TORASEMIDE SANDOZ 10 mg TABLETS

2. What you need to know before you take Torasemida Sandoz

Do not take Torasemida Sandoz:

• if you are allergic to the active substance or to 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

Talk to your doctor or pharmacist before you start taking Torasemida Sandoz.

• During long-term treatment and especially in elderly patients, your doctor will perform periodic blood tests to monitor 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 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 sodium, calcium, and magnesium levels.
• If you have gout (uric acid accumulation in the body).
• If you are allergic to sulfonamides.

Children

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

Elderly

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

Taking Torasemida Sandoz with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any 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,
• antibiotics of the aminoglycoside group, cytostatic platinum derivatives, such as cisplatin (cancer treatment medicine), and cephalosporins: may increase kidney or ear toxicity,
• salicylates, as they may increase the risk of gout attacks,
• cumarin derivatives,
• non-steroidal anti-inflammatory medicines (e.g., ibuprofen, indomethacin), which may reduce the effect of diuretics and increase the risk of renal failure,
• antihypertensives (particularly ACE inhibitors) may produce hypotension and increase the risk of renal failure,
• probenecid, which may reduce the effect of torasemide,
• muscle relaxants and theophylline,
• lithium, as torasemide may increase the adverse effects of lithium,
• cholestyramine (medicine to decrease blood cholesterol levels): may decrease the effect of torasemide.

Taking Torasemida Sandoz with food and drinks

The tablets can be taken with or without food. They are swallowed without chewing, with a little 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 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 women who are breast-feeding, 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.

Torasemida Sandoz 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 23 mg of sodium (1mmol) per tablet; this is, essentially, "sodium-free".

3. How to take Torasemida Sandoz

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again if you have doubts.

Remember to take your medicine.

They can be administered at any time regarding meals, at convenience. They are swallowed without chewing, with a little liquid, preferably with breakfast.

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

The recommended dose in adults is:

In edemaassociated with congestive heart failure, renal or hepatic disease:The recommended 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 convenient.

In hypertension:The recommended initial dose is 2.5 mg 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 Torasemida Sandoz than you should

If you have taken more Torasemida Sandoz than you should, talk to your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount used. In case of overdose, an increased amount of urine may be produced, and drowsiness, confusion, weakness, and dizziness may appear.

If you forget to take Torasemida Sandoz

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.

4. Possible side effects

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

Side effects may appear with the following frequencies:

Very common side effects: may affect more than 1 in 10 patients

Common side effects: may affect up to 1 in 10 patients

Uncommon side effects: may affect up to 1 in 100 patients

Rare side effects: may affect up to 1 in 1,000 patients

Very rare side effects: may affect up to 1 in 10,000 patients

Frequency not known: cannot be estimated from the available data

The following side effects have been reported:

Common side effects:

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 side effects:

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

Rare side effects:

Increased urea and/or creatinine in the blood.

Very rare side effects:

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 blood, anemia, cerebral ischemia (decreased blood flow to the brain), numbness in the body (paresthesia), confusional state, visual disturbance, ringing in the ears (tinnitus), deafness, infarction (acute myocardial infarction), lack of heart blood flow (myocardial ischemia), angina pectoris, loss of consciousness (syncope), hypotension, obstruction of blood vessels (embolism), dry mouth, pancreatitis (inflammation of the pancreas).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Torasemida Sandoz

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 CAD. 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 further information

Composition of Torasemida Sandoz:

Torasemida Sandoz 5 mg tablets:

• The active substance is torasemide. Each tablet contains 5 mg of torasemide.
• The other ingredients (excipients) are: lactose monohydrate, maize starch, sodium carboxymethyl starch (type A), colloidal anhydrous silica, and magnesium stearate.

Torasemida Sandoz 10 mg tablets:

• The active substance is torasemide. Each tablet contains 10 mg of torasemide.
• The other ingredients (excipients) are: lactose monohydrate, maize starch, sodium carboxymethyl starch (type A), colloidal anhydrous silica, and magnesium stearate.

Appearance of the product and pack contents

Torasemida Sandoz 5 mg 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.

Torasemida Sandoz 10 mg 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 authorization holder and manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

PLIVA HRVATSKA D.O.O.

Prilaz Baruna Filipovica 25

ZAGREB – 10000

Croatia

Date of last revision of this package leaflet: May 2020

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