Prospect: Information for the User

Torasemida Teva 5 mg Tablets EFG

Torasemida Teva 10 mg Tablets EFG

Torasemida

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

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

3. How to take Torasemida Teva

4. Possible adverse effects

5. Storage of Torasemida Teva

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 Teva is indicated for the treatment of:

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

- Hypertension.

Do not take Torasemida Teva

• if you are allergic to the active ingredient, sulfonylureas, or any of the other components of

this medication (listed in section 6)

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Torasemida Teva.

Be especially careful with Torasemida Teva:

• if you have severe liver disease, as the use of torasemida may 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 cardiac arrhythmias.
• if you have gout or diabetes mellitus.
• if you have kidney failure or have problems urinating.
• if you have low blood pressure (hypotension).

Older patients

No differences in efficacy or safety have been observed according to the patient's age.

Children and adolescents

The safety and efficacy in children have not been established.

Other medications and Torasemida Teva

Inform your doctor or pharmacist if you are taking or have recently takenor may need to take anothermedication.

You must also inform your doctor if you are taking any of the following medications with which torasemida may interact:

• 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 potassium elimination produced by these medications. -Aminoglycoside antibiotics: may increase the renal or ototoxicity of these medications. -Cisplatin (cancer medication), lithium (antidepressant medication), salicylates, etacrynic acid: may increase the toxicity of these.
• Non-steroidal anti-inflammatory drugs (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.

Taking Torasemida Teva with food, drinks, and alcohol

The tablets can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

The use of torasemida is not recommended during pregnancy.

Breastfeeding

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

Driving and using machines

This medication may affect your ability to drive and use machines, especially if taken simultaneously with alcohol.

Torasemida Teva contains lactose and sodium

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with him before taking this medication.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially “sodium-free”.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Torasemida Teva tablets are for oral administration. The tablets should be taken in the morning, without chewing, with a small amount of liquid.

The tablet can be divided into equal doses.

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 twice as much if deemed necessary.

Hypertension.

The usual initial dose is 2.5 to 5 mg per day, but your doctor may increase it up to 10 mg per day or prescribe another additional antihypertensive.

Geriatric patients

The same dose as in adults should be used.

Use in children

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

If you take more Torasemida Teva than you should

If you have taken more Torasemida Teva than you should, consult your doctor or pharmacist immediately. In case of overdose, more urine may be produced and drowsiness, confusion, weakness, and dizziness may appear. In case of overdose or accidental ingestion, also consult the Toxicological Information Service, phone (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.

If you forgot to take Torasemida Teva

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

If you interrupt treatment with Torasemida Teva

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

• Prolonged treatment may lead to alterations in the balance of water and salts in the body.

• The following adverse effects have been described 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 discomfort in the extremities may occur, 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.

• Due to increased urine production, a decrease in blood pressure, confusion, 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 fluid and salts have been lost.

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

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not store at a temperature above 30°C.

Do not use this medication 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. Dispose of the packagingand the medicines you no longer need at the SIGREpoint at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and the medicines you no longer need. By doing so, you will help protect the environment.

Torasemide Teva Composition

• The active ingredient is torasemide
• The other components are lactose, cornstarch, sodium glycolate starch from potato (Type A), colloidal silica, and magnesium stearate.

Product Appearance and Packaging Content

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

Torasemide Teva 10mg are biconvex, round, white or almost white, scored on one side, and marked with 916 on the other. They are presented in packs of 30 tablets.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108 - Madrid

Responsible Manufacturer

Teva Operations Poland S.p. z.o.o.

Ul. Mogilska 80, 31-546 Kraków

Poland

or

PLIVA HRVATSKA D.O.O.

Prilaz Baruna Filipovica 25,

1000, Zagreb

Croatia

This leaflet was approved in March 2022