URINORM 100 mg TABLETS

Introduction

Package Leaflet: Information for the User

URINORM 100 mg tablets

benzbromarone

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Urinorm and what is it used for
2. What you need to know before you take Urinorm
3. How to take Urinorm
4. Possible side effects
5. Storage of Urinorm
6. Contents of the pack and other information

1. What is Urinorm and what is it used for

This medicine is used for the treatment of gout (it helps to eliminate uric acid through the kidneys).

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

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

Certain patients with kidney function impairment or kidney transplant.

2. What you need to know before you take Urinorm

Do not take Urinorm:

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• if you have:
• • Uric acid kidney stones.
  • Hepatic porphyria.
  • Concomitant administration of hepatotoxic medicines, especially antitubercular drugs (see section Other medicines and Urinorm).
  • Excessive elimination of uric acid through 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 tests should be performed through blood tests. Your doctor will determine how often these tests should be performed.

Important warning:

Because liver problems can occur during treatment with Urinorm, you should stop taking the medicine and contact your doctor immediately if you experience nausea, vomiting, abdominal pain, jaundice (yellowing of the skin and/or eye conjunctiva) or fatigue.

As with other medicines that treat gout, taking Urinorm should not be started during an acute gout attack.

At the start of treatment, your doctor should take the necessary precautions to avoid an acute gout attack.

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

Drink plenty of alkaline water to avoid the formation of kidney stones.

Follow the dietary regimen recommended by your doctor.

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

Other medicines and Urinorm

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

• The concomitant administration of hepatotoxic medicines, especially antitubercular drugs (see section Do not take Urinorm), should be avoided. Additionally, as mentioned above, it may constitute a risk factor for the development of liver toxicity.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

Urinorm containslactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

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

3. How to take Urinorm

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Urinorm should be administered orally.

The recommended dose is half or one tablet per day. Depending on 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 a meal and/or dinner.

If you take more Urinormthan you should

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

If you forget to take Urinorm:

In case you forget to take a dose, take the next dose at the scheduled time and dose. Do not take a double dose to make up for the forgotten doses.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following may appear:

• Gastrointestinal problems, mainly diarrhea or nausea.
• At the start of treatment and due to the possible formation of uric acid kidney stones, kidney colic and gout crises may appear.
• Rarely, allergic skin reactions.
• Rarely, liver problems that can be serious may also appear.

Reporting of side effects

If you experience any side effect, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Urinorm

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Urinorm

• The active substance is benzbromarone. Each tablet contains 100 mg of benzbromarone.
• The other ingredients are corn starch, lactose, povidone K-90, sodium carboxymethyl starch type A (potato) and magnesium stearate.

Appearance of the product and pack contents

White to very light yellow flat tablets with a score line.

Package with 30 tablets.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Evolan Pharma AB

P.O. Box 120, SE-182 12 Danderyd, Sweden

Manufacturer:

Piramal Healthcare UK Limited

Whalton Road - Morpeth, Northumberland - NE613YA - United Kingdom

Piramal Pharma Solutions (Dutch) B.V.

Level, 7e verdieping, Bargelaan 200, 2333 CW

Leiden, Netherlands

Local representative:

Vegal Farmacéutica, S.L.

Vía de las Dos Castillas 9C, portal 2, 2ºC, 28224 Pozuelo de Alarcón (Madrid), Spain

Date of last revision of this leaflet:March 2023

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