ISODIUR 10 mg TABLETS

2. What you need to know before taking Isodiur

Do not take Isodiur

• If you are allergic to torasemide, sulfonylureas (medicines for treating diabetes) or 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 kidney problems or difficulty urinating.
• if you have severe liver function impairment.
• 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 medicines and Isodiur

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

You should also inform your doctor if you are using any of the following medicines, which may interact with torasemide:

• Cardiac glycosides such as digoxin (heart medicines), antihypertensives (particularly ACE inhibitors), theophylline (asthma medicine): 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 (cancer treatment medicine), lithium (antidepressant), salicylates, ethacrynic acid: may increase the toxicity of these medicines.
• Non-steroidal anti-inflammatory medicines (e.g., ibuprofen, indomethacin), probenecid (gout medicine), cholestyramine (cholesterol-lowering medicine): may decrease the effect of torasemide.
• Diabetes medicines: may decrease the effect of these medicines.

Taking 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, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

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

Driving and using machines

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

Isodiur contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Isodiur

Follow exactly the administration instructions of this medicine indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

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

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 up 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 up to 10 mg per day or prescribe an 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 Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken. It is recommended to take the package and package leaflet of the medicine to the healthcare professional.

In case of overdose, increased 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 scheduled time.

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

4. Possible side effects

Like all medicines, Isodiur can cause side effects, although not everybody gets 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 salt 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 with 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 salts have been lost.

Occasionally, increased uric acid, sugar, triglycerides, and cholesterol levels in the blood have been observed.

If you experience any side effects not mentioned in this leaflet, or if any of the side effects become serious, inform your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side 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 package after CAD. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

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

Return any unused medicine to the pharmacy, or take it to a designated collection point. If you are unsure, ask your pharmacist how to dispose of the medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Isodiur 10 mg tablets

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

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

Appearance and packaging of the product

Isodiur is a round, white or almost white tablet. The tablets are packaged in PVC-aluminum blisters, and each package 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 last revision of this leaflet:April 2011

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