TORASEMIDE NORMON 10 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Torasemide Normon 10 mg Tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• 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 only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Torasemide Normon is and what it is used for
2. What you need to know before taking Torasemide Normon
3. How to take Torasemide Normon
4. Possible side effects
5. Storage of Torasemide Normon
6. Contents of the pack and further information

1. What Torasemide Normon is and what it is used for

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

Torasemide Normon 10 mg is indicated for the treatment of:

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

2. What you need to know before taking Torasemide Normon

Do not take Torasemide Normon

• If you are allergic to torasemide, sulfonamides, or any other component of Torasemide Normon.
• If you have anuria (absence of urine production).

Be cautious with Torasemide Normon

• If you have severe liver disease, as the use of torasemide may precipitate a coma.
• If you have low sodium or potassium levels in your blood 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 renal insufficiency 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 medications

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

Additionally, you should inform your doctor if you are using 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 Torasemide Normon 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.

Pregnancy

The use of torasemide is not recommended during pregnancy.

Breastfeeding

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

Driving and using machines

This medication may cause dizziness or drowsiness. This may occur more frequently at the start of treatment, when your doctor increases the dose, or if you consume alcohol. Do not drive or operate tools or machines if you feel dizzy or drowsy.

Torasemide Normon contains lactose

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.

3. How to take Torasemide Normon

Follow your doctor's instructions for taking torasemide exactly. Consult your doctor or pharmacist if you have any questions.

Remember to take your medication. Your doctor will indicate the duration of your treatment with Torasemide Normon. Do not stop treatment before this, as it may worsen your condition.

Torasemide tablets are for oral administration.

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 mg to 5 mg per day, but your doctor may increase it up to 10 mg per day or prescribe an additional antihypertensive medication.

Elderly:

The same dose as for adults should be used.

Use in children:

There is no experience with the use of torasemide in children, so its use is not recommended in this population.

If you think the effect of Torasemide Normon is too strong or too weak, inform your doctor or pharmacist.

If you take more Torasemide Normon than you should

If you have taken more Torasemide Normon than you should, consult your doctor or pharmacist immediately or call the Toxicology Information Service (Telephone 91 562 04 20), indicating the medication and the amount ingested. It is recommended to bring the packaging and the package leaflet of the medication to the healthcare professional. In case of overdose, an increased amount of urine may be produced, and drowsiness, confusion, weakness, and dizziness may appear.

If you forget to take Torasemide Normon

Do not take a double dose to make up for forgotten doses. Take your doses as soon as you remember and, the next day, take it at the corresponding time.

4. Possible side effects

Like all medications, Torasemide Normon can cause side effects, although not everyone will experience them.

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

The following side effects have been described with the use of torasemide, especially at the start of treatment: 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 who have difficulty urinating (e.g., due to prostate hypertrophy), the increased urine flow may lead to urinary retention.

As a consequence of excessive diuresis, a decrease in blood pressure, 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 fluid and salts have been lost.

Occasionally, increases in blood uric acid, sugar, triglycerides, and cholesterol have been observed.

If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

5. Storage of Torasemide Normon

Keep out of the reach and sight of children.

No special storage conditions are required. Store in the original packaging.

Expiry date:Do not use Torasemide Normon after the expiry date indicated on the packaging after CAD. The expiry 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 packaging and any unused medication. This will help protect the environment.

6. Contents of the pack and further information

Composition of Torasemide Normon

The active ingredient of Torasemide Normon 10 mg tablets EFG is torasemide.

The other ingredients are: lactose monohydrate, cornstarch, colloidal silica, and magnesium stearate.

Appearance of the product and packaging contents

Torasemide Normon 10 mg are white or almost white, round, biconvex, scored, and engraved with T10.

Torasemide Normon is available in packs of 30 tablets, each containing 10 mg of torasemide.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the last revision of this package leaflet:May 2025

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.

You can access detailed and updated information about this medication by scanning the QR code included in the package leaflet and packaging with your smartphone.

You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/68876/P_68876.html.