BIOFLOR Capsule, hard Ref.[28145] Active ingredients: Saccharomyces boulardii

Special warnings

There have been very rare cases of fungaemia (and blood cultures positive for Saccharomyces strains) and sepsis reported mostly in patients with central venous catheter, critically ill or immunocompromised patients, most often resulting in pyrexia. In most cases, the outcome has been satisfactory after cessation of treatment by Saccharomyces boulardii, administration of antifungal treatment and removal of the catheter when necessary. However, the outcome was fatal in some critically ill patients (see sections 4.3 and 4.8).

As with all medicines made from living micro-organisms, special attention must be paid to the handling of the product in the presence of patients mainly with central venous catheter but also with peripheral catheter, even not treated with Saccharomyces boulardii, in order to avoid any contamination by hands and/or the spread of microorganisms by air (see section 4.2).

Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose galactose malabsorption should not take this medicine.

Precautions for use

BIOFLOR 200 mg contains living cells. This drug should therefore not be mixed with very hot (over 50°C), iced or alcoholic drinks or food.

The treatment does not replace rehydration when this is necessary. The rehydration dose and its route of administration (oral-IV) should be adapted to the severity of the diarrhoea and to the age and state of health of the patient.

Because of its fungal nature, BIOFLOR 200 mg must not be administered with systemic or oral antifungal drugs.

There are no reliable animal teratogenesis data.

Clinically, no malformative nor fetotoxic effect has been reported to date. However, monitoring of pregnancies exposed to this medicine is insufficient to rule out any risk.

Hence, as a precautionary measure, it is preferable to avoid using this medicine during pregnancy.

In the absence of data, it is preferable to avoid using this medicine during lactation.

BIOFLOR 200 mg has no influence on the ability to drive or use machines.

Rare cases of epigastric disturbances have been reported, not requiring that treatment to be discontinued.

Infections and Infestations

Very rare: Fungaemia in patients with a central venous catheter and in critically or immunocompromised patients (see section 4.4).

Frequency not known (cannot be estimated from the available data): Sepsis in critically ill or immunocompromised patients (see section 4.4).

Skin and subcutaneous tissue disorders

Very rare: some cases of intolerability reactions have been reported in the form of pruritus, urticaria, skin rash. Swelling of the connective tissue of the face (angioedema).

Immune system disorders

Some cases of anaphylactic reaction or even shock have been reported.

Gastrointestinal disorders

Frequency not known (cannot be estimated from the available data): constipation.

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. Healthcare professionals are asked to report any suspected adverse reactions viaPharmaceutical Services, Ministry of Health, CY-1475, www.moh.gov.cy/phs, Fax: +357 22608649.

None.