Torasemide Combix 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

TORASEMIDE COMBIX 10 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you think that any of the side effects you experience is severe or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What TORASEMIDE COMBIX 10 mg tablets are and what they are used for
2. Before you take TORASEMIDE COMBIX 10 mg tablets
3. How to take TORASEMIDE COMBIX 10 mg tablets
4. Possible side effects
5. How to store TORASEMIDE COMBIX 10 mg tablets
6. Further information

1. What TORASEMIDE COMBIX 10 mg tablets is and what it is used for

Torasemide is a diuretic medicine (increases urine elimination) belonging to the group known as "High-ceiling diuretics: sulfonamides, single drugs".

Torasemide 10 mg is indicated for the treatment of:

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

2. BEFORE TAKING TORASEMIDE COMBIX 10 mg TABLETS

Do not take TORASEMIDE COMBIX 10 mg:

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

Take special care with TORASEMIDE COMBIX 10 mg:

• If you have severe liver disease, as the use of torasemide could precipitate a coma.
• 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 cardiac glycosides, as this increases the risk of cardiac arrhythmias.
• If you have gout or diabetes mellitus.
• If you suffer from renal insufficiency or have difficulty 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 medicines:

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

You should also inform your doctor if you are taking any of the following medicines, with which torasemide may interact:

• Cardiac glycosides such as digoxin (medicines for the heart), antihypertensives (particularly ACE inhibitors), theophylline (medicine for the treatment of asthma): 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 (medicine for cancer treatment), lithium (antidepressant medicine), salicylates, etacrynic acid: may increase the toxicity of these.
• Non-steroidal anti-inflammatory drugs (e.g. ibuprofen, indomethacin), probenecid (anti-gout medicine), cholestyramine (medicine to reduce blood cholesterol levels): may reduce the effect of torasemide.
• Medicines for the treatment of diabetes: may reduce their effect.

Taking TORASEMIDE COMBIX 10 mg with food and drinks

The tablets may 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.

The use of torasemide during pregnancy is not recommended.

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

Driving and operating machinery:

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

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

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

This medicine does not contain gluten.

3. HOW TO TAKE TORASEMIDE COMBIX 10 mg TABLETS

Follow exactly the administration instructions for TORASEMIDE COMBIX 10 mg given by your doctor. If you have any doubts, consult your doctor or pharmacist. Remember to take your medication.

Your doctor will determine the duration of your treatment with TORASEMIDE COMBIX 10 mg. Do not stop treatment earlier, as this could worsen your condition.

Torasemide tablets are for oral use.

The tablets may be taken with or without food. They should be taken in the morning, without chewing, with a small amount of liquid.

Adults

Treatment of edema associated with congestive heart failure, renal or hepatic disease.

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

Hypertension.

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

Elderly:

The same dosage as in adults should be used.

Children:

There is no experience regarding the use of torasemide in children, therefore its use is not recommended in this population group.

If you feel that the effect of TORASEMIDE COMBIX 10 mg is too strong or too weak, inform your doctor or pharmacist.

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

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

In the event of an overdose, increased urine output may occur, along with drowsiness, confusion, weakness, and dizziness.

If you forget to take TORASEMIDE 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 following day, take it at your usual time.

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

4. Possible adverse effects

Like all medicines, TORASEMIDE COMBIX 10 mg can cause adverse effects, although not everyone experiences 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 every 100 patients treated.

Uncommon: 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, disturbances in the body's water and electrolyte balance may occur.

The following adverse effects have been reported with the use of torasemide, 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 occur; in individual cases, visual disturbances and allergic reactions (e.g. burning sensation, redness, photosensitivity) may be observed.

In patients with difficulty urinating (e.g. due to prostate enlargement), increased urinary flow may lead to urinary retention.

As a consequence of excessive diuresis, a drop in blood pressure may occur, along with confusion, and exceptionally, thrombosis, cardiac arrhythmia, angina pectoris, acute myocardial infarction, sudden loss of consciousness (syncope), and circulatory collapse, especially if large amounts of fluid and electrolytes have been lost.

Occasionally, increases in blood levels of uric acid, glucose, triglycerides, and cholesterol have been observed.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of TORASEMIDE COMBIX 10 mg tablets

Keep out of the reach and sight of children.

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

Expiry:

Do not use TORASEMIDE COMBIX 10 mg after the expiry date which is stated on the packaging after EXP. The expiry date refers to 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 and packaging that you no longer need. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of TORASEMIDE COMBIX 10 mg:

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

Appearance of the product and contents of the pack

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

Marketing Authorization Holder and Manufacturer

Holder:

LABORATORIOS COMBIX, S.L.U

C/ Badajoz 2, Edificio 2