Saccharomyces Boulardii CNCM I-745

Registered South African indications:

• Diarrhoea associated with antibiotic therapy
• Non-specific acute diarrhoea

Suitable for use in infants, children, adults and in the elderly

Registered South African contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Patients with a central venous catheter in situ
• Critically ill patients or immunocompromised patients due to risk of fungaemia
• Patients with congenital galactosaemia, glucose and galactose malabsorption syndrome or lactase deficiency (because of the presence of lactose)
• Patients taking alcohol
• Patients taking oral or systemic antifungal medicines
• Patients with fructose intolerance (because of the presence of fructose and sorbitol) (sachet)

South African recommendations

Caution in the following patient groups

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment

Risk of contamination and colonisation

• Should not be opened in close proximity to patients with a venous central catheter or a peripheral catheter, even if they are not treated with Saccharomyces boulardii, to avoid colonisation of the catheter via hand transmission or airborne spread of microorganisms

Fungaemia and sepsis

• Cases of fungaemia (blood cultures positive for Saccharomyces strains) and sepsis have been reported, mostly in patients who were critically ill, immunocompromised, or had a central venous catheter. These cases most often present with pyrexia
• In most instances, outcomes were satisfactory after discontinuation of Saccharomyces boulardii, initiation of antifungal therapy, and removal of the catheter when necessary
• However, fatal outcomes have occurred in some critically ill patients

Infants and children

• If diarrhoea persists after 2 days of treatment, treatment must be reviewed and the need for rehydration using an oral or intravenous solution envisaged
• Diarrhoea may be a symptom of a more serious underlying disease. If diarrhoea persists for more than 2 days, or there is blood in stools, or fever develops, treatment should be reconsidered

Rehydration

• Rehydration by drinking copious amounts of salty or sweet drinks is recommended, in order to compensate for fluid losses due to diarrhoea

Use with antifungal agents 

• Because of its fungal nature, Saccharomyces boulardii should not be used concomitantly with antifungal agents (see Contraindications)

Administration precautions

• Saccharomyces boulardii consists of living cells and should not be mixed with liquids or food that are too hot (above 50 °C), iced, or contain alcohol. Therefore, it should not be used concomitantly with hot beverages, ice cream, or alcoholic drinks

Excipient precautions

• The capsule contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this product
• The sachet contains lactose, fructose and sorbitol. Patients with hereditary fructose intolerance (HFI), rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this product

Ability to drive and use machines

• This product is not expected to affect the ability to drive or operate machinery, as Saccharomyces boulardii CNCM I-745 is not absorbed into the bloodstream

Forms avail. in SA and covered in this monograph: cap, sac

South African registered indications and dosages

Diarrhoea associated with antibiotic therapy

• Oral (cap, sac): 500mg, twice a day; Duration of treatment: 1-3 weeks

Non-specific acute diarrhoea

• Oral (cap, sac): 250mg, twice a day; Duration of treatment: 1-3 weeks

May be taken in conjunction with antibiotics and other anti-diarrhoeal medication

Method of administration

Capsule: The capsule must be swallowed with a glass of water. In case the capsule is open, the powder of the capsule must be stirred into water immediately prior to intake

Sachet: Pour the contents of the sachet(s) in a little amount of water or sweetened beverage, mix and drink immediately

Due to a risk of airborne contamination, capsules and sachets should not be opened in patient rooms. Healthcare providers should wear gloves during handling of probiotics for administration, then promptly discard the gloves and properly wash their hands

The capsule and sachet should not be opened in close proximity of patients with a venous central catheter or with a peripheral catheter, even not treated with Saccharomyces boulardii to avoid any colonisation of the catheter, transmitted by the hands and/or the spread of microorganisms by air (see Warnings and Precautions)

Paed. forms avail. in SA and covered in this monograph: cap, sac

South African registered indications and dosages

Diarrhoea associated with antibiotic therapy
Non-specific acute diarrhoea

Infants and children

• Oral (cap, sac): 250mg, twice a day; Duration of treatment: 1-3 weeks (see below for method of administration)

May be taken in conjunction with antibiotics and other anti-diarrhoeal medication

Method of administration

Capsule: The capsule must be swallowed with a glass of water. In case the capsule is open, the powder of the capsule must be stirred into water immediately prior to intake. In infants and small children under 6 years of age, it is recommended not to swallow the capsule (risk of false passage), but to open it and add its content to a food or sweetened drink

Sachet: Pour the contents of the sachet(s) in a little amount of water or sweetened beverage, mix and drink immediately

Due to a risk of airborne contamination, capsules and sachets should not be opened in patient rooms. Healthcare providers should wear gloves during handling of probiotics for administration, then promptly discard the gloves and properly wash their hands

The capsule and sachet should not be opened in close proximity of patients with a venous central catheter or with a peripheral catheter, even not treated with Saccharomyces boulardii to avoid any colonisation of the catheter, transmitted by the hands and/or the spread of microorganisms by air (see Warnings and Precautions)

Pregnancy

South African recommendations

• Caution; not recommended
• Safety in pregnancy has not been established
• It is preferable, as a precautionary measure, not to use this medicine during pregnancy

Breastfeeding

South African recommendations

• Caution; not recommended
• Safety in breastfeeding has not been established
• It is preferable, as a precautionary measure, not to use this medicine during breastfeeding

Fertility

South African recommendations

• No information available

South African recommendations

• Caution; no information available

South African recommendations

• Caution; no information available

South African recommendations

• No dose adjustment recommended

Infections and Infestations

Very rare

• Fungemia (in patients with a central venous catheter, and in hospitalised, immunocompromised patients)

Unknown

• Sepsis in critically ill or immunocompromised patients

Immune System Disorders

Very rare

• Anaphylactic reaction or even shock

Gastrointestinal Disorders

Rare

• Flatulence

Unknown

• Constipation

Skin and Subcutaneous Tissue Disorders

Very rare

• Allergic reactions
  • Pruritus
  • Wheal formation (urticaria)
  • Skin rash, either locally restricted or affecting the entire body (local or generalised exanthema)
  • Swelling of the connective tissue of the face (angioedema)

• Antifungal agents

None routine

Acute infectious diarrhoeas result from a disruption of the gastrointestinal ecosystem thus favouring the colonisation by enteropathogens and promoting their ability to upset the enterosystemic water cycle. Thus along with specific antidiarrhoeal medication, there should also be active rehydration of the patient.

Saccharomyces boulardii CNCM I-745 is a living yeast, which is active in the gastrointestinal tract. This yeast has an antagonistic effect against the overgrowth of different enteropathogenic bacteria (Shigella dysenteriae, Salmonella typhi, Escherichia coli) and Candida albicans.

It also enhances non-specific immune defences in the case of experimental bacterial (Staphylococcus aureus, Salmonella enteritidis) or fungal (Candida albicans) invasions. These actions re-establish the equilibrium of the gastrointestinal ecosystem and so reduce diarrhoea.

Saccharomyces boulardii CNCM I-745 also synthesises and supplies vitamin B components within the gastrointestinal tract. This yeast is genetically resistant to antibacterial medicines and so can be taken in conjunction with antibiotics to prevent diarrhoea.

Capsule 250mg

• Inteflora 250 (Pharmacare Limited)

Sachet 250mg

• Inteflora Sachets (Pharmacare Limited)