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ALFASIGMA SpA

Yovis 1 g 10 sachets granules for oral suspension

Yovis 1 g 10 sachets granules for oral suspension

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Yovis 1 g is a medicine based on freeze-dried live lactic ferments in granule sachets for oral suspension , useful for restoring intestinal bacterial flora . Indicated in cases of diarrhea , colitis , enteritis and intestinal dysbiosis caused by antibiotics , it helps regulate the intestine and reduce swelling and abdominal discomfort in adults and children aged 6 and over.

NET WEIGHT OF THE PRODUCT

EAN

029305012

MINSAN

029305012

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Yovis 1 g 10 sachets granules for oral suspension is a supplement based on freeze-dried live lactic ferments , designed to help restore and maintain the balance of the intestinal bacterial flora . Each sachet contains a balanced blend of probiotics, including Streptococcus salivarius subsp. thermophilus , Bifidobacterium brevis , Bifidobacterium animalis lactis , Lactobacillus acidophilus , Lactobacillus plantarum , Lactobacillus paracasei , Lactobacillus delbrueckii subsp. bulgaricus and Enterococcus faecium , for a total of billions of colony-forming units (CFU) per dose.

Thanks to its formulation in granules for oral suspension , Yovis 1 g is particularly suitable for adults and children aged 6 years and over who require targeted support in the case of intestinal disorders such as diarrhea, colitis, enteritis or intestinal dysbiosis due to antibiotic therapies or dietary imbalances. Taking Yovis 1 g helps regulate intestinal function , effectively counteracting symptoms related to alterations in the bacterial flora, such as swelling, abdominal pain and bowel irregularity.

The product is easy to take : the granules can be dissolved in water, milk or other non-hot drinks, ensuring practical administration even outside the home. Yovis 1 g is also ideal as an intestinal regulator during and after antibiotic treatments, to promote intestinal well-being and prevent the onset of gastrointestinal disorders.

The presence of high-quality freeze-dried lactic ferments ensures high vitality of the probiotics until the moment of intake, for an effective and targeted action. Yovis 1 g 10 sachets is the optimal solution for those who want to maintain or restore the balance of the intestinal flora in a safe and natural way, contributing to the general well-being of the body.


ACTIVE INGREDIENTS

Active ingredients contained in Yovis 1 g 10 sachets granules for oral suspension - What is the active ingredient of Yovis 1 g 10 sachets granules for oral suspension?

Yovis 1 g Granules for oral suspension One sachet contains: Active ingredients : Lyophilized live lactic ferments 1.0 g The lactic ferments have the following composition: Streptococcus salivarius subsp. thermophilus minimum 204 billion UFC Bifidobacteria (Bifidobacterium brevis , Bifidobacterium animalis lactis) minimum 93 billion UFC Lactobacillus acidophilus minimum 2 billion UFC Lactobacillus plantarum minimum 220 million UFC Lactobacillus paracasei minimum 220 million UFC Lactobacillus delbrueckii subsp. bulgaricus minimum 300 million UFC Enterococcus faecium minimum 30 million UFC Excipients with known effects: lactose and sucrose. One sachet contains: lactose 2.0 g sucrose 63 mg Yovis 250 mg Granules for oral suspension One sachet contains: Active ingredients : Lyophilized live lactic ferments 250 mg The lactic ferments have the following composition: Streptococcus salivarius subsp. thermophilus minimum 48 billion UFC Bifidobacteria (Bifidobacterium brevis , Bifidobacterium animalis lactis) minimum 22 billion UFC Lactobacillus acidophilus minimum 460 million UFC Lactobacillus plantarum minimum 50 million UFC Lactobacillus paracasei minimum 50 million UFC Lactobacillus delbrueckii subsp. bulgaricus minimum 70 million CFU Enterococcus faecium minimum 7 million CFU Excipients with known effects: lactose and sucrose One sachet contains: lactose 59 mg sucrose 21 mg Yovis 250 mg Hard capsules One capsule contains: Active ingredients : Lyophilized live lactic ferments 250 mg The lactic ferments have the following composition: Streptococcus salivarius subsp. thermophilus minimum 48 billion CFU Bifidobacteria (Bifidobacterium brevis, Bifidobacterium animalis lactis) minimum 22 billion CFU Lactobacillus acidophilus minimum 460 million CFU Lactobacillus plantarum minimum 50 million CFU Lactobacillus paracasei minimum 50 million CFU Lactobacillus delbrueckii subsp. bulgaricus minimum 70 million CFU Enterococcus faecium minimum 7 million CFU Excipients with known effect: lactose and sucrose One capsule contains: lactose 23.6 mg sucrose 8.4 mg For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Yovis 1 g 10 sachets granules for oral suspension - What does Yovis 1 g 10 sachets granules for oral suspension contain?

