Codex 5 Billion Zambon 20 Sachets

Codex 5 Billion Zambon - Medical Device

Composition

Codex 5 billion hard capsules Each capsule contains: active ingredient: Saccharomyces boulardii 5 billion live germs (in the form of 250 mg of lyophilized powder) Codex 5 billion powder for oral suspension Each sachet contains: active ingredient: Saccharomyces boulardii 5 billion live germs (in the form of 250 mg of lyophilized powder) For a full list of excipients, see section 6.1

Excipients

Codex 5 billion hard capsules Each capsule contains: lactose; magnesium stearate; jelly; Titanium dioxide Codex 5 billion powder for oral suspension Each sachet contains: lactose monohydrate, fructose, colloidal anhydrous silica, all fruit flavor.

Therapeutic 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.

Dosage

Adults: 1–2 capsules / 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.

Contraindications

• Hypersensitivity 'to the active substance or to any of the excipients
• Patients with central venous catheter; allergy to yeast.

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 the data deriving from the monitoring of pregnant women exposed to the drug are insufficient, it is not possible to exclude every risk.

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.

Expiry and retention

Check the expiration date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored. Warning: do not use the medicine after the expiry date indicated on the package.

Warnings

Do not mix the product with too hot liquids or with 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 (spread 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 hard capsules contain lactose; they do not contain gluten.

The powder for oral suspension contains lactose and fructose; does not contain gluten.

Composition

Active ingredient: Saccharomyces boulardii 5 billion live germs (in the form of 250 mg of lyophilized powder) Excipients: lactose; magnesium stearate; jelly; titanium dioxide

Format

Box of 20 sachets.