Package leaflet: Information for the patient

LACTEOL 10 billion oral powder and 5 billion hard capsules

LACTOBACILLUS LB . (Lactobacillus fermentum and Lactobacillus delbrueckii)
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, consult your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice improvement or if your symptoms worsen after a few days.

Contents of this leaflet:

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

1. What LACTEOL is and what it is used for

LACTEOL contains the active substance Lactobacillus LB, which belongs to the group of lactic acid bacteria (lactic acid producers) normally present in the intestine. These bacteria help maintain optimal conditions of the intestinal mucosa and prevent the growth of other bacteria that may cause diarrhoea.
LACTEOL is indicated for the treatment of diarrhoea associated with disturbances of the intestinal bacterial flora in children and adults.
Consult your doctor if you do not feel better or if you feel worse after a few days.

2. What you should know before taking LACTEOL

Do not take LACTEOL

if you are allergic to any of the ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking LACTEOL.
Consult your doctor or pharmacist if diarrhoea persists for more than 2 or 3 days after starting treatment.

Children
This product should be used in combination with rehydration therapy, especially in children under two years of age.
Such therapy may also be necessary in children over 2 years of age.
Your doctor will determine whether fluids should be administered orally or intravenously depending on the severity of diarrhoea, the child's age and general health condition.
In case of symptoms in infants, medical advice must be sought before starting treatment.

Other medicines and LACTEOL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions with other medicines have been reported.

LACTEOL with food and drink
No interactions between LACTEOL and food have been reported.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Data regarding the use of LACTEOL in pregnant women are insufficient.
As a precautionary measure, it is preferable to avoid using LACTEOL during pregnancy.

Breastfeeding
There is insufficient information on the excretion of LACTEOL and its metabolites in human milk.
As a precautionary measure, it is preferable to avoid using LACTEOL during breastfeeding.

Driving and using machines
LACTEOL does not affect the ability to drive vehicles or operate machinery.

LACTEOL hard capsules contain lactose
This medicine contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

LACTEOL sachets contain lactose and sucrose
This medicine contains lactose and sucrose, two types of sugars. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take LACTEOL

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Dosage, method and frequency of administration

Lacteol hard capsules: Take one capsule with water. The recommended dose is 2–4 capsules per day. In more severe cases (acute diarrhoea):
- Day 1: 2 capsules, three times a day;
- From day 2 until 2 days after symptoms have disappeared: 2 capsules, twice a day.
Lacteol sachets: Dissolve and mix the contents of one sachet in half a glass of water.

The recommended dose is 1–2 sachets per day.
In more severe cases (acute diarrhoea):

Day 1: 1 sachet, three times a day;
From day 2 until 2 days after symptoms have disappeared: 1 sachet, twice a day.

Do not exceed the recommended doses without medical advice. Use only for short-term treatment.
Use in children
The contents of the capsule or sachet may be dissolved in a bottle with water or milk.
If you take more LACTEOL than you should
There are no known cases of overdose.
In case of accidental ingestion of an excessive dose of LACTEOL, contact your doctor immediately or go to the nearest hospital.
If you forget to take LACTEOL
Do not take a double dose to make up for the missed dose.
If you stop taking LACTEOL
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 everybody will experience them.
No side effects have been reported with the use of this medicine.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly through the national reporting system at the following website:
https://www.aifa.gov.it/web/guest/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.
.

5. How to store LACTEOL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Lacteol capsules: store at a temperature not exceeding 25°C.
Lacteol sachets: no special storage precautions required.
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 LACTEOL 5 billion hard capsules contains

The active substance is Lactobacillus LB powder ( Lactobacillus fermentum and Lactobacillus delbrueckii ). Each hard capsule contains 170 mg of Lactobacillus LB powder (inactivated, lyophilized microbial cells) in fermented culture medium, corresponding to 5 billion Lactobacillus LB.
The other components are: neutralized and lyophilized culture medium, lactose monohydrate, calcium carbonate, silicic acid, talc, magnesium stearate, anhydrous lactose, gelatin.

What LACTEOL 10 billion oral powder contains

The active substance is Lactobacillus LB powder ( Lactobacillus fermentum and Lactobacillus delbrueckii ). Each sachet contains 340 mg of Lactobacillus LB powder (inactivated, lyophilized microbial cells) in fermented culture medium, corresponding to 10 billion Lactobacillus LB.

The other components are: neutralized and lyophilized culture medium, lactose monohydrate, calcium carbonate, silicic acid, banana-orange flavour, sucrose.

Description of the appearance of LACTEOL and contents of the pack

LACTEOL 5 billion hard capsules
Pack containing 20 hard capsules for oral use.

LACTEOL 10 billion oral powder
Pack containing 10 sachets for oral use.

Marketing Authorization Holder
BRUSCHETTINI s.r.l. - Via Isonzo, 6, 16147 - Genoa (Italy)

Manufacturer
ADARE PHARMACEUTICAL S.A.S – Route De Bû, 78550 - Houdan (France)