SPECIAL WARNINGS

- Avoid prolonged treatments.

PATIENT ADVICE

Consult your doctor and/or pharmacist if symptoms persist or worsen after several days of treatment. Avoid longer than recommended treatments.

- It is normal for urine to have a brownish to greenish coloration, which is not serious.

- Inform your doctor and/or pharmacist if you experience any of these symptoms:

* Fever, pain or burning when urinating, or blood in the urine.

CONTRAINDICATIONS

- Hypersensitivity to bearberry or any other component of the medication.

- Kidney disorders, such as [KIDNEY FAILURE].

ADVANCED AGE

No specific problems have been described in elderly women that would require a dosage adjustment.

EFFECTS ON DRIVING

It does not appear to have a significant effect.

PREGNANCY

Animal safety: no data available.

Safety in humans: There are no adequate and well-controlled studies in humans. It is recommended to avoid use during pregnancy.

Effects on fertility: no specific studies have been conducted in humans.

INDICATIONS

- Treatment in adult women of the symptoms of mild lower urinary tract infections (e.g., cystitis), such as burning sensation when urinating and/or frequent urination

Its use is based exclusively on traditional use.

Its use in men is not recommended.

INTERACTIONS

- Urine alkalizers. Alkalizing substances (e.g. bicarbonate, carbonated drinks, coffee, tea, excessive alcohol) could reduce the effectiveness of bearberry.

LACTATION

Animal safety: no data available.

Safety in humans: It is unknown whether it is excreted in breast milk, and the potential consequences for the infant. Its use during breastfeeding is not recommended.

CHILDREN

Safety and efficacy have not been evaluated in girls and adolescents < 18 years, therefore its use is not recommended.

GUIDELINES FOR PROPER ADMINISTRATION

Swallow the tablets whole with enough water.

Administration with food: can be taken with or without food.

POSOLOGY

- Adults: 2 tablets/12 h. Maximum dose 2 tablets/6 h.

- Girls and adolescents < 18 years: not recommended.

- Elderly women: no specific dosage recommendations have been made.

Treatment duration: Avoid treatments longer than 5 consecutive days without a doctor's recommendation. If symptoms do not improve or worsen after 4 days, consult your doctor. Avoid more than 5 treatment cycles per year.

Missed dose: Take the next dose at the usual time. Do not double the next dose.

DOSAGE IN HEPATIC INSUFFICIENCY

No specific dosage recommendations have been made.

DOSAGE IN RENAL INSUFFICIENCY

Contraindicated.

PRECAUTIONS

- Serious infections. If symptoms such as fever, spasms, dysuria, or blood in the urine appear, it is advisable to consult a doctor.

- Prolonged use. Bearberry leaves contain the flavonoid arbutin, whose hydrolysis yields hydroquinone, a substance that has been associated in some studies with genotoxicity and carcinogenicity. Therefore, prolonged treatment should be avoided, limiting use to a maximum of 5 consecutive days and a maximum of 5 annual cycles of 5 days each, unless otherwise directed by a physician.

PRECAUTIONS RELATING TO EXCIPIENTS

This medicine contains lactose. Patients with hereditary lactose or galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.

ADVERSE REACTIONS

Adverse reactions are described according to each frequency interval, being considered very common (>10%), common (1-10%), uncommon (0.1-1%), rare (0.01-0.1%), very rare (<0.01%) or of unknown frequency (cannot be estimated from the available data).

- Digestive: frequency unknown [NAUSEA] and [VOMITING], [GASTRALGIA].

OVERDOSE

Symptoms: Overdosing on bearberry leaf has been linked to symptoms such as nausea, vomiting, gastric hyperacidity, and kidney irritation.

Measures to be taken:

- Antidote: there is no specific antidote.

- General disposal measures: none have been described.

- Monitoring: patient's clinical status.

- Treatment: symptomatic.