TORASEMIDE COMBIX 10 mg TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

TORASEMIDA COMBIX 10 mg tablets EFG

Read the package leaflet carefully before starting to take this medication.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medication has been prescribed to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Contents of the package leaflet:

1. What TORASEMIDA COMBIX 10 mg tablets are and what they are used for.
2. Before taking TORASEMIDA COMBIX 10 mg tablets.
3. How to take TORASEMIDA COMBIX 10 mg tablets.
4. Possible side effects.
5. Storage of TORASEMIDA COMBIX 10 mg tablets.
6. Additional information.

1. What TORASEMIDA COMBIX 10 mg tablets are and what they are used for.

Torasemida is a diuretic medication (increases urine elimination) and belongs to the group of so-called "High-ceiling diuretics: sulfonamides, monodrugs".

Torasemida 10 mg is indicated for the treatment of:

• Edema (fluid retention) due to congestive heart failure, kidney or liver disease.
• Hypertension.

2. BEFORE TAKING TORASEMIDA COMBIX 10 mg tablets

Do not take TORASEMIDA COMBIX 10 mg:

• If you are allergic (hypersensitive) to torasemida, sulfonilureas, or any of the other components of TORASEMIDA COMBIX 10 mg.
• If you have anuria (absence of urine production).

Be careful with TORASEMIDA COMBIX 10 mg:

• If you have severe liver disease, as the use of torasemida could precipitate a coma.
• If you have low sodium or potassium levels in your blood or low blood volume.
• If you have heart problems, especially if you are being treated with digitalis glycosides, as it increases the risk of cardiac arrhythmias.
• If you have gout or diabetes mellitus.
• If you have kidney failure or problems urinating.
• If you have low blood pressure (hypotension).
• Children, as the safety and efficacy of torasemida in children have not been established.

Use of other medications:

Tell your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Also, inform your doctor if you are taking any of the following medications that may interact with torasemida:

• Cardiac glycosides such as digoxin (heart medications), antihypertensives (especially 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 medication), lithium (antidepressant), 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 torasemida.
• Diabetes medications: may decrease the effect of these medications.

Taking TORASEMIDA COMBIX 10 mg with food and drinks

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

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any medication.

The use of torasemida is not recommended during pregnancy.

It is unknown whether torasemida passes into breast milk, so its use is not recommended during breastfeeding.

Driving and using machines:

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

Important information about some of the components of TORASEMIDA COMBIX 10 mg

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.

This medication does not contain gluten.

3. HOW TO TAKE TORASEMIDA COMBIX 10 mg tablets

Follow the administration instructions of TORASEMIDA COMBIX 10 mg exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts. Remember to take your medication.

Your doctor will indicate the duration of your treatment with TORASEMIDA COMBIX 10 mg. Do not stop treatment before, as it may worsen your condition.

Torasemida tablets are for oral administration.

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

Adults

Treatment of edema associated with congestive heart failure, kidney or liver disease.

The initial dose ranges from 5 mg to 20 mg per day, but your doctor may increase it up to approximately double if deemed necessary.

Hypertension.

The usual initial dose is 2.5 to 5 mg per day, but your doctor may increase it up to 10 mg per day or prescribe an additional antihypertensive medication.

Elderly:

The same dose as for adults should be used.

Children:

There is no experience with the use of torasemida in children, so its use is not recommended in this population.

If you think the effect of TORASEMIDA COMBIX 10 mg is too strong or too weak, inform your doctor or pharmacist.

If you take more TORASEMIDA COMBIX 10 mg than you should:

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone (91) 562.04.20, indicating the medication and the amount ingested.

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

If you forget to take TORASEMIDA COMBIX 10 mg:

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

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 product, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, TORASEMIDA COMBIX 10 mg may cause side effects, although not everyone will experience them.

Adverse reactions may occur with the following frequency:

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.

With prolonged treatment, alterations in water and salt balance in the body may appear.

The following side effects have been described with the use of torasemida, especially 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).

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 prostate hypertrophy), the increased urine flow may lead to urinary retention.

As a consequence of excessive diuresis, a decrease in blood pressure, confusion, 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 salts have been lost.

Occasionally, increases in blood uric acid, sugar, triglycerides, and cholesterol have been observed.

If you consider that any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

5. Storage of TORASEMIDA COMBIX 10 mg tablets

Keep out of the reach and sight of children.

Do not store above 30°C. Store in the original package.

Expiration date:

Do not use TORASEMIDA COMBIX 10 mg after the expiration date stated on the package after EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the package and any unused medications. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of TORASEMIDA COMBIX 10 mg:

• The active ingredient is torasemida. Each tablet contains 10 mg of torasemida.
• The other components (excipients) are: lactose monohydrate, cornstarch, sodium starch glycolate (type A), colloidal anhydrous silica, and magnesium stearate.

Appearance of the product and package contents

TORASEMIDA COMBIX 10 mg are biconvex, round, white or almost white tablets, scored on one side and marked with 916 on the other. They are available in packages of 30 tablets.

Marketing authorization holder and manufacturer

Holder:

LABORATORIOS COMBIX, S.L.U.

C/ Badajoz 2, Edificio 2