Uro-vaxom
Poland
Table of Contents
Warning! Keep the package leaflet! Information on the immediate packaging in a foreign language.
Uro-Vaxom
6 mg, hard capsules
Please read the entire leaflet carefully before using 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 another person, even if their symptoms are identical.
- If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Table of contents of the leaflet:
- What Uro-Vaxom is and what it is used for
- Important information before taking Uro-Vaxom
- How to take Uro-Vaxom
- Possible side effects
- How to store Uro-Vaxom
- Contents of the pack and other information
1. What Uro-Vaxom is and what it is used for
Uro-Vaxom contains a lysate of Escherichia coli bacteria, which are the most common cause of urinary tract infections.
In animals, administration of Uro-Vaxom has been shown to increase resistance to experimentally induced infections due to activation of macrophages, B lymphocytes, immunocompetent cells in Peyer's patches, and increased levels of secretory IgA in the intestines.
In humans, Uro-Vaxom stimulates T lymphocytes, induces production of endogenous interferon, and increases the level of secretory immunoglobulin IgA in urine.
Uro-Vaxom is used for:
- prevention of recurrent lower urinary tract infections
- supportive treatment of acute urinary tract infections in children from 4 years of age and in adults.
2. Information before taking Uro-Vaxom
When not to use Uro-Vaxom
- if the patient is allergic to lyophilized lysate of Escherichia coli or to any of the other components of this medicine (listed in section 6).
Warnings and precautions
Before starting Uro-Vaxom, discuss this with your doctor or pharmacist.
If skin reactions, fever or localized swelling (edema) occur, discontinue use of the medicine, as such reactions may be of allergic origin.
If taking immunosuppressive medicines, inform your doctor.
These medicines are used to suppress the body's immune responses (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 established.
Uro-Vaxom and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
To date, no interactions between Uro-Vaxom and other medicines have been reported.
Pregnancy, breastfeeding and fertility
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Pregnancy
There are no data on any adverse effects of the medicine on the embryo/fetus.
There are no data or only limited data on the use of Uro-Vaxom in pregnant women. As a precautionary measure, the use of Uro-Vaxom during pregnancy should be avoided.
Breastfeeding
No studies have been conducted to evaluate 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 operating machinery
Uro-Vaxom has no influence on the ability to drive or operate machinery.
3. How to take Uro-Vaxom
This medicine should always be taken as directed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
Uro-Vaxom is an oral medicine.
Recommended dose (in children aged 4 years and older, and adults):
To prevent recurrent lower urinary tract infections, take 1 capsule daily before a meal for 90 consecutive days (3 months).
Supportive treatment of acute infections:
1 capsule daily before a meal until symptoms resolve, but for at least 10 days.
This medicine may be used as supportive treatment alongside other antibacterial medicines.
Taking more Uro-Vaxom than recommended
There have been no reported cases of adverse effects caused by overdose.
Nevertheless, in the event of an overdose, consult your doctor.
Missed dose of Uro-Vaxom
If you miss one dose, continue treatment as before the next day. Do not take a double dose to make up for the missed capsule.
Stopping Uro-Vaxom treatment
Do not interrupt or discontinue treatment prematurely 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, this medicine 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, diarrhoea, indigestion
Uncommon (may affect up to 1 in 100 people):
abdominal pain, fever, allergic reactions, urticaria, itching, rash
Very rare (may affect up to 1 in 10,000 people):
oral cavity swelling, hair loss, swelling of ankles, feet or fingers
Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 side effects helps provide more information on the safety of this medicine.
5. How to store Uro-Vaxom
Keep this 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 stated month.
Store at a temperature of 15-25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This helps protect the environment.
6. Contents of the packaging and other information
What Uro-Vaxom contains
The active substance is:
lyophilisate OM-89 60 mg
containing:
lyophilised lysate of Escherichia coli 6 mg
propyl gallate (E 310) 84 micrograms
monosodium glutamate (E 621) 3.03 mg
mannitol up to 60 mg
The other ingredients are:
pregelatinised starch (maize), magnesium stearate, mannitol.
Capsule shell composition: gelatin, yellow iron oxide (E 172), red iron oxide (E 172),
titanium dioxide (E 171).
What Uro-Vaxom capsules look like and contents of the pack
Uro-Vaxom is supplied as opaque hard capsules with a yellow body and an orange cap.
Pack: 30 hard capsules (3 blisters of 10 capsules in a cardboard box).
Pack: 90 hard capsules (9 blisters of 10 capsules in a cardboard box).
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in the Czech Republic, 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, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing Authorisation Number in the Czech Republic, country of export: 59/229/89-C
Parallel Import Licence Number: 213/25