Codex 20 Sachets 5 billion 250 mg

WARNINGS
Do not mix with too hot liquids or alcoholic solutions. In consideration of the fungal nature of Saccharomyces boulardii, it 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. It is necessary to pay particular attention to the handling of the product in the presence of patients with central venous catheter to avoid any contamination involving the hands and / or the spread of spores by air. In fact, in patients with central venous catheter, even if not treated with Saccharomyces boulardii, very rare cases of fungemia (spread of yeast in the blood) have been reported which very often manifests itself with pyrexia and positive blood culture of Saccharomyces strains. All of these cases resolved favorably following treatment with antifungals and, where necessary, removal of the catheter. Contains lactose and fructose and is therefore not suitable for patients with rare hereditary problems of galactose or fructose intolerance, Lapp lactase deficiency or glucose / galactose malabsorption. It does not contain gluten.
PHARMACOTHERAPEUTIC CATEGORY
Antidiarrheal microorganisms.
STORAGE
No special storage precautions.
CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active substance or to any of the excipients. Patients with central venous catheter. Allergy to yeasts.
NAME
CODEX 5 BILLION POWDER FOR ORAL SUSPENSION
EXCIPIENTS
Lactose monohydrate, fructose, anhydrous colloidal silica, all fruit flavor.
SIDE EFFECTS
Rare cases of flatulence, and very rare cases of allergic reactions in the form of face edema (angioedema) and / or pruritus, wheals (urticaria) and localized or systemic rash have been reported following the administration of Codex. In addition, very rare cases of anaphylactic reaction or shock have been reported. Report any suspected adverse reactions via the national reporting system.
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 under the direct supervision of the doctor who will evaluate the risk / benefit ratio.
INDICATIONS
Prophylaxis and treatment of intestinal dysmicrobism induced by antibiotics and sulfonamides and of the dysvitaminosis 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. Treatment of candidiasis of the gastrointestinal tract.
INTERACTIONS
In view of the fungal nature of Saccharomyces boulardii, do not administer during topical or systemic antifungal therapy.
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 recommended to administer it at regular intervals, preferably 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.
ACTIVE PRINCIPLES
Saccharomyces boulardii 5 billion live germs (in the form of 250 mg of lyophilized powder).