ROTERUTES * 30CPR RIV 105MG

ROTERUTES * 30CPR RIV 105MG

Therapeutic indications

Traditional herbal medicine used in women to treat symptoms of mild lower urinary tract infections (e.g. bladder infections), such as burning sensation during urination and / or frequent urination. The use of this traditional medicinal product of plant origin, for the indicated therapeutic indications, is based exclusively on the experience of many years of use.

Dosage and method of use

DosageAdults: 2 film-coated tablets twice a day. The maximum dosage is 2 film-coated tablets four times a day. Use in men is not recommended (see section 4.4 "Special warnings and precautions for use").Pediatric populationUse in children and adolescents under 18 years of age is not recommended (see section 4.4 "Special warnings and precautions for use").Method of administrationOral use. The film-coated tablets should be swallowed whole with water.Duration of treatmentLike all medicines containing arbutin, medicines containing bearberry leaf extract should not be taken for more than 5 consecutive days, except on medical advice. If symptoms persist for more than 4 days or worsen while using the medicine, a doctor or qualified healthcare professional should be consulted. Medicines containing bearberry leaf extract should not be used for more than five episodes per year.

Contraindications

- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. - Kidney problems.

Side effects

Gastrointestinal disordersNausea, vomiting and stomach pain have been reported, the frequency of which is unknown. In case of adverse reactions other than those listed, a doctor or a qualified healthcare professional should be consulted.Reporting of suspected adverse reactionsReporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

Patients with rare hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take Roteruti, film-coated tablets. Use in men is not recommended due to problems that require medical supervision. If you experience symptoms or symptoms such as fever, dysuria, spasms or blood in your urine while using the medicine, you should consult a doctor or a qualified healthcare professional. Uvae ursi folium can cause a greenish-brown discoloration of the urine.Pediatric populationThe possibility of use in children and adolescents under the age of 18 has not been established due to the lack of sufficient data; this use is not recommended due to problems that require the advice of a doctor.

Pregnancy and breastfeeding

PregnancyThe safety of this medicine in pregnancy has not been established. Therefore its use during pregnancy should be avoided (see section 5.3 "Preclinical safety data").Feeding timeThe safety of this medicine during breastfeeding has not been established. In the absence of sufficient data, use during lactation is not recommended.FertilityThere are no data on the effects of Roteruti, film-coated tablets on male and female fertility.

Expiry and retention

Do not store above 25 ° C.

Interactions with other drugs

No interaction was reported.

Overdose

No cases of overdose have been reported.

Active principles

Each film-coated tablet contains 425.25 mg - 519.75 mg of extract (as dry extract) ofArctostaphylos uva-ursi(L.),folium(bearberry leaf), corresponding to 105 mg of hydroquinone derivatives, calculated as anhydrous arbutin (by spectrophotometry). Extraction solvent: water. Excipient with known effect: lactose. For the full list of excipients, see section 6.1.

Excipients

Microcrystalline cellulose, lactose monohydrate, talc, poly (o-carboxymethyl) starch, sodium salt, anhydrous colloidal silica, magnesium stearate, macrogol 3350, polyvinyl alcohol, titanium dioxide E171, red iron oxide E172, yellow iron oxide E172, black iron oxide E172 . Excipients of the vegetable preparation: maltodextrin.