ISODIUR 10 MG TABLETS

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Isodiur 10 mg tablets

torasemide

Read all of 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, and you should not give it to other people, 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.

Contents of this 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. How to store Isodiur.

6. Contents of the pack and other information.

1. What Isodiur is and what it is used for

Isodiur contains torasemide, which belongs to a group of medicines known as antihypertensive diuretics.

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

2. What you need to know before taking Isodiur

Do not take Isodiur

• If you are allergic to torasemide, to sulfonylureas (medicines used to treat diabetes), or to any of the other ingredients of this medicine (listed in section 6).
• If you have anuria (absence of urine production).

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine:

• if you have low blood pressure (hypotension).
• if you have a kidney problem or have difficulty urinating.
• if you have severe liver function impairment.
• if you have low levels of sodium or potassium in your blood, or reduced blood volume.
• if you have gout (accumulation of uric acid 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 patient age.

Other medicines and Isodiur

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

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

• Cardiac glycosides such as digoxin (heart medications), antihypertensives (particularly ACE inhibitors), theophylline (asthma medication): the effect of these medicines may be increased.
• Mineralocorticoids, glucocorticoids, and laxatives: may increase potassium loss caused by these medicines.
• Aminoglycoside antibiotics: may increase kidney or ear toxicity.
• Cisplatin (a medicine used to treat cancer), lithium (an antidepressant medicine), salicylates, etacrynic acid: may increase the toxicity of these medicines.
• Non-steroidal anti-inflammatory medicines (e.g., ibuprofen, indomethacin), probenecid (a medicine for gout), cholestyramine (a medicine to lower blood cholesterol levels): may reduce the effect of torasemide.
• Medicines used to treat diabetes: may reduce the effect of these medicines.

Taking Isodiur with food and drink

The tablets may 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

The use of torasemide is not recommended during pregnancy or in women who are breastfeeding, as it is unknown whether torasemide passes into breast milk.

Driving and using machines

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

Isodiur contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Isodiur

Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Your doctor will tell you how long to take this medicine. Do not stop treatment earlier, as your condition may worsen.

The tablets should be taken orally. They may be taken with or without food. They should be taken in the morning, without chewing, with some liquid.

Adults

In edema associated with congestive heart failure, renal or hepatic disease: the initial dose ranges from 5 mg to 20 mg once daily, but your doctor may increase it up to approximately double if considered appropriate.

In hypertension: the usual initial dose is 2.5 mg to 5 mg once daily, but your doctor may increase it up to 10 mg daily or prescribe an additional antihypertensive.

If you take more Isodiur than you should

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

In case of overdose, increased urine output may occur, along with somnolence, confusion, weakness, and dizziness.

If you forget to take Isodiur

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

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

4. Possible adverse effects

Like all medicines, Isodiur can cause adverse effects, although not everyone will experience them.

The adverse effects may occur with the following frequencies:

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

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

Uncommon: 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 reported:

With prolonged treatment, disturbances in the body's water and electrolyte balance may occur.

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

In rare cases, dry mouth and discomfort in the limbs may occur; in individual cases, visual disturbances and allergic reactions (e.g. burning sensation, redness, photosensitivity) may be observed.

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

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

Occasionally, increases in blood levels of uric acid, glucose, triglycerides, and cholesterol have been observed.

If you consider any of the adverse effects you are experiencing to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Isodiur

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

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.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste.

Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Isodiur 10 mg tablets

The active substance is torasemide. Each tablet contains 10 mg of torasemide.

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

Appearance of the product and pack contents

Isodiur tablets are round, white or almost white. The tablets are presented in PVC-aluminum blisters, and each pack contains 30 or 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 most recent revision of this leaflet: April 2011

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es