Package leaflet: Information for the patient

Eptavis 1 g granules for oral suspension, 250 mg granules for oral suspension, 250 mg hard capsules

Lyophilized live lactic acid bacteria
Please read 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 instructed you.

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.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after 14 days.

Contents of this leaflet:

What Eptavis is and what it is used for
What you need to know before taking Eptavis
How to take Eptavis
Possible side effects
How to store Eptavis
Contents of the pack and other information

1. What Eptavis is and what it is used for

Eptavis 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 in Eptavis helps restore balance to the intestinal microflora
in cases of disruption of the microflora itself.
Eptavis is indicated for the treatment of:

diseases associated with disturbances of the intestinal bacterial flora, such as diarrhoea, inflammation of the intestine (enteritis), inflammation of the colon, a part of the intestine (colitis)
disturbances of the intestinal bacterial flora caused by antibiotic treatment.

2. What you need to know before taking Eptavis

Do not take Eptavis

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 Eptavis 1 g granules for oral suspension because it contains high amounts of lactose (see section “Eptavis 1 g granules for oral suspension contains lactose and sucrose”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Eptavis.
In particular, consult your doctor before taking Eptavis or giving it to your child if:

you or your child currently have or have previously suffered from intestinal disorders associated with fever.
you or your child currently have or have previously experienced episodes of pancreatic inflammation (pancreatitis).

Other medicines and Eptavis
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other
medicines.
To date, no interactions between Eptavis and other medicines have been reported.
Eptavis with food and drink
No interactions between Eptavis and food have been reported.
Pregnancy and breastfeeding
Eptavis may be used during pregnancy and breastfeeding only under the direct supervision of your doctor.
Driving and using machines
Eptavis does not affect the ability to drive vehicles or operate machinery.
Eptavis 250 mg granules for oral suspension contains lactose and sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this
medicine.
Eptavis 1 g granules for oral suspension contains lactose and sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this
medicine.
Eptavis contains 2 g of lactose (1 g glucose and 1 g galactose) per dose. This should be taken into account in
patients with diabetes mellitus; the recommended daily dose (1–3 sachets) therefore provides 2–6 g of
lactose. If your doctor has diagnosed you with lactose intolerance, you must not take this medicine
(see section “Do not take Eptavis”).
Eptavis hard capsules contain lactose and sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this
medicine.

3. How to take Eptavis

Take this medicine exactly as directed by your doctor or pharmacist. If in doubt, consult your
doctor or pharmacist.
The recommended dose is:
Eptavis 1 g granules for oral suspension
Adults: 1–3 sachets per day
Children: 1 sachet per day
Eptavis 250 mg granules for oral suspension
Adults: 4 sachets 1–3 times daily, 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
Eptavis 250 mg hard capsules
Adults: 4 capsules 1–3 times daily
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
Mix the contents of the sachets with water, milk, or another non-hot drink.
The capsules are openable; the contents of the capsule may be dissolved in water, milk, or another non-hot drink.
The average duration of treatment is 1–2 weeks, according to medical advice.
Take particular care not to exceed the recommended dose without first consulting your doctor, and do not take Eptavis for longer than 14 days.
Eptavis may be taken at any time of day.
Consult 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 Eptavis than you should
In case of accidental ingestion/overdose of Eptavis, contact your doctor immediately or go to the nearest hospital.
If you forget to take Eptavis
Do not take a double dose to make up for the forgotten dose.
If you stop taking Eptavis
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences 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 Eptavis.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please consult your doctor or pharmacist. You can also report side effects directly via the national reporting system at 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 Eptavis

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 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 Eptavis contains
Eptavis 1 g granules for oral suspension

The active substances are freeze-dried live lactic acid bacteria. Each sachet contains 1 g of freeze-dried live lactic acid bacteria 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 components are: lactose, cryoprotectants (skimmed milk powder, lactose, sucrose, yeast extract, water, sodium malate, sodium glutamate, Tween 80, ascorbic acid, silica).

Eptavis 250 mg granules for oral suspension

The active substances are freeze-dried live lactic acid bacteria. Each sachet contains 250 mg of freeze-dried live lactic acid bacteria 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 components are: colloidal silica, magnesium stearate, maize starch, cryoprotectants (skimmed milk powder, lactose, sucrose, yeast extract, water, sodium malate, sodium glutamate, Tween 80, ascorbic acid, silica).

Eptavis 250 mg hard capsules

The active substances are freeze-dried live lactic acid bacteria. Each capsule contains 250 mg of freeze-dried live lactic acid bacteria 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 components are: colloidal silica, magnesium stearate, maize 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).

Description of the appearance of Eptavis and contents of the pack
Eptavis 1 g granules for oral suspension
Each pack contains 10 sachets with 1 g of active substance in granular form for oral use.
Eptavis 250 mg granules for oral suspension
Each pack contains 10 sachets with 250 mg of active substance in granular form for oral use.
Eptavis 250 mg hard capsules
Each pack contains 20 hard gelatin capsules for oral use.
Marketing Authorization Holder
Alfasigma S.p.A. – Viale Sarca, n. 223 - 20126 Milano (MI)
Manufacturer
S.I.I.T. S.r.l.
Via Ariosto 50/60
20090 Trezzano S/N.