Lakcid Gastromed

Leaflet attached to the packaging: patient information

Lakcid GASTROMED, powder for oral suspension

Not less than 12 billion CFU of Lactobacillus rhamnosusbacteria

Read the leaflet carefully before taking the 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 doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this 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 Lakcid Gastromed and what is it used for
• 2. Important information before taking Lakcid Gastromed
• 3. How to take Lakcid Gastromed
• 4. Possible side effects
• 5. How to store Lakcid Gastromed
• 6. Contents of the packaging and other information

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

Lakcid Gastromed is a powder for oral suspension. It contains Lactobacillus rhamnosusbacterial strains, which, like other lactic acid bacteria, colonize the intestinal mucosa and normalize the gut microflora. They have a strong ability to adhere to human intestinal cells. The results of studies have confirmed that these strains survive in the gastric juice environment and are resistant to the action of bile acids, which allows them to adapt and survive in the gastrointestinal tract. By competing for substrates and colonization sites on the intestinal mucosa and producing lactic acid as a result of anaerobic sugar decomposition, they create unfavorable conditions for the development of most pathogenic microorganisms. These strains have natural resistance to: cotrimoxazole, metronidazole, vancomycin.

Indications for the use of Lakcid Gastromed:

• Supportive treatment for viral diarrhea in children,
• Supportive treatment for functional bowel disorders caused by a lack of normal bacterial flora,
• Prevention of traveler's diarrhea,
• Bowel disorders caused by antibiotic therapy.

2. Important information before taking Lakcid Gastromed

When not to take Lakcid Gastromed:

Warnings and precautions

Before starting treatment with Lakcid Gastromed, the patient should discuss it with their doctor. The medicine is intended for oral use. Do not inject. There is a risk of bacteremia (sepsis). Single cases of infectious endocarditis in a patient in a severe state caused by Lactobacillus rhamnosusinfection have been reported. Treatment with a medicine containing Lactobacillus rhamnosusmay, in exceptional cases, cause septic infections in patients at increased risk, mainly in premature infants or children born at term but with 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 independently of meal times.

Pregnancy and breastfeeding

The medicine can be used in pregnant and breastfeeding women.

Driving and using machines

Lakcid Gastromed does not affect the ability to drive and use machines.

Lakcid Gastromed contains sucrose, lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Lakcid Gastromed

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist. Oral administration. Before use, remove the cap from the vial and pull out the rubber stopper. Add a small amount of boiled and cooled water or milk to the vial, mix thoroughly. Pour the contents of the vial onto a spoon. Before use, tear the sachet at the notch. Dissolve the contents of the sachet in about 1/8 cup of boiled and cooled water or milk, mix thoroughly. Recommended dose: If the doctor does not recommend otherwise: children from 2 months of age: 1 time a day, 1 dose (contents of the vial or sachet), adults: 2 times a day, 1 dose (contents of the vial or sachet).

Taking a higher dose of Lakcid Gastromed than recommended

No cases of overdose have been reported.

4. Possible side effects

Like all medicines, Lakcid Gastromed can cause side effects, although not everybody gets them. The following side effects may occur: Frequency not known (frequency cannot be estimated from the available data):

• Bacteremia (sepsis), infectious endocarditis - in patients in a severe state and patients at increased risk (see section Warnings and precautions).

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should inform their doctor or pharmacist. 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, Tel.: +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. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Lakcid Gastromed

The medicine should be stored out of sight and reach of children. Store in a refrigerator (2°C - 8°C). Protect from light. Within the validity period, the medicine can 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 specified month. Medicines should not be disposed of via wastewater or household waste containers. Patients should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Lakcid Gastromed contains

• The active substances of the medicine are Lactobacillus rhamnosusbacteria, not less than 12 billion CFU*/dose (contents of the sachet or vial)
• Lactobacillus rhamnosusstrain 573L/1**
• Lactobacillus rhamnosusstrain 573L/2**
• Lactobacillus rhamnosusstrain 573L/3**

*CFU - Colony Forming Unit (English: Colony Forming Unit)
**strains occur in equal quantitative proportions

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

What Lakcid Gastromed looks like and what the packaging contains

What Lakcid Gastromed looks like

The powder in the vial is a formless or crystalline-needle-like dry mass with a color from light to dark beige. After reconstitution, a uniform suspension without visible mechanical impurities is formed. The powder in the sachet has the form of loose, crushed particles with a color from light to dark beige. After reconstitution, a uniform suspension with a color from light to dark beige is formed, without visible mechanical impurities.

Packaging

5 vials with powder for 1 dose
10 vials with powder for 1 dose
5 sachets with powder for 1 dose
10 sachets with powder for 1 dose
Not all pack sizes may be marketed.

Marketing authorization 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

Date of last update of the leaflet: