FORDIURAN 1 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Fordiuran 1 mg Tablets

Bumetanide

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Fordiuran and what is it used for
2. What you need to know before taking Fordiuran
3. How to take Fordiuran
4. Possible side effects
5. Storage of Fordiuran
6. Package Contents and Additional Information

1. What is Fordiuran and what is it used for

Fordiuran contains bumetanide, which is an active ingredient with diuretic activity, used to reduce fluid retention (edema) and to treat high blood pressure (hypertension) in adults.

2. What you need to know before taking Fordiuran

Do not take Fordiuran:

• if you are allergic to bumetanide or any of the other ingredients of this medication (listed in section 6).
  • if you have low levels of sodium or potassium in your blood.
  • if you have anuria (absence of urine production).
  • if you have hepatic encephalopathy (alteration of brain function due to severe liver dysfunction).
  • if you are dehydrated.
  • if you are breastfeeding.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Fordiuran.

Be particularly careful with Fordiuran:

• if you have ever had a severe skin rash or skin peeling, blisters, or sores in the mouth after taking Fordiuran or other sulfonamides, such as loop diuretics.
• if you have liver dysfunction. In this case, you should inform your doctor.
• if you have low blood pressure (hypotension).
• if you have or have had diabetes mellitus or gout.
• if you normally have problems urinating.
• if you have kidney dysfunction.
• if you are allergic to sulfonamides, as you may have an allergic reaction to Fordiuran.

During treatment, your doctor may recommend periodic monitoring of your blood sodium and potassium levels.

Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with Fordiuran treatment. Stop using Fordiuran and consult a doctor immediately if you notice any symptoms related to these severe skin reactions described in section 4.

Using Fordiuran with Other Medications

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Fordiuran may interact with:

• heart medications such as digoxin (cardiac glycosides)
• medications for heart rhythm disorders
• non-steroidal anti-inflammatory medications (NSAIDs) used to treat arthritis or other muscle or bone problems
• medications for high blood pressure
• medications that cause potassium loss
• certain antibiotics (such as aminoglycosides)
• medications used to treat gout
• medications containing lithium, used to treat certain mental disorders.

If you are being treated with medications containing lithium, inform your doctor, as you may need to have periodic blood tests.

Pregnancy and Breastfeeding

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

If you are pregnant, you should only use Fordiuran if your doctor considers it necessary.

Fordiuran should not be used during breastfeeding.

Driving and Using Machines

Treatment with Fordiuran generally does not affect your ability to drive or use machines.

However, dizziness may occur during treatment, which you should take into account if you drive or use machines.

Important Information for Athletes

This medication contains a component, bumetanide, which may result in a positive doping test.

Fordiuran Contains Lactose

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

3. How to Take Fordiuran

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

Remember to take your medication.

The tablets should be swallowed with a little water or other liquid.

The recommended dose is:

In most patients, the initial dose is 0.5 mg (1/2 tablet) - 1 mg (1 tablet) per day, preferably in the morning. The dose may be increased up to 2 mg (2 tablets), two or three times a day, until a satisfactory diuretic response is achieved.

The number of tablets per day may be adjusted if your doctor considers it necessary.

Use in Children

The use of Fordiuran is not recommended in children.

If You Take More Fordiuran Than You Should

If you have taken more Fordiuran than you should, consult your doctor immediately.

At high doses and during long-term treatment, Fordiuran may cause electrolyte imbalance, dehydration, and polyuria (production of large amounts of urine). Symptoms of electrolyte imbalance include dry mouth, thirst, weakness, lethargy, somnolence, confusion, gastrointestinal disorders, restlessness, muscle pain, and cramps and convulsions.

In case of overdose or accidental ingestion, you can also contact the Toxicology Information Service. Phone 91 562 04 20.

If You Forget to Take Fordiuran

If you forget a dose, take another as soon as possible or, if the next dose is near, wait until then. Then continue as instructed. Do not take a double dose to make up for forgotten doses.

If You Stop Taking Fordiuran

Your doctor will indicate the duration of your treatment with Fordiuran. Take the medication until the end of the treatment. Do not stop treatment before, as it may be harmful to your health.

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

• Commonside effects (affecting 1 to 10 in 100 patients):

Alterations in sodium, potassium, or chloride levels in the blood, dizziness (including postural hypotension and vertigo), fatigue (including lethargy, somnolence, asthenia, and malaise), headache, abdominal pain and discomfort, nausea, muscle cramps, muscle pain, and urinary problems.

• Uncommonside effects (affecting 1 to 10 in 1,000 patients):

Blood disorders (decrease in white blood cells, red blood cells, and/or platelets), dehydration, metabolic disorders including decreased glucose tolerance, increased uric acid concentration in the blood, gout, syncope, hearing disorders, chest pain and discomfort, decreased blood pressure, breathing difficulties, cough, vomiting, diarrhea, constipation, dry mouth, thirst, skin rashes, dermatitis, eczema, urticaria, itching, sensitivity to light, kidney failure (including renal failure), and swelling of feet, ankles, and legs (peripheral edema).

Stop using Fordiuran and seek medical attention immediately if you notice any of the following symptoms:

• Red patches, or circular or target-shaped patches on the chest, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Fordiuran

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

Store below 30°C. Keep the blister pack in the outer packaging to protect it from light.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If you have any questions, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Fordiuran

• The active ingredient is bumetanide. Each tablet contains 1 mg of bumetanide.
• The other ingredients are cornstarch, lactose monohydrate, povidone, polysorbate 80, colloidal anhydrous silica, agar-agar, talc, and magnesium stearate.

Appearance of the Product and Package Contents

Flat, circular, white tablets.

Each package contains 20 tablets.

Marketing Authorization Holder

Karo Pharma AB

Box 16184

103 24 Stockholm

Sweden

Manufacturer

Allphamed Pharbil Arzneimittel GmbH, Nextpharma Group

Hildebrandstraße 10-12

37081 Göttingen

Germany

Or

LEO PHARMACEUTICAL PRODUCTS

Industriparken, 55, Ballerup DK 2750

Denmark

Or

Laboratoires LEO, S.A.

39, Route de Chartres –

Vernouillet Cedex - F-28500

France.

You can request more information about this medication from the local representative of the marketing authorization holder:

Tora Laboratories, S.L.U.

Avenida de Oporto, 60

28019 Madrid

Spain

Date of the Last Revision of this Package Leaflet: November 2024

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