PROSPECTO : INFORMATION FOR THE USER

Isodiur HTA 2.5 mg tablets

torasemide

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

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

3.How to take Isodiur HTA

4.Possible adverse effects

5Storage of Isodiur HTA

6.Contents of the package and additional informationl

Isodiur HTA contains torasemide which belongs to a group of medicines called anti-hypertensive diuretics.

Isodiur HTA is indicated in adults for the treatment of:

Essential hypertension

Do not take Isodiur HTA

• If you are allergic to torasemide, to sulfonylureas (diabetes medications) or to 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 medicationIf any of the following cases apply to you, inform your doctor. Your doctor will take this into account during treatment with this medication:

• If you have kidney problems or have trouble urinating
• If you have severe liver disease, as the use of torasemide could precipitate a coma state.
• If you have low blood levels of sodium, potassium or reduced blood volume.
• If you have gout (accumulation of uric acid in the body)
• If you have diabetes mellitus
• If you have heart problems, especially if you are being treated with digitalis glycosides, as it increases the risk of arrhythmias.
• If you have low blood pressure

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 HTA

Inform your doctor or pharmacist if you are taking, have taken recently 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-hypertensives (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), 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.

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

Torasemide 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 vehicles or operate machinery, especially if taken simultaneously with alcohol.

Isodiur HTA 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. In case of doubt, consult your doctor or pharmacist.

Remember to take your medication.

Your doctor will indicate the duration of your treatment with this medication. Do not discontinue treatment beforehand, 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 small amount of liquid.

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 antihypertensive medication in addition.

If you take more Isodiur HTA 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 915620420, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Isodiur HTA

Do not take a double dose to compensate for the missed doses.

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

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

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

Prolonged treatment may lead to disturbances in the body's water and salt balance.

The following adverse effects have been described with the use of torsemide, especially 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).

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.

A patient with difficulty urinating (e.g., due to prostate hypertrophy), increased urine flow may lead to urinary retention.

As a consequence of excessive diuresis (excessive urine secretion), hypotension, confusion states, and, exceptionally, thrombosis, cardiac 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, elevations in blood levels of uric acid, sugar, 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 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 conditions for conservation

Medications should not be disposed of through drains or in the trash.

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

Composition of Isodiur HTA 2.5 mg tablets.

The active ingredient is torasemide. Each tablet contains 2.5 mg of torasemide.

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

Appearance of the product and contents of the packaging

The tablets are round, white, or almost white. The tablets are presented in PVC-aluminum blisters. Each package 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

Date of the last review of this leaflet: April 2011

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