Codex 10 sachets 5mld 250mg

CODEX * 10BUST 5MLD 250MG

Therapeutic 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 etiology. - Prophylaxis and treatment of "traveler's diarrhea". - Treatment of irritable bowel syndrome with altered alvus - Treatment of candidiasis of the gastrointestinal tract.

Dosage and method of use

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 Codex at regular intervals, preferably on an empty stomach or at least 15 minutes before meals. During therapy with antibiotics, administer Codex 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. Due to the risk of airborne contamination, sachets should not be opened in patient environments. When handling probiotics for administration to patients, healthcare professionals should wear disposable gloves, dispose of them immediately after use and wash their hands thoroughly (see section 4.4).

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients with central venous catheter. Allergy to yeasts, especially aSaccharomyces boulardii. Critically ill or immunocompromised patients due to the risk of fungemia (see section 4.4).

Side effects

The following undesirable effects have been reported following administration of Codex:

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting systemwww.aifa.gov.it/content/segnalazioni-reazioni-avverse .

Special warnings

Do not mix Codex with too hot liquids or with alcoholic solutions. In view of the fungal nature ofSaccharomyces boulardii, Codex should not be administered during topical or systemic antifungal therapy. General informations - Treatment of diarrhea is not a substitute for rehydration when needed. The extent of rehydration and its route of administration should be commensurate with the severity of the diarrhea and the age and state of health of the patient. - There have been very rare cases of fungemia (and positive blood cultures forSaccharomyces) and sepsis mostly in patients with central venous catheter, critically ill or immunocompromised, resulting in most cases in pyrexia. In the majority of cases the outcome was satisfactory after discontinuation of treatment withSaccharomyces boulardii, the administration of antifungal treatment and the removal of the catheter, if necessary. However, the outcome was fatal in some critically ill patients (see sections 4.3 and 4.8). - As with all drugs based on live microorganisms, special attention must be paid when handling the product, mainly in the presence of patients with a central venous catheter, but also in the presence of patients with a peripheral venous catheter, even if not treated withSaccharomyces boulardii, in order to avoid contact contamination and / or spread of microorganisms by air (see section 4.2). Important information about some of the ingredients CODEX 5 billion powder for oral suspension- containslactose.Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicine. - contains 471.90 mg offructoseper sachet.Patients with hereditary fructose intolerance should not be given this medicine. containssorbitol.This medicine contains 0.1 mg of sorbitol per sachet. - does not contain gluten.

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 medicinal product, all risks cannot be excluded. Despite theSaccharomyces boulardiiits administration is not absorbed during pregnancy and during the lactation period, it should be carried out only in case of real need under the direct supervision of the doctor who will evaluate the risk / benefit ratio.

Expiration and retention

No special storage precautions.

Interactions with other drugs

In view of the fungal nature ofSaccharomyces boulardii, Codex should not be administered during topical or systemic antifungal therapy.

Overdose

In case of overdosing, no special interventions are required.

Active principles

Codex 5 billion powder for oral suspensionEach sachet contains: active ingredient:Saccharomyces boulardii5 billion live germs (in the form of 250 mg of lyophilized powder) Excipients with known effects: fructose, lactose, sorbitol (contained in the all fruits flavor). For the full list of excipients, see section 6.1

Excipients

Codex 5 billion powder for oral suspensionEach sachet contains: lactose monohydrate, fructose, anhydrous colloidal silica, all fruit flavor (containing sorbitol).