PATIENT INFORMATION LEAFLET

TORASEMIDA COMBIX 10 mg tablets EFG

Read this leaflet carefully before you start taking this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If you think you have suffered a side effect, you can help us by reporting it directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

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

Torasemida 10 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 10 mg:

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

Be especially careful with TORASEMIDA COMBIX 10 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 to 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 beverages

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.

Torsemide is not recommended during pregnancy.

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

Driving and operating machinery:

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

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

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

This medication does not contain gluten.

Follow exactly the administration instructions for TORASEMIDA COMBIX 10 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 10 mg. Do not discontinue treatment beforehand, as it 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 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 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 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 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 10 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 10 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 patients treated.

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

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

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

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, confusion states, 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 that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of 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 10 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 10 mg Composition:

• 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), anhydrous colloidal silica, and magnesium stearate.

Product Appearance and Packaging Contents

TORASEMIDA COMBIX 10 mg are biconvex, round, white or almost white, scored on one side and marked with 916 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