NEFRODOL

INSTRUCTION

for the medical use of the medicinal product

NEFRODOL®

Composition:

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

1 tablet contains dried medicinal plants in powder form:

Centaury herb (Herba Centaurii)                                18 mg,

Lovage root (Radix Levistici)                                      18 mg,

Rosemary leaf (Folia Rosmarini)                                18 mg;

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

Pharmaceutical Form: Coated tablets.

Physical and Chemical Properties: Round, biconvex tablets, coated from orange to brown in color.

Pharmacotherapeutic Group: Urological agents. ATC code G04BX.

Pharmacological Properties:

Pharmacodynamics:

The components of the herbal medicinal product exhibit a complex activity manifested in anti-inflammatory, antioxidant, antispasmodic, and analgesic effects. Nefrodol® also has antibacterial and diuretic effects, which are due to substances contained in the plant 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:

Increased individual sensitivity to any component of the product or to other plants of the Apiaceae family (e.g., anise, fennel), and to anethole (i.e., a component of essential oils containing, for example, anise and fennel).

Peptic ulcer.

Edema due to heart failure or kidney function impairment and/or doctor’s recommendation regarding fluid intake restriction.

Interaction with Other Medicinal Products and Other Forms of Interaction:

Unknown.

If the simultaneous use of any other medicinal products is necessary, consult a doctor.

Special Instructions:

In case of prolonged fever, spasms, blood in urine, urinary disorders, and acute urinary retention, it is necessary to immediately consult a doctor.

Patients with intolerance to some sugars should consult a doctor before starting Nefrodol® tablets.

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

Note for patients with diabetes: 1 tablet contains an average of 0.02 bread units (BU).

Use During Pregnancy or Breastfeeding:

Pregnancy:

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

Experimental studies have not shown any signs of reproductive toxicity.

The use of Nefrodol® tablets during pregnancy is possible after consultation with a doctor.

Breastfeeding:

Due to the lack of data on the penetration of Nefrodol® or its metabolites into breast milk, the risk to infants cannot be excluded, therefore, the product should not be used during breastfeeding.

Ability to Influence Reaction Speed When Driving or Operating Other Mechanisms:

The product does not affect the ability to drive vehicles or operate other mechanisms.

Method of use and doses.

Unless otherwise prescribed by a doctor, the product should be taken by adults and children aged 12 years and over as 2 tablets 3 times a day (total daily dose – 6 tablets).

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

It is necessary to ensure adequate fluid intake along with the consumption of the product.

The duration of treatment is determined individually by a doctor. If the product is well tolerated, it may be prescribed for a long term.

Children:

The product is not recommended for use in children under 12 years of age.

Overdose:

There are no known cases of poisoning due to overdose of the product.

Treatment is symptomatic.

Side Effects:

Gastrointestinal tract disorders (nausea, vomiting, diarrhea) occur frequently. Allergic reactions may occur in case of increased sensitivity to the components of the product, including urticaria, itching, and skin hyperemia.

In case of any adverse reactions, the use of the product should be discontinued, and a doctor should be consulted.

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.

Leave category.

Without a prescription.

Manufacturer.

Technolog PJSC.

The location of the manufacturer and the address of the place of its activity.

Ukraine, 20300, Cherkasy region, Uman city, Stara Prorizna street, building 8.

The applicant

LLC “Pharmaceutical company “Salutaris”.

Location of the applicant.

Kyiv, Druzhby Narodiv Boulevard, 9.

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