TORASEMIDE COMBIX 5 mg TABLETS

Introduction

Package Leaflet: Information for the User

TORASEMIDA COMBIX 5 mg Tablets EFG

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the package leaflet:

1. What TORASEMIDA COMBIX 5 mg Tablets are and what they are used for
2. Before you take TORASEMIDA COMBIX 5 mg Tablets
3. How to take TORASEMIDA COMBIX 5 mg Tablets
4. Possible side effects
5. Storage of TORASEMIDA COMBIX 5 mg Tablets
6. Further information

1. What TORASEMIDA COMBIX 5 mg Tablets are and what they are used for

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

Torasemide 5 mg is indicated for the treatment of:

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

2. Before you take TORASEMIDA COMBIX 5 mg Tablets

Do not take TORASEMIDA COMBIX 5 mg:

• If you are allergic (hypersensitive) to torasemide, sulfonylureas, or any of the other ingredients of TORASEMIDA COMBIX 5 mg.
• If you have anuria (absence of urine production).

Be cautious with TORASEMIDA COMBIX 5 mg:

• If you have severe liver disease, as the use of torasemide may 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 renal insufficiency or urinary problems.
• If you have low blood pressure (hypotension).
• Children, as the safety and efficacy of torasemide in children have not been established.

Use of other medicines:

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

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

• Cardiac glycosides such as digoxin (heart medicines), antihypertensives (especially 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 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 TORASEMIDA COMBIX 5 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 medicine.

Torasemide is not recommended during pregnancy.

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

Driving and using machines:

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

Important information about some of the ingredients of TORASEMIDA COMBIX 5 mg

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

This medicine does not contain gluten.

3. How to take TORASEMIDA COMBIX 5 mg Tablets

Follow exactly the administration instructions of TORASEMIDA COMBIX 5 mg indicated by your doctor. Consult your doctor or pharmacist if you have doubts. Remember to take your medicine.

Your doctor will indicate the duration of your treatment with TORASEMIDA COMBIX 5 mg. Do not stop the treatment before, as it may worsen your disease.

Torasemide 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, renal or hepatic 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 5 mg per day or prescribe an additional antihypertensive.

Elderly:

The same dose as for adults should be used.

Children:

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

If you think the action of TORASEMIDA COMBIX 5 mg is too strong or too weak, inform your doctor or pharmacist.

If you take more TORASEMIDA COMBIX 5 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 medicine 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 5 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 further questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, TORASEMIDA COMBIX 5 mg can cause side effects, although not everybody gets 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, disturbances of water and salt balance in the body may occur.

The following side effects have been described with the use of torasemide, 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 limbs may occur, 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 experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. Storage of TORASEMIDA COMBIX 5 mg Tablets

Keep out of the reach and sight of children.

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

Expiry date:

Do not use TORASEMIDA COMBIX 5 mg after the expiry date stated on the package after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Further information

Composition of TORASEMIDA COMBIX 5 mg:

• The active ingredient is torasemide. Each tablet contains 5 mg of torasemide.
• The other ingredients (excipients) are: lactose monohydrate, corn starch, sodium starch glycolate (type A), colloidal anhydrous silica, and magnesium stearate.

Appearance of the product and package contents

TORASEMIDA COMBIX 5 mg are biconvex, round, white or almost white tablets, scored on one side and marked with 915 on the other. They are available in packages of 30 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

LABORATORIOS COMBIX, S.L.U

C/ Badajoz 2, Edificio 2

This leaflet was approved in March 2010