Urosal

Package Leaflet: Information for the Patient

UROSAL

300 mg+300 mg, tablets
Methenamine+ Phenylsalicylate

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

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor, pharmacist, or nurse.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If after 3 days there is no improvement or you feel worse, contact your doctor.

Table of Contents of the Leaflet:

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

1. What is Urosal and what is it used for

Urosal acts antibacterially in the intestines, bile ducts, and urinary tract thanks to the combined activity of methenamine and phenylsalicylate.
It acts as a disinfectant, anti-inflammatory, and analgesic. The medicine is used in urinary tract infections, pyelonephritis, cystitis, cholecystitis, biliary tract inflammation, diarrhea, and intestinal inflammation.
If after 3 days there is no improvement or you feel worse, consult your doctor.

2. Important information before taking Urosal

When not to take Urosal

Do not take Urosal if you are hypersensitive to salicylates and phenol, have renal failure, peptic ulcer disease, bleeding disorders, severe liver failure, significant metabolic acidosis, or dehydration.
Do not take Urosal in the third trimester of pregnancy (see section "Pregnancy, breastfeeding, and fertility").

Warnings and precautions

Before starting Urosal, consult your doctor, pharmacist, or nurse.
In case of asthma, do not take without consulting your doctor.

Urosal and other medicines:

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Do not take with sulfonamides. Due to the content of salicylates, Urosal enhances the effect of anticoagulant, anti-pyretic, and medicines that may adversely affect the gastrointestinal tract and hematopoietic system. In the case of anticoagulant medicines, this interaction may cause bleeding.

Urosal with food and drink

Take after a meal, with a glass of water.

Pregnancy, breastfeeding, and fertility

Before taking any medicine, consult your doctor.
Do not take Urosal if you are in the last 3 months of pregnancy, as it may harm the unborn child or cause problems during delivery. It may cause kidney and heart disorders in the unborn child. It may increase the risk of bleeding in the mother and child and cause delayed or prolonged delivery.During the first 6 months of pregnancy, it is not recommended to take Urosal unless absolutely necessary and recommended by a doctor.If treatment is necessary during this period or when trying to conceive, use the smallest dose for the shortest possible time. From the 20th week of pregnancy, Urosal may cause kidney function disorders in the unborn child if taken for more than a few days. This may lead to a decrease in the amount of amniotic fluid surrounding the child (oligohydramnios) or narrowing of the arterial duct (ductus arteriosus) in the child's heart. If treatment is necessary for more than a few days, the doctor may recommend additional monitoring.

Driving and using machines:

The medicine does not affect psychophysical abilities, the ability to drive vehicles, or operate machinery.

Urosal contains sucrose and lactose

If you have previously been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.

3. How to take Urosal

Orally: 3 times a day, 1 tablet after a meal, with a glass of water.
If you feel that the effect of the medicinal product is too strong or too weak, consult your doctor.

Overdose of Urosal

In case of taking a larger dose than recommended, consult your doctor or pharmacist immediately.

Missed dose of Urosal

Take the next dose as soon as possible.

4. Possible side effects

Like all medicines, Urosal can cause side effects, although not everybody gets them.
Blood and lymphatic system disorders
Frequency not known (frequency cannot be estimated from the available data): leukopenia (decrease in white blood cell count), thrombocytopenia, anemia
Gastrointestinal disorders
Common (occurring in 1 to 10 out of 100 patients): gastrointestinal disorders
Rare (occurring in 1 to 10 out of 10,000 patients): intestinal irritation and abdominal pain
Renal and urinary disorders
Rare: urinary tract irritation, pain when urinating, burning, and feeling of urgency when urinating
Frequency not known: hematuria (presence of blood in the urine)
Skin and subcutaneous tissue disorders
Frequency not known: allergic skin reactions

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. 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,
tel.: +48 22 49-21-301, fax: +48 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Urosal

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C. Store in the original packaging to protect from moisture.
Do not use Urosal after the expiry date stated on the packaging after "Expiry date".
The expiry date refers to the last day of the month.
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 Urosal contains

1 tablet contains 300 mg of methenamine and 300 mg of phenylsalicylate, as well as excipients:
potato starch, sucrose, magnesium stearate, carboxymethylcellulose (type A), lactose monohydrate, talc, gelatin, sodium lauryl sulfate.

What Urosal looks like and contents of the pack

Packaging: a container containing 20 tablets, with a lid and a desiccant, in a cardboard box.

Marketing authorization holder and manufacturer

Zakłady Chemiczno-Farmaceutyczne "VIS" Sp. z o.o.,
ul. Św. Elżbiety 6a
41-905 Bytom
To obtain more detailed information, contact the local representative of the marketing authorization holder:
Zakłady Chemiczno-Farmaceutyczne "VIS" Sp. z o.o.,
ul. Św. Elżbiety 6a
41-905 Bytom
tel (32) 2589555,
e-mail: firma@vis-farm.pl

Date of last revision of the leaflet: