Sutril HTA 2.5 mg tablets
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
SUTRIL HTA 2.5 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 serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Leaflet contents:
- What SUTRIL HTA 2.5 mg tablets are and what they are used for
- Before you take SUTRIL HTA 2.5 mg tablets
- How to take SUTRIL HTA 2.5 mg tablets
- Possible side effects
- How to store SUTRIL HTA 2.5 mg tablets
- Further information
1. What SUTRIL HTA 2.5 mg tablets are and what they are used for
Sutril HTA 2.5 mg is a diuretic medicine (increases urine elimination) that belongs to the group of medicines known as "high-ceiling diuretics". It is indicated for:
- the 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 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 failure with absence of urine production.
- If you have severe impairment of liver function.
- 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 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 that may interact with torasemide:
- Cardiac glycosides such as digoxin (heart medications), antihypertensives (particularly ACE inhibitors), theophylline (a medicine for asthma treatment): 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 cancer treatment), lithium (an antidepressant medicine), salicylates, ethacrynic acid: may increase the toxicity of these medicines.
- Non-steroidal anti-inflammatory drugs (e.g., ibuprofen, indomethacin), probenecid (an antigout medicine), cholestyramine (a medicine to lower blood cholesterol levels): may reduce the effect of torasemide.
- Medicines used to treat diabetes: may reduce their effectiveness.
Taking SUTRIL HTA 2.5 mg with food and drinks
The tablets should be taken with some liquid, without chewing, during breakfast.
Use in children
As 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 patient 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 using machines
This medicine may impair reaction capability, which should be taken into account if you need to drive or operate machinery. The effect is intensified if alcohol is consumed concurrently.
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 HTA 2.5 mg tablets
Follow exactly the administration instructions for SUTRIL HTA 2.5 mg as indicated by your doctor.
Consult your doctor or pharmacist if you have any doubts.
The usual 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 an additional antihypertensive.
SUTRIL HTA 2.5 mg tablets are for oral use.
The tablets should be taken with a little liquid, without chewing, at breakfast.
If you take more SUTRIL HTA 2.5 mg than you should
If you have taken more Sutril than you should, you may produce a larger amount of urine and experience drowsiness, confusion, weakness, and dizziness.
In case of overdose or accidental ingestion, contact 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 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 adverse effects
Like all medicines, SUTRIL HTA 2.5 mg may produce adverse effects, although not everyone experiences them.
During prolonged treatment, disturbances in water-salt balance may occur.
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, diarrhoea, constipation) may appear.
In rare cases, dry mouth and discomfort in the extremities may occur; in individual cases, visual disturbances and allergic reactions (e.g. burning sensation, 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, 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 discomfort (e.g. loss of appetite, nausea, vomiting, stomach pain, constipation, diarrhoea), asthenia, dyspepsia, weakness, fatigue, tiredness, increased blood pH (metabolic alkalosis), electrolyte and fluid imbalance (e.g. decreased total blood volume, decreased sodium and/or potassium in blood), 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, bladder distension (e.g. due to prostate hypertrophy), increased liver enzymes (e.g. elevated gamma-glutamyl transferase).
Rare (may affect up to 1 in 1,000 people)
Discomfort in extremities, elevated blood urea, elevated creatinine in blood.
Very rare (may affect up to 1 in 10,000 people)
Rash, allergic reactions (e.g. itching, skin rash, burning sensation, redness), photosensitivity reaction (sensitivity to sunlight).
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), reduced 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, numbness or tingling sensation in the body (paraesthesia), reduced blood flow to the brain (cerebral ischaemia), paraesthesia, 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 through 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 HTA 2.5 mg tablets
Keep out of the reach and sight of children.
Do not use SUTRIL HTA 2.5 mg after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE point located in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. ADDITIONAL INFORMATION
Composition of SUTRIL HTA 2.5 mg tablets
- The active substance is torasemide 2.5 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 HTA 2.5 mg tablets are white, round tablets. They are packaged in packs containing 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 most recent review of the leaflet: January 2024