TORASEMIDE TARBIS 10 mg TABLETS

Introduction

Package Leaflet: Information for the User

TORASEMIDA TARBIS 10 mg tablets EFG

Read the entire package leaflet carefully before starting to take this medication.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you personally 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 side effects you are experiencing to be serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Contents of the package leaflet:

1. What TORASEMIDA TARBIS 10 mg tablets are and what they are used for
2. Before taking TORASEMIDA TARBIS 10 mg tablets
3. How to take TORASEMIDA TARBIS 10 mg tablets
4. Possible side effects
5. Storage of TORASEMIDA TARBIS 10 mg tablets
6. Additional information

1. What TORASEMIDA TARBIS 10 mg tablets are and what they are used for

Torasemide is a diuretic medication (increases urine elimination) and belongs to the group of medications called "High-ceiling diuretics". Torasemide 10 mg is indicated for:

• Treatment of arterial hypertension
• Treatment of edema (swelling due to fluid retention) due to altered cardiac function (e.g., heart failure)
• Treatment of edema of hepatic or renal origin.

2. Before taking TORASEMIDA TARBIS 10 mg tablets

Do not take TORASEMIDA TARBIS 10 mg:

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

Be cautious when taking TORASEMIDA TARBIS 10 mg:

• If you have low blood pressure (hypotension)
• If you have renal insufficiency with absence of urine production
• If you have severe liver function impairment
• If you have low blood levels of sodium or potassium or low blood volume (hypovolemia)
• If you have gout or diabetes mellitus.

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.

Additionally, you should inform your doctor if you are taking any of the following medications that may interact with torasemide:

• Cardiac glycosides such as digoxin (heart medications), antihypertensives (particularly ACE inhibitors), theophylline (medication for asthma treatment): the effect of these medications may be increased.
• Mineralocorticoids, glucocorticoids, and laxatives: may increase potassium elimination caused by these medications.
• Aminoglycoside antibiotics: may increase kidney or ear toxicity.
• Cisplatin (cancer treatment medication), lithium (antidepressant medication), salicylates, ethacrynic acid: may increase the toxicity of these medications.
• Non-steroidal anti-inflammatory medications (e.g., ibuprofen, indomethacin), probenecid (gout medication), cholestyramine (medication to lower blood cholesterol levels): may decrease the effect of torasemide.
• Diabetes medications: may decrease the effect of these medications.

Taking TORASEMIDA TARBIS 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.

Use in children

Since the safety and efficacy of torasemide in children have not been established, the use of torasemide in children is not recommended.

Use in the elderly

No differences in efficacy or safety have been observed according to the patient's age.

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any medication.

The use of torasemide is not recommended during pregnancy.

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

Driving and using machines:

This medication may affect your ability to drive and use machines. The effect is increased if taken simultaneously with alcohol.

Important information about some of the components of TORASEMIDA TARBIS 10 mg

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

This medication does not contain gluten.

3. How to take TORASEMIDA TARBIS 10 mg tablets

Follow the administration instructions of TORASEMIDA TARBIS 10 mg exactly 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 TARBIS 10 mg. Do not stop treatment before this, as it may worsen your condition.

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 10 mg per day or prescribe an additional antihypertensive medication.

If you take more TORASEMIDA TARBIS 10 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 medication and the amount ingested.

In case of overdose, increased urine production may occur, and drowsiness, confusion, weakness, and dizziness may appear.

If you forget to take TORASEMIDA TARBIS 10 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 other questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, TORASEMIDA TARBIS 10 mg may cause side 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 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.

The following side effects have been reported:

- With prolonged treatment, alterations in water and salt balance in the body may appear.

- Occasionally, especially at the start of treatment, the following may appear: 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 extremities may appear, and in individual cases, visual disturbances and allergic reactions (e.g., itching, redness, photosensitivity) may be observed.

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

- Due to increased urine production, a decrease in blood pressure, confusion, and exceptionally, thrombosis, 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 consider any of the side effects you are experiencing to be serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

5. Storage of TORASEMIDA TARBIS 10 mg tablets

Keep out of the reach and sight of children.

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

Expiration date:

Do not use TORASEMIDA TARBIS 10 mg after the expiration date stated on the package after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the package and any unused medications. This will help protect the environment.

6. Additional information

Composition of TORASEMIDA TARBIS 10 mg:

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

Appearance of the product and package contents

TORASEMIDA TARBIS 10 mg are biconvex, round, white or almost white tablets, scored on one side and marked with 916 on the other. They are available in packages of 30 tablets.

Marketing authorization holder and manufacturer

Holder:

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Manufacturer:

TEVA OPERATIONS POLAND SP.Z.O.O. Ul. Mogilska 80 (Krakow) - 31-546 - Poland

PLIVA HRVATSKA D.O.O. Prilaz Baruna Filipovica 25 ZAGREB 10000 Croatia

This package leaflet was approved in October 2004