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Codex 5 Billion Saccharomyces Boulardii 250mg 12 Capsules
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Codex 5 Miliardi Saccharomyces Boulardii 250mg 12 Capsule
Manufacturer
BIOCODEX
SKU
029032075
Active principle
SACCAROMICETI BOULARDII
NAME
CODEX 5 BILLION HARD CAPSULES
PHARMACOTHERAPEUTIC CATEGORY
Antidiarrheal microorganisms.
ACTIVE PRINCIPLES
Saccharomyces boulardii 5 billion live germs (in the form of 250 mg of lyophilized powder).
EXCIPIENTS
Lactose; magnesium stearate; jelly; titanium dioxide.
INDICATIONS
Prophylaxis and treatment of intestinal dysmicrobism and related diarrheal syndromes.
CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active substance or to any of the excipients; patients with central venous catheter, yeast allergy.
DOSAGE
Adults: 1-2 capsules 2 times a day. Unless otherwise prescribed by a doctor. It is advisable to administer the drug at regular intervals, possibly on an empty stomach or at least 15 minutes before meals. During therapy with antibiotics, administer the medicine at the same time as these.
STORAGE
No special storage precautions.
WARNINGS
Do not mix the drug with too hot liquids or alcoholic solutions. In view of the fungal nature of Saccharomyces boulardii, the medicinal product 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; does not contain gluten.
INTERACTIONS
In view of the fungal nature of Saccharomyces boulardii, the medicinal product should not be administered during topical or systemic antifungal therapy.
SIDE EFFECTS
Rare cases of flatulence, and very rare cases of allergic reactions in the form of facial edema (angioedema) and / or pruritus, hives (urticaria) and localized or systemic rashes have been reported following the administration of the drug. 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 drug is important, as it allows continuous monitoring of the benefit / risk ratio of the drug.
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.
CODEX 5 BILLION HARD CAPSULES
PHARMACOTHERAPEUTIC CATEGORY
Antidiarrheal microorganisms.
ACTIVE PRINCIPLES
Saccharomyces boulardii 5 billion live germs (in the form of 250 mg of lyophilized powder).
EXCIPIENTS
Lactose; magnesium stearate; jelly; titanium dioxide.
INDICATIONS
Prophylaxis and treatment of intestinal dysmicrobism and related diarrheal syndromes.
CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active substance or to any of the excipients; patients with central venous catheter, yeast allergy.
DOSAGE
Adults: 1-2 capsules 2 times a day. Unless otherwise prescribed by a doctor. It is advisable to administer the drug at regular intervals, possibly on an empty stomach or at least 15 minutes before meals. During therapy with antibiotics, administer the medicine at the same time as these.
STORAGE
No special storage precautions.
WARNINGS
Do not mix the drug with too hot liquids or alcoholic solutions. In view of the fungal nature of Saccharomyces boulardii, the medicinal product 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; does not contain gluten.
INTERACTIONS
In view of the fungal nature of Saccharomyces boulardii, the medicinal product should not be administered during topical or systemic antifungal therapy.
SIDE EFFECTS
Rare cases of flatulence, and very rare cases of allergic reactions in the form of facial edema (angioedema) and / or pruritus, hives (urticaria) and localized or systemic rashes have been reported following the administration of the drug. 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 drug is important, as it allows continuous monitoring of the benefit / risk ratio of the drug.
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.