ISODIUR 5 mg TABLETS

Introduction

PACKAGE LEAFLET:INFORMATIONFOR THE USER

Isodiur 5 mg tablets

torasemide

Read the entire package leaflet carefully before starting to take this medication because 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 Isodiur is and what it is used for
2. What you need to know before taking Isodiur
3. How to take Isodiur
4. Possible side effects

5 Conservation of Isodiur

1. Contents of the pack and further information

1. What Isodiur is and what it is used for

Isodiur contains torasemide, which belongs to a group of medications called antihypertensive diuretics.

Isodiur is indicated in adults for the treatment and prevention of edema (swelling due to fluid retention) caused by congestive heart failure, liver and kidney disease, and for the treatment of hypertension.

2. What you need to know before taking Isodiur

Do not take Isodiur

• If you are allergic to torasemide, sulfonylureas (medications for treating diabetes), or any of the other components of this medication (listed in section 6).
• If you have anuria (absence of urine production).

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication:

• if you have low blood pressure (hypotension).
• if you have kidney problems or difficulty urinating.
• if you have severe liver dysfunction
• if you have low sodium or potassium levels in your blood, or a reduced blood volume.
• if you have gout (uric acid accumulation in the body).
• if you have diabetes mellitus.

Use in children

Since the safety and efficacy of torasemide in children have not been established, its use is not recommended in this population.

Use in elderly patients

No differences in efficacy or safety have been observed according to the patient's age.

Other medications and Isodiur

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

In addition, you should inform your doctor if you are using any of the following medications that may interact with torasemide:

• Cardiac glycosides such as digoxin (heart medications), antihypertensives (particularly ACE inhibitors), theophylline (asthma medication): the effect of these medications may be increased.
• Mineralocorticoids, glucocorticoids, and laxatives: may increase potassium elimination caused by these medications.
• Aminoglycoside antibiotics: may increase kidney or ear toxicity.
• Cisplatin (cancer treatment medication), lithium (antidepressant medication), salicylates, ethacrynic acid: may increase the toxicity of these medications.
• Non-steroidal anti-inflammatory medications (e.g., ibuprofen, indomethacin), probenecid (gout medication), cholestyramine (cholesterol-lowering medication): may decrease the effect of torasemide.
• Diabetes medications: may decrease the effect of these medications.

Taking Isodiur with food and beverages

The tablets can be taken with or without food (see also Section 3: 'How to take Isodiur').

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.

Torasemide is not recommended during pregnancy or in breastfeeding women, as it is unknown whether torasemide passes into breast milk.

Driving and using machines

This medication may affect your ability to drive or use machines, especially if taken simultaneously with alcohol.

Isodiur contains lactose

This medication 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 Isodiur

Follow the administration instructions for this medication exactly as indicated by your doctor. If you have any doubts, consult your doctor or pharmacist again.

Remember to take your medication.

Your doctor will indicate the duration of your treatment with Isodiur. Do not stop treatment before this, as it may worsen your condition.

The tablets should be taken orally. They can be taken with or without food. They should be taken in the morning, without chewing, with a little liquid.

Adults

In edema associated with congestive heart failure, kidney or liver disease:The initial dose ranges from 5 mg to 20 mg per day, in a single dose, but your doctor may increase it to approximately double if deemed necessary.

In hypertension:The usual initial dose is 2.5 mg to 5 mg per day, in a single dose, but your doctor may increase it to 10 mg per day or prescribe an additional antihypertensive medication.

If you take more Isodiur than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, go to the nearest hospital, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the package leaflet of the medication to the healthcare professional.

In case of overdose, excessive urine production may occur, and drowsiness, confusion, weakness, and dizziness may appear.

If you forget to take Isodiur

Do not take a double dose to make up for the forgotten dose.

Take your dose as soon as you remember, and the next day, take it at the corresponding time.

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

4. Possible side effects

Like all medications, Isodiur can cause side effects, although not everyone experiences them.

Side effects may occur with the following frequencies:

Very common: affects more than 1 in 10 patients treated.

Common: affects between 1 and 10 in 100 patients treated.

Uncommon: affects between 1 and 10 in 1,000 patients treated.

Rare: affects between 1 and 10 in 10,000 patients treated.

The following side effects have been reported:

With prolonged treatment, water and electrolyte balance disorders may occur in the body.

Occasionally, at the start of treatment, headache, dizziness, fatigue, weakness, muscle cramps, and gastrointestinal disorders (e.g., loss of appetite, stomach pain, nausea, vomiting, diarrhea, constipation) may appear.

In rare cases, dry mouth and limb discomfort may occur, and in individual cases, visual disturbances and allergic reactions (e.g., itching, redness, photosensitivity) may be observed.

In patients who have difficulty urinating (e.g., due to prostate hypertrophy), the increased urine flow may lead to urinary retention.

Due to increased urine production, a decrease in blood pressure, confusion, and exceptionally, thrombosis, arrhythmia, angina pectoris, acute myocardial infarction, sudden loss of consciousness (syncope), and circulatory collapse may occur, especially if large amounts of fluid and electrolytes have been lost.

Occasionally, elevated blood levels of uric acid, sugar, triglycerides, and cholesterol have been observed.

If you consider any of the side effects you are experiencing to be serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Isodiur

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

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

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste.

Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Isodiur 5 mg tablets.

The active ingredient is torasemide. Each tablet contains 5 mg of torasemide.

The other components (excipients) are lactose monohydrate (see section 2: 'Isodiur contains lactose'), cornstarch, colloidal silicon dioxide, and magnesium stearate.

Appearance of the product and pack contents

Isodiur is a round, white or almost white tablet. The tablets are presented in PVC-aluminum blisters, and each pack contains 30 and 500 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

ITALFARMACO S.A.

San Rafael, 3

28108 Alcobendas (Madrid)

Tel.: 91 657 2323

Manufacturer:

KERN PHARMA S.L.

Polígono Industrial Colón II. C/Venus, 72. 08228 Terrassa. Barcelona

Date of the last revision of this package leaflet: April 2011

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