Package Insert: Information for the Patient

Torasemide Sandoz 5 mg Tablets EFG

Torasemide Sandoz 10 mg Tablets EFG

Read this package insert carefully before you start taking this medicine because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed for you only, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

• If you experience any side effects, consult your doctor or pharmacist,even if they are not listed in this package insert. See section 4.

Torasemida Sandoz contains torasemida, a medication that belongs to the group of medications known as diuretic anti-hypertensive agents.

Torasemida is indicated for:

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

Do not take Torasemida Sandoz:

• if you are allergic to the active ingredient or to any of the other components of this medication (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 to take Torasemida Sandoz.

• During long-term treatment and especially in advanced age, your doctor will perform periodic blood tests to monitor various values such as potassium, glucose, uric acid, creatinine, and lipids.
• Urinary retention should be corrected before and during treatment with this medication.
• If you have kidney disease, you should be treated.
• If you have severe liver disease, especially if it has affected the brain.
• This medication may alter heart, skeletal, and intestinal muscle cells. Potassium levels should be monitored during treatment with this medication.
• Sodium levels should be monitored before or during treatment.
• In patients with reduced blood volume, this medication should be administered under medical supervision.
• If you have hypotension, it should be corrected before or during treatment with this medication.
• If you have arrhythmias, blood tests should be performed to monitor sodium, calcium, and magnesium levels.
• If you have gout (accumulation of uric acid in the body).
• If you are allergic to sulfonamides.

Children

Due to the lack of established safety and efficacy of torasemida in children (<18 years old)

Advanced age

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

Taking Torasemida Sandoz with other medications

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

You must also inform your doctor if you are taking any of the following medications that may interact with torasemida:

• Cardiac glycosides such as digoxin (heart medications),which may have more adverse effects,
• antidiabetic medications, whose action may be reduced,
• aminoglycoside antibiotics, platinum-derived cytostatics, such as cisplatino (cancer treatment medication), and cefalosporins: may increase the toxicity to the kidneys or ears,
• salicylates, which may increase the risk of gout attacks,
• cumarinic derivatives,
• non-steroidal anti-inflammatory drugs (e.g., ibuprofen, indomethacin), which may reduce the effect of diuretics and increase the risk of renal failure,
• anti-hypertensive medications (particularly IECA) may cause hypotension and increase the risk of renal failure,
• probenecid, which may reduce the effect of torasemida,
• muscle relaxants and theophylline,
• lithium, as torasemida may increase the adverse effects of lithium,
• cholestyramine (medication to reduce blood cholesterol levels): may reduce the effect of torasemida.

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, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using any medication. Torasemida is not recommended during pregnancy, nor in breastfeeding women, as it is unknown whether torasemida passes into breast milk.

Driving and operating machines

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

Torasemida Sandoz contains lactose and sodium

This medication contains lactose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

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

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Remember to take your medication.

It can be taken at any time in relation to meals, at your convenience. It is swallowed without chewing, with a little liquid, preferably with breakfast.

Your doctor will inform you of the duration of your treatment with Torasemida Sandoz. Do not discontinue treatment beforehand, as this could worsen your condition.

The recommended dose in adults is:

Inedemaassociated with congestive heart failure, kidney disease or liver disease:The recommended initial dose ranges from 5 mg to 20 mg per day, in a single dose, but your doctor may increase it to approximately double if deemed necessary.

Inhypertension:The recommended initial dose is 2.5 mg to 5 mg per day, in a single dose, but your doctor may increase it 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, consult your doctor, pharmacist or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used. In case of overdose, a greater amount of urine may be produced and drowsiness, confusion, weakness and dizziness may appear.

If you forgot to take Torasemida Sandoz

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 time it is due.

Like all medicines, this medicine may cause side effects, although not everyone will experience 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

Unknown frequency: cannot be estimated from available data

The following side effects have been described:

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 disturbances (e.g., loss of appetite, abdominal pain, nausea, vomiting, diarrhea, constipation), muscle spasms, fatigue, tiredness.

Uncommon side effects:

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

Rare side effects:

Increased blood urea and/or creatinine.

Very rare side effects:

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

Unknown frequency

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), confusion, visual disturbances, ear ringing (tinnitus), hearing loss, myocardial infarction, heart ischemia, angina pectoris, loss of consciousness (syncope), hypotension, vascular obstruction (embolism), dry mouth, pancreatitis.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis 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 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 packaging and unused medications at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Torasemida Sandoz:

Torasemida Sandoz 5 mg tablets:

• The active ingredient is torasemide. Each tablet contains 5 mg of torasemide.
• The other components (excipients) are: lactose monohydrate, cornstarch, carboxymethylcellulose sodium (type A), anhydrous colloidal silica, and magnesium stearate.

Torasemida Sandoz 10 mg tablets:

• The active ingredient is torasemide. Each tablet contains 10 mg of torasemide.
• The other components (excipients) are: lactose monohydrate, cornstarch, carboxymethylcellulose sodium (type A), anhydrous colloidal silica, and magnesium stearate.

Appearance of the product and content of the packaging

Torasemida Sandoz 5 mgare biconvex, round, white or almost white, scored on one side, and marked with 915 on the other. They are presented in packs of 30 tablets.

Torasemida Sandoz 10 mgare biconvex, round, white or almost white, scored on one side, and marked with 916 on the other. They are presented in packs of 30 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

PLIVA HRVATSKA D.O.O.

Prilaz Baruna Filipovica 25

ZAGREB – 10000

Croatia

Last review date of this leaflet: May 2020

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/