Fordiuran 1 mg tablets
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Fordiuran 1 mg tablets
Bumetanide
Read the entire 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, 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 Fordiuran is and what it is used for
- What you need to know before taking Fordiuran
- How to take Fordiuran
- Possible side effects
- How to store Fordiuran
- Contents of the pack and other information
1. What Fordiuran is and what it is used for
Fordiuran contains bumetanide, an active substance with diuretic activity, which is used to reduce fluid retention (edema) and for the treatment of high blood pressure (hypertension) in adults.
2. What you need to know before starting to take Fordiuran
Do not take Fordiuran:
- if you are allergic to bumetanide or to any of the other components of this medicine (listed in section 6).
- if you have low levels of sodium or potassium in the blood.
- if you have anuria (absence of urine production).
- if you have hepatic encephalopathy (brain dysfunction due to severe liver impairment).
- if you are dehydrated.
- if you are breastfeeding.
Warnings and precautions
Talk to your doctor or pharmacist before starting to take Fordiuran.
Be especially careful with Fordiuran:
- if you have ever had a severe skin rash, skin peeling, blisters, or mouth sores after taking Fordiuran or other sulfonamides, such as loop diuretics.
- if you have any liver problems. In this case, you must inform your doctor.
- if you have low blood pressure (hypotension).
- if you have or have ever had diabetes mellitus or gout.
- if you usually have difficulty urinating.
- if you have any kidney problems.
- if you are allergic to sulfonamides, as you may experience an allergic reaction to Fordiuran.
During treatment, your doctor may recommend periodic monitoring of your blood levels of sodium and potassium.
Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with Fordiuran treatment. Stop using Fordiuran and seek immediate medical advice if you notice any of the symptoms related to these serious skin reactions described in section 4.
Use of Fordiuran with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Fordiuran may interact with:
- heart medications such as digoxin (cardiac glycosides)
- medications used to treat heart arrhythmias
- non-steroidal anti-inflammatory drugs (NSAIDs) used to treat arthritis or other muscle or bone problems
- medications used to treat 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 will require periodic blood monitoring in this case.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
If you are pregnant, you should only use Fordiuran if your doctor considers it necessary.
Fordiuran must not be used during breastfeeding.
Driving and using machines
Treatment with Fordiuran generally does not affect the ability to drive or operate machinery.
However, dizziness may occur during treatment, which you should take into account if driving or operating machinery.
Important information for athletes
This medicine contains an ingredient, bumetanide, which may lead to a positive analytical result in doping control tests.
Fordiuran contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.
3. How to take Fordiuran
Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
Remember to take your medicine.
The tablets should be swallowed with a little water or any other liquid.
Recommended dose:
In most patients, the initial dose is 0.5 mg (1/2 tablet) – 1 mg (1 tablet) daily, 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 appropriate.
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, drowsiness, confusion, gastrointestinal disturbances, restlessness, muscle pain and cramps, and seizures.
In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 91 562 04 20.
If you forget to take Fordiuran
If you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take the next one at the usual time. Do not take a double dose to make up for a missed dose.
If you stop taking Fordiuran
Your doctor will advise you on the duration of your treatment with Fordiuran. Continue taking the medicine for the full duration of the treatment. Do not stop treatment prematurely, as this may be harmful to your health.
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 can cause adverse effects, although not everyone will experience them.
- Common adverse effects (affecting between 1 and 10 out of every 100 patients):
Changes in blood levels of sodium, potassium, or chloride, 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.
- Uncommon adverse effects (affecting between 1 and 10 out of every 1,000 patients):
Blood disorders (reduction in the number of white blood cells, red blood cells, and/or platelets), dehydration, metabolic disturbances including decreased glucose tolerance, increased blood uric acid concentration, gout, syncope, auditory disturbances, chest pain and discomfort, low blood pressure, breathing difficulties, cough, vomiting, diarrhea, constipation, dry mouth, thirst, skin rashes, dermatitis, eczema, urticaria, itching, photosensitivity, renal failure (including kidney failure), and swelling of feet, ankles, and legs (peripheral edema).
Stop using Fordiuran and seek immediate medical attention if you experience any of the following symptoms:
- Non-elevated reddish patches, or circular or target-shaped skin rashes on the chest, often with central blisters, skin peeling, or ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.
Reporting of adverse effects
If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not mentioned in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Fordiuran
Keep this medicine 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 medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Fordiuran
- The active substance is bumetanide. Each tablet contains 1 mg of bumetanide.
- The other components are corn starch, monohydrate lactose, povidone, polysorbate 80, anhydrous colloidal silica, agar-agar, talc and magnesium stearate.
Appearance of the medicinal product and contents of the pack
White, flat, circular tablets.
Each pack contains 20 tablets.
Marketing Authorization Holder
Karo Pharma AB
Box 16184
103 24 Stockholm
Sweden
Manufacturer responsible for production
Allphamed Pharbil Arzneimittel GmbH, Nextpharma Group
Hildebrandstraße 10-12
37081 Göttingen
Germany
Or
LEO PHARMACEUTICAL PRODUCTS
Industriparken, 55, Ballerup DK 2750
Denmark
You can request further information about this medicinal product by contacting the local representative of the Marketing Authorization Holder:
Tora Laboratories, S.L.U.
Avenida de Oporto, 60
28019 Madrid
Spain
Date of the most recent review of this leaflet: November 2024
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.