TORASEMIDE SANDOZ 5 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Torasemide Sandoz 5 mg Tablets EFG

Torasemide Sandoz 10 mg Tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

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

• This medication has been prescribed to 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Torasemide Sandoz is and what it is used for
2. What you need to know before taking Torasemide Sandoz
3. How to take Torasemide Sandoz
4. Possible side effects
5. Storage of Torasemide Sandoz
6. Contents of the pack and further information

1. What Torasemide Sandoz is and what it is used for

Torasemide Sandoz contains torasemide, a medication belonging to the group of medications known as antihypertensive diuretics.

Torasemide is indicated for:

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

2. What you need to know before taking Torasemide Sandoz

Do not take Torasemide Sandoz:

• if you are allergic to the active substance or any of the other ingredients of this medication (listed in section 6),
• if you have anuria (absence of urine production) due to renal failure,
• if you have severe liver function impairment.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Torasemide Sandoz.

• During long-term treatment, especially in the elderly, 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, it should be treated.
• If you have severe liver disease, especially if it has affected the brain.
• This medication may affect muscle cells in the heart, skeleton, and intestine. 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 (uric acid accumulation in the body).
• If you are allergic to sulfonamides.

Children

Since the safety and efficacy of torasemide in children (< 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 Torasemide Sandoz with other medications

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

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

• Cardiac glycosides such as digoxin (heart medications), which may have more side effects,
• antidiabetic medications, whose action may be reduced,
• aminoglycoside antibiotics, platinum-based cytostatics such as cisplatin (cancer treatment medication), and cephalosporins: may increase kidney or ear toxicity,
• salicylates, as they may increase the risk of gout attacks,
• cumarin derivatives,
• non-steroidal anti-inflammatory medications (e.g., ibuprofen, indomethacin), which may reduce the effect of diuretics and increase the risk of renal failure,
• antihypertensive medications (particularly ACE inhibitors) may cause 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 (medication to reduce cholesterol levels in the blood): may decrease the effect of torasemide.

Taking Torasemide 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, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using any medication. The use of torasemide is not recommended during pregnancy or in breastfeeding women, as it is unknown whether torasemide passes into breast milk.

Driving and using machines

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

Torasemide Sandoz contains lactose and sodium

This medication contains lactose. If your doctor has told you 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".

3. How to take Torasemide Sandoz

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

Remember to take your medication.

The tablets can be taken at any time regarding meals, as convenient. They are swallowed without chewing, with a little liquid, preferably with breakfast.

Your doctor will indicate the duration of your treatment with Torasemide Sandoz. Do not stop treatment before, as it may worsen your condition.

The recommended dose in adults is:

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

In hypertension:The initial recommended 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 an additional antihypertensive medication.

If you take more Torasemide Sandoz than you should

If you have taken more Torasemide Sandoz than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used. In case of overdose, increased urine production and somnolence, confusion, weakness, and dizziness may occur.

If you forget to take Torasemide 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 medications, this medication can cause side effects, although not everyone experiences them.

Side effects may occur 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 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 the 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 volume, 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 rashes), 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, anemia, cerebral ischemia (decreased blood flow to the brain), numbness in the body (paresthesia), confusion, visual disturbances, ringing in the ears (tinnitus), hearing loss, myocardial infarction (heart attack), decreased heart blood flow (myocardial ischemia), angina pectoris, loss of consciousness (syncope), hypotension, blood vessel obstruction (embolism), dry mouth, pancreatitis (inflammation of the pancreas).

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Torasemide Sandoz

Keep this medication out of sight and reach of children.

Do not store above 30°C.

Do not use this medication after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Place the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the pack and further information

Composition of Torasemide Sandoz:

Torasemide Sandoz 5 mg tablets:

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

Torasemide Sandoz 10 mg tablets:

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

Appearance of the product and packaging contents

Torasemide 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.

Torasemide 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 the last revision of this package leaflet: May 2020

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