Package Insert: Information for the User

SUTRIL 5 mg Tablets

Torasemide

Read this package insert carefully before starting to take the medication

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you personally and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this package insert, inform your doctor or pharmacist.

Sutril 5 mg is a diuretic medication (increases urine elimination) that belongs to the group of medications called "High Ceiling Diuretics". It is indicated for:

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

Do not take SUTRIL HTA 2.5 mg

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

Be especially 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 medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

You must 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), anti-hypertensives (particularly ACE inhibitors), theophylline (asthma medication): the effect of these medications may be increased,
• Mineralocorticoids, glucocorticoids, and laxatives: may increase the elimination of potassium produced by these medications,
• Aminoglycoside antibiotics: may increase the toxicity to the kidneys or ears,
• Cisplatin (cancer medication), lithium (antidepressant), salicylates, etacrynic acid: may increase the toxicity of these medications,
• Non-steroidal anti-inflammatory medications (e.g. ibuprofen, indomethacin), probenecid (gout medication), cholestyramine (cholesterol-lowering medication): may decrease the effect of torasemide,
• Diabetes medications: may decrease the effect of these medications.

Taking SUTRIL HTA 2.5 mg with food and beverages

The tablets should be taken with a small amount of liquid, without chewing, with breakfast.

Use in children

Due to the lack of established safety and efficacy of torasemide in children, the use of Torasemide in children is not recommended.

Use in the elderly

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

The use of torasemide during pregnancy is not recommended.

The passage of torasemide into breast milk is unknown, so its use during breastfeeding is not recommended.

Driving and operating machinery

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

Sutril HTA 2.5 mg contains lactose

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

Follow exactly the administration instructions for SUTRIL 5 mg as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

The normal dose in adults is:

• Treatment of edema associated with congestive heart failure, kidney disease, or liver disease

The initial dose ranges from 5 mg to 20 mg per day, but your doctor may increase it up to approximately double as needed.

• Hypertension

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

SUTRIL 5 mg tablets are for oral administration.

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

If you take more SUTRIL 5 mg than you should

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

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

If you forgot to take SUTRIL 5 mg

Do not take a double dose to compensate for the missed doses.

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

Like all medicines, SUTRIL 5 mg may cause side effects, although not everyone will experience them.

During prolonged treatment, disturbances of the hydro-saline balance may appear.

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

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

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

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

The following side effects have been described:

Frequent (may affect up to 1 in 10 people)

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

Rare (may affect up to 1 in 100 people)

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

Rare (may affect up to 1 in 1000 people)

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

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

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

Frequency unknown (cannot be estimated from available data)

Acute myocardial infarction, decrease in blood pressure, thrombosis, angina pectoris, cardiac rhythm disturbances, hypotension, increased heart rate, circulatory collapse (especially if large amounts of liquid and salts have been lost), heart ischemia, syncope, vascular obstruction (embolism), decreased platelet count (thrombocytopenia), decreased white blood cell count (leucopenia), anemia, visual disturbances, tinnitus, hearing loss, pancreatitis, dry mouth, numbness in the body (paresthesia), decreased cerebral blood flow (cerebral ischemia), confusion state, severe skin reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis).

Reporting of 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 prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine

Keep out of reach and sight of children.

Do not use SUTRIL 5 mg after the expiration date indicated 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.Deposit the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy.If in doubt, please ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of SUTRIL 5 mg tablets

• The active ingredient is torasemide 5 mg.
• The other components (excipients) are: lactose, cornstarch, colloidal silicon dioxide, and magnesium stearate.

Appearance of the product and contents of the package

SUTRIL 5 mg tablets are white, round, and scored tablets. They are presented in packages of 30 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the Authorization

FERRER INTERNACIONAL, S.A.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Responsible for manufacturing

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

Last review date of this leaflet:January 2024