Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Luivac
3 mg, tablets
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet to be able to read it again if necessary.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Luivac and what is it used for

Luivac is an immunostimulant medicine taken orally.
The antigenic structures present in Luivac are absorbed through the gastrointestinal tract epithelium and reach immune system cells in the gastrointestinal tract area. This leads to stimulation of defense mechanisms throughout the mucosal immune system, including the bronchial tree.
Indications:
Adults
Prophylaxis of recurrent respiratory tract infections (RTI) in adults.
Children and adolescents
Prophylaxis of recurrent respiratory tract infections (RTI) in children from 4 years of age.

2. Information before using Luivac

When not to use Luivac

if the patient is allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6).
in patients with acute gastrointestinal inflammation, because accelerated intestinal transit may impair the effectiveness of the product.

Due to insufficient experience and the possibility of complex interactions, Luivac should not be used
in patients with autoimmune diseases.
Warnings and precautions
Before starting treatment with Luivac, consult your doctor or pharmacist.
Luivac is not recommended for the prevention of pneumonia, as there are no clinical data
supporting such an effect.
As with any non-specific immunotherapy, concomitant administration of specific vaccinations is not recommended.
Children and adolescents
Luivac should not be administered to children under 4 years of age.
Luivac and other medicines
Inform your doctor or pharmacist about any medicines the patient is currently taking, has recently taken, or plans to take.
No interactions with other medicines have been reported.
In patients undergoing immunosuppressive treatment, the response to vaccination may be reduced.
Luivac with food and drink
Tablets should be taken on an empty stomach, swallowed with a small amount of liquid.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine. Due to lack of data, Luivac should not be used during pregnancy.
There are no restrictions regarding the use of Luivac during breastfeeding.
Driving and using machines
Luivac has no influence on the ability to drive or operate machinery.

3. How to use Luivac

This medicine should always be used according to the instructions given by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
The recommended dose is
Luivac tablets should be taken for 28 consecutive days in two cycles separated by a
28-day break.
The tablets should be taken on an empty stomach, swallowed with a small amount of liquid.
Treatment with Luivac is usually initiated during a period free of infections. In the case of
acute infection, Luivac may be used concomitantly with antibiotics, but it cannot replace
anti-inflammatory treatment.
Use of a higher than recommended dose of Luivac
No cases of poisoning have been reported.
Missed dose of Luivac
Do not take a double dose to make up for a missed dose of Luivac.
Discontinuation of Luivac
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everybody will experience them.

Not very common (may affect more than 1 in 1,000 people but less than 1 in 100):

mild gastrointestinal disturbances
skin reactions.

Very rare (may affect no more than 1 in 10,000 people):

thrombocytopenia
joint pain.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of 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.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Luivac

Keep this medicine out of sight and reach of children.
Protect from light.
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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Luivac contains
1 tablet contains:
bacterial lysate 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
Other ingredients: mannitol, microcrystalline cellulose, sodium carboxymethyl starch (type A),
magnesium stearate, colloidal anhydrous silica.

What Luivac looks like and contents of the pack
PVC-Al-PVC/Al blisters in a cardboard box.
Packs contain 28 tablets (2 blisters) or 56 tablets (4 blisters).
For further information, please contact the responsible party or the parallel importer.

Responsible party in Romania, country of export:
Labormed Pharma S.A.
Bd. Theodor Pallady nr. 44B, Sector 3
Bucharest, Romania

Manufacturer:
DAIICHI SANKYO EUROPE GmbH
Luitpoldstrasse 1, 85276 Pfaffenhofen/iim
Germany

Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw

Authorization number in Romania, country of export: 4595/2012/01
4595/2012/02

Authorization number for parallel import: 79/24

Translation of the weekday symbols printed next to each tablet in the immediate packaging:
Lu - Monday
Ma - Tuesday
Mi - Wednesday
Jo - Thursday
Vi - Friday
Sâ - Saturday
Du - Sunday