Uro-vaxom

Patient Information Leaflet: User Information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Uro-Vaxom

6 mg, hard capsules

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their illness symptoms are the same.
• 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.

Table of Contents of the Leaflet:

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

1. What is Uro-Vaxom and what is it used for

Uro-Vaxom contains a lyophilized bacterial lysate of Escherichia coli, most commonly responsible for urinary tract infections.
In animals, after administration of Uro-Vaxom, increased resistance to experimentally induced infections has been demonstrated, resulting from the activation of macrophages, B lymphocytes, immunocompetent cells in Peyer's patches, and an increase in the level of secretory IgA in the intestines.
In humans, Uro-Vaxom stimulates T lymphocytes, induces the production of endogenous interferon, and increases the level of secretory immunoglobulin IgA in urine.
Uro-Vaxom is used to:

• prevent recurrent lower urinary tract infections
• treat acute urinary tract infections in children from 4 years of age and in adults as an adjunctive therapy.

2. Important information before taking Uro-Vaxom

When not to use Uro-Vaxom

Escherichia colilysate or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to take Uro-Vaxom, discuss it with your doctor or pharmacist.
If skin reactions, fever, or limited swelling (edema) occur, discontinue the use of the medicine, as these reactions may have an allergic basis.
If you are taking immunosuppressive drugs, inform your doctor.
These drugs are used to suppress the body's immune response (e.g., after organ transplantation) and may reduce or inhibit the therapeutic effect of Uro-Vaxom.

Children

The efficacy and safety of Uro-Vaxom in children under 4 years of age have not been studied.

Uro-Vaxom and other medicines

Tell your doctor or pharmacist about all the medicines you are taking (using) now or have recently taken, as well as any medicines you plan to take (use).
No interactions have been found between Uro-Vaxom and other medicines.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Pregnancy
There are no data on the adverse effects of the medicine in relation to the embryo/fetus.
There are no data or only limited data on the use of Uro-Vaxom in pregnant women. As a precaution, avoid using Uro-Vaxom during pregnancy.
Breastfeeding
No studies have been conducted to assess the use of the medicine in breastfeeding women.
Therefore, caution should be exercised during breastfeeding.
Fertility
There are no data on the effect on fertility.

Driving and using machines

Uro-Vaxom does not affect the ability to drive or use machines.

3. How to take Uro-Vaxom

Always take this medicine exactly as your doctor or pharmacist has told you.
If you are not sure, consult your doctor or pharmacist.
Uro-Vaxom is a medicine for oral use.
Recommended dose (for children from 4 years of age and adults):
To prevent recurrent lower urinary tract infections, take 1 capsule per day, before a meal, for 90 consecutive days (3 months).
Adjunctive treatment of acute infections:
1 capsule per day, before a meal, until symptoms resolve, but for at least 10 days.
The medicine can be used as adjunctive therapy with other antibacterial medicines.

Overdose of Uro-Vaxom

No cases of adverse effects due to overdose have been reported.
However, in case of overdose, consult a doctor.

Missing a dose of Uro-Vaxom

If you miss a dose, continue treatment the next day as before.
Do not take a double dose to make up for the missed capsule.

Stopping Uro-Vaxom treatment

Do not stop or prematurely terminate treatment without consulting your doctor.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Uro-Vaxom can cause side effects, although not everybody gets them.
The following side effects have been observed:
Common (may affect up to 1 in 10 people):
headache, nausea, diarrhea, indigestion
Uncommon (may affect up to 1 in 100 people):
abdominal pain, fever, allergic reactions, hives, itching, rash
Rare (may affect up to 1 in 10,000 people):
mouth swelling, hair loss, swelling of the ankles, feet, or fingers

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor or pharmacist.
Side effects can also be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Uro-Vaxom

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the month stated.
Store in a temperature between 15-25°C.
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 Uro-Vaxom contains

The active substance is:
lyophilized OM-89
60 mg
which contains:
lyophilized Escherichia colilysate
6 mg
propyl gallate (E 310)
84 micrograms
sodium glutamate (E 621)
3.03 mg
mannitol
up to 60 mg
The other ingredients are:
maize starch, magnesium stearate, mannitol.
The capsule shell contains: gelatin, yellow iron oxide (E 172), red iron oxide (E 172), titanium dioxide (E 171).

What Uro-Vaxom looks like and contents of the pack

Uro-Vaxom is in non-transparent capsules with a yellow body and an orange cap.
Packaging: 30 hard capsules (3 blisters of 10 capsules in a cardboard box).
Packaging: 90 hard capsules (9 blisters of 10 capsules in a cardboard box).
For more detailed information, consult the marketing authorization holder or the parallel importer.

Marketing authorization holder in the Czech Republic, the country of export:

OMEDICAMED Unipessoal Lda
Avenida António Augusto de Aguiar nº 19 – 4º
1050-012 Lisbon, Portugal

Manufacturer:

FLAVINE PHARMA FRANCE
3 voie d’Allemagne
13127 Vitrolles, France

Parallel importer:

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

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in the Czech Republic, the country of export:59/229/89-C

Parallel import authorization number: 213/25

Date of leaflet approval: 20.06.2025

[Information about the trademark]