Patient Information Leaflet

Lacidofil, hard capsules
Lactobacillus helveticus R0052, Lacticaseibacillus rhamnosus R0011
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If your symptoms do not improve or if you feel worse, consult your doctor.

Table of Contents

What Lacidofil is and what it is used for
Important information before taking Lacidofil
How to take Lacidofil
Possible side effects
How to store Lacidofil
Contents of the pack and other information

1. What Lacidofil is and what it is used for

Lacidofil is a probiotic, meaning it contains microorganisms (lactic acid bacteria) that exert beneficial effects on the body.
Lactic acid bacteria naturally occur in the human gastrointestinal tract. They form a natural barrier, protect against pathogenic microorganisms, and help maintain bacterial flora balance in the digestive system. Therefore, this medicine is used in the following cases:

prevention of gastrointestinal flora disturbances 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 listed in section 6,
if the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact 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 procedures, particularly those with a history of myocarditis or endocarditis, and after cardiac or gastrointestinal surgery including oral cavity procedures (including tooth extraction), as open wounds may constitute potential entry sites for bacterial infection,
patients with bloody diarrhoea, especially infants and elderly individuals, as increased intestinal permeability may represent a potential gateway for bacterial infection,
patients with impaired immune function or receiving immunosuppressive drugs, including transplant recipients, patients undergoing radiotherapy or chemotherapy, patients with immunological disorders, premature infants, patients with AIDS, lymphoma, or undergoing long-term corticosteroid therapy,
children with short bowel syndrome, in whom lactic acidosis may be a complication following probiotic use. In these patients, administration of lactic acid-producing strains such as L. helveticus should be monitored and discontinued immediately if increased blood lactate levels occur.

Lacidofil and other medicines
No cases of interactions with other medicines have been reported.
Inform your doctor about all medicines you are currently taking, including those obtained without a prescription.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
Lacidofil has no influence on the ability to drive or operate machinery.

3. How to use Lacidofil

Dosage
Prevention of gastrointestinal flora disturbances during and after antibiotic therapy,
prevention of traveler's diarrhea:

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

This medicine should be used for at least 10 days, starting from the day antibiotic treatment begins or before and during travel.

Supportive treatment during and after antibiotic therapy, recurrent pseudomembranous colitis:

Infants: 1 capsule per day
Children aged 1 to 4 years: 1 capsule twice daily
Children aged 4 to 12 years: 1 capsule three times daily
Adults and adolescents over 12 years of age: 1 to 2 capsules three times daily

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. If swallowing is not possible (infants), the capsule contents may be mixed with food or cool water.

Use of a higher than recommended dose of Lacidofil
Cases of overdose have not been reported.

Missed dose of Lacidofil
Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
In very rare cases, hypersensitivity reactions have been reported, manifesting as rash or diarrhoea.
In such cases, discontinuation of the medicine until resolution of symptoms is recommended.
No other adverse effects are known.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse effects can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Adverse effects may also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Lacidofil

Keep this medicine out of sight and reach of children.
Store the medicine in a refrigerator (2°C–8°C).
The medicine may be stored outside the refrigerator (at a temperature below 25°C) for up to 14 days. After this period,
any unused medicine must be discarded. Medicine stored outside the refrigerator must not be returned
to the refrigerator.
Do not use this medicine after the expiry date (EXP) stated on the packaging.

6. Contents of the packaging and other information

What Lacidofil contains
One capsule contains 2x10 CFU lactic acid bacteria: Lacticaseibacillus rhamnosus R0011,
Lactobacillus helveticus R0052
*CFU - colony forming unit (Eng. Colony Forming Unit).
Other ingredients: ascorbic acid, magnesium stearate, maltodextrin, gelatin

Marketing Authorisation 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

For further information, please contact the representative of the
Marketing Authorisation Holder:
Glenmark Pharmaceuticals Sp. z o.o.
Ul. Dziekonińskiego 3
00-728 Warsaw, Poland