Package Insert: Information for the User

TORASEMIDA COMBIX 5 mg Tablets EFG

Read this package insert carefully before starting to take this medication.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• 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 package insert, inform your doctor or pharmacist.

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

Torasemida 5 mg is indicated for the treatment of:

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

Do not take TORASEMIDA COMBIX 5 mg:

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

Be especially careful with TORASEMIDA COMBIX 5 mg:

• If you have severe liver disease, as the use of torasemide could precipitate a coma state.
• If you have low blood levels of sodium or potassium 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 have problems urinating.
• If you have low blood pressure (hypotension).
• Children, as the safety and efficacy of torasemide in children have not been established.

Use of other medications:

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

You must also inform your doctor if you are taking any of the following medications with which torasemide may interact:

• Cardiac glycosides such as digoxin (heart medications), antihypertensives (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 on the kidneys or ears.
• Cisplatin (cancer medication), lithium (antidepressant), salicylates, etacrynic acid: may increase the toxicity of these.
• Nonsteroidal anti-inflammatory drugs (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 TORASEMIDA COMBIX 10 mg with food and drinks

The tablets can be taken with or without food. They should be taken in the morning, not chewed, with a little liquid.

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any medication.

Torsemide is not recommended during pregnancy.

The passage of torsemide into breast milk is unknown, so it is not recommended during breastfeeding.

Driving and operating machines:

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

Important information about one of the components of TORASEMIDA COMBIX 5 mg

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

This medication does not contain gluten.

Follow exactly the administration instructions for TORASEMIDA COMBIX 5 mg 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 5 mg. Do not discontinue treatment beforehand, as this may worsen your condition.

Torasemide tablets are for oral administration.

Torasemide tablets can be taken with or without food. They should be taken in the morning, not chewed, with a small amount of liquid.

Adults

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

The initial dose ranges from 5 mg to 20 mg per day, but your doctor may increase it 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 to 5 mg per day or prescribe another additional antihypertensive.

Seniors:

The same dose as in 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 group.

If you estimate that 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 Toxicological Information Service, phone (91) 562.04.20, indicating the medication and the amount ingested.

In case of overdose, a greater amount of urine may be produced, and drowsiness, confusion, weakness, and dizziness may appear.

If you forgot to take TORASEMIDA COMBIX 5 mg:

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 scheduled time.

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

Like all medications, TORASEMIDA COMBIX 5 mg may produce adverse effects, although not everyone will experience them.

Adverse reactions may appear with the following frequency:

Very frequent: Affects more than 1 in 10 treated patients.

Frequent: Affects between 1 and 10 in every 100 treated patients.

Occasional: Affects between 1 and 10 in every 1,000 treated patients.

Rare: Affects between 1 and 10 in every 10,000 treated patients.

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

The following adverse effects have been described with the use of torasemida, 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 discomfort in the extremities may appear, and in individual cases, visual alterations and allergic reactions (e.g., itching, redness, photosensitivity) may be observed.

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

As a consequence of excessive diuresis, a decrease in blood pressure, states of confusion, and exceptionally, thrombosis, alteration of heart rhythm, angina pectoris, acute myocardial infarction, sudden loss of consciousness (syncope), and circulatory collapse may occur, especially if large amounts of liquid and salts 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.

Keep out of the reach and sight of children.

Do not store at a temperature above 30°C. Store in the original packaging.

Expiration date:

Do not use TORASEMIDA COMBIX 5 mg after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

TORASEMIDA COMBIX 5 mg Composition:

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

Product Appearance and Packaging Contents

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

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder:

LABORATORIOS COMBIX, S.L.U

C/ Badajoz 2, Edificio 2

This leaflet was approved in March 2010