Canepron® n

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT KANEFRON® N (CANEPHRON® N)

Composition:

Active substances: 100 ml of oral drops contain liquid extract (1:56) from 1.8 g of a mixture of rosemary leaves (Folia Rosmarini), lovage root (Radix Levistici), and centaury herb (Herba Centaurii) (1:1:1) [extraction agents: 1st fraction: ethanol 59% (v/v), 2nd–4th fractions: purified water];

Excipients: none.

Ethanol content − 19% (v/v).

Pharmaceutical form. Oral drops.

Main physicochemical properties: clear or slightly cloudy yellowish-brown liquid with a lovage odour.

Slight cloudiness or sedimentation may occur during storage.

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

Pharmacological properties.

Pharmacodynamics. The components contained in the herbal medicinal product exhibit complex activity, manifested as anti-inflammatory, antioxidant, spasmolytic, and analgesic effects. In addition, Canephron® N has antibacterial and diuretic effects, which are due to substances contained in the herbal components of the drug.

Clinical characteristics.

Indications. A herbal medicinal product for the comprehensive treatment of inflammatory diseases of the urinary tract.

Prevention of urinary stone formation, including after their removal.

Contraindications. Peptic ulcer, increased individual sensitivity to any component of the medicinal product or to other plants of the Apiaceae family (Apiaceae) (e.g. anise, fennel), and to anethole (a component of essential oils found, for example, in anise and fennel).

Irrigation therapy should not be performed in cases of edema due to heart failure or impaired kidney function, or if the patient has been advised to reduce fluid intake.

Interaction with other medicinal products and other forms of interaction. Unknown.

If simultaneous use with any other medicinal products is necessary, a physician should be consulted. The effect of other drugs may be weakened or enhanced.

Special precautions for use

During storage of the medicinal product, cloudiness or precipitation may occur; however, this does not affect its efficacy.

If fever, spasms, presence of blood in urine, urinary disturbances or acute urinary retention persist, medical advice must be sought immediately.

This medicinal product contains 19% ethanol. One dose, according to the instructions, contains up to 0.75 g of alcohol. There is a potential health risk for patients suffering from liver disease, alcohol dependence, epilepsy, organic brain disorders, as well as for pregnant and breastfeeding women and children.

Use during pregnancy or breastfeeding

Pregnancy

Animal studies have not revealed any direct or indirect harmful effects on pregnancy progression. To date, experience with the use of Canephronâ N in pregnant women is very limited. For safety reasons, Canephronâ N is not recommended during pregnancy.

Breastfeeding

It is not known whether Canephronâ N or its active substances/metabolites are excreted in human milk. Risk to the newborn/infant cannot be excluded. Canephronâ N should not be used during lactation.

Reproductive function

Data on the effect on human fertility are lacking. Studies in animals have not shown any effects on fertility in males or females.

Ability to influence reaction speed when driving or operating machinery
The medicinal product, at recommended doses, does not impair the ability to drive or operate machinery; however, the ethanol content should be taken into account.

Dosage and Administration

If the physician has not prescribed otherwise, the medicinal product should be administered to adults and children aged 12 years and older at a dose of 50 drops three times a day (total daily dose − 150 drops).

Adults usually take the drops undiluted. If necessary (e.g. due to bitter taste in children), the drops may be taken with any liquid. Shake well before use! When administering the drops, hold the bottle vertically.

During treatment, ensure adequate fluid intake.

The duration of treatment is determined individually by the physician. If the product is well tolerated, it may be prescribed for a prolonged period. Follow the recommendations provided in the section "Special Instructions".

Children. The medicinal product should not be used in children under 12 years of age.

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

Side effects.

Gastrointestinal disturbances (nausea, vomiting, diarrhea) are commonly observed. Allergic reactions may occur in case of hypersensitivity to the components of the medicinal product, including rash, urticaria, itching, skin hyperemia. Frequency is unknown.

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

Shelf life. 2 years.

After first opening of the bottle, the medicinal product is suitable for use for 6 months.

Do not use the product after the expiry date stated on the packaging.

The shelf life determines that the product may be used until the last day of the indicated month.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C, in a place inaccessible to children.

Packaging. 100 ml in a bottle in a cardboard box.

Availability. Over-the-counter.

Manufacturer/Applicant.

Bionorica SE / Bionorica SE.

Address of manufacturer and its place of business / address of applicant and applicant's representative.

Kerchensteinerstrasse, 11-15, 92318, Neumarkt, Germany /
Kerschensteinerstrasse, 11-15, 92318 Neumarkt, Germany.

Contact details of the manufacturer's representative in Ukraine, LLC "Bionorica":
Phone: 044 521 86 00; Fax: 044 521 86 01, [email protected]