Codex 5 Billion 250 mg 12 Tablets | Buy Online at Farmaclick

What is Codex 5 Billion 250 mg 12 Capsules

PHARMACOTHERAPEUTIC CATEGORY:

Antidiarrheal microorganisms.

ACTIVE INGREDIENTS:

Codex 5 billion hard capsules.
Each capsule contains: 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.

EXCIPIENTS:

Codex 5 billion hard capsules.
Each capsule contains: lactose; magnesium stearate; gelatin; titanium dioxide

INDICATIONS:

Prophylaxis and treatment of intestinal dysmicrobism and related diarrheal syndromes.

CONTRAINDICATIONS/SIDE EFFECTS:

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

DOSAGE:

Adults: 1-2 capsules 2 times a day.
Unless otherwise prescribed by a physician.
It is recommended to administer Codex at regular intervals, preferably on an empty stomach or at least 15 minutes before meals.
During antibiotic therapy, administer Codex simultaneously with the antibiotics.
Due to the risk of airborne contamination, capsules should not be opened in areas where patients are located.
When handling probiotics to be administered to patients, healthcare personnel should wear disposable gloves, dispose of them immediately after use, and wash their hands thoroughly (see paragraph 4.4).

STORAGE:

No special storage precautions.

WARNINGS:

Do not mix Codex with liquids that are too hot or with alcoholic solutions.
Given 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 route of administration must be proportionate to the severity of the diarrhea and the patient's age and health status.
Very rare cases of fungemia (and positive blood cultures for Saccharomyces strains) and sepsis have occurred, mostly in patients with a central venous catheter, critically ill or immunocompromised patients, resulting in pyrexia in most cases.
In the majority of cases, the outcome was satisfactory after discontinuation of Saccharomyces boulardii treatment, administration of antifungal treatment, and removal of the catheter, where necessary.
However, the outcome was fatal in some critically ill patients (see paragraphs 4.3 and 4.8).
As with all drugs based on live microorganisms, particular attention must be paid during product handling, 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 with Saccharomyces boulardii, in order to avoid contact contamination and/or the spread of microorganisms via the air (see paragraph 4.2).
Important information about some excipients CODEX 5 billion hard capsules - contains lactose.
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicine - it does not contain gluten.

INTERACTIONS:

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

UNDESIRABLE EFFECTS:

The following side effects have been reported following the administration of Codex.
Skin and subcutaneous tissue disorders.
Very rare: (allergic reactions) facial edema (angioedema), pruritus, wheals (urticaria), and localized or systemic rash.
Immune system disorders.
Very rare: anaphylactic reaction or shock.
Gastrointestinal disorders.
Rare: flatulence; frequency not known: constipation.
Infections and infestations.
Very rare: fungemia in patients with a central venous catheter and in critically ill or immunocompromised patients (see paragraph 4.4); frequency not known: sepsis in critically ill or immunocompromised patients (see section 4.4).
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 required to report any suspected adverse reaction via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

PREGNANCY AND BREASTFEEDING:

No reliable information is available regarding teratogenicity in animals.
Clinically, no cases of malformations and fetotoxic effects have been reported.
However, since data derived from monitoring pregnant women exposed to the medicine are insufficient, it is not possible to exclude any risk.
Although Saccharomyces boulardii is not absorbed, its administration during pregnancy and during the breastfeeding period should only be carried out in case of real necessity under the direct supervision of a doctor who will evaluate the risk/benefit ratio.