Leaflet: information for the user

Torasemida Teva-ratio 5 mg tablets EFG

Torasemida Teva-ratio 10 mg tablets EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult 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 it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

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

3. How to take Torasemida Teva-ratio

4. Possible side effects

5. Storage of Torasemida Teva-ratio

6. Contents of the pack and additional information

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

Torasemida is indicated for the treatment of:

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

or liver disease.

- Hypertension.

Do not take TorasemidaTeva-ratio

• 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.

Be especially careful with this medication:

• if you have a 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).
• children, as the safety and efficacy of torasemida in children have not been established.

Children and Adolescents

The safety and efficacy in children have not been established.

Other Medications and Torasemida Teva-ratio

Inform your doctor or pharmacist if you are taking or have taken recently or may need to take other medications.

You should 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.
• Nonsteroidal 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-ratio 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 to breast milk is unknown, so its use is not recommended during breastfeeding.

Driving and Operating Machines

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

Torasemida Teva-ratio 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 1 mmol of sodium (23 mg) 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. In case of doubt, ask your doctor or pharmacist.

Your doctor will indicate the duration of your treatment with torasemida. Do not discontinue treatment beforehand, as this could worsen your condition.

Torasemida tablets are for oral administration. The tablets should be taken in the morning, without chewing, with a little liquid. The tablet can be divided into equal doses.

The recommended dose is:

Adults

Treatment of edema associated with congestive heart failure, renal or hepatic 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 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 in this population is not recommended.

If you take more Torasemida Teva-ratio than you should

If you have taken more torasemida than you should, consult your doctor or pharmacist immediately. In case of overdose, excessive urination, drowsiness, confusion, weakness, and dizziness may occur. In case of overdose or accidental ingestion, also consult the Toxicological Information Service, phone (91) 562.04.20.

If you forgot to take Torasemida Teva-ratio

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

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 all people will experience them.

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

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

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

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

• Prolonged treatment may lead to alterations in the balance of water and salts in the body.
• At the beginning of treatment, the following adverse effects have been described: 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 appear, and in individual cases, visual alterations 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, 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.

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 of 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 and blister 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 medication that you no longer need at the SIGREpoint of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and the medication that you no longer need. By doing so, you will help protect the environment.

Composition of Torasemida Teva-ratio

• The active ingredient is torasemida
• The other components are lactose, cornstarch, carboxymethylcellulose sodium (type A) (from potato), colloidal silica, and magnesium stearate.

Appearance of the product and content of the container

TorasemidaTeva-ratio 5 mg are biconvex, round, white or almost white, scored on one side and marked with 915 on the other. They are presented in containers of 30 tablets.

TorasemidaTeva-ratio 10mg are biconvex, round, white or almost white, scored on one side and marked with 916 on the other. They are presented in containers of 30tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva Pharma, S.L.U.

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

28108 Alcobendas, Madrid (Spain)

Responsible for manufacturing

Teva OperationsPoland s.p. z.o.o

Ul. Mogilska 80, 31-546 Kraków

Poland

or

MERCKLE GMBH

Ludwig-Merckle-Strasse, 3

Blaubeuren CP: D-89143

Germany

or

PLIVA HRVATSKA D.O.O.

Prilaz Baruna Filipovica 25, ZAGREB.

Croatia

Last review date of this leaflet:February 2022

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

You can access detailed and updated information about this medicine by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/72174/P_72174.html

QR code + URL