TORASEMIDE TEVA-RATIO 5 mg TABLETS

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

Do not take Torasemide Teva-ratio

• if you are allergic to torasemide, sulfonamides (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) in renal failure.
• if you have severe liver function impairment.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with torasemide.

• During long-term treatment and especially in elderly patients, your doctor will perform periodic blood tests to check different values such as potassium, glucose, uric acid, creatinine, lipids.
• Urinary retention should 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 alter muscle cells in 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 sodium, potassium, calcium, and magnesium levels.
• If you have gout (uric acid accumulation in the body).

• If you are allergic to sulfonamides.

Children and adolescents

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

Use in elderly patients

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

Other medicines and Torasemide Teva-ratio

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

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

• Cardiac glycosides such as digoxin (heart medicines), which may have more side effects.
• Antidiabetic medicines, whose action may be reduced.
• Antihypertensives (particularly ACE inhibitors) may produce hypotension and increase the risk of renal failure.
• Muscle relaxants and theophylline.
• Aminoglycoside antibiotics, platinum-derived cytostatics such as cisplatin (cancer treatment medicine), and cephalosporins: 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 (medicine to lower cholesterol levels in the blood): may decrease the effect of torasemide.

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

The tablets can be taken with or without food. They are swallowed without chewing, with a little liquid, preferably in the morning.

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.

The use of torasemide is not recommended during pregnancy or in breastfeeding women, as it is not known whether torasemide passes into breast milk.

Driving and using machines

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

Torasemide Teva-ratio contains lactose and sodium

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

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

3. How to take Torasemide Teva-ratio

Follow exactly the administration instructions of this medicine contained in this leaflet or as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Your doctor will indicate the duration of your treatment with torasemide. Do not stop treatment before, as it could worsen your disease.

Remember to take your medicine. It can be administered at any time regarding meals, at your convenience. It is swallowed without chewing, with a little liquid, preferably with breakfast. The tablet can be divided into equal doses.

The recommended dose in adults is:

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

The initial dose ranges from 5 mg to 20 mg per day, in a single dose, but your doctor may increase it up to approximately double if deemed necessary.

In hypertension.

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

If you take more Torasemide Teva-ratio than you should

If you have taken more torasemide than you should, consult your doctor or pharmacist immediately. In case of overdose, increased urine production and somnolence, confusion, weakness, and dizziness may occur. In case of overdose or accidental ingestion, also consult the Toxicology Information Service, phone 91 562 04 20.

If you forget to take Torasemide Teva-ratio

Do not take a double dose to make up for forgotten doses. Take your dose as soon as you remember and, the next day, take it at the corresponding time.

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.

Side effects may occur with the following frequencies:

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

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

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

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

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

Frequency not known: cannot be estimated from the 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 disorders (e.g., loss of appetite, abdominal pain, nausea, vomiting, diarrhea, constipation), muscle spasms, fatigue, tiredness.

Uncommon:

Increased liver enzymes, urinary retention, increased gallbladder volume, increased uric acid, glucose, and lipids such as triglycerides or cholesterol in the blood.

Rare:

Increased urea and/or creatinine in the blood.

Very rare:

Allergic skin reactions (itching and skin spots), sensitivity to sunlight.

Frequency not known:

Severe skin reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis), decreased platelet and/or white blood cell count in the blood, anemia, cerebral ischemia (decreased blood flow to the brain), numbness in the body (paresthesia), confusion, visual disturbances, ringing in the ears (tinnitus), deafness, infarction (acute myocardial infarction), lack of heart blood flow (myocardial ischemia), angina pectoris, loss of consciousness (syncope), hypotension, blood vessel obstruction (embolism), dry mouth, pancreatitis (inflammation of the pancreas).

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 leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: 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-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 which is stated on the carton and blister after EXP. The expiry date is the last day of the month stated.

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 protect the environment.

6. Contents of the pack and other information

Composition of Torasemide Teva-ratio

• The active substance is torasemide.
• The other ingredients are lactose, cornstarch, sodium carboxymethyl starch (type A) (from potato), colloidal silicon dioxide, and magnesium stearate.

Appearance of the product and pack contents

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

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

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11 Edificio Albatros B, 1ª Planta

28108 Alcobendas, Madrid

Spain

Manufacturer

Teva Operations Poland sp. 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 last revision 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 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

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