Codex 5 Miliardi 250mg Saccharomyces Boulardii 20 Bustine

NAME
CODEX 5 BILLION POWDER FOR ORAL SUSPENSION

PHARMACOTHERAPEUTIC CATEGORY
Antidiarrheal microorganisms.

ACTIVE PRINCIPLES
Saccharomyces boulardii 5 billion live germs (in the form of 250 mg of lyophilized powder).

EXCIPIENTS
Lactose monohydrate, fructose, anhydrous colloidal silica, all-fruit flavor.

INDICATIONS
Prophylaxis and treatment of intestinal dysmicrobism induced by antibiotics and sulfonamides and of the disvitaminosis caused by them; therapy of acute diarrhea of various etiologies; prophylaxis and treatment of traveler's diarrhea; treatment of irritable bowel syndrome with altered alvus; therapy of candidiasis of the gastrointestinal tract.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity to the active substance or to any of the excipients; patients with central venous catheter; allergy to yeast.

DOSAGE
Adults: 1-2 sachets 2 times a day. Children from 0 to 3 years: 1 sachet 2 times a day. Children from 3 to 12 years: 1 sachet 3 times a day. Unless otherwise prescribed by a doctor. It is advisable to administer the medicine at regular intervals, possibly on an empty stomach or at least 15 minutes before meals. During therapy with antibiotics, administer the drug at the same time as these. For infants or children it is advisable to pour the contents of the sachet into the bottle, or into a little sweetened liquid.

STORAGE
No special storage precautions.

WARNINGS
Do not mix the medicine with too hot liquids or alcoholic solutions. In view of the fungal nature of Saccharomyces boulardii, the drug should not be administered during topical or systemic antifungal therapy. Treatment of diarrhea is not a substitute for rehydration when needed. The extent of rehydration and its route of administration must be commensurate with the severity of the diarrhea and the age and state of health of the patient. As for all medicines based on living microorganisms, it is necessary to pay particular attention to the handling of the product in the presence of patients with central venous catheters to avoid any contamination involving the hands and / or the spread of spores by air. In fact, very rare cases of fungemia (diffusion of yeast in the blood) have been reported in patients with central venous catheter, even if not treated with Saccharomyces boulardii, which very often manifests itself with pyrexia and blood culture positive for Saccharomyces strains. All of these cases resolved favorably following treatment with antifungals and, where necessary, removal of the catheter. The medicine contains lactose and fructose; does not contain gluten.

INTERACTIONS
In view of the fungal nature of Saccharomyces boulardii, the drug should not be administered during topical or systemic antifungal therapy.

SIDE EFFECTS
Rare cases of flatulence have been reported following administration of the drug, and very rare cases of allergic reactions in the form of face edema (angioedema) and / or pruritus, wheals (urticaria) and localized or systemic rash. In addition, very rare cases of anaphylactic reaction or shock have been reported. The reporting of suspected adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product.

PREGNANCY AND BREASTFEEDING
No reliable information is available regarding teratogenicity in animals. Clinically no cases of malformations and foetotoxic effects have been reported. However, as there are insufficient data from the monitoring of pregnant women exposed to the drug, it is not possible to exclude all risks. Although Saccharomyces boulardii is not absorbed, its administration during pregnancy and during the lactation period, should be carried out only in case of real need.