Luivac

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, 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.

Leaflet Contents:

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

1. What Luivac is and what it is used for

Luivac is an immunostimulant medicine taken orally.
The antigenic structures present in Luivac are absorbed through the gastrointestinal tract epithelium and reach the immune system cells in the gastrointestinal tract area. This leads to stimulation of defense mechanisms throughout the mucosal immune system, including in 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, as accelerated intestinal transit may impair the medicine's effectiveness.

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.

Other medicines and Luivac

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for future use.
No interactions with other medicines have been reported.
In patients receiving immunosuppressive therapy, 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 or 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 as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
The recommended dose is
Luivac should be taken for 28 consecutive days in two cycles separated by a 28-day
break.
The tablets should be swallowed on an empty stomach with a small amount of liquid.
Treatment with Luivac usually begins during a period free of infections. In the case of
acute infection, Luivac may be used simultaneously 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.
Stopping treatment with Luivac
If you have any further doubts regarding the use of this medicine, consult your
doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Uncommon (may affect more than 1 in 1,000 but less than 1 in 100 people):

• mild gastrointestinal disturbances
• skin reactions

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

• thrombocytopenia
• joint pain

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in the leaflet, inform a doctor or pharmacist. Adverse reactions 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 181 C,
02-222 Warsaw, Tel.: +48 22 49 21 301,
Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions 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 carton and blister. The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Proper disposal helps protect the environment.

6. Contents of the pack and other information

Staphylococcus aureus
Streptococcus mitis
Streptococcus pyogenes
Streptococcus pneumoniae
Klebsiella pneumoniae
Moraxella (Branhamella) catarrhalis
Haemophilus influenzae

What Luivac contains
1 tablet contains:
bacterial lysate of each of the following strains 3 mg
(each strain at least 1 x 10^9 microorganisms):
Staphylococcus aureus,
Streptococcus mitis,
Streptococcus pyogenes,
Streptococcus pneumoniae,
Klebsiella pneumoniae,
Moraxella (Branhamella) catarrhalis,
Haemophilus influenzae
mannitol 40 mg

The other ingredients are: 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 foil blisters in a cardboard box. The packs contain 28 tablets (2 blisters)
or 56 tablets (4 blisters).

For more detailed information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder 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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing Authorisation Numbers in Romania, country of export: 4595/2012/01
4595/2012/02

Translation of weekday abbreviations on the blister:
Lu - Monday
Ma - Tuesday
Mi - Wednesday
Jo - Thursday
Vi - Friday
Sâ - Saturday
Du - Sunday

Parallel Import Authorisation Number: 3/24