Uro-vaxom

Package Leaflet: Information for the User

Uro-Vaxom

6 mg, hard capsules

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your 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 for:

• preventing recurrent lower urinary tract infections
• supportive treatment of acute urinary tract infections in children from 4 years of age and in adults.

2. Important information before taking Uro-Vaxom

When not to take Uro-Vaxom

• if you are allergic to the lyophilized lysate of Escherichia colior 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.
In case of skin reactions, fever, or limited swelling (edema), 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 occurrence of adverse events 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, Uro-Vaxom should be avoided 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 operate machines.

3. How to take Uro-Vaxom

Take this medicine always as directed by your doctor or pharmacist. If you are unsure, 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 meals, for 90 consecutive days (3 months).
Supportive treatment of acute infections:
1 capsule per day, before meals, until symptoms disappear, but for at least 10 days.
The medicine can be used as supportive treatment with other antibacterial medicines.

Overdose of Uro-Vaxom

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

Missed 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 questions about the use of this medicine, ask 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 not listed in this leaflet, please inform 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 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this 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 blister and carton after "EXP" or "Expiry Date". The expiry date refers to the last day of the month stated.
Store in a temperature below 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:
OM-89 lyophilisate
60 mg
which contains:
lyophilized Escherichia coli lysate
6 mg
propyl gallate (E 310)
84 micrograms
sodium glutamate (E 621)
3.03 mg
Mannitol
up to 60 mg
The other ingredients are:
starch (gelatinized), magnesium stearate, propyl gallate (E 310), sodium glutamate (E 621),
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.
Pack of 30 hard capsules (3 blisters of 10 capsules in a carton).
Pack of 90 hard capsules (9 blisters of 10 capsules in a carton).
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

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
To obtain more detailed information, please contact the representative of the marketing authorization holder:
Qpharma Sp. z o.o.
ul. Wichrowa 7F/10
04-682 Warsaw
phone +48 22 590 57 00
qpharma@qpharma.pl

Date of last revision of the leaflet: