BOP Coated tablet Bottle/60

Film-coated tablet.
Bottle of 60.

For a coated tablet:

Birch (Betula pendula Roth and/or Betula pubescens Ehrh. or hybrids of 2 species) (dry leaf extract of): 76 mg
Extraction solvent: water.
Herbal substance/native extract ratio: 4-8: 1.

Olive (Olea europaea, L.) (dry leaf extract of): 45,5 mg
Extraction solvent: water.
Herbal substance/native extract ratio: 3-5: 1.

Excipient with known effect: sucrose.

Traditional herbal medicinal product used:

• to promote renal elimination of water in mild cases of water retention
• to increase urine production in cases of minor urinary disorders,

provided that any serious pathology has been excluded beforehand by a doctor.

Its use is restricted to the specified indications on the exclusive basis of long-standing use.

B O P, coated tablet is indicated in adults.

Dosage

Reserved for adults.

2 tablets 3 times a day.

The recommended dosage is 2 tablets in the morning, 2 tablets at midday, 2 tablets in the evening.

Do not exceed 6 tablets per day.

Paediatric population

In the absence of sufficient data, use of this medicine is not recommended in children and adolescents under 18 years of age (see section Warnings and precautions).

Method of administration

Oral use.

Swallow the tablets with a sufficient quantity of water.

To ensure an increase in urine volume, adequate fluid intake is necessary during treatment.

Duration of treatment

2 to 4 weeks.

If symptoms persist during use of this medicine, a doctor or pharmacist must be consulted.

Hypersensitivity to the active substances, to birch pollen or to any of the excipients listed in section Composition.

This medicine is contraindicated in conditions where low fluid intake is recommended (for example, severe heart or kidney diseases).

Patients with heart disease or renal insufficiency should consult a doctor before taking this medicine.

If symptoms worsen during use of the medicine, a doctor or pharmacist must be consulted.

In case of difficulty urinating or presence of blood in the urine, or onset of fever or spasms during use of the medicine, a doctor or pharmacist must be consulted.

This medicine contains sucrose. Patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase/isomaltase deficiency (rare hereditary diseases) must not take this medicine.

Paediatric population

Use in children and adolescents under 18 years of age has not been established due to the absence of adequate data. B O P, coated tablet is not recommended in children and adolescents under 18 years of age.

No interaction studies have been performed.

Pregnancy

Safety in pregnant women has not been established. In the absence of sufficient data, use of this medicine is not recommended during pregnancy.

Breast-feeding

Safety in breastfeeding women has not been established. In the absence of sufficient data, use of this medicine is not recommended during breastfeeding.

Fertility

No studies have been carried out.

The effects on the ability to drive vehicles and use machines have not been studied.

Side effects have been reported:

• Gastrointestinal disorders (nausea, vomiting, diarrhoea).
• Allergic reactions (itching, skin rash, urticaria, allergic rhinitis).

The frequency of this type of reaction is not known.

If other side effects not mentioned above occur, a doctor or qualified healthcare professional should be consulted.

Reporting of suspected adverse reactions

Reporting of suspected adverse effects after the drug has been registered is important. It allows continuous monitoring of the benefit/risk profile of the drug. Health professionals report any suspected adverse effect through the national reporting system: the National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres - Website: https://signalement.social-sante.gouv.fr.

No cases of overdose have been reported.

The genotoxicity study conducted in vitro with the aqueous dry extract of olive contained in the specialty B O P, coated tablet, allows the conclusion of no mutagenic effect in the Ames test.

The positive result obtained in the Ames test performed on the aqueous dry extract of birch contained in B O P, coated tablet, could be attributed to the presence of flavonoids, such as quercetin and kaempferol, and is therefore of no genotoxic relevance in humans.

No carcinogenicity study nor reproductive and developmental toxicity study has been performed.

3 years.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.