Yovis
Italy
Table of Contents
Package leaflet: Information for the patient
Yovis 1 g granules for oral suspension
Lyophilised mixture of live lactic acid bacteria
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to.
- Keep this leaflet. You may need to read it again.
- If you need more information or advice, consult your pharmacist.
- If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
- Contact your doctor if you do not notice any improvement, or if your symptoms worsen after 14 days.
Contents of this leaflet:
- What Yovis is and what it is used for
- What you need to know before taking Yovis
- How to take Yovis
- Possible side effects
- How to store Yovis
- Contents of the pack and other information
1. What Yovis is and what it is used for
Yovis contains as its active ingredient live lactic acid bacteria (including lactobacilli and bifidobacteria), microorganisms which have an anti-diarrheal effect.
The mixture of lyophilized live bacteria present in Yovis helps restore the balance of intestinal microflora in cases of its disruption.
Yovis is indicated for the treatment of:
- Diseases associated with alterations of intestinal bacterial flora, such as diarrhea, intestinal inflammations (enteritis), inflammation of the colon, a part of the intestine (colitis).
- Alterations of intestinal bacterial flora caused by treatment with an antibiotic medicine.
2. What you need to know before taking Yovis
Do not take Yovis
- if you are allergic to lactic ferments or to any of the other ingredients of this medicine (listed in section 6);
- if your doctor has diagnosed you with lactose intolerance, you must not take Yovis 1 g granules for oral suspension because it contains high amounts of lactose (see section “Yovis 1 g granules for oral suspension contains lactose and sucrose”).
Warnings and precautions
Talk to your doctor or pharmacist before taking Yovis.
In particular, consult your doctor before taking Yovis or giving it to your child if:
- you or your child currently suffer or have previously suffered from intestinal disorders associated with fever.
- you or your child currently have or have previously had episodes of pancreatic inflammation (pancreatitis).
Other medicines and Yovis
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other
medicines.
To date, no interactions between Yovis and other medicines have been reported.
Yovis with food and drinks
No interactions between Yovis and food have been reported.
Pregnancy and breastfeeding
Yovis may be used during pregnancy and breastfeeding only under the direct supervision of your doctor.
Driving and using machines
Yovis does not impair the ability to drive vehicles or operate machinery.
Yovis contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this
medicine.
Yovis contains 2 g of lactose (1 g glucose and 1 g galactose) per dose; therefore, the recommended daily
dosage (1–3 sachets) provides 2–6 g of lactose.
This should be taken into account in patients with diabetes mellitus.
3. How to take Yovis
Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Recommended dose:
Adults: 1–3 sachets per day
Children: 1 sachet per day
The contents of the sachets can be dissolved in water, milk, or another non-hot beverage.
The average duration of treatment is 1–2 weeks, according to medical advice.
Pay special attention not to exceed the recommended dose without first consulting your doctor, and do not take Yovis for longer than 14 days.
Yovis can be taken at any time of day.
Contact your doctor if you do not feel better or if you feel worse after 14 days, if the symptoms recur repeatedly, or if you notice any recent changes in their characteristics.
If you take more Yovis than you should
In case of accidental ingestion or overdose of Yovis, contact your doctor immediately or go to the nearest hospital.
If you forget to take Yovis
Do not take a double dose to make up for the missed dose.
If you stop taking Yovis
If you have any questions about the use of this medicine, consult your doctor or pharmacist.
4. 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)
Abdominal pain, constipation*.
Side effects with unknown frequency (frequency cannot be estimated from the available data)
Itching, urticaria.
* during prolonged treatment with Yovis.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Yovis
Keep this medicine out of the sight and reach of children.
Store in the refrigerator (2°C – 8°C).
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Yovis contains
- The active substance is a mixture of lyophilized live lactic acid bacteria. Each sachet contains 1 g of lyophilized live lactic acid bacteria with the following composition: Streptococcus thermophilus (Z57; 9Y), minimum 204 billion CFU; Bifidobacteria [( Bifidobacterium breve (Bbr8; Bl10) , Bifidobacterium animalis subsp. lactis (Bi1)], minimum 93 billion CFU; Lactobacillus acidophilus (LA1; K8), minimum 2 billion CFU; Lactobacillus plantarum (14D), minimum 220 million CFU; Lactobacillus paracasei (101/37), minimum 220 million CFU; Lactobacillus delbrueckii subsp . bulgaricus (LB2), minimum 300 million CFU; Enterococcus faecium (P-21906; SF95), minimum 30 million CFU.
- The other components are: lactose, cryoprotectants (L-Cysteine, Maltodextrin).
Description of the appearance of Yovis and contents of the pack
Each pack contains 10 sachets with 1 g of active substance in granular form for oral use.
Marketing Authorization Holder
Alfasigma S.p.A. – Via Ragazzi del ’99, n. 5 - 40133 Bologna (BO)
Manufacturer
Alfasigma S.p.A. - Via Pontina km 30,400 - 00071 Pomezia (RM)