SUTRIL HTA 2.5 mg TABLETS

Introduction

Package Leaflet: Information for the User

SUTRIL HTA 2.5 mg Tablets

Torasemide

Read the entire package leaflet carefully before starting to take the medication

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

Contents of the package leaflet:

1. What SUTRIL HTA 2.5 mg tablets are and what they are used for
2. Before taking SUTRIL HTA 2.5 mg tablets
3. How to take SUTRIL HTA 2.5 mg tablets
4. Possible side effects
5. Storage of SUTRIL HTA 2.5 mg tablets
6. Additional information

1. What SUTRIL HTA 2.5 mg tablets are and what they are used for

Sutril HTA 2.5 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.

2. BEFORE TAKING SUTRIL HTA 2.5 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 medications

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

In addition, you should inform your doctor if you are taking any of the following medications that may interact with torasemide:

• cardiac glycosides such as digoxin (heart medications), antihypertensives (especially ACE inhibitors), theophylline (medication for asthma treatment): the effect of these medications may be increased,
• mineralocorticoids, glucocorticoids, and laxatives: may increase potassium elimination caused by these medications,
• aminoglycoside antibiotics: may increase kidney or ear toxicity,
• cisplatin (cancer treatment medication), lithium (antidepressant medication), salicylates, ethacrynic acid: may increase the toxicity of these medications,
• non-steroidal anti-inflammatory medications (e.g., ibuprofen, indomethacin), probenecid (gout medication), cholestyramine (medication to decrease blood cholesterol levels): may decrease the effect of torasemide,
• medications for diabetes treatment: may decrease the effect of these medications.

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 medication.

The use of torasemide during pregnancy is not recommended.

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

Driving and using machines

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

3. HOW TO TAKE SUTRIL HTA 2.5 mg tablets

Follow the administration instructions of SUTRIL HTA 2.5 mg indicated by your doctor.

Consult your doctor or pharmacist if you have any doubts.

The normal dose in adults 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 medication.

SUTRIL HTA 2.5 mg tablets are for oral administration.

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

If you take more SUTRIL HTA 2.5 mg than you should

If you have taken more Sutril than you should, it may cause increased urine production and appear somnolence, 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 medication and the amount ingested.

If you forget to take SUTRIL HTA 2.5 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 medications, SUTRIL HTA 2.5 mg may cause side effects, although not everyone will experience them.

During prolonged treatment, hydroelectrolytic 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 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), the increased urine flow may lead to urinary retention. Due to increased urine production, a decrease in blood pressure, confusion, 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 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, dyspepsia, weakness, 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 extremities, elevated blood urea, elevated blood creatinine.

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, cardiac rhythm disturbances, 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, paresthesia, confusional 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 not mentioned in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of SUTRIL HTA 2.5 mg tablets

Keep out of the reach and sight of children.

Do not use SUTRIL HTA 2.5 mg after the expiration date indicated 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. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of SUTRIL HTA 2.5 mg tablets

• The active ingredient is torasemide 2.5 mg.
• The other components (excipients) are: lactose, cornstarch, colloidal silicon dioxide, and magnesium stearate.

Appearance of the product and packaging content

SUTRIL HTA 2.5 mg tablets are white and round. They are available 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

ROCHE FARMA, S.A.

Josefa Valcarcel, 42

28027 Madrid

Spain

Or

FERRER INTERNACIONAL, S.A.

C/ Buscallá, 1-9

08173 Sant Cugat del Vallès- Barcelona

Spain

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