Yovis 1 g 10 sachets granules for oral suspension

In ottemperanza all'articolo 118 “autorizzazione della pubblicità presso il pubblico” del decreto legislativo 24 aprile 2006, numero 219

INDICATIONS

Intestinal dysmicrobial syndromes: diarrheal and dyspeptic syndromes due to altered bacterial flora (diarrhoea, non-specific enteritis, colitis); intestinal dysmicrobism caused by antibiotics.

ACTIVE INGREDIENTS

Yovis 1 g Granules for oral suspension One sachet contains: Active ingredients: Freeze-dried 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 CFU 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: Freeze-dried live lactic ferments 250 mg 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 UFC 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: Freeze-dried live lactic ferments 250 mg 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 UFC Enterococcus faecium minimum 7 million UFC Excipients with known effects: lactose and sucrose One capsule contains: lactose 23.6 mg sucrose 8.4 mg For the complete list of excipients, see section 6.1.

EXCIPIENTS

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, corn 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).

CONTRAINDICATIONS AND SIDE EFFECTS

Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1. Yovis 1 g granules for oral suspension contains lactose. Patients suffering from rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.

DOSAGE

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 a day, preferably before meals Yovis 250 mg Hard capsules Adults: 4 capsules 1–3 times a day Pediatric 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 other non-hot drink. The capsules can be opened; the contents of the capsule can be dissolved in water or milk or other non-hot drink. The average duration of treatment is 1–2 weeks, according to medical opinion.

CONSERVATION

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

WARNINGS

Yovis 250 mg hard capsules and Yovis 250 mg and 1 g granules for oral suspension also contain sucrose. Patients suffering from 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 contains 2 g of lactose (1 g of glucose and 1 g of galactose) per dose; the recommended daily dosage (1–3 sachets) therefore provides 2–6 g of lactose. To be taken into consideration in people suffering from diabetes mellitus. Patients with liver failure No data are available on the use of Yovis in patients with liver impairment. Patients with renal failure No data are available on the use of Yovis in patients with renal insufficiency. 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

Not reported.

SIDE EFFECTS

The reactions tovverse have been identified from clinical studies, literature and post-marketing of Yovis/Eptavis. The 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).

Gastrointestinal disorders - Adverse reactions (MedDRA Preferred Term [PT]): constipation* abdominal pain. Frequency: Uncommon.

Skin and subcutaneous tissue disorders - Adverse reactions (MedDRA Preferred Term [PT]): pruritus urticaria. Frequency: Not known.

*prolonged treatment Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. 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

No overdose reactions have been reported. Pediatric population No overdose reactions have been reported in the pediatric population.

PREGNANCY AND BREASTFEEDING

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.

EFFECTS ON DRIVING ABILITY

Yovis does not alter the ability to drive or use machines.