BIOFLOR Powder for oral suspension Ref.[28146] Active ingredients: Saccharomyces boulardii

Special warnings

If symptoms persist for more than 2 days of treatment at usual posology, the therapeutic approach will be reevaluated.

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.

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.

Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product.

Precautions for use

The patients must be told of the need:

• to rehydrate themselves by drinking copious amounts of salty or sweet drinks, in order to compensate for fluid losses due to diarrhea (mean daily water requirement of an adult is 2 liters);
• to eat while they have diarrhea: excluding certain types of food and especially raw salads, fruit, green vegetables, spicy foods and iced foods or drinks, and preferring grilled meats and rice.

Since BIOFLOR consists of living cells that develop at 37°C: do not mix it with a liquid or food which is too hot (more than 50°C), iced or containing alcohol.

Because of its fungal nature, BIOFLOR 100 mg must not be administered with systemic or oral antifungal drugs. No other interaction is expected.

Fertility

No data available.

Pregnancy

Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).

BIOFLOR is not recommended during pregnancy.

Lactation

Saccharomyces boulardii CNCM I-745 is not excreted in human milk. BIOFLOR can be used during breast-feeding.

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

Adverse reactions encountered most often are as follows: very common (>1/10), common (≥1/100, <1/10), uncommon (≥1/1,000, <1/100), rare (≥1/10,000, <1/1,000), very rare (<1/10,000, including isolated cases), frequency not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing severity.

Gastrointestinal disorders

Rare: Flatulence.

Not known: constipation.

Skin and subcutaneous tissue disorders

Very rare: Rash, cutaneous allergy, urticaria, pruritus, swelling of the connective tissue of the face (angioedema).

Immune system disorders

Very rare: Anaphylactic reaction, exanthem.

Infections and Infestations

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

Not known: Sepsis in critically ill or immunocompromised patients (see section 4.4).

Reporting of suspected adverse reactions:

Reporting suspected adverse reactions is an important way to gather more information to continuously monitor the benefit/risk balance of the medicinal product. Any suspected adverse reaction should be reported to Pharmaceutical Services, Ministry of Health, CY-1475, www.moh.gov.cy/phs, Fax: 357 22608649.

None.