Luivac

Package Leaflet: Information for the Patient

LUIVAC,

3 mg, tablets

Read the package leaflet carefully before using the medicine, as it contains

important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor and should not be given to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is Luivac and what is it used for

Luivac is an immunostimulating agent used orally.
The antigenic structures present in Luivac are absorbed by the gastrointestinal tract epithelium and enter the cells of the immune system in the gastrointestinal tract area. This leads to the stimulation of defense mechanisms throughout the mucosal immune system, including the bronchial tree.
Indications for use:
Adults
Prevention of recurrent respiratory tract infections (RTI) in adults..
Children and adolescents
Prevention of recurrent respiratory tract infections (RTI) in children from 4 years of age.

2. Important information before using Luivac

When not to use Luivac

• if the patient is hypersensitive to the active substances or any of the other ingredients of this medicine (listed in section 6).
• in patients with acute gastrointestinal inflammation, as the action of the preparation is disturbed in the case of accelerated intestinal passage.

Due to insufficient experience and the possibility of complex interactions, the medicine should not be used
in patients with autoimmune diseases.

Warnings and precautions

Before starting to use Luivac, discuss it with your doctor or pharmacist.
It is not recommended to use Luivac to prevent pneumonia, as there are no clinical trial data confirming such an effect.
As with any non-specific immunotherapy, it is not recommended to use specific vaccinations at the same time.

Children and adolescents

Luivac should not be given to children under 4 years of age.

Luivac and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take.
No interactions with other medicines have been found.
In patients undergoing immunosuppressive treatment, the response to vaccination may be weakened.

Luivac with food and drink

Tablets should be swallowed on an empty stomach, with a small amount of liquid.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Due to the lack of data, the medicine should not be used in pregnant women.
No contraindications to the use of Luivac during breastfeeding.

Driving and using machines

Luivac does not affect the ability to drive and use machines.

3. How to use Luivac

This medicine should always be used as directed by your doctor or pharmacist. In case of doubts, consult your doctor or pharmacist.
The recommended dose is
Luivac should be taken for 28 consecutive days in two cycles separated by a 28-day break.
Tablets should be swallowed on an empty stomach, with a small amount of liquid.
Treatment with Luivac usually starts during a period free from infection. In the case of an acute infection, Luivac may be used at the same time as antibiotics, but it cannot replace anti-inflammatory treatment.

Using more than the recommended dose of Luivac

No cases of overdose have been reported.

Missing a dose of Luivac

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

Stopping the use of Luivac

In case of any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Luivac can cause side effects, although not everybody gets them.
Uncommon (may affect up to 1 in 100 people)

• mild gastrointestinal disorders
• skin reactions

Rare (may affect up to 1 in 10,000 people)

• thrombocytopenia
• joint pain

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your 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 181 C,
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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Luivac

Keep the medicine out of the sight and reach of children.
No special precautions for storage of the medicinal product.
Protect from light.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP".
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Luivac contains

1 tablet contains:
Active substance LW50020R
43 mg
lysate of bacteria of each of the following strains
3 mg
(each strain at least 1 x 10 microorganisms):
Staphylococcus aureus,
Streptococcus mitis,
Streptococcus pyogenes,
Streptococcus pneumoniae,
Klebsiella pneumoniae,
Moraxella (Branhamella) catarrhalis
Haemophilus influenzae
mannitol
40 mg
Other ingredients are: mannitol, microcrystalline cellulose, glycolic starch (type A), magnesium stearate, anhydrous colloidal silica

What Luivac looks like and contents of the pack

Blisters: lower part consisting of three layers: polyamide film, aluminum foil, PVC film;
upper part: aluminum foil coated with a transparent protective layer.
Packs contain 28 tablets (2 blisters) or 56 tablets (4 blisters).

Marketing authorization holder:

Zentiva k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic

Manufacturer:

Daiichi Sankyo Europe GmbH
Luitpoldstrasse 1, 85276 Pfaffenhofen/Ilm, Germany

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

Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
phone: +48 22 375 92 00

Date of last revision of the leaflet: