of the medicine are possible.

Reporting of adverse reactions after drug registration is of great importance. It allows monitoring of the benefit-risk balance of this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy of the medicinal product through the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life. 3 years.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging. 10 capsules in a blister pack, 3 blisters per cardboard box.

Availability category. Over-the-counter.

Manufacturer. LLC "VALARTIN PHARMA".

Manufacturer's address and location of business activity.

60, Hrushevskoho St., village Chayky, Kyiv-Sviatoshyn District, Kyiv Oblast, 08135, Ukraine.