Canephron Uno

The sugar-coated tablets are orange, round, biconvex with a smooth surface.
Each sugar-coated tablet contains: Centaurium erythraea Rafn s.l. (Centaury herb) 36 mg, Levisticum officinale Koch., radix (Lovage root) 36 mg, Rosmarinus officinalis L., folium (Rosemary leaf) 36 mg.
Excipients/Inactive Ingredients: The other ingredients are: Tablet core: Lactose monohydrate; magnesium stearate; maize starch; povidone K 25; colloidal anhydrous silica.
Coating: Calcium carbonate; virgin castor oil; iron (III) oxide (E 172); maize starch; dextrin; glucose, liquid; montanglycol wax; povidone K 30, sucrose, wax-free shellac, riboflavin (E 101); talc, titanium dioxide (E 171).

Phyto-Urological.
Pharmacology: Pharmacodynamics: In several clinical trials Canephron lead to a fast decline of complaints within the framework of inflammatory diseases of the efferent urinary tract. The results observed during these clinical trials indicate anti-inflammatory, spasmolytic, anti-nociceptive and antibacterial effects of Canephron.
These clinical data are supplemented and supported by results of preclinical studies.
The active pharmaceutical ingredient of Canephron Uno, the drug mixture of Centaurium erythraea, Levisticum officinale, and Rosmarinus officinalis, offers a multi-facetted activity with anti-adhesive, antioxidant, anti-inflammatory, spasmolytic, and anti-nociceptive effects. In addition, antibacterial and diuretic activities are described for individual plants of the drug mixture.
Based on these effects, Canephron can reduce symptoms associated with acute lower uncomplicated urinary tract infections, such as inflammatory pain, spasms and frequent micturition. In addition, anti-adhesive effects support the elimination of bacteria from the urinary tract.
Pharmacokinetics: No pharmacokinetic data are available.
Toxicology: Preclinical safety data: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single dose and repeated dose toxicity, genotoxicity, toxicity to reproduction and development. Data regarding carcinogenic potential of Canephron Uno are not available.

Canephron Uno is a traditional herbal medicinal product for supportive treatment and as an adjuvant to specific measures in cases of mild complaints (such as frequent urination, burning micturition, and increased urge to urinate) caused by inflammatory diseases of the efferent urinary tract; to achieve flushing of the urinary tract in order to reduce deposition of urinary stones.

Adults and adolescents from the age of 12 years take 1 sugar-coated tablet 3 times daily.
Children: Canephron Uno should not be used in children under 12 years of age.
Impaired renal or hepatic function: There are insufficient data for specific dosage recommendations in case of impaired renal/hepatic function.
For oral use.
Canephron Uno should be taken unchewed, preferably with some liquid (e.g. a glass of water). A single dose of Canephron Uno should be taken 3 times a day (morning, noon, evening). Adequate fluid intake should be ensured.
If the symptoms worsen or if there is no improvement after 3 days, a doctor must be consulted. The medicinal product should not be used in self-medication for more than 2 weeks.

No cases of overdose have been reported to date.
Treatment of overdose: In case of overdose symptomatic treatment should be initiated.

In case of hypersensitivity to centaury herb (Centaurii herba), lovage root (Levistici radix), rosemary leaf (Rosmarini folium), to other plants of the Apiaceae (Umbelliferae family, e.g. anise, fennel), to anethole (a component of essential oils) or to any of the excipients of the medicinal product.
In case of peptic ulcer.
In case of oedema due to impaired heart or kidney function and/or if a reduced fluid intake was recommended by the doctor.

Consult the doctor immediately if persisting fever, pain in lower abdomen, spasms, blood in urine, micturition disorder and acute urinary retention (sudden inability to urinate despite a full bladder) occur.
This medicinal product contains lactose monohydrate, glucose and sucrose. Patients with rare hereditary problems of fructose/galactose intolerance, glucose-galactose malabsorption, sucrase-isomaltase insufficiency or total lactase deficiency should not take this medicinal product.
Note for diabetics: One sugar-coated tablet contains on average 0.3 g of available carbohydrates.
Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been performed.
Use in Children: Canephron Uno should not be used in children under the age of 12 years.

A moderate amount of data on pregnant women indicate no risk of malformations or a harmful effect on the foetus/newborn (foetal/neonatal toxicity) associated with Canephron Uno. The use of Canephron Uno may be considered during pregnancy under medical supervision, if necessary.
It is unknown whether Canephron Uno or its active substances/metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded. Canephron Uno should not be used during breast-feeding.

Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Seek medical attention immediately at the first sign of any adverse drug reaction. If symptoms persist, consult a doctor.

Gastrointestinal complaints (nausea, abdominal discomfort, diarrhoea) have been observed commonly (may affect up to 1 in 10 people).
Hypersensitivity/allergic reactions may occur. Their frequency is not known (cannot be estimated from the available data).
In these cases, stop the intake of Canephron Uno and consult a physician.

No interaction studies have been performed. There are no known interactions with other medicinal products to date.

Store at temperatures not exceeding 30 °C.
Sugar-coated tablets must be protected from moisture.

Urinary Antiseptics

G04B - UROLOGICALS ; Used in the treatment of urological problems.

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