Package leaflet: information for the patient

Lakcid GASTROMED, powder for oral suspension
Not less than 12 billion CFU of Lactobacillus rhamnosus rods
Please read carefully the entire leaflet before taking this medicine, as it contains important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by a physician or pharmacist.

Keep this leaflet, so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If symptoms do not improve or if you feel worse, contact your doctor.

Table of contents

What Lakcid Gastromed is and what it is used for
Important information before using Lakcid Gastromed
How to take Lakcid Gastromed
Possible side effects
How to store Lakcid Gastromed
Contents of the package and other information

1. What Lakcid Gastromed is and what it is used for

Lakcid Gastromed is a powder for preparing an oral suspension. It contains strains of Lactobacillus rhamnosus bacteria, which, like other lactic acid bacteria, colonize the intestinal mucosa and normalize gastrointestinal microflora. These strains demonstrate strong adhesion ability to human intestinal cells. Research results have confirmed that these strains survive in gastric juice environment and are resistant to bile salts, enabling their adaptation and viability in the gastrointestinal tract. By competing for substrates and colonization sites on the intestinal mucosa, and by producing lactic acid through anaerobic sugar breakdown, they create unfavorable conditions for the growth of most pathogenic microorganisms. These strains possess natural resistance to: cotrimoxazole, metronidazole, vancomycin.

Indications for use of Lakcid Gastromed:

supportive treatment of viral diarrhoea in children,
supportive treatment of functional intestinal disorders caused by lack of normal bacterial flora,
prevention of travellers' diarrhoea,
intestinal disturbances caused by antibiotic therapy.

2. Important information before using Lakcid Gastromed

When not to take Lakcid Gastromed:

if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6), including milk protein.

Warnings and precautions
Before starting treatment with Lakcid Gastromed, consult your doctor.
This medicine is intended for oral use only. Do not inject.
There is a risk of developing bacteremia (sepsis). Single cases of infectious endocarditis caused by Lactobacillus rhamnosus infection have been reported in severely ill patients.
Treatment with a medicine containing Lactobacillus rhamnosus may exceptionally lead to septic infections in patients at increased risk, primarily in premature infants or full-term newborns with congenital defects or impaired organ function.

Lakcid Gastromed and other medicines
No interactions have been reported.

Lakcid Gastromed with food and drink
The medicine can be taken regardless of meal times.

Pregnancy and breastfeeding
Lakcid Gastromed may be used in pregnant and breastfeeding women.

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

Lakcid Gastromed contains sucrose and lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Lakcid Gastromed

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Oral use.
Immediately before use, remove the cap from the vial and take out the rubber stopper. Add a small amount of boiled water or milk cooled to room temperature to the vial, and mix thoroughly. Pour the contents of the vial onto a teaspoon.
Immediately before use, tear open the sachet at the cut line. Dissolve the contents of the sachet in approximately \⅛ of a glass of boiled water or milk cooled to room temperature, and mix thoroughly.
Recommended dose
Unless otherwise advised by a doctor:
children from 2 months of age: 1 dose (contents of vial or sachet) once daily,
adults: 1 dose (contents of vial or sachet) twice daily.
Taking more Lakcid Gastromed than recommended
No cases of overdose have been reported.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
The following adverse reactions may occur:
Frequency unknown (frequency cannot be estimated from the available data):

bacteraemia (sepsis), infective endocarditis – in critically ill patients and patients at increased risk (see section Warnings and precautions).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform a doctor or pharmacist. Adverse reactions can be
reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Lakcid Gastromed

Keep the medicine out of sight and reach of children.
Store in a refrigerator (2°C - 8°C). Protect from light.
Within the valid shelf-life period, the medicine may be stored for 1 month at a temperature of 15°C - 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Lakcid Gastromed contains

The active substances in the medicine are Lactobacillus rhamnosus bacilli, not less than 12 billion CFU*/dose (content of a sachet or vial)
strain Lactobacillus rhamnosus 573L/1**
strain Lactobacillus rhamnosus 573L/2**
strain Lactobacillus rhamnosus 573L/3**

*CFU - Colony Forming Unit
**The strains are present in equal quantitative proportions

Other ingredients of the medicine are: skimmed milk, sucrose.

What Lakcid Gastromed looks like and contents of the packaging
What Lakcid Gastromed looks like
The powder in the vial is an amorphous or crystalline-needle-like dry mass, ranging in color from light to dark beige. After reconstitution, a homogeneous suspension is formed, without visible mechanical impurities.
The powder in the sachet consists of free-flowing, finely divided particles, ranging in color from light to dark beige. After reconstitution, a homogeneous suspension is formed, ranging in color from light to dark beige, without visible mechanical impurities.
Packaging
5 vials with powder, 1 dose each
10 vials with powder, 1 dose each
5 sachets with powder, 1 dose each
10 sachets with powder, 1 dose each
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01
Manufacturer
„BIOMED-LUBLIN” Wytwórnia Surowic i Szczepionek Spółka Akcyjna
ul. Uniwersytecka 10, 20-029 Lublin