Package Insert: Information for the User

URINORM 100 mg Tablets

benzbromarona

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Urinorm and for what it is used

2. What you need to know before starting to take Urinorm

3. How to take Urinorm

4. Possible adverse effects

5. Storage of Urinorm

6. Contents of the package and additional information

This medication is used for the treatment of gout (promotes renal elimination of uric acid).

Urinormshould be used only in patients who do not respond or tolerate allopurinol (another medication to reduce uric acid) for the treatment of:

• Severe gout (gout that affects various joints or produces a significant accumulation of uric acid in them).

Certain patients with renal function impairment or kidney transplant.

Do not take Urinorm:

• if you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6).
• if you have:
• • Uric acid kidney stones.
  • Porphyria hepatica.
  • Concurrent administration of hepatotoxic medications and especially antitubercular drugs (see section Other medications and Urinorm).
  • Excessive elimination of uric acid through the urine.
  • Gout due to a blood disorder.

Warnings and precautions

Before starting treatment, and subsequently during at least the first year of treatment, liver function checks should be performed through blood tests. Your doctor will determine how frequently these tests should be performed.

Like other medications for gout, Urinorm should not be initiated during an acute gout attack.

Your doctor should take necessary precautions to prevent an acute gout attack at the start of treatment.

Before starting treatment, it is recommended to control the amount of uric acid eliminated through the urine over 24 hours.

Drink plenty of alkaline water to prevent kidney stone formation.

Follow the dietary regimen recommended by your doctor.

Urinorm should be administered with caution in cases of kidney disease that affects kidney function.

Other medications and Urinorm

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

• Concurrent administration of hepatotoxic medications and especially antitubercular drugs (see section Do not take Urinorm) should be avoided. Additionally, as previously indicated, it may constitute a risk factor for the development of liver toxicity.

• Salicylates (acetylsalicylic acid and derivatives) reduce the effect of the medication.
• Concurrent administration with pyrazinamide may reduce the effect of Urinorm. Additionally, as previously indicated, it may constitute a risk factor for the development of liver toxicity.
• Urinorm may increase the action of antivitamin K (oral anticoagulants).

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

This medication should not be administered to pregnant women or breastfeeding women.

Urinorm containslactose and sodium

This medication contains lactose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Urinorm should be administered orally.

The recommended dose is half or one tablet per day. According to the results obtained, this dose may be reduced or increased up to two tablets per day, which should be taken in one or two doses during or at the end of meals and/or dinner.

If you take more Urinorm than you should

Nausea, vomiting, diarrhea, and liver and kidney function problems may appear. Your doctor will take the necessary measures. In cases of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service. Phone 91 562 04 20 indicating the medication and the amount ingested. It is recommended to bring the packaging and the leaflet to the healthcare professional.

If you forgot to take Urinorm:

If you forget to take a dose, take the next dose at the scheduled time and dose. Do not take a double dose to compensate for the missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medicationmay produce adverse effects, although not all people may experience them.

They may appear:

• Gastrointestinal problems, mainly diarrhea or nausea.
• At the beginning of treatment and due to the possible formation of kidney stones caused by uric acid, they may appear renal colic and gout attacks.
• Rarely, allergic reactions on the skin.
• Rarely, liver problems may also appear, which can be severe.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is about possible adverse effects that do not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications you no longer need at the SIGRE point of your pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Urinorm

• The active ingredient is benzbromarone. Each tablet contains 100 mg of benzbromarone.
• The other components are cornstarch, lactose, povidone K-90, carboxymethylcellulose sodium type A (from potato) and magnesium stearate.

Appearance of the product and contents of the packaging

White to very light yellow, flat, scored tablets.

Packaging with 30 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Kyowa Kirin Holdings B.V.

Bloemlaan 2, 2132NP Hoofddorp

Netherlands

Manufacturer:

Piramal Healthcare UK Limited

Whalton Road - Morpeth, Northumberland - NE613YA - United Kingdom

Piramal Pharma Solutions (Dutch) B.V.

Level, 7th floor, Bargelaan 200, 2333 CW

Leiden, Netherlands

Local representative:

Kyowa Kirin Farmaceutica S.L.

Avda. de Burgos, 17 1st floor

28036 Madrid

Last review date of this leaflet:March2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).