TORASEMIDE COMBIX 5 MG TABLETS EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

TORASEMIDE COMBIX 5 mg Tablets EFG

Read the entire 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 and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet Contents:

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

1. What TORASEMIDE COMBIX 5 mg tablets are and what they are used for

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

Torasemide 5 mg is indicated for the treatment of:

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

2. BEFORE TAKING TORASEMIDE COMBIX 5 mg TABLETS

Do not take TORASEMIDE COMBIX 5 mg:

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

Take special care with TORASEMIDE COMBIX 5 mg:

• If you have severe liver disease, as the use of torasemide could precipitate a coma-like 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 cardiac glycosides, as this 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 torasemide in children have not been established.

Use of other medicines:

Inform your doctor or pharmacist if you are taking or have recently taken 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 (heart medications), antihypertensives (particularly ACE inhibitors), theophylline (a medication 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.
• Antibiotics of the aminoglycoside group: may increase kidney or ear toxicity.
• Cisplatin (a medication for cancer treatment), lithium (an antidepressant medication), salicylates, ethacrynic acid: may increase the toxicity of these agents.
• Non-steroidal anti-inflammatory drugs (e.g. ibuprofen, indomethacin), probenecid (an antigout medication), cholestyramine (a medication to lower blood cholesterol levels): may reduce the effect of torasemide.
• Medications for the treatment of diabetes: may reduce the effect of these medicines.

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 small amount of liquid.

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any medication.

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 use of machines:

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

Important information about some of the components of TORASEMIDE COMBIX 5 mg

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

This medicine does not contain gluten.

3. HOW TO TAKE TORASEMIDA COMBIX 5 mg TABLETS

Follow exactly the administration instructions for TORASEMIDA COMBIX 5 mg provided 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 TORASEMIDA COMBIX 5 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 some liquid.

Adults

Treatment of edema associated with congestive heart failure, renal or liver 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 5 mg daily or prescribe an additional antihypertensive agent.

Elderly:

The same dose 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 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone (91) 562.04.20, indicating the medication and the amount ingested.

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

If you forget to take TORASEMIDA COMBIX 5 mg:

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

Take your dose as soon as you remember, and the following day, take it at the 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 5 mg may produce adverse effects, although not everyone experiences them.

Adverse reactions may occur with the following frequency:

Very common: Affects more than 1 in every 10 treated patients.

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

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

The following adverse effects have been reported with the use of torasemide, particularly 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 who have difficulty urinating (e.g. due to prostate enlargement), increased urine 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, please inform your doctor or pharmacist.

5. Storage of TORASEMIDE COMBIX 5 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 5 mg after the expiry date 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 unused medicines and their packaging. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of TORASEMIDE COMBIX 5 mg:

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

Appearance of the medicinal product and contents of the pack

TORASEMIDE 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 packs of 30 tablets.

Marketing Authorization Holder and Manufacturer

Holder:

LABORATORIOS COMBIX, S.L.U
C/ Badajoz 2, Edificio 2

This leaflet was approved in March 2010