SUTRIL 5 mg TABLETS

2. BEFORE TAKING SUTRIL 5 mg tablets

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.

Be careful with SUTRIL HTA 2.5 mg

Use of other medicines

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

In addition, you should 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 (particularly ACE inhibitors), theophylline (medicine for asthma treatment): the effect of these medicines may be increased,
• mineralocorticoids, glucocorticoids, and laxatives: may increase potassium elimination caused by these medicines,
• antibiotics of the aminoglycoside group: may increase kidney or ear toxicity,
• cisplatin (cancer treatment medicine), lithium (antidepressant medicine), salicylates, etacrynic acid: may increase the toxicity of these medicines,
• non-steroidal anti-inflammatory medicines (e.g. ibuprofen, indomethacin), probenecid (gout medicine), cholestyramine (medicine to lower blood cholesterol levels): may decrease the effect of torasemide,
• diabetes treatment 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 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 medicine.

Torasemide is not recommended during pregnancy.

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

Driving and using machines

This medicine may alter reaction capacity, which should be taken into account if you need to drive or operate machines. 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 certain sugars, consult with them before taking this medicine.

3. HOW TO TAKE SUTRIL 5 mg tablets

Follow exactly the administration instructions of SUTRIL 5 mg 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 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 if necessary.

• 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 an additional antihypertensive.

SUTRIL 5 mg tablets are for oral administration.

The tablets should 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 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 ingested.

If you forget to take SUTRIL 5 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 5 mg can cause side effects, although not everyone gets them.

During prolonged treatment, electrolyte and fluid balance disorders 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, redness, photosensitivity) may be observed.

In patients who have difficulty urinating (e.g. due to prostate hypertrophy), the increased urine flow may cause urinary retention. Due to increased urine production, a drop 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 described:

Frequent (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, dizziness, 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 urea in blood, elevated creatinine in blood

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

Rash, allergic reactions (e.g. itching, skin spots, redness, 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 (thrombocytopenia), decreased white blood cell count (leukopenia), anemia, visual disturbances, tinnitus, deafness, pancreatitis, dry mouth, sensation of numbness in the body (paresthesia), cerebral ischemia, confusional state, severe skin reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis).

Reporting of side effects

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

5. Storage of SUTRIL 5 mg tablets

Keep out of the 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 wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE point. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of SUTRIL 5 mg tablets

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

Appearance of the product and packaging content

SUTRIL 5 mg tablets are white, round, and scored. They come in packages 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 leaflet:January 2024