Yovis 1 g Granules for oral suspension: Lactose, cryoprotectants (skimmed milk powder, lactose, sucrose, yeast extract, water, sodium malate, sodium glutamate, tween 80, ascorbic acid, silica). Yovis 250 mg Granules for oral suspension: Colloidal silica, magnesium stearate, maize starch, cryoprotectants (skimmed milk powder, lactose, sucrose, yeast extract, water, sodium malate, sodium glutamate, tween 80, ascorbic acid, silica). Yovis 250 mg Hard capsules: colloidal silica, magnesium stearate, corn starch, gelatin, titanium dioxide, indigo carmine, quinoline yellow, cryoprotectants (skimmed milk powder, lactose, sucrose, yeast extract, water, sodium malate, sodium glutamate, tween 80, ascorbic acid, silica).

DIRECTIONS

Therapeutic indications Yovis 1 g 10 sachets granules for oral suspension - Why is Yovis 1 g 10 sachets granules for oral suspension used? What is it used for?

Intestinal dysmicrobic syndromes: diarrheal and dyspeptic syndromes due to altered bacterial flora (diarrhea, nonspecific enteritis, colitis); intestinal dysmicrobism due to antibiotics.

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Yovis 1 g 10 sachets granules for oral suspension - When should Yovis 1 g 10 sachets granules for oral suspension not be used?

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Yovis 1 g granules 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.

DOSAGE

Quantity and method of taking Yovis 1 g 10 sachets granules for oral suspension - How do you take Yovis 1 g 10 sachets granules for oral suspension?

Dosage Yovis 1 g Granules for oral suspension Adults : 1–3 sachets per day Yovis 250 mg Granules for oral suspension Adults : 4 sachets 1–3 times per day, preferably before meals Yovis 250 mg Hard capsules Adults : 4 capsules 1–3 times per day Paediatric population Yovis 1 g Granules for oral suspension Children 6–12 years: 1 sachet per day Yovis 250 mg Granules for oral suspension Children : 0–6 months: 1 sachet per day 6–12 months: 1–2 sachets per day 1–3 years: 2 sachets per day 3–6 years: 2–3 sachets per day 6–12 years: 4 sachets per day Yovis 250 mg Hard capsules Children : 0–6 months: 1 capsule per day 6–12 months: 1–2 capsules per day 1–3 years: 2 capsules per day 3–6 years: 2–3 capsules per day 6–12 years: 4 capsules per day Method of administration The contents of the sachets can be dissolved in water or milk or another non-hot drink. The capsules can be opened; the contents of the capsule can be dissolved in water or milk or another non-hot drink. The average duration of treatment is 1–2 weeks, according to medical advice.

CONSERVATION

Storage Yovis 1 g 10 sachets granules for oral suspension - How do you store Yovis 1 g 10 sachets granules for oral suspension?

Store in the refrigerator (2°C – 8°C).

WARNINGS

Warnings Yovis 1 g 10 sachets granules for oral suspension - About Yovis 1 g 10 sachets granules for oral suspension it is important to know that:

Yovis 250 mg hard capsules and Yovis 250 mg and 1 g granules for oral suspension also contain sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. Yovis 1 g Granules for oral suspension contain 2 g lactose (1 g glucose and 1 g galactose) per dose; the recommended daily dosage (1–3 sachets) therefore provides 2–6 g lactose. To be taken into account in patients with diabetes mellitus. Patients with hepatic impairment No data are available on the use of Yovis in patients with hepatic impairment. Patients with renal impairment No data are available on the use of Yovis in patients with renal impairment. Other special populations Since rare cases of infectious complications have occurred with the use of probiotics in patients at risk of severe acute pancreatitis, caution is recommended in this population.

INTERACTIONS

Interactions Yovis 1 g 10 sachets granules for oral suspension - Which medicines or foods can modify the effect of Yovis 1 g 10 sachets granules for oral suspension?

Not reported.

SIDE EFFECTS

Like all medicines, Yovis 1 g 10 sachets granules for oral suspension can cause side effects - What are the side effects of Yovis 1 g 10 sachets granules for oral suspension?

Adverse reactions have been identified from clinical studies, literature and post-marketing of Yovis/Eptavis. Information is reported according to MedDRA system organ classification (SOC). Adverse events are classified according to frequency: Very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1,000, <1/100), rare (≥1/10,000, <1/1,000), very rare (<1/10,000), not known (frequency cannot be estimated from the available data).
MedDRA System Organ Class (SOC) Adverse reactions (MedDRA Preferred Term [PT]) Frequency
Gastrointestinal disorders constipation* abdominal pain Uncommon
Skin and subcutaneous tissue disorders itching hives Not known
*prolonged treatment 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 Yovis 1 g 10 sachets granules for oral suspension - What are the risks of Yovis 1 g 10 sachets granules for oral suspension in case of overdose?

No overdose reactions have been reported. Paediatric population No overdose reactions have been reported in the paediatric population.

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 Yovis 1 g 10 sachets granules for oral suspension.

Pregnancy Yovis can be used during pregnancy only under the direct supervision of a doctor. Breastfeeding Yovis can be used during breastfeeding only under the direct supervision of a doctor. Fertility No fertility studies have been conducted.

DRIVING AND USE OF MACHINERY

Take Yovis 1 g 10 sachets granules for oral suspension before driving or using machines - Does Yovis 1 g 10 sachets granules for oral suspension affect driving or using machines?

Yovis does not alter the ability to drive vehicles or use machinery.
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