Sutril 5 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

SUTRIL 5 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally; do not give it to others, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

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

1. What SUTRIL 5 mg tablets are and what they are used for

Sutril 5 mg is a diuretic medicine (increases urine elimination) belonging to the group of medicines known as "High-ceiling diuretics". It is indicated for:

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

2. BEFORE TAKING SUTRIL 5 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 sulfonamides.
• 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 insufficiency 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 taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

You should also inform your doctor if you are taking any of the following medicines, with which torasemide may interact:

• 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.
• Antibiotics of the aminoglycoside group: may increase kidney or ear toxicity.
• Cisplatin (a medicine for the treatment of cancer), lithium (an antidepressant medicine), salicylates, etacrynic acid: may increase their toxicity.
• Non-steroidal anti-inflammatory drugs (e.g. ibuprofen, indomethacin), probenecid (a medicine for gout), cholestyramine (a medicine to lower blood cholesterol levels): may reduce the effect of torasemide.
• Medicines used to treat diabetes: may reduce their effect.

Taking SUTRIL HTA 2.5 mg with food and drink

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 patient age.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking 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 when driving or operating machinery. The effect is intensified if taken concomitantly with alcohol.

Sutril HTA 2.5 mg contains lactose

This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. HOW TO TAKE SUTRIL 5 mg TABLETS

Follow exactly the administration instructions for SUTRIL 5 mg provided by your doctor. If you have any doubts, consult your doctor or pharmacist.

The usual dose in adults is:

• Treatment of oedema associated with congestive heart failure, renal or hepatic disease

The initial dose ranges from 5 mg to 20 mg daily, but your doctor may increase it up to approximately double if necessary.

• Hypertension

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

SUTRIL 5 mg tablets are for oral use.

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

If you take more SUTRIL 5 mg than you should

If you have taken more Sutril than you should, you may experience increased urine output, 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 medicine and the amount ingested.

If you forget to take SUTRIL 5 mg

Do not take a double dose to make up for missed 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 5 mg can produce 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 disturbances (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 enlargement), increased urine flow may lead to urinary retention. Due to increased urine production, a drop in blood pressure, confusion, and, very rarely, 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 levels 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 disturbances (e.g. loss of appetite, nausea, vomiting, stomach pain, constipation, diarrhoea), asthenia, fatigue, increased blood pH (metabolic alkalosis), fluid and electrolyte 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 urine flow in patients with difficulty urinating, gallbladder distension (e.g. due to prostate enlargement), increased liver enzymes (e.g. elevated gamma-glutamyl transferase).

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, burning sensation, redness), photosensitivity reaction (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, obstruction of blood vessels (embolism), decreased platelet count (thrombocytopenia), decreased white blood cell count (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 type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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. Storage of SUTRIL 5 mg tablets

Keep out of the reach and sight of children.

Do not use SUTRIL 5 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 or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of SUTRIL 5 mg tablets

• The active substance is torasemide 5 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 5 mg tablets are white, round, scored tablets. Packaged 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 most recent revision of this leaflet: January 2024