Inteflora Sachets 250 mg

INTEFLORA SACHET has been used for:

• Diarrhoea associated with antibiotic therapy.
• Non-specific acute diarrhoea. Suitable for use in infants, children, adults and in the elderly.

May be taken in conjunction with antibiotics and other anti-diarrhoeal medication. Length of treatment can range from 1 week to 3 weeks.

Diarrhoea associated with antibiotic therapy

• Adults: Take two sachets twice a day.

Non-specific acute diarrhoea

• Adults: Take one sachet twice a day.

Paediatric population

Diarrhoea associated with antibiotic therapy

• Infants and children: Give one sachet twice a day.

Non-specific acute diarrhoea

• Infants and children: Give one sachet twice a day.

Method of administration

For oral administration. Pour the contents of the sachet(s) in a little amount of water or sweetened beverage, mix and drink immediately (see section 4.4). Due to a risk of airborne contamination, 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 (see section 4.4).

INTEFLORA SACHET is contraindicated in:

• Patients with a known hypersensitivity to any component contained in INTEFLORA SACHET (see sections 2 and 6.1).
• Patients with a central venous catheter in situ.
• Critically ill patients or immunocompromised patients due to risk of fungaemia (see section 4.4).
• Because of the presence of lactose, this medicine is contraindicated in patients with congenital galactosaemia, glucose and galactose malabsorption syndrome or lactase deficiency (see section 4.4).
• Because of the presence of fructose and sorbitol, this medicine is contraindicated in patients with fructose intolerance (see section 4.4).
• Patients taking alcohol.
• Patients taking oral or systemic antifungal medicines (see section 4.5).

INTEFLORA 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 section 4.2 Method of administration). There have been 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). In 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. In infants, children and adults be aware of the following:

1. Rehydration by drinking copious amounts of salty or sweet drinks is recommended, in order to compensate for fluid losses due to diarrhoea.
2. INTEFLORA SACHET should not be used concomitantly with antifungals (see sections 4.3 and 4.5).
3. Since INTEFLORA SACHET consist of living cells, do not mix the content of INTEFLORA SACHET with liquid or food which are too hot (more than 50 u00b0C), iced or contains alcohol (see sections 4.2 and 4.3). Therefore INTEFLORA SACHET should not be used concomitantly with hot beverages, ice cream and alcohol (see section 4.2 and 4.3).

Excipients INTEFLORA 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 INTEFLORA SACHET.

Because of its fungal nature, do not combine INTEFLORA SACHET with an oral or systemic antifungal medication (see section 4.3).

Safety of INTEFLORA SACHET in pregnancy and lactation has not been established.

Pregnancy

It is preferable, as a precautionary measure, not to use this medicine during pregnancy.

Lactation

It is preferable, as a precautionary measure, not to use this medicine during lactation.

Fertility

No data.

INTEFLORA SACHET is not expected to influence on the ability to drive and use machines as Saccharomyces boulardii CNCM I - 745, as contained in INTEFLORA SACHET, is not absorbed into the blood.

a) Tabulated list of adverse reactions

System organ class

• Rare
• Very rare
• Unknown

Infections and infestations

• Fungemia in patients with a central venous catheter, and in hospitalised, immunocompromised patients (see section 4.4).
• Sepsis in critically ill or immunocompromised patients

Immune system disorders

• Anaphylactic reaction or even shock

Gastrointestinal disorders

• Flatulence
• Constipation

Skin and subcutaneous tissue disorders

• Allergic reactions: pruritus, wheal formation (urticaria), skin rash, either locally restricted or affecting the entire body (local or generalized exanthema), swelling of the connective tissue of the face (angioedema).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare providers are asked to report any suspected adverse reactions to: SAHPRA: https://www.sahpra.org.za/Publications/Index/8 Aspen Pharmacare: E-mail: [email protected] Tel: 0800 118 088

Saccharomyces boulardii CNCM I - 745 is not absorbed into the blood circulation and any overdose is merely excreted via the gastrointestinal tract.