Yovis - Package Leaflet

Active ingredients: Freeze-dried live lactic ferments

Yovis 1 g granules for oral suspension
Yovis 250 mg granules for oral suspension
Yovis 250 mg hard capsules

Indications

What is Yovis and what is it for

Yovis contains as active ingredient live lactic ferments (including lactobacilli and bifidobacteria), microorganisms that have an "action against diarrhea.

The mixture of freeze-dried live bacteria present in Yovis performs a "rebalancing action on the intestinal microflora, in case of alterations in the microflora itself. Yovis is indicated for the treatment of:

  • Diseases related to alterations of the intestinal flora such as diarrhea, inflammation of the intestine (enteritis), inflammation of the colon, part of the intestine (colitis).
  • Changes in the intestinal flora caused by treatment with an antibiotic medicine.

Contraindications

When Yovis should not be used

Don't take Yovis

  • if you are allergic to lactic acid bacteria or any of the other ingredients of this medicine (listed in section 6);
  • if your doctor has diagnosed you with lactose intolerance, you should not take Yovis 1 g granules for oral suspension as it contains high amounts of lactose (see section "Yovis 1 g granules for oral suspension contains lactose and sucrose").

Precautions for use

What you need to know before you take Yovis

Talk to your doctor or pharmacist before taking Yovis.

In particular, consult your doctor before taking Yovis or giving your child to take if:

  • you or your child have or have suffered in the past from intestinal disorders associated with fever.
  • you or your child have or have ever had episodes of inflammation of the pancreas (pancreatitis).

Interactions

Other medicines and Yovis

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

To date, no interactions of Yovis with other medicines have been reported.

Yovis with food and drink

No interactions of Yovis with food have been reported.

Warnings

It is important to know that:

Pregnancy and breastfeeding

Yovis can be used during pregnancy and breastfeeding only under the direct supervision of your doctor.

Driving and using machines

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

Yovis 250 mg granules for oral suspension contain lactose and sucrose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Yovis 1 g granules for oral suspension contains lactose and sucrose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Yovis 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.

If your doctor has diagnosed you with lactose intolerance, you should not take this medicine (see section "Do not take Yovis").

To be taken into consideration in people with diabetes mellitus.

Yovis hard capsules contain lactose and sucrose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Dosage and method of use

How to take Yovis

Always take this medicine as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
The recommended dose is:

Yovis 1 g granules for oral suspension

Adults: 1-3 sachets per day

Children: 1 sachet per day

Yovis 250 mg granules for oral suspension

Adults: 4 sachets 1-3 times a day, preferably before meals.

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

Adults: 4 capsules 1-3 times a day

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

The contents of the bags 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.

Take special care not to exceed the recommended dose without first consulting your doctor and do not take Yovis for more than 14 days.

Yovis can be taken at any time of the day.

Talk to your doctor if you do not feel better or if you feel worse after 14 days, if the disorder occurs repeatedly or if you notice any recent change in its characteristics.

If you forget to take Yovis

Do not take a double dose to make up for a forgotten dose.

If you stop taking Yovis

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Overdose

If you take more Yovis than you should

In case of accidental ingestion / intake of an overdose of Yovis, notify your doctor immediately or go to the nearest hospital.

Side effects

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Uncommon side effects (may affect up to 1 in 100 people)

Pain in the abdomen, constipation *.

Undesirable effects with frequency not known (frequency cannot be estimated from the available data)

Itching, hives.

* in prolonged treatment with Yovis.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-unasospetta-reazione-avversa.

By reporting side effects you can help provide more information on the safety of this medicine.

Expiry and Retention

How to store Yovis

Keep this medicine out of the sight and reach of children.

Store in a refrigerator (2 ° C - 8 ° C).

Do not use this medicine after the expiry date which is stated on the package after "EXP". The expiry date refers to the last day of that month.

Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

Composition and Pharmaceutical Form

What Yovis contains

Yovis 1 g granules for oral suspension

  • The active ingredients are freeze-dried live lactic ferments. Each sachet contains 1 g of lyophilized live lactic ferments with the following composition: Streptococcus salivarius subsp. thermophilus, minimum 204 billion CFU; Bifidobacteria (Bifidobacterium brevis, Bifidobacterium animalis lactis), minimum 93 billion CFU; Lactobacillus acidophilus, minimum 2 billion CFU; Lactobacillus plantarum, minimum 220 million CFU; Lactobacillus paracasei, minimum 220 million CFU; Lactobacillus delbrueckii subsp. bulgaricus, minimum 300 million CFU; Enterococcus faecium, minimum 30 million CFU.
  • The other ingredients are: lactose, cryoprotectives (skimmed milk powder, lactose, sucrose, yeast extract, water, sodium malate, sodium glutamate, tween 80, ascorbic acid, silica).

Yovis 250 mg granules for oral suspension

  • The active ingredients are freeze-dried live lactic ferments.Each sachet contains 250 mg of lyophilized live lactic ferments with 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.
  • The other ingredients are: 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

  • The active ingredients are freeze-dried live lactic ferments. Each capsule contains 250 mg of lyophilized live lactic ferments with 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.
  • The other ingredients are: colloidal silica, magnesium stearate, corn starch, gelatin, titanium dioxide, indigo carmine, quinoline yellow, cryoprotective (skimmed milk powder, lactose, sucrose, yeast extract, water, sodium malate, sodium glutamate, tween 80, ascorbic acid, silica).

Other Information

What Yovis looks like and contents of the pack

Yovis 1 g granules for oral suspension

Each pack contains 10 sachets with 1 g of active ingredient in granular form for oral use.

Yovis 250 mg granules for oral suspension

Each pack contains 10 sachets with 250 mg of active ingredient in granular form for oral use.

Yovis 250 mg hard capsules

Each pack contains 20 hard gelatin capsules for oral use.

Further information on Yovis is available in the Summary of Product Characteristics available on the Official Website of the Italian Medicines Agency

Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in December 2020.
The information present may not be up-to-date. For a correct use of this information, see the page: Disclaimer and Useful Information.
For the most up-to-date version, access to the website of the Italian Medicines Agency (AIFA) is recommended.

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