Lacidofil

Package Leaflet: Information for the Patient

Lacidofil,hard capsules
Lactobacillus helveticusR0052, Lacticaseibacillus rhamnosusR0011

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

• 1. What is Lacidofil and what is it used for
• 2. Important information before using Lacidofil
• 3. How to use Lacidofil
• 4. Possible side effects
• 5. How to store Lacidofil
• 6. Contents of the pack and other information

1. What is Lacidofil and what is it used for

Lacidofil is a probiotic, meaning it contains microorganisms (lactic acid bacteria) that have a beneficial effect on the body.
Lactic acid bacteria are found in the human gastrointestinal tract. They form a natural barrier, protecting against pathogenic microorganisms and maintaining the balance of bacterial flora in the gastrointestinal tract. For this reason, this medicine is used in the following cases:

• prevention of disturbances in the gut microflora during and after antibiotic therapy
• prevention of traveler's diarrhea
• supportive treatment during and after antibiotic therapy
• recurrent pseudomembranous colitis

2. Important information before using Lacidofil

When not to use Lacidofil:

• if the patient is allergic to the active substance or any of the excipients of the medicine (listed in section 6),
• if the patient has previously been diagnosed with intolerance to some sugars, the patient should consult a doctor before taking the medicine,
• if the patient is allergic to cow's milk protein or soy,

Warnings and precautions

Patients belonging to the following groups should consult a doctor before using this medicine:

• patients with fever, vomiting, or severe abdominal pain,
• patients with acute pancreatitis,
• patients with a central venous catheter and patients after surgical operations, particularly with a history of myocarditis or pericarditis, and after cardiac or gastrointestinal surgery, also within the oral cavity (including after tooth extraction), as open wounds are a potential gateway for bacterial infection,
• patients with bloody diarrhea, especially infants and the elderly, as the gut-blood barrier is a potential gateway for bacterial infection,
• patients with impaired immunity and those taking immunosuppressive drugs, including patients after transplants, during radio or chemotherapy, with impaired immune system, premature infants, patients with AIDS, with lymphoma, or undergoing long-term corticosteroid therapy,
• children with short bowel syndrome, in whom lactic acidosis may be a complication after the use of probiotics. In these patients, the use of lactic acid-producing strains such as L. helveticusshould be monitored and discontinued immediately in case of an increase in blood lactate levels.

Lacidofil and other medicines

No cases of interaction with other medicines have been reported.
The doctor should be informed about all medicines taken recently, even those that are available without a prescription.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.

Driving and using machines

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

3. How to use Lacidofil

Dosage
Prevention of disturbances in the gut microflora during and after antibiotic therapy, prevention of traveler's diarrhea:

• Children under 4 years: 1 capsule per day
• Children from 4 to 12 years: 1 to 2 capsules per day
• Adults and adolescents over 12 years: 1 capsule three times a day

This medicine should be used for at least 10 days, starting from the day of initiation of antibiotic treatment or before and during travel.
Supportive treatment during and after antibiotic therapy, recurrent pseudomembranous colitis:

• Infants: 1 capsule per day
• Children from 1 to 4 years: 1 capsule twice a day
• Children from 4 to 12 years: 1 capsule three times a day
• Adults and adolescents over 12 years: 1 to 2 capsules three times a day

The medicine should be used for at least 14 days.
Method of administration
The capsule should be taken orally during a meal or up to 30 minutes before a meal. In case of inability to swallow (infants), the contents of the capsule can be mixed with food or cold water.

Using a higher dose of Lacidofil than recommended

No cases of overdose have been reported.

Missing a dose of Lacidofil

A double dose should not be taken to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In very rare cases, hypersensitivity reactions have been reported, manifesting as a rash or diarrhea. In such cases, it is recommended to discontinue the use of the medicine until the symptoms resolve.
No other side effects are known.

Reporting side effects

If any side effects occur, including any possible side effects not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Lacidofil

The medicine should be stored out of sight and reach of children.
The medicine should be stored in a refrigerator (2°C - 8°C).
The medicine can be stored outside the refrigerator (at a temperature below 25°C) for 14 days. After this time, any unused medicine should be discarded. The medicine stored outside the refrigerator cannot be put back in the refrigerator.
The medicine should not be used after the expiry date (EXP) stated on the packaging.

6. Contents of the pack and other information

What Lacidofil contains

One capsule contains 2x10 CFU of lactic acid bacteria: Lacticaseibacillus rhamnosusR0011, Lactobacillus helveticusR0052
*CFU - Colony Forming Unit.
The other ingredients are: ascorbic acid, magnesium stearate, maltodextrin, gelatin

Marketing authorization holder

LALLEMAND SAS
19 rue des Briquetiers - Blagnac - 31700 Blagnac
France

Manufacturer

Creapharm Industry
29 rue Léon Faucher
51100 Reims
France
Lallemand SAS
4 chemin du Bord de l’Eau
15130 St Simon
France

To obtain more detailed information, please contact the representative of the marketing authorization holder:

Glenmark Pharmaceuticals Sp. z o. o.
Ul. Dziekońskiego 3
00-728 Warsaw, Poland

Date of the last update of the leaflet: