Torasemide Teva-Ratio 5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Torasemide Teva-ratio 5 mg tablets EFG

Torasemide Teva-ratio 10 mg tablets EFG

Read all of 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Torasemide Teva-ratio is and what it is used for
2. What you need to know before taking Torasemide Teva-ratio
3. How to take Torasemide Teva-ratio
4. Possible side effects
5. How to store Torasemide Teva-ratio
6. Contents of the pack and other information

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

Torasemida is a medicine that belongs to a group of medicines called antihypertensive diuretics.

Torasemida is indicated for:

• Treatment and prevention of oedema (swelling due to fluid retention) caused by congestive heart failure, renal and hepatic disorders.
• Treatment of essential arterial hypertension.

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

Do not take Torasemida Teva-ratio

• if you are allergic to torasemide, sulfonylureas (medicines used to treat diabetes), or any of the other ingredients of this medicine (listed in section 6).
• if you have anuria (absence of urine production) due to renal failure.
• if you have severe impairment of liver function.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take torasemide.

• During long-term treatment, and especially in elderly patients, your doctor will periodically perform blood tests to monitor various parameters such as potassium, glucose, uric acid, creatinine, and lipids.

• Urinary retention must be corrected before and during treatment with this medicine.

• If you have kidney disease, it should be treated.

• If you have severe liver disease, especially if it has affected the brain.

• This medicine may affect muscle cells of the heart, skeleton, and intestine. Potassium levels should be monitored during treatment with this medicine.

• Sodium levels should be monitored before or during treatment.

• In patients with reduced blood volume, this medicine should be administered under medical supervision.

• If you have hypotension, it should be corrected before or during treatment with this medicine.

• If you have arrhythmias, blood tests should be performed to monitor levels of sodium, potassium, calcium, and magnesium.

• If you have gout (accumulation of uric acid in the body).

• If you are allergic to sulfonamides.

Children and adolescents

As the safety and efficacy of torasemide in children (< 18 years) have not been established, its use is not recommended in this population group.

Use in elderly people

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

Other medicines and Torasemida Teva-ratio

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

• Cardiac glycosides such as digoxin (heart medications), which may have increased adverse effects.

• Antidiabetic medicines, whose action may be reduced.

• Antihypertensive medicines (particularly ACE inhibitors), which may cause hypotension and increase the risk of renal failure.

• Muscle relaxants and theophylline.

• Antibiotics of the aminoglycoside group, platinum-derived cytostatics such as cisplatin (a medicine used to treat cancer), and cephalosporins: these may increase kidney or ear toxicity.

• Salicylates, as they may increase the risk of gout attacks.

• Coumarin derivatives.

• Lithium, as torasemide may increase the adverse effects of lithium.

• Non-steroidal anti-inflammatory medicines (e.g., ibuprofen, indomethacin), which may reduce the effect of diuretics and increase the risk of renal failure.

• Probenecid, which may reduce the effect of torasemide.

• Cholestyramine (a medicine used to lower blood cholesterol levels): may reduce the effect of torasemide.

Taking Torasemida Teva-ratio with food, drinks, and alcohol

The tablets may be taken with or without food. They should be swallowed whole with some liquid, preferably in the morning.

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

The use of torasemide is not recommended during pregnancy or in women who are breast-feeding, as it is unknown whether torasemide passes into breast milk.

Driving and using machines

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

Torasemida Teva-ratio contains lactose and sodium

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

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

3. How to take Torasemida Teva-ratio

Follow exactly the instructions for use of this medicine provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Your doctor will indicate how long you should take torasemide. Do not stop treatment earlier, as your condition may worsen.

Remember to take your medicine. It can be taken at any time in relation to meals, as convenient. Swallow the tablet without chewing, with a little liquid, preferably with breakfast. The tablet may be divided into equal doses.

The recommended dose in adults is:

In oedema associated with congestive heart failure, renal or liver disease.

The initial dose ranges from 5 mg to 20 mg once daily. However, your doctor may increase it up to approximately double if considered appropriate.

In hypertension.

The initial dose is 2.5 to 5 mg once daily. However, your doctor may increase it up to 10 mg daily or prescribe an additional antihypertensive.

If you take more Torasemida Teva-ratio than you should

If you have taken more torasemide than you should, contact your doctor or pharmacist immediately. In case of overdose, you may experience increased urine output and develop somnolence, confusion, weakness, and dizziness. In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone number 91 562 04.20.

If you forget to take Torasemida Teva-ratio

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Adverse effects may occur with the following frequencies:

Very common: affects more than 1 in 10 treated patients.

Common: affects between 1 and 10 in every 100 treated patients.

Uncommon: affects between 1 and 10 in every 1,000 treated patients.

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

Very rare: affects fewer than 1 in every 10,000 treated patients.

Frequency not known: cannot be estimated from available data.

Common:

Increased blood pH (metabolic alkalosis), electrolyte and fluid imbalance (e.g. decreased total blood volume, decreased sodium and/or potassium in blood), headache, dizziness, gastrointestinal disturbances (e.g. loss of appetite, abdominal pain, nausea, vomiting, diarrhoea, constipation), muscle spasms, fatigue, tiredness.

Uncommon:

Increased liver enzymes, urinary retention, gallbladder distension, increased blood levels of uric acid, glucose, and lipids such as triglycerides or cholesterol.

Rare:

Increased blood levels of urea and/or creatinine.

Very rare:

Skin allergic reactions (itching and skin rashes), photosensitivity reaction.

Frequency not known:

Severe skin reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis), decreased number of platelets and/or leukocytes in blood, anaemia, cerebral ischaemia (reduced blood flow to the brain), sensation of numbness in the body (paraesthesia), confusional state, visual disturbances, ringing in the ears (tinnitus), deafness, infarction (acute myocardial infarction), lack of blood flow to the heart (myocardial ischaemia), angina pectoris, loss of consciousness (syncope), hypotension, blockage of blood vessels (embolism), dry mouth, inflammation of the pancreas (pancreatitis).

Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Torasemide Teva-ratio

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 stated on the packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Torasemida Teva-ratio

• The active substance is torasemide.
• The other components are lactose, maize starch, sodium carboxymethyl starch (type A) (from potato), colloidal silica, and magnesium stearate.

Appearance of the product and contents of the container

Torasemida Teva-ratio 5 mg: biconvex, round, white or almost white tablets, scored on one side and marked with "915" on the other. Packaged in containers of 30 tablets.

Torasemida Teva-ratio 10 mg: biconvex, round, white or almost white tablets, scored on one side and marked with "916" on the other. Packaged in containers of 30 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

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

28108 Alcobendas, Madrid

Spain

Manufacturer

Teva Operations Poland 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

Date of latest review of this leaflet: June 2025

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

You can access detailed and up-to-date information on this medicine by scanning with your mobile phone (smartphone) the QR code included on the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/72174/P_72174.html

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