Inteflora 250 Capsules 250 mg Capsules

INTEFLORA 250 capsules have been used for:

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

Posology

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 capsules twice a day.

Non-specific acute diarrhoea

Adults: Take one capsule twice a day.

Paediatric population

Diarrhoea associated with antibiotic therapy

Infants and children: Give one capsule twice a day. Note the special recommendations in infants and children below six years of age in section u2018Method of administrationu2019 below.

Non-specific acute diarrhoea

Infants and children: Give one capsule twice a day. Note the special recommendations in infants and children below six years of age in section u2018Method of administrationu2019 below.

Method of administration

For oral administration. 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 (see section 4.4). Due to a risk of airborne contamination, capsules 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 250 is contraindicated in:

• Patients with a known hypersensitivity to any component contained in INTEFLORA 250 (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).
• Patients taking alcohol.
• Patients taking oral or systemic antifungal medicines (see section 4.5).

INTEFLORA 250 CAPSULES 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 (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 250 should not be used concomitantly with antifungals (see sections 4.3 and 4.5).
3. Since INTEFLORA 250 consist of living cells, do not mix the content of INTEFLORA 250 with liquid or food which is too hot (more the 50 u00b0C), iced or contains alcohol (see sections 4.2 and 4.3). Therefore INTEFLORA 250 should not be used concomitantly with hot beverages, ice cream and alcohol (see section 4.2 and 4.3).

Excipients INTEFLORA 250 contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take INTEFLORA 250.

Because of its fungal nature, do not combine INTEFLORA 250 with an oral or systemic antifungal medication (see section 4.3).

Safety of INTEFLORA 250 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 250 is not expected to have an influence on the ability to drive and use machines as Saccharomyces boulardii CNCM I-745, as contained in INTEFLORA 250, 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 via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: 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.