TORASEMIDE NORMON 5 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Torasemide Normon 5 mg Tablets EFG

Read this package leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible 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 you take 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 medicine (increases urine production) and belongs to the group of so-called "High-ceiling diuretics: sulfonamides, monodrugs".

Torasemide Normon 5 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 you take Torasemide Normon

Do not take Torasemide Normon

• If you are allergic to torasemide, sulfonilureas, or any of the other ingredients 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 state.
• 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 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

Tell 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 using any of the following medicines that may interact with torasemide:

• Cardiac glycosides such as digoxin (heart medicines), antihypertensives (especially ACE inhibitors), theophylline (asthma medicine): 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 (cancer medicine), lithium (antidepressant), salicylates, ethacrynic acid: may increase the toxicity of these medicines.
• Non-steroidal anti-inflammatory medicines (e.g., ibuprofen, indomethacin), probenecid (gout medicine), cholestyramine (cholesterol-lowering medicine): may decrease the effect of torasemide.
• Diabetes medicines: may decrease the effect of these medicines.

Taking Torasemide Normon with food and drinks

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

Ask your doctor or pharmacist for advice before taking any medicine.

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

3. How to take Torasemide Normon

Follow exactly the administration instructions of torasemide indicated by your doctor. Ask your doctor or pharmacist if you have any doubts.

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

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.

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 action of Torasemide Normon is too strong or too weak, tell 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 medicine and the amount ingested. It is recommended to take the packaging and the package leaflet of the medicine 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 medicines, Torasemide Normon can cause side effects, although not everybody gets 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 think any of the side effects you are suffering from is serious, or if you notice any side effects not mentioned in this package leaflet, tell 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 stated on the packaging after EXP. The expiry date is 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 no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Torasemide Normon

The active substance of Torasemide Normon 5 mg tablets EFG is torasemide.

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

Appearance and packaging of the product

Torasemide Normon 5 mg are white or almost white, round, biconvex, scored, and serigraphed with T5.

Torasemide Normon is available in packs of 30 tablets, each containing 5 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 on this medicine 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 on this medicine by scanning the QR code included in the package leaflet and packaging with your mobile phone (smartphone).

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

https://cima.aemps.es/cima/dochtml/p/67313/P_67313.html.