ROTERUTES 30CPR RIV 105MG

RIVESTITE ROTHERS WITH FILM

active ingredients

Each movie-coated tablet contains 425.25 mg - 519.75 mg of extract (as dry extract) Arctostaphylos grapes (L.), folio (uva ursina leaf), corresponding to 105 mg of hydroquinone derivatives, calculated as arbutina anidra (mediante spectrophotometry). Extraction solvent: water. Excipient with known effects: lactose. For the full list of excipients, see paragraph 6.1.

Excellent

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

Therapeutic indications

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

Contraindications

- Hypersensitivity to the active ingredient or any of the excipients listed in the paragraph 6.1. - Renal disturbances.

Population

Population Adults: 2 tablets coated with movies twice a day. The maximum dosage is equal to 2 tablets coated with movies four times a day. Use in men is not recommended (see paragraph 4.4 "Special warnings and precautions of use"). Pediatric population Use in children and adolescents under the age of 18 is not recommended (see paragraph 4.4 "Special warnings and precautions of employment"). Method of administration Oral use. Tablets covered with film must be swallowed whole with water. Duration of treatment Like all arbutin-containing medicines containing ursin grape leaf extract should not be taken for more than 5 consecutive days, if not after medical indication. If symptoms persist for more than 4 days or worse during the use of the medicine, you must consult a doctor or a qualified health professional. Drugs containing ursin leaf extract should not be used for more than five episodes a year.

Conservation

Do not store at temperature above 25°C.

Warnings

Patients suffering from a rare hereditary intolerance to galactose, lactase deficiency or glucose-galactose mal absorption should not take Roteruti, tablets coated with movies. Use in men is not recommended due to problems requiring supervision of a doctor. If during use of the medicinal product there are disturbances or symptoms such as fever, dysuria, spasms or blood in the urine, it is necessary to consult a doctor or a qualified health professional. Uvae ursi folium can cause a brown-greenish coloring of the urine. Pediatric population The possibility of use in children and adolescents under the age of 18 has not been established due to the absence of sufficient data; this use is not recommended due to problems requiring medical advice.

Interactions

No interaction has been reported.

Effects

Gastrointestinal diseases There have been reported nausea, vomiting and stomachache, whose frequency is not known. In case of adverse reactions other than those listed, you must consult a doctor or a qualified health professional. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

No overdose cases have been reported.

Pregnancy

The safety of this medicine during pregnancy has not been established. Therefore its use during pregnancy must be avoided (see paragraph 5.3 "Preclinical safety data").

Food

The safety of this medicine during breastfeeding has not been established. In the absence of sufficient data, use during lactation is not recommended.

Fertility

Data on the effects of Roteruti, tablets coated with male and female fertility films are not available.

Source: Farmadati