Package Insert: Information for the Patient

Torasemide NORMON 5 mg Tablets EFG

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Torasemide NORMON and how is it used

2. What you need to know before starting to take Torasemide NORMON

3. How to take Torasemide NORMON

4. Possible adverse effects

5. Storage of Torasemide NORMON

6. Contents of the package and additional information

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

Torasemida NORMON 5 mg is indicated for the treatment of:

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

- Hypertension.

Do not take Torasemida NORMON

-If you are allergic to torasemida, sulfonilureas, or any of the other components of torasemida NORMON.

• If you have anuria (absence of urine production).

Be especially careful with Torasemida NORMON

• If you have a severe liver disease, as the use of torasemida could precipitate a coma 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 digitalis glycosides, as it increases the risk of arrhythmias.
• If you have gout or diabetes mellitus.
• If you have kidney failure or have problems urinating.
• If you have low blood pressure (hypotension).
• Children, as the safety and efficacy of torasemida 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.

You should also inform your doctor if you are using any of the following medications that may interact with torasemida:

• Cardiac glycosides such as digoxin (heart medications), anti-hypertensives (particularly ACE inhibitors), theophylline (asthma medication): the effect of these medications may be increased.
• Mineralocorticoids, glucocorticoids, and laxatives: may increase the elimination of potassium produced by these medications.
• Aminoglycoside antibiotics: may increase the toxicity to the kidneys or ears.
• Cisplatin (cancer medication), lithium (antidepressant), salicylates, etacrynic acid: may increase the toxicity of these medications.
• Non-steroidal anti-inflammatory medications (e.g. ibuprofen, indomethacin), probenecid (gout medication), cholestyramine (cholesterol-lowering medication): may decrease the effect of torasemida.
• Diabetes medications: may decrease the effect of these medications.

Taking Torasemida 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 small amount of liquid.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Pregnancy

The use of torasemida during pregnancy is not recommended.

Breastfeeding

The passage of torasemida into breast milk is unknown, so its use during breastfeeding is not recommended.

Driving and operating machinery

This medication may cause dizziness or drowsiness. This may occur more frequently at the beginning of treatment, when your doctor increases the 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 medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

Follow exactly the administration instructions for torasemida indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

Remember to take your medication. Your doctor will indicate the duration of your treatment with Torasemida NORMON. Do not suspend treatment beforehand, as this could worsen your condition.

Torsemide tablets are for oral administration.

Adults:

Treatment of edema associated with congestive heart failure, kidney disease, or liver 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 another additional antihypertensive.

Seniors:

The same dose as in adults should be used.

Use in children:

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

If you estimate that the action 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, consult your doctor or pharmacist immediately or call the Toxicological Information Service (Telephone 91 562 04 20), indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional. In case of overdose, a greater amount of urine may be produced, and drowsiness, confusion, weakness, and dizziness may appear.

If you forgot to take Torasemida NORMON

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

Like all medications, Torasemida NORMON may produce adverse effects, although not everyone will experience them.

Prolonged treatment may lead to alterations in the body's water and salt balance.

The following adverse effects have been described with the use of torasemida, especially 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 limb discomfort 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), increased urine flow may lead to urinary retention.

As a consequence of excessive diuresis, a decrease in blood pressure, confusion states, and exceptionally, thrombosis, cardiac arrhythmia, angina pectoris, acute myocardial infarction, sudden loss of consciousness (syncope), and circulatory collapse may occur, especially if large amounts of liquid and salts have been lost.

Occasionally, elevations in blood levels of uric acid, sugar, triglycerides, and cholesterol have been observed.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of the reach and sight of children.

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

Expiration Date:Do not use Torasemida NORMON after the expiration date indicated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

Composition of Torasemida NORMON

The active ingredient of Torasemida NORMON 5 mg tablets EFG is torasemida.

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

Appearance of the product and contents of the packaging

Torasemida NORMON 5 mg are white or almost white, round, biconvex, scored and printed with T5 tablets.

Torasemida NORMON is presented in packs of 30 tablets, each tablet containing 5 mg of torasemida.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

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

This leaflet was approved in March 2011