CODEX 12CPS 5MLD 250MG

CODEX 5 MILIARD CAPSULE READ

active ingredients

Codex 5 billion rigid capsules Each capsule contains: active ingredient: Saccharomyces boulardii 5 billion live germs (in the form of 250 mg of lyophilized powder) Excipient with known effect: lactose. For the full list of excipients, see paragraph 6.1

Excellent

Codex 5 billion rigid capsules Each capsule contains: lactose; magnesium stearate; gelatine; titanium dioxide

Therapeutic indications

Prophylaxis and treatment of intestinal dysmicrobism and related diarrhoic syndromes.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. Patients bearers of central venous catheter. Allergy to yeasts, in particular Saccharomyces boulardii. Patients under critical conditions or immunocompromised patients, due to the risk of acting (see paragraph 4.4.).

Population

Adults: 1-2 capsules 2 times a day. Save different prescription. Codex is recommended at regular intervals, possibly fasting or at least 15 minutes before meals. In course of antibiotic therapy administer Codex at the same time. Due to the risk of airborne contamination, the capsules should not be opened in environments where patients are located. During the manipulation of probiotics to be administered to patients, healthcare personnel must wear disposable gloves, dispose immediately after use and thoroughly wash their hands (see paragraph 4.4).

Conservation

No special precaution for conservation.

Warnings

Do not mix Codex with liquids too hot or with alcohol solutions. In view of the fungal nature of Saccharomyces boulardii, Codex should not be administered during topical or systemic antifungal therapy. General information - The treatment of diarrhea is not a substitute for rehydration when necessary. The extent of rehydration and its way of administration must be measured at the severity of diarrhea and at the age and health of the patient. - Very rare cases of functionmia have occurred (and positive hemocultures for strains of Saccharomy) and sepsis mostly in patients with central venous catheter, patients in critical or immunocompromised conditions, resulting in most cases in pyrexia. In most cases the outcome was satisfactory after the termination of treatment with Saccharomyces boulardii, the administration of an antifungal treatment and the removal of the catheter where necessary. However, the outcome was fatal in some patients under critical conditions (see paragraph 4.3 and 4.8). - As with all medicines based on live microorganisms, it is necessary to pay particular attention during product manipulation, mainly in the presence of patients with central venous catheter, but also in the presence of patients with peripheral venous catheter, although not treated with Saccharomyces boulardii, in order to avoid contamination by contact and/or diffusion of microorganisms by air (see paragraph 4.2). Important information about some excipients CODEX 5 billion rigid capsules - contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose mal absorption, should not take this medicine - it does not contain gluten.

Interactions

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

Effects

Following the administration of Codex, the following side effects were reported:

Organic systemic classification	Rare	Very rare	Frequency not known
Skin and subcutaneous tissue pathologies		allergic reactions: facial edema (angioedema), itching, pomps (orticaria) and localized or systemic rash.
Immune system pathologies		Anaphylactic reaction or shock.
Gastrointestinal diseases	Flatulence		Constipation
Infections and infestations		Phungemia in patients with central venous catheter and in patients under critical or immunocompromised conditions (see paragraph 4.4).	Sepsis in patients under critical or immunocompromised conditions (see section 4.4)

Reporting of suspicious adverse reactions. The reporting of suspicious 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. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

In case of overdose, special interventions are not required.

No reliable information on teratogenicity in animals is available. Clinically no malformations and fetotoxic effects have been reported. However, since the data resulting from the monitoring of pregnant women exposed to the medicinal product is insufficient, no risk can be excluded. Despite the Saccharomyces boulardii it is not absorbed, its administration during pregnancy and during the breastfeeding period, should be carried out only in case of actual need under the direct control of the doctor who will assess the risk/benefit ratio.

Source: Farmadati