Urinorm 100 mg tablets
Spain
Table of Contents
Package Leaflet: Information for the User
Introduction
Package Leaflet: Information for the User
URINORM 100 mg tablets
benzbromarone
Read the entire 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 questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Leaflet Contents
- What Urinorm is and what it is used for
- What you need to know before taking Urinorm
- How to take Urinorm
- Possible side effects
- How to store Urinorm
- Contents of the pack and other information
1. What Urinorm is and what it is used for
This medicine is used for the treatment of gout (it promotes renal excretion of uric acid).
Urinorm should only be used in patients who do not respond to or do not tolerate allopurinol (another medicine used to reduce uric acid) for the treatment of:
- Severe gout (gout affecting multiple joints or causing significant accumulation of uric acid in the joints).
Certain patients with impaired renal function or renal transplant recipients.
2. What you need to know before starting to 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:
- Renal calculi (kidney stones) due to uric acid.
- Hepatic porphyria.
- Concomitant administration of hepatotoxic drugs, and especially antituberculosis agents (see section "Other medicines and Urinorm").
- Excessive excretion of uric acid in the urine.
- Gout caused by a blood disorder.
Warnings and precautions
Before starting treatment, and subsequently at least once during the first year of treatment, liver function should be monitored through blood tests. Your doctor will determine how often these tests should be performed.
Important warning:
Since liver problems may occur during treatment with Urinorm, you must stop taking the medicine and contact your doctor immediately if you experience nausea, vomiting, abdominal pain, jaundice (yellowing of the skin and/or the conjunctiva of the eye), or fatigue.
As with other drugs used to treat gout, treatment with Urinorm should not be initiated during an acute attack of gout.
At the beginning of treatment, your doctor should take necessary precautions to prevent an acute gout attack.
Before starting treatment, it is advisable to measure the amount of uric acid excreted in the urine over a 24-hour period.
Drink plenty of alkaline water to help prevent the formation of kidney stones.
Follow the dietary regimen recommended by your doctor.
Urinorm should be administered with caution if you have any kidney disease affecting kidney function.
Other medicines and Urinorm
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
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Concomitant administration of hepatotoxic drugs should be avoided, and especially antituberculosis agents (see section "Do not take Urinorm"). In addition, as stated above, this may constitute a risk factor for the development of hepatotoxicity.
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Salicylates (acetylsalicylic acid and derivatives) reduce the effect of the medicine.
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Concomitant administration with pyrazinamide may reduce the effect of Urinorm. In addition, as stated above, it may constitute a risk factor for the development of hepatotoxicity.
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Urinorm may enhance the effect of vitamin K antagonists (oral anticoagulants).
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
This medicine must not be administered to pregnant or breastfeeding women.
Urinorm contains lactose and sodium
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him or her before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, it is essentially "sodium-free".
3. How to take Urinorm
Follow exactly the instructions for use of this medicine as given by your doctor. If you are unsure, consult your doctor or pharmacist again.
Urinorm is 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 meals.
If you take more Urinorm than you should
Nausea, vomiting, diarrhea, and liver or kidney function problems may occur. Your doctor will take appropriate measures. In cases of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 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:
If 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 missed doses.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
The following may occur:
- Stomach and intestinal problems, mainly diarrhoea or nausea.
- At the beginning of treatment, and due to the possible formation of uric acid kidney stones, renal colic and gout attacks may occur.
- Rarely, allergic skin reactions.
- Rarely, liver problems, which may be serious, may also occur.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse 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 stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and unused medicines. 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 components are corn starch, lactose, povidone K-90, sodium carboxymethylstarch type A (from potato), and magnesium stearate.
Appearance of the product and contents of the pack
Flat tablets, white to very light yellow in color, with a score line.
Pack containing 30 tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Evolan Pharma AB
P.O. Box 120, SE-182 12 Danderyd, Sweden
Manufacturer:
Piramal Healthcare UK Limited
Whalton Road - Morpeth, Northumberland - NE61 3YA - United Kingdom
Piramal Pharma Solutions (Dutch) B.V.
Level, 7e verdieping, Bargelaan 200, 2333 CW
Leiden, The Netherlands
Local representative:
Vegal Farmacéutica, S.L.
Vía de las Dos Castillas 9C, portal 2, 2ºC, 28224 Pozuelo de Alarcón (Madrid), Spain
Date of the most recent review of this leaflet: March 2023
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).