Codex 5 billion 10 sachets powder for oral suspension

Codex 5 billion 10 sachets powder for oral suspension is a probiotic based on Saccharomyces boulardii , a live yeast that helps restore the balance of the intestinal flora . Each sachet contains 5 billion live cells, ensuring effective action in the treatment and prevention of diarrhea of ​​various origins, including traveler's diarrhea and diarrhea associated with the use of antibiotics and sulphonamides. Codex is also indicated for the prophylaxis and treatment of intestinal dysbiosis and vitamin deficiencies caused by alterations of the bacterial flora, as well as support in irritable bowel syndrome with altered bowel habits and candidiasis of the gastrointestinal tract .

The powder formulation for oral suspension makes Codex 5 billion particularly practical and suitable for both adults and children , offering a rapid and well-tolerated solution for intestinal well-being . The selected excipients, such as lactose monohydrate, fructose and tutti i frutti flavouring , ensure good palatability and ease of use. Codex 5 billion does not contain gluten and is ideal for those looking for a lactic ferment with proven efficacy for the treatment of acute diarrhea and the prevention of alterations of the intestinal flora during antibiotic therapies or travel.

Thanks to the presence of Saccharomyces boulardii , Codex 5 billion acts in a targeted way to counteract the proliferation of pathogenic microorganisms and promote the rebalancing of the intestinal flora, helping to reduce gastrointestinal disorders and improve the quality of life. The pack of 10 sachets is ideal for short treatment cycles or for those who need probiotic support during periods of particular intestinal stress.

ACTIVE INGREDIENTS

Active ingredients contained in Codex 5 billion 10 sachets powder for oral suspension - What is the active ingredient of Codex 5 billion 10 sachets powder for oral suspension?

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 freeze-dried powder) Excipients with known effects: fructose, lactose, sorbitol (contained in the tutti frutti flavour). For the full list of excipients, see section 6.1

EXCIPIENTS

Composition of Codex 5 billion 10 sachets powder for oral suspension - What does Codex 5 billion 10 sachets powder for oral suspension contain?

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

DIRECTIONS

Therapeutic indications Codex 5 billion 10 sachets powder for oral suspension - Why is Codex 5 billion 10 sachets powder for oral suspension used? What is it used for?

- Prophylaxis and treatment of intestinal dysbiosis induced by antibiotics and sulphonamides and of the vitamin deficiencies caused by them. - Treatment of acute diarrhea of ​​various etiologies. - Prophylaxis and treatment of "traveler's diarrhea". - Treatment of irritable bowel syndrome with altered bowel habits. - Treatment of candidiasis of the gastrointestinal tract.

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Codex 5 billion 10 sachets powder for oral suspension - When should Codex 5 billion 10 sachets powder for oral suspension not be used?

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

DOSAGE

Quantity and method of taking Codex 5 billion 10 sachets powder for oral suspension - How to take Codex 5 billion 10 sachets powder for oral suspension?

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 your doctor. It is recommended to administer Codex at regular intervals, possibly on an empty stomach or at least 15 minutes before meals. During treatment with antibiotics, administer Codex at the same time as these. For infants or children, it is recommended to pour the contents of the sachet into the feeding bottle, or into a little sugared liquid. Due to the risk of airborne contamination, the sachets should not be opened in the environment where patients are present. When handling probiotics to be administered to patients, healthcare personnel must wear disposable gloves, dispose of them immediately after use and wash their hands thoroughly (see section 4.4).

CONSERVATION

Storage Codex 5 billion 10 sachets powder for oral suspension - How do you store Codex 5 billion 10 sachets powder for oral suspension?

No special storage precautions.

WARNINGS

Warnings Codex 5 billion 10 sachets powder for oral suspension - About Codex 5 billion 10 sachets powder for oral suspension it is important to know that:

Do not mix Codex with very hot liquids or alcoholic solutions. Due to the fungal nature of Saccharomyces boulardii , Codex should not be administered during topical or systemic antifungal therapy. General information - Treatment of diarrhoea is not a substitute for rehydration, when necessary. The amount of rehydration and its administration route should be commensurate with the severity of the diarrhoea and the age and health of the patient. - Very rare cases of fungemia (and positive blood cultures for Saccharomyces strains) and sepsis have occurred mostly in critically ill or immunocompromised patients with central venous catheters, resulting in most cases in pyrexia. In the majority of cases, satisfactory outcome has been achieved after discontinuation of treatment with Saccharomyces boulardii , administration of antifungal treatment and removal of the catheter, where necessary. However, the outcome was fatal in some critically ill patients (see sections 4.3 and 4.8). - As with all medicinal products based on live microorganisms, special care must be taken 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 with Saccharomyces boulardii , in order to avoid contamination by contact and/or spread of microorganisms by air (see section 4.2). Important information about some of the excipients CODEX 5 billion powder for oral suspension - contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine. - contains 471.90 mg of fructose per sachet . Patients with hereditary fructose intolerance should not be given this medicine. contains sorbitol. This medicine contains 0.1 mg sorbitol per sachet. - does not contain gluten.

INTERACTIONS

Interactions Codex 5 billion 10 sachets powder for oral suspension - Which medicines or foods can modify the effect of Codex 5 billion 10 sachets powder for oral suspension?

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

SIDE EFFECTS

Like all medicines, Codex 5 billion 10 sachets powder for oral suspension can cause side effects - What are the side effects of Codex 5 billion 10 sachets powder for oral suspension?

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

Systemic organic classification	Rare	Very rare	Frequency not known
Skin and subcutaneous tissue disorders		allergic reactions: facial swelling (angioedema), itching, hives (urticaria) and localized or systemic rash.
Immune system disorders		Anaphylactic reaction or shock.
Gastrointestinal disorders	Flatulence		Constipation
Infections and infestations		Fungemia in patients with central venous catheters and in critically ill or immunocompromised patients (see section 4.4).	Sepsis in critically ill or immunocompromised patients (see section 4.4)

Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse .

OVERDOSE

Overdose Codex 5 billion 10 sachets powder for oral suspension - What are the risks of Codex 5 billion 10 sachets powder for oral suspension in case of overdose?

In case of overdose, no special interventions are required.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Codex 5 billion 10 sachets powder for oral suspension.

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

DRIVING AND USE OF MACHINERY

Taking Codex 5 billion 10 sachets powder for oral suspension before driving or using machines - Does Codex 5 billion 10 sachets powder for oral suspension affect driving or using machines?

No studies on the ability to drive and use machines have been performed.