TORASEMIDE TEVA 5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Torasemide Teva 5 mg Tablets EFG

Torasemide Teva 10mg Tablets EFG

Torasemide

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 is Torasemide Teva and what is it used for
2. What you need to know before you take Torasemide Teva
3. How to take Torasemide Teva
4. Possible side effects
5. Storage of Torasemide Teva
6. Contents of the pack and further information

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

Torasemide is a diuretic medicine (increases urine production) and belongs to the group of so-called "High-ceiling diuretics: sulfonamides, monodrugs".

Torasemide Teva 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 Teva

Do not take Torasemide Teva

• if you are allergic to the active substance, to sulfonilureas or to any of the other ingredients of this medicine (listed in section 6)

if you have anuria (failure of the kidneys to produce urine).

Warnings and precautions

Consult your doctor or pharmacist before taking Torasemide Teva.

Be particularly careful with Torasemide Teva:

• if you have severe liver disease, as the use of torasemide may precipitate a coma.
• if you have low sodium or potassium levels in your blood or a 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 kidney problems or difficulty urinating.
• if you have low blood pressure (hypotension).

Elderly 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 medicines and Torasemide Teva

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.

You should also tell your doctor if you are taking any of the following medicines, as torasemide may interact with them:

• Cardiac glycosides such as digoxin (heart medicines), antihypertensives (in particular 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 reduce the effect of torasemide.
• Diabetes medicines: may reduce the effect of these medicines.

Taking Torasemide 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Torasemide is not recommended during pregnancy.

Breastfeeding

It is not known whether torasemide passes into breast milk, therefore it is not recommended during breastfeeding.

Driving and using machines

This medicine may affect your ability to drive or use machines, especially if taken with alcohol.

Torasemide Teva contains lactose and sodium

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

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

3. How to take Torasemide Teva

Always take this medicine exactly as described in this package leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

The torasemide tablets are for oral use. The tablets should be taken in the morning, without chewing, with a little liquid.

The tablet can be divided into equal doses.

Adults

Treatment of edema associated with congestive heart failure, renal or hepatic disease.

The initial dose is between 5 mg and 20 mg per day, but your doctor may increase it to approximately double if 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.

Elderly patients

The same dose as for adults should be used.

Use in children

There is no experience with the use of torasemide in children, therefore it is not recommended in this population.

If you take more Torasemide Teva than you should

If you have taken more Torasemide Teva than you should, talk to a doctor or pharmacist immediately. In case of overdose, increased urine production may occur, and drowsiness, confusion, weakness, and dizziness may appear. In case of overdose or accidental ingestion, also contact the Toxicology Information Service, telephone (91) 562.04.20, indicating the medicine and the amount taken. It is recommended to take the packaging and package leaflet of the medicine to the healthcare professional.

If you forget to take Torasemide Teva

Do not take a double dose to make up for forgotten doses.

If you stop taking Torasemide Teva

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

• Prolonged treatment may cause disturbances in the body's water and salt balance.

• At the start of treatment, the following side effects have been described: headache, dizziness, fatigue, weakness, muscle cramps, and gastrointestinal disorders (e.g. loss of appetite, stomach pain, nausea, vomiting, diarrhea, constipation).

• Rarely, dry mouth and discomfort in the limbs 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), the increased urine flow may lead to urinary retention.

• Due to increased urine production, a drop 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, increased levels of uric acid, sugar, triglycerides, and cholesterol in the blood have been observed.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly to the Spanish Medicines Agency: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Torasemide Teva

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

Do not store above 30°C.

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and further information

Composition of Torasemide Teva

• The active substance is torasemide
• The other ingredients are lactose, maize starch, sodium starch glycolate (Type A), colloidal silica, and magnesium stearate.

Appearance of the product and packaging

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

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

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edifício Albatros B, 1ª planta,

Alcobendas, 28108 - Madrid

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 package leaflet was approved in March 2022