Luivac

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Luivac

3 mg, tablets

You should carefully read the contents of the leaflet before using the medicine, as it contains

important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, you should 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 packaging and other information

1. What is Luivac and what is it used for

Luivac is an immunostimulating medicine used orally.
The antigenic structures present in Luivac are absorbed by the epithelium of the gastrointestinal tract and enter the cells of the immune system in the gastrointestinal tract area. This leads to the stimulation of defense mechanisms throughout the immune system of the mucous membranes, 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 allergic 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 disrupted in the case of accelerated intestinal passage.

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

Warnings and precautions

Before starting to use Luivac, you should discuss it with your doctor or pharmacist.
It is not recommended to use Luivac to prevent pneumonia, as there are no data from clinical trials 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

You should tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as 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, you should consult your doctor or pharmacist 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 in accordance with the recommendations of your doctor or pharmacist. If you have any doubts, you should 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 acute infection, Luivac may be used at the same time as antibiotics, but it cannot replace anti-inflammatory treatment.

Using a higher dose of Luivac than recommended

No cases of overdose have been reported.

Missing a dose of Luivac

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

Stopping the use of Luivac

If you have any further doubts about using this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Luivac can cause side effects, although they may not occur in everyone.
Not very common (may occur more often than 1/1000, but less often than 1 in 100 people)

• mild gastrointestinal disorders
• skin reactions

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

• thrombocytopenia
• joint pain

Reporting side effects

If you experience any side effects, including any not listed in the leaflet, you should 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, Tel.: +48 22 49 21 301, Fax: + 48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Luivac

The medicine should be stored in a place that is 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 should not be disposed of via wastewater or household waste. You should ask your 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

Staphylococcus aureus
Streptococcous mitis
Streptococcous pyogenes
Streptococcous 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 microorganisms):
Staphylococcus aureus,
Streptococcous mitis,
Streptococcous pyogenes,
Streptococcous pneumoniae,
Klebsiella pneumoniae,
Moraxella (Branhamella) catarrhalis
Haemophilus influenzae
mannitol
40 mg
The other ingredients are: mannitol, microcrystalline cellulose, sodium carboxymethylcellulose (type A), magnesium stearate, anhydrous colloidal silica.

What Luivac looks like and what the pack contains

Blisters of PVC-Al-PVC/Al foil in a cardboard box. The packs contain 28 tablets (2 blisters)
or 56 tablets (4 blisters).
To obtain more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, the 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

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Romania, the country of export:4595/2012/01
4595/2012/02
Translation of abbreviations for days of the week from the blister:
Lu- Monday
Ma- Tuesday
Mi- Wednesday
Jo- Thursday
Vi- Friday
Sâ- Saturday
Du- Sunday

Parallel import authorization number: 3/24

Date of leaflet approval: 04.01.2024

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