Patient Information Leaflet

UROSAL
300 mg + 300 mg, tablets
Methenaminum + Phenylis salicylas
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
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, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any side effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
If there is no improvement or if you feel worse after 3 days, consult your doctor.

Contents of this leaflet:

What Urosal is and what it is used for
Important information before taking Urosal
How to take Urosal
Possible side effects
How to store Urosal
Contents of the pack and other information

1. What Urosal is and what it is used for
Urosal exerts antibacterial action in the intestines, biliary and urinary tracts due to the combined activity of methenamine and phenyl salicylate.
It has antiseptic, anti-inflammatory, and analgesic properties. The medicine is used in cystitis, pyelonephritis, nephritis, inflammatory conditions of the gallbladder and biliary tract, diarrhea, and intestinal dyspepsia.
If there is no improvement after 3 days or if 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 or phenol, have renal insufficiency, peptic ulcer disease, hemorrhagic diathesis, severe hepatic insufficiency, marked metabolic acidosis, or dehydration.
Do not use Urosal during 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 bronchial asthma, do not use without consulting a doctor.

Urosal with other medicines
Inform your doctor or pharmacist about any medicines you are currently taking, have recently taken, or plan to take.
Do not use with sulfonamides. Due to its salicylate content, Urosal enhances the effects of anticoagulants, antipyretics, and drugs that adversely affect the gastrointestinal tract and hematopoietic system. In the case of anticoagulants, this interaction may lead to bleeding.

Urosal with food and drink
Take after meals, with water.

Pregnancy, breastfeeding and fertility
Consult your doctor before taking any medicine.
Do not take Urosal if you are in the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. It may cause kidney and heart problems in the unborn child. It may increase the risk of bleeding in both mother and child and may delay or prolong labor. Use during the first six months of pregnancy is not recommended unless absolutely necessary and prescribed by a doctor. If treatment is required during this period or when trying to conceive, the lowest possible dose for the shortest possible duration should be used. From the 20th week of pregnancy, Urosal may cause impaired kidney function in the unborn child if taken for longer than a few days. This may lead to reduced amniotic fluid volume (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for longer than a few days, your doctor may recommend additional monitoring.

Driving and operating machinery
Urosal does not impair psycho-physical performance, ability to drive or operate machinery.

Urosal contains sucrose and lactose
If you have been previously diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to use Urosal

Orally: 3 times daily, 1 tablet after meals, taken with water.
If you feel that the effect of the medicinal product is too strong or too weak, consult your doctor.
Taking a higher than recommended dose of Urosal
If you take more than the recommended dose, seek immediate advice from your doctor or pharmacist.
Missing a dose of Urosal
Take the next dose as soon as possible.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Blood and lymphatic system disorders
Frequency unknown (frequency cannot be estimated from available data): leukopenia
(decreased white blood cell count), thrombocytopenia, anaemia
Gastrointestinal disorders
Common (occurs in 1 to 10 out of 100 patients): gastrointestinal disturbances
Rare (occurs in 1 to 10 out of 10,000 patients): intestinal irritation and abdominal pain
Renal and urinary disorders
Rare: urinary tract irritation, pain during urination, burning sensation and urinary urgency
Frequency unknown: haematuria (presence of red blood cells in urine)
Skin and subcutaneous tissue disorders
Frequency unknown: skin allergic reactions
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in the leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Urosal

Keep the medicine out of sight and reach of children.
Store below 25°C. Keep in the original packaging
to protect from moisture.
Do not use Urosal after the expiry date stated on the packaging following
"Expiry date".
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask
your pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.

6. Contents of the package and other information

What Urosal contains
One tablet contains 300 mg of methenamine and 300 mg of sodium salicylate, and excipients:
potato starch, sucrose, magnesium stearate, carboxymethyl starch (type A), lactose monohydrate,
talc, gelatin, sodium lauryl sulfate.

What Urosal looks like and contents of the pack
Pack: a container with 20 tablets, closed with a cap containing a desiccant, in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Chemiczno-Farmaceutyczne Zakłady „VIS” Spółka z o.o.,
ul. Św. Elżbiety 6a
41-905 Bytom

For further information, please contact the local representative of the Marketing Authorisation Holder:
Chemiczno-Farmaceutyczne Zakłady „VIS” Spółka z o.o.,
ul. Św. Elżbiety 6a
41-905 Bytom
tel (32) 2589555,
e-mail: [email protected]