Package Leaflet: Information for the Patient

Fordiuran 1 mg Tablets

Bumetanide

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

-Keep this leaflet, as 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.See section 4.

1. What Fordiuran is and what it is 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. Contents of the pack and additional information

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

Do not take Fordiuran:

-if you are allergic to bumetanida or any of the other components 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 especially careful with Fordiuran:

-if you have ever had a severe skin rash or peeling of the skin, blisters, or mouth sores after taking Fordiuran or other sulfonamides, such as diuretics.

-if you have any liver impairment. Inform your doctor in this case.

-if you have low blood pressure (hypotension).

-if you have or have had diabetes mellitus or gout.

-if you normally have difficulty urinating.

-if you have any kidney impairment.

-if you are allergic to sulfonamides, as you may experience an allergic reaction to Fordiuran.

During treatment, your doctor may recommend regular blood checks for your 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 experience any symptoms related to these severe skin reactions described in section 4.

Use of Fordiuran with other medications

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

Fordiuran may interact with:

-heart medications such as digoxin (cardiotonic glycosides)

-medications for treating heart arrhythmias

-non-steroidal anti-inflammatory drugs (NSAIDs) used to treat arthritis or other muscle or bone problems

-medications for treating high blood pressure

-medications that cause potassium elimination

-some 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 will need to have regular blood checks.

Pregnancy and breastfeeding

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

Only use Fordiuran if your doctor considers it necessary if you are pregnant.

Fordiuran should not be used during breastfeeding.

Driving and operating machinery

Treatment with Fordiuran generally does not affect your ability to drive or operate machinery.

However, dizziness may occur during treatment, which you should be aware of if you drive or operate machinery.

Important information for athletes

This medication contains a component, bumetanida, which may result in a positive analytical result in doping control tests.

Fordiuran contains lactose

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

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

Remember to take your medication.

The tablets should be swallowed with a little water or any 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 obtained.

The number of tablets per day may be modified 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 an electrolyte imbalance, dehydration, and polyuria (production of large amounts of urine). Symptoms of electrolyte imbalance include dry mouth, thirst, weakness, lethargy, drowsiness, confusion, gastrointestinal disturbances, restlessness, muscle pain, and cramps, and seizures.

In case of overdose or accidental ingestion, you may also consult the Toxicological Information Service. Phone 91 562 04 20.

If you forgot to takeFordiuran

In case of forgotten 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 compensate for the missed doses.

If you interrupt the treatment withFordiuran

Your doctor will indicate the duration of your treatment with Fordiuran. Take the medication until you finish the treatment. Do not discontinue treatment prematurely, as it may be harmful to your health.

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

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

• Adverse EffectsFrequent(affecting between 1 and 10 of every 100 patients):

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

• Adverse EffectsRare(affecting between 1 and 10 of every 1,000 patients):

Blood alterations (decrease in white blood cell, red blood cell, and/or platelet count), dehydration, metabolic disorders including decreased glucose tolerance,increased blood uric acid concentration, gout, syncope,auditory alterations, chest pain and discomfort, decreased blood pressure, respiratory difficulty, cough, vomiting, diarrhea, constipation, dry mouth, thirst, skin eruptions, dermatitis, eczema, urticaria, itching, light sensitivity, renal insufficiency (including renal failure) and peripheral edema (swelling of feet, ankles, and legs).

Stop using Fordiuran and seek immediate medical attention if you observe any of the following symptoms:

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

If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.

Reporting 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 prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

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

Do not usethis medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGREpoint of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Fordiuran

- The active ingredient is bumetanide. Each tablet contains 1 mg of bumetanide.

- The other components are cornstarch, lactose monohydrate, povidone, polisorbate 80, anhydrous colloidal silica, agar-agar, talc, and magnesium stearate.

Appearance of the product and content of the container

Flat, circular tablets, white in color.

Each container contains 20 tablets.

Marketing Authorization Holder

Karo Pharma AB

Box 16184

103 24 Stockholm

Sweden

Responsible for manufacturing

Allphamed Pharbil Arzneimittel GmbH, Nextpharma Group

Hildebrandstraße 10-12

37081 Göttingen

Germany

O

LEO PHARMACEUTICAL PRODUCTS

Industriparken, 55, Ballerup DK 2750

Denmark

O

Laboratoires LEO, S.A.

39, Route de Chartres –

Vernouillet Cedex - F-28500

France.

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

Tora Laboratories, S.L.U.

Avenida de Oporto, 60

28019 Madrid

Spain

Last review date of this leaflet: November 2024

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.