SUTRIL 10 mg TABLETS

Introduction

Package Leaflet: Information for the User

SUTRIL 10 mg Tablets

Torasemide

Read the package leaflet carefully before starting to take the medicine

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet.

Contents of the package leaflet:

1. What SUTRIL 10 mg Tablets are and what they are used for
2. Before taking SUTRIL 10 mg Tablets
3. How to take SUTRIL 10 mg Tablets
4. Possible side effects
5. Storage of SUTRIL 10 mg Tablets
6. Further information

1. What SUTRIL 10 mg Tablets are and what they are used for

Sutril 10 mg is a diuretic medicine (increases urine production) that belongs to the group of medicines called "High-ceiling Diuretics". It is indicated for:

• treatment of edema (swelling due to fluid retention) resulting from altered cardiac function (e.g. heart failure).
• treatment of edema of hepatic and renal origin.

2. Before taking SUTRIL 10 mg Tablets

Do not take SUTRIL HTA 2.5 mg

• If you are allergic (hypersensitive) to the active substance or any of the other ingredients of SUTRIL HTA 2.5 mg.
• if you are allergic to sulfonylureas
• if you have anuria (absence of urine production).

Be careful with SUTRIL HTA 2.5 mg

• if you have low blood pressure (hypotension)
• if you have renal insufficiency with absence of urine production
• if you have severe liver function impairment
• if you have low blood levels of sodium or potassium or low blood volume (hypovolemia)
• if you have gout or diabetes mellitus

Use of other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

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), antihypertensives (especially ACE inhibitors), theophylline (asthma medicine): the effect of these medicines may be increased,
• mineralocorticoids, glucocorticoids, and laxatives: may increase potassium loss caused by these medicines,
• aminoglycoside antibiotics: may increase kidney or ear toxicity,
• cisplatin (cancer medicine), lithium (antidepressant), salicylates, ethacrynic acid: may increase toxicity of these medicines,
• non-steroidal anti-inflammatory medicines (e.g. ibuprofen, indomethacin), probenecid (gout medicine), cholestyramine (cholesterol-lowering medicine): may decrease the effect of torasemide,
• diabetes medicines: may decrease the effect of these medicines.

Taking SUTRIL HTA 2.5 mg with food and drinks

The tablets should be taken with a little liquid, without chewing, with breakfast.

Use in children

Since the safety and efficacy of torasemide in children have not been established, the use of Torasemide in children is not recommended.

Use in the elderly

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Torasemide is not recommended during pregnancy.

It is not known whether torasemide passes into breast milk, so its use is not recommended during breastfeeding.

Driving and using machines

This medicine may affect your ability to react, which should be taken into account if you need to drive or operate machinery. The effect is increased if taken simultaneously with alcohol.

Sutril HTA 2.5 mg contains lactose

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

3. How to take SUTRIL 10 mg Tablets

Follow the administration instructions of SUTRIL 10 mg exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

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

SUTRIL 10 mg tablets are for oral administration.

The tablets should be taken with a little liquid, without chewing, with breakfast.

If you take more SUTRIL 10 mg than you should

If you have taken more Sutril than you should, it may cause increased urine production and drowsiness, confusion, weakness, and dizziness.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone (91) 562 04 20, indicating the medicine and the amount taken.

If you forget to take SUTRIL 10 mg

Do not take a double dose to make up for forgotten doses.

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

4. Possible side effects

Like all medicines, SUTRIL 10 mg can cause side effects, although not everybody gets them.

During prolonged treatment, disturbances of the hydroelectrolytic balance may appear.

Occasionally, especially at the start of treatment, headache, dizziness, fatigue, weakness, muscle cramps, and gastrointestinal disorders (e.g. loss of appetite, stomach pain, nausea, vomiting, diarrhea, constipation) may appear.

In rare cases, dry mouth and discomfort in the limbs may appear, and in individual cases, visual disturbances and allergic reactions (e.g. itching, skin rash, photosensitivity) may be observed.

In patients who have difficulty urinating (e.g. due to prostate hypertrophy), the increased urine flow may lead to urinary retention. Due to increased urine production, a decrease in blood pressure, confusion, and exceptionally, thrombosis, arrhythmia, angina pectoris, acute myocardial infarction, sudden loss of consciousness (syncope), and circulatory collapse may occur, especially if large amounts of fluid and salts have been lost.

Occasionally, increases in blood uric acid, sugar, triglycerides, and cholesterol have been observed.

The following side effects have been reported:

Common (may affect up to 1 in 10 people)

Gastrointestinal disorders (e.g. loss of appetite, nausea, vomiting, stomach pain, constipation, diarrhea), asthenia, fatigue, increased blood pH (metabolic alkalosis), electrolyte and fluid imbalance (e.g. decreased blood volume, decreased sodium and/or potassium in blood), muscle spasms, headache, dizziness, drowsiness, increased urination frequency, erectile dysfunction.

Uncommon (may affect up to 1 in 100 people)

Digitalis intoxication, increased blood glucose, uric acid, and lipids such as triglycerides or cholesterol, urinary retention due to increased urine flow in patients with difficulty urinating, increased bladder volume (e.g. due to prostate hypertrophy), increased liver enzymes (e.g. elevated gamma-glutamyltransferase)

Rare (may affect up to 1 in 1,000 people)

Discomfort in the limbs, elevated blood urea, elevated blood creatinine.

Very rare (may affect up to 1 in 10,000 people)

Rash, allergic reactions (e.g. itching, skin rash, photosensitivity).

Frequency not known (cannot be estimated from available data)

Acute myocardial infarction, decreased blood pressure, thrombosis, angina pectoris, arrhythmia, hypotension, increased heart rate, circulatory collapse (especially if large amounts of fluid and salts have been lost), myocardial ischemia, syncope, embolism, decreased platelet count in blood (thrombocytopenia), decreased white blood cell count in blood (leukopenia), anemia, visual disturbances, tinnitus, deafness, pancreatitis, dry mouth, sensation of numbness in the body (paresthesia), cerebral ischemia, confusion, severe skin reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis).

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 package leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of SUTRIL 10 mg Tablets

Keep out of the reach and sight of children.

Do not use SUTRIL 10 mg after the expiry date stated on the packaging after CAD. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to the pharmacy's SIGRE point. If you have any doubts, ask your pharmacist how to dispose of the packaging and unused medicine. This will help protect the environment.

6. FURTHER INFORMATION

Composition of SUTRIL 10 mg Tablets

• The active substance is torasemide 10 mg.
• The other ingredients (excipients) are: lactose, corn starch, colloidal silicon dioxide, and magnesium stearate.

Appearance of the product and packaging contents

SUTRIL 10 mg tablets are white, round, and scored. They come in packs of 30 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

FERRER INTERNACIONAL, S.A.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

FERRER INTERNACIONAL, S.A.

C/ Buscallá, 1-9

08173 Sant Cugat del Vallès- Barcelona

Spain

Or

ROCHE FARMA, S.A.

Josefa Valcarcel, 42

Madrid

Spain

Date of the last revision of this package leaflet:January 2024