Package Insert: Information for the User

TORASEMIDA TARBIS 5 mg Tablets EFG

Read this package insert carefully before starting to take this medication.

• 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 for 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 adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this package insert, inform your doctor or pharmacist.

Torasemida is a diuretic medication (increases urine elimination) and belongs to the group of medications called "High Ceiling Diuretics". Torasemida 5 mg is indicated for:

• The treatment of arterial hypertension
• The treatment of edemas (swelling due to fluid retention) resulting from altered cardiac function (e.g. due to heart failure)
• The treatment of edemas of hepatic or renal origin

Do not take TORASEMIDA TARBIS 5 mg:

• If you are allergic (hypersensitive) to torasemide, or to any of the other components of TORASEMIDA TARBIS 5 mg.
• If you are allergic to sulfonylureas
• If you have anuria (absence of urine production).

Be especially careful with TORASEMIDA TARBIS 5 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.

You should also 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 (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.
• Nonsteroidal anti-inflammatory drugs (e.g. ibuprofen, indomethacin), probenecid (gout medication), cholestyramine (cholesterol-lowering medication): may decrease the effect of torasemide.
• Diabetes medications: may decrease the effect of these medications.

Taking TORASEMIDA TARBIS 5 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 small amount of liquid.

Use in children

Due to the lack of established safety and efficacy of torasemide in children, the use of Torasemida 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 during pregnancy is not recommended.

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

Driving and operating machinery:

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

Important information about one of the components of TORASEMIDA TARBIS 5 mg

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

This medication does not contain gluten.

Follow exactly the administration instructions for TORASEMIDA TARBIS 5 mg as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts. Remember to take your medication.

Your doctor will inform you of the duration of your treatment with TORASEMIDA TARBIS 5 mg. Do not discontinue treatment prematurely, as this may worsen your condition.

Torasemide tablets are for oral administration.

Torasemide tablets can be taken with or without food. They should be taken in the morning, without chewing, with a small amount of liquid.

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 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 to 10 mg per day or prescribe an additional antihypertensive medication.

If you take more TORASEMIDA TARBIS 5 mg than you should:

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service at (91) 562.04.20, indicating the medication and the amount ingested.

Overdose may cause increased urine production and symptoms such as drowsiness, confusion, weakness, and dizziness.

If you forget to take TORASEMIDA TARBIS 5 mg:

Do not take a double dose to compensate for the missed dose.

Take your dose as soon as you remember and, the next day, take it at the scheduled time.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medications, TORASEMIDA TARBIS 5 mg may produce adverse effects, although not everyone will experience them.

Adverse reactions may appear with the following frequency:

Very frequent: Affects more than 1 in 10 patients treated.

Frequent: Affects between 1 and 10 in every 100 patients treated.

Occasional: Affects between 1 and 10 in every 1,000 patients treated.

Rare: Affects between 1 and 10 in every 10,000 patients treated.

The following adverse effects have been described:

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

-Occasionally 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) may appear.

-In rare cases, dry mouth and discomfort in the extremities may appear, and in individual cases, visual alterations and allergic reactions (e.g., itching, redness, photosensitivity) may be observed.

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

-Due to increased urine production, a decrease in blood pressure, states of 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 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 reach and sight of children.

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

Expiration:

Do not use TORASEMIDA TARBIS 5 mg after the expiration date that appears 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 TARBIS 5 mg:

• The active ingredient is torasemida. Each tablet contains 5 mg of torasemida.

• The other components (excipients) are: lactose monohydrate, cornstarch, sodium starch glycolate (type A), anhydrous colloidal silica, and magnesium stearate.

Appearance of the product and contents of the package

TORASEMIDA TARBIS 5 mg are biconvex, round, white or almost white, scored tablets on one side and marked with 915 on the other. They are presented in packages of 30 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder:

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Responsible for manufacturing:

TEVA OPERATIONS POLAND SP.Z.O.O.

Ul. Mogilska 80

(Krakow) - 31-546 - Poland

or

PLIVA HRVATSKA D.O.O.

Prilaz Baruna Filipovica 25

ZAGREB 10000 Croatia

This leaflet was revised in March 2010