Ultra-Levura 250 Mg 20 Granulated Envelopes Oral Suspension

Ultra-Levura (250 Mg 20 Envelopes Granules Oral Suspension)

ACTION AND MECHANISM

Antidiarrheal Bacterial Microorganism It acts by replacing the pathogenic flora of the intestine with another similar to the physiological one.

INDICATIONS

- Symptomatic treatment of nonspecific acute [DIARREA] and in the prevention and symptomatic treatment of diarrheal processes produced by the administration of antibiotics.

POSOLOGY

"GRANULATED FOR ORAL SUSPENSION":

- Adults and adolescents> 18 years: 250-500 mg / 24 h, distributed in 2 doses in the morning and at night.

- Children <12 years: 250 mg / 24 h. Use under medical control in children <2 years.

- Elderly: no specific dosage recommendations have been established.

RULES FOR THE CORRECT ADMINISTRATION

- Envelopes: dissolve the contents of the envelopes in a glass of water. Ingest immediately after.

Due to the risk of air pollution, envelopes or capsules should not be opened in patient rooms. Healthcare professionals should wear gloves while handling probiotics for administration and then dispose of them quickly and wash their hands properly.

Administration with food: preferably administered before meals.

CONTRAINDICATIONS

- Hypersensitivity to the active substance, to yeasts (especially saccharomyces boulardii) or to any of the excipients.

- Patients with central venous catheter.

- Patients seriously ill or with [IMMUNODEFICIENCY] due to a risk of fungemia (see Precautions).

PRECAUTIONS

- Infection There have been very rare cases of fungemia with fever (and positive blood cultures by strains of Saccharomyces), mainly in patients with central venous catheter, seriously ill or immunocompromised. In most cases, the patient recovered by stopping treatment, administering antifungals and removing the catheter when necessary. However, fatal cases have been described (see Contraindications).

Pay special attention to the manipulation of the drug in the presence of patients mainly with central venous catheter, but also with peripheral catheter, although they do not receive treatment with Saccharomyces boulardii, to avoid any contamination through the hands or the spread of microorganisms through the air.

PRECAUTIONS RELATING TO EXCIPIENTS

- This medicine contains fructose. Patients with hereditary [INTOLERANCE TO FRUCTOSE] should not take this medication.

- This medicine contains lactose. Patients with hereditary or galactose [INTOLERANCE TO LACTOSE], Lapp lactase insufficiency or glucose or galactose malabsorption should not take this medicine.

- This medicine contains lactose. The intake of amounts greater than 5 g daily should be taken into account in patients with [DIABETES] and with intolerance to certain sugars.

- This medicine contains fructose. The intake of amounts greater than 5 g daily should be taken into account in patients with [DIABETES] and with intolerance to certain sugars.

PATIENT ADVICE

- Tell your doctor and / or pharmacist if diarrhea persists for more than 2 days or blood appears in the stool or fever.

SPECIAL WARNINGS

- Evaluate the patient if diarrhea persists more than 2 days or blood appears in the stool or fever, reconsidering the treatment and the need to introduce oral or parenteral rehydration.

- Cases of fungemia have been reported in patients treated with Saccharomyces boulardii, including some with fatal outcome in critically ill patients. Therefore, its use is contraindicated in critically ill patients, as well as in immunosuppressed patients, and in carriers of a central venous catheter. On the other hand, patients who are in the vicinity of those who are being treated with S. boulardii, may also be exposed to the risk of contamination by the microorganisms of the drug. Therefore, special attention should be paid during the handling of the product in the presence of critically or immunocompromised patients, or in the presence of a central or peripheral venous catheter that is not being treated with this medicine. To avoid any contamination through the hands or the spread of microorganisms by air, envelopes or capsules should not be opened in patients' rooms. Healthcare professionals should wear gloves while handling probiotics and then dispose of them quickly and wash their hands properly.

INTERACTIONS

- Oral or systemic antifungal treatments, due to the fungal nature of saccharomyces boulardii yeast. Avoid joint administration.

- Very hot drinks or foods (above 50ºC), ice cream or alcohol containing since Saccharomyces boulardii contains living cells. Avoid administering sacharomyces boulardii with this type of beverage or food.

PREGNANCY

Animal safety : no data available.

Safety in humans : adequate and well-controlled studies in humans are not available. Its administration is only accepted if there are no safer therapeutic alternatives, and the benefits outweigh the possible risks.

Fertility effects : no specific studies have been conducted in humans.

LACTATION

There are no relative data in breastfeeding women. Although saccharomyces boulardii is not absorbed, it is preferable to evaluate the benefit / risk ratio before using it during breastfeeding.

ADVERSE REACTIONS

Adverse reactions are described according to each frequency range, being considered very frequent (> 10%), frequent (1-10%), rare (0.1-1%), rare (0.01-0.1%) , very rare (<0.01%) or of unknown frequency (cannot be estimated from the available data).

- Digestive: rare [FLATULENCE].

- Infectious: very rare fungemia in patients with central venous catheter and in critically or immunocompromised patients (see Precautions and Contraindications).

- Allergic: very rare [HYPERSENSITIVITY REACTIONS], with [PRURITO], [URTICARIA], [EXANTEMATIC ERUPTIONS], [ANGIOEDEMA] or [ANAFILAXIA].

ADVERSE REACTIONS CONCERNING EXCIPIENTS

- This medicine contains lactose, which may have milk proteins. It could cause [HYPERSENSITIVITY REACTIONS] in people with a cow's milk protein allergy.

- [DENTAL CARIES]. This medicine contains fructose. In case of oral administration in which the medicine is in contact with the teeth (eg oral liquids, lozenges and chewable tablets) and will be used long term (2 or more weeks), it can cause tooth decay.

Ultra-Levura 250 Mg 20 Envelopes Granules Oral Suspension Envelopes