Nephrodol®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT NEFRODOL® NEFRODOL

Composition:

Active ingredients: centaury herb, lovage root, rosemary leaves;

One tablet contains dried medicinal plants in the form of powder:

centaury herb (Herba Centaurii) 18 mg,

lovage root (Radix Levistici) 18 mg,

rosemary leaves (Folia Rosmarini) 18 mg;

Excipients: maize starch; colloidal anhydrous silicon dioxide; lactose monohydrate; povidone; magnesium stearate; white sugar; hypromellose; titanium dioxide (E 171); talc; polyethylene glycol; iron oxide red (E 172); riboflavin (E 101).

Pharmaceutical form. Film-coated tablets.

Main physicochemical properties: round, biconvex, film-coated tablets ranging in color from orange to brown.

Pharmacotherapeutic group. Agents used in urology. ATC code G04BX.

Pharmacological properties.

Pharmacodynamics.

The components contained in the herbal medicinal product have complex activity, manifested in anti-inflammatory, antioxidant, spasmolytic, and analgesic effects. Neffdol® also has antibacterial and diuretic effects, which are due to substances present in the herbal components of the drug.

Clinical characteristics.

Indications.

For the complex treatment of inflammatory diseases of the urinary tract.

Prevention of urinary stone formation, including after their removal.

Contraindications.

Hypersensitivity to any component of the medicinal product or to other plants of the Apiaceae family (e.g., anise, fennel), or to anethole (i.e., a component of essential oils found, for example, in anise and fennel).

Peptic ulcer.

Edema due to heart failure or impaired kidney function and/or physician's recommendation to restrict fluid intake.

Interaction with other medicinal products and other forms of interaction.

Not known.

If simultaneous use with any other medicinal products is required, consult a physician.

Special precautions for use.

In case of prolonged fever, spasms, presence of blood in urine, urinary disorders, or acute urinary retention, immediate medical advice must be sought.

Patients with known sensitivities to certain sugars should consult their physician prior to starting treatment with Neofrodol® tablets.

The drug should not be used in patients with rare hereditary forms of fructose intolerance, galactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome, or sucrase-isomaltase deficiency.

Note for diabetic patients. 1 tablet contains on average 0.02 bread units (BU).

Use during pregnancy or breastfeeding.

Pregnancy.

Observational experience in pregnant women (300–1000 newborns) indicates no risk of fetal malformations or fetal/neonatal toxicity associated with Neofrodol® tablets.

Experimental studies have shown no evidence of reproductive toxicity.

Neofrodol® tablets may be used during pregnancy only after consultation with a physician.

Breastfeeding.

Due to the lack of data on the passage of Neofrodol® or its metabolites into breast milk, the risk to infants cannot be excluded; therefore, the drug should not be used during breastfeeding.

Ability to influence reaction speed when driving or operating machinery.

The drug does not affect the ability to drive vehicles or operate machinery.

Dosage and Administration.

If the doctor has not prescribed otherwise, the medicine should be taken by adults and children aged 12 years and older at a dose of 2 tablets three times daily (total daily dose – 6 tablets).

The tablets should be swallowed whole, without chewing, with sufficient amount of liquid (e.g., a glass of water).

Adequate fluid intake should be maintained during treatment with this medicine.

The duration of treatment is determined individually by the physician. If the drug is well tolerated, it may be prescribed for a prolonged period.

Children.

The medicine is not recommended for children under 12 years of age.

Overdose.

Cases of poisoning due to overdose have not been reported.
Treatment is symptomatic.

Adverse reactions.

Gastrointestinal disturbances are common (nausea, vomiting, diarrhea). Allergic reactions may occur in case of hypersensitivity to the components of the drug, including urticaria, itching, skin hyperemia.

If any adverse reactions occur, discontinue use of the drug and consult a physician.

Shelf life. 4 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 ˚C.

Packaging.

10 tablets in a blister; 6 blisters in a cardboard box.

Prescription category.

Over-the-counter.

Manufacturer.

JSC "Tekhnolog" (responsible for manufacturing, primary and secondary packaging, batch control and testing, excluding batch release)

LLC «FC «SALYUTARIS» (responsible for batch release, excluding batch control and testing)

Manufacturer's address and location of its business activities.

JSC "Tekhnolog": Ukraine, 20300, Cherkasy region, city of Uman, Staroproryzna Street, 8.

LLC «FC «SALYUTARIS»: Ukraine, 04071, Kyiv, Verkhniy Val St., 66-B.

Marketing authorization holder.

LLC «FC «SALYUTARIS».

Address of the marketing authorization holder.

Ukraine, 57453, Mykolaiv region, Mykolaiv district, village of Kobleve, Odeska Street, 4