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BIOFLOR 250MG 10'S SACHETS (Z)


    RM 30.00

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Contents
Lyophilized Saccharomyces boulardii CNCM I-745.

Description
Capsule: 250 mg of Saccharomyces boulardii CNCM I-745 (lyophilized yeast cells).
Each capsule is required to present a minimum Saccharomyces boulardii CNCM I-745 of 2.5 x 109 CFU.
Powder for oral suspension: 250 mg of Saccharomyces boulardii CNCM I-745 (lyophilized yeast cells).
Each sachet is required to present a minimum Saccharomyces boulardii CNCM I-745 of 2.5 x 109 CFU.
Appearance after reconstitution: liquid suspension with a milky appearance.
Excipients/Inactive Ingredients: Capsule: lactose, magnesium stearate.
Composition of the capsule shell: gelatin, titanium dioxide (E171).
Powder for oral suspension: lactose, fructose, colloidal anhydrous silica, tutti-frutti flavour.

Indications/Uses
Treatment of acute infectious diarrhoea of infants (powder for oral suspension only), children and adults;
Prevention of antibiotic-associated diarrhoea in children and adults;
Addition to vancomycin/metronidazole-treatment to prevent recurrence of Clostridium difficile diseases in adults;
Prevention of tube-feeding associated diarrhoea in adults.

Dosage/Direction for Use
Recommended Dosage: Capsule: Children (> 6 years old): 1 to 2 capsules daily.
Adults: 1 or 2 capsules, once or twice daily. Capsules should be swallowed with a glass of water.
The capsules can be taken either during, before or after meals. In young children under 6 years of age, it is recommended not to swallow capsules (risk of false passage) and to use the powder for oral suspension in sachet.
Powder for oral suspension: Infants and children: 1 or 2 sachets daily.
Adults: 1 or 2 sachets, once or twice daily.
The sachets can be taken either during, before or after meals. Pour the contents of the sachet in a glass of water or sweetened beverage, mix, and drink. The powder can also be mixed with food or poured into a baby's feeding-bottle.
BIOFLOR 250 mg contains living cells. This drug should therefore not be mixed with very hot (over 50°C), iced or alcoholic drinks or food.
Treatment duration: Treatment of acute infectious diarrhoea of infants, children and adults: approximately 1 week.
Prevention of antibiotic-associated diarrhoea in children and adults: treatment should be started within 48 to 72 hours of the beginning of treatment with antibiotics and it should continue for at least three days and not longer than 4 weeks after the treatment with antibiotics is ended.
Addition to vancomycin/metronidazole-treatment to prevent recurrence of Clostridium difficile diseases in adults: treatment should be started as soon possible after the beginning of antibiotic treatment and it should continue for 4 weeks.
Prevention of tube-feeding associated diarrhoea in adults: during the period of tube-feeding.
The maximum duration of treatment in the usual indications is 4 weeks.

Method and Route of Administration: Capsule: Capsules should be swallowed with a glass of water. In young children under 6 years of age, it is recommended not to swallow capsules (risk of false passage) and to use the powder for oral suspension in sachet.
Powder for oral suspension: Pour the contents of the sachet in a little amount of water or sweetened beverage, mix, and drink. The powder can also be mixed with food or poured into a baby's feeding-bottle. It should not be poured or mixed with very cold or very hot liquids or food nor alcoholic drinks.

Overdosage
No case reported. If the patient has taken more Bioflor than the patient should, contact a pharmacist or a physician for advice.

Contraindications
Hypersensitivity to one of the components;
Patients with central venous catheter (see Precautions).
Critically ill patients or immunocompromised patients due to a risk of fungaemia. (See Precautions.)
IF IN DOUBT, IT IS ESSENTIAL TO SEEK THE ADVICE OF A DOCTOR OR A PHARMACIST.

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