Torasemide Normon 10 mg tablets EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Torasemide Normon 10 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• 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 only; do not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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. How to store Torasemide Normon
6. Contents of the pack and other information

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

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

Torasemida Normon 10 mg is indicated for the treatment of:

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

2. What you need to know before starting to take Torasemida Normon

Do not take Torasemida Normon

• If you are allergic to torasemide, sulfonylureas, or any of the other ingredients of Torasemida Normon.
• If you have anuria (absence of urine production).

Take special care with Torasemida Normon

• 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 digitalis glycosides, as this 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 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 asthma treatment): 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 (a cancer treatment medicine), lithium (an antidepressant medicine), salicylates, etacrynic acid: may increase the toxicity of these medicines.
• Non-steroidal anti-inflammatory drugs (e.g. ibuprofen, indomethacin), probenecid (a gout medicine), cholestyramine (a medicine to reduce blood cholesterol levels): may reduce the effect of torasemide.
• Medicines for the treatment of diabetes: may reduce the effect of these medicines.

Taking Torasemida Normon 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.

Pregnancy

The use of torasemide during pregnancy is not recommended.

Breastfeeding

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

Driving and using machines

This medicine may cause dizziness or drowsiness. This may be more likely at the beginning of treatment, when your doctor increases your dose, or if you consume alcohol. Do not drive or operate tools or machinery if you feel dizzy or drowsy.

Torasemida Normon contains lactose

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

3. How to take Torasemida Normon

Follow exactly the dosing instructions for torasemide as given by your doctor. If you have any doubts, consult your doctor or pharmacist.

Remember to take your medicine. Your doctor will tell you how long to continue treatment with Torasemida Normon. Do not stop treatment earlier, as this could worsen your condition.

Torasemide tablets are for oral use.

Adults:

Treatment of oedema associated with congestive heart failure, renal or liver disease: The initial dose ranges from 5 mg to 20 mg daily. However, your doctor may increase it up to approximately double if considered appropriate.

Hypertension: The usual initial dose is 2.5 mg to 5 mg daily. Your doctor may increase this up to 10 mg daily or prescribe an additional antihypertensive.

Elderly:

The same dosage as in adults should be used.

Use in children:

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

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

If you take more Torasemida Normon than you should

If you have taken more Torasemida Normon than you should, contact your doctor or pharmacist immediately or call the Toxicology Information Service (Telephone 91 562 04 20), stating the medication and the amount ingested. It is recommended to bring the medicine packaging and leaflet to the healthcare professional. In case of overdose, increased urine output may occur, along with somnolence, confusion, weakness, and dizziness.

If you forget to take Torasemida Normon

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

4. Possible adverse effects

Like all medicines, Torasemida Normon may produce adverse effects, although not everyone experiences them.

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, diarrhoea, constipation).

In rare cases, dry mouth and discomfort in the extremities may occur; 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 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, 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: Do not use torasemide Normon 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 medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Torasemida Normon

The active substance of Torasemida Normon 10 mg tablets EFG is torasemide.

The other components are: monohydrate lactose, corn starch, colloidal silica, and magnesium stearate.

Appearance of the product and contents of the pack

Torasemida Normon 10 mg are white or almost white, round, biconvex, scored tablets with the imprint T10.

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

Marketing Authorization Holder and Manufacturing Responsible

LABORATORIOS NORMON, S.A.

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

Date of the most recent review of this leaflet: May 2025

Detailed and up-to-date information on this medicinal product 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 up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging.

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

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