PROSPECTO :INFORMATIONFOR THE USER

Isodiur 10 mg tablets

torasemide

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

1.What Isodiur is and for what it is used.

2.What you need to know before starting to take Isodiur.

3.How to take Isodiur.

4.Possible adverse effects.

5Storage of Isodiur.

6.Contents of the package and additional information.

Isodiur contains torasemide, which belongs to a group of medicines called diuretic anti-hypertensives.

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 insufficiency, and for the treatment of hypertension.

Do not take Isodiur

• If you are allergic to torasemide, to sulfonylureas (diabetes medications) or to any of the other ingredients 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 a kidney problem or difficulty urinating.
• If you have severe liver function impairment.
• If you have low blood levels of sodium or potassium, or reduced blood volume.
• If you have gout (accumulation of uric acid in the body).
• If you have diabetes mellitus.

Use in children

Due to the lack of established safety and efficacy of torasemide in children, its use is not recommended in this population group.

Use in elderly people

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.

You should also inform your doctor if you are using any of the following medications that may interact with torasemide:

• Cardiac glycosides such as digoxin (heart medications), anti-hypertensive medications (particularly ACE inhibitors), theophylline (asthma medication): the effect of these medications may be increased.
• Mineralocorticoids, glucocorticoids and laxatives: may increase the elimination of potassium produced by these medications.
• Aminoglycoside antibiotics: may increase the toxicity to the kidneys or ears.
• Cisplatin (cancer medication), lithium (antidepressant medication), salicylates, etacrynic acid: may increase the toxicity of these.
• 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.

Isodiur with food and drinks

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

Torsemide is not recommended during pregnancy, nor in women breastfeeding, as its passage into breast milk is unknown.

Driving and operating machinery

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

Isodiur contains lactose

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

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

Remember to take your medication.

Your doctor will inform you of the duration of your treatment with this medication. Do not discontinue treatment prematurely, as this 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 small amount of liquid.

Adults

Inedema associated with congestive heart failure, kidney disease, 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.

Inhypertension: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 another additional antihypertensive.

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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

In case of overdose, a greater amount of urine may be produced and drowsiness, confusion, weakness, and dizziness may appear.

If you forgot to take Isodiur

Do not take a double dose to compensate for the missed dose. Take your dose as soon as you remember and, the next day, take it at the time it is due.

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

Like all medications, Isodiur may cause adverse effects, although not everyone will experience them.

Adverse effects may appear with the following frequencies:

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

Frequent: affects between 1 and 10 in every 100 patients treated.

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

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

The following adverse effects have been described:

With prolonged treatment, disturbances in the balance of water and salts in the body may appear.

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

In rare cases, dry mouth and discomfort in the extremities may appear, 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 an enlarged prostate), increased urine flow may lead to urinary retention.

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

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

If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

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 the Spanish System for Pharmacovigilance of Medicinal Products 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.

Do not use this medication after the expiration date that appears 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 drains or trash.

Deposit the packaging and medications you no longer need at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Isodiur 10 mg tablets

The active ingredient is torasemide. Each tablet contains 10 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 content of the container

Isodiur are round white or almost white tablets. The tablets are presented in PVC-aluminum blisters and each container contains 30 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

ITALFARMACO S.A.

San Rafael, 3

28108 Alcobendas (Madrid)

Tel.: 91 657 2323

Responsible for manufacturing:

KERN PHARMA S.L.

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

Last review date of this leaflet:April 2011

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