Sutril 10 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

SUTRIL 10 mg tablets

Torasemide

Read the entire leaflet carefully before you start taking this medicine

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you personally and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What SUTRIL 10 mg tablets are and what they are used for
2. Before you take SUTRIL 10 mg tablets
3. How to take SUTRIL 10 mg tablets
4. Possible side effects
5. How to store SUTRIL 10 mg tablets
6. Further information

1. What SUTRIL 10 mg tablets is and what it is used for

Sutril 10 mg is a diuretic medicine (increases urine elimination) that belongs to a group of medicines called "high-ceiling diuretics". It is indicated for:

• the treatment of edema (swelling due to fluid retention) resulting from impaired cardiac function (e.g., heart failure).
• the 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 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).

Take special care with SUTRIL HTA 2.5 mg

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

Use of other medicines

Inform your doctor or pharmacist if you are using or have recently used any 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 (medicines for the heart), antihypertensives (particularly ACE inhibitors), theophylline (a medicine for the treatment of asthma): 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 (a medicine for the treatment of cancer), lithium (an antidepressant medicine), salicylates, ethacrynic acid: may increase the toxicity of these,
• non-steroidal anti-inflammatory drugs (e.g. ibuprofen, indomethacin), probenecid (an antigout medicine), cholestyramine (a medicine to reduce blood cholesterol levels): may reduce the effect of torasemide,
• medicines for the treatment of diabetes: may reduce the effect of these.

Taking SUTRIL HTA 2.5 mg with food and drinks

The tablets should be taken with some 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 is not recommended in children.

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.

The use of torasemide during pregnancy is not recommended.

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

Driving and use of machines

This medicine may impair reaction ability, 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 medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to TAKE SUTRIL 10 mg tablets

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

The usual dose for 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, you may experience increased urine output and symptoms such as drowsiness, confusion, weakness, and dizziness.

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

If you forget to take SUTRIL 10 mg

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

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

4. Possible adverse effects

Like all medicines, SUTRIL 10 mg can cause adverse effects, although not everyone will experience them.

During prolonged treatment, disturbances in water and electrolyte balance may occur.

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

Rarely, dry mouth and discomfort in the limbs may occur; 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 urinary flow may lead to urinary retention. Due to increased urine production, a drop 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, increased levels in blood of uric acid, glucose, triglycerides, and cholesterol have been observed.

The following adverse effects have been reported:

Frequent (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

Digitalis intoxication, increased blood levels of glucose, uric acid, and lipids such as triglycerides or cholesterol, urinary retention due to increased urinary flow in patients with difficulty urinating, increased bladder distension (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 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 spots, stinging, redness), photosensitivity reactions (sensitivity to sunlight).

Frequency not known (cannot be estimated from available data)

Acute myocardial infarction, drop in 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), inadequate blood supply to the heart (myocardial ischaemia), syncope, blockage of blood vessels (embolism), decreased number of platelets in blood (thrombocytopenia), decreased number of white blood cells in blood (leucopenia), anaemia, visual disturbances, ringing in the ears (tinnitus), deafness, inflammation of the pancreas (pancreatitis), dry mouth, sensation of numbness in the body (paraesthesia), reduced blood supply to the brain (cerebral ischaemia), confusion, severe skin reactions (e.g. Stevens-Johnson Syndrome, toxic epidermal necrolysis).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Conservation 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 EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or in household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of SUTRIL 10 mg tablets

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

Appearance of the medicinal product and contents of the pack

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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 most recent revision of this leaflet: January 2024