Package Leaflet: Information for the User

Torasemide Cinfa 10 mg Tablets EFG

Read this leaflet carefully before you start taking this medicinebecause it contains important information for you.

• 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 only. Do not pass it on to others even if their symptoms are the same as yours, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

torasemidacinfa belongs to a group of medicines called diuretic anti-hypertensive agents.

torasemida cinfa is indicated for the treatment and prevention of edemas (fluid retention) due to congestive heart failure, hepatic and renal insufficiency.

Do not take torasemide cinfa

• If you are allergic to torasemida, sulfonylureas (diabetes medications) or any of the other components of this medication (listed in section 6).
• If you have anuria (absence of urine production) in renal failure.
• If you have severe liver function impairment.

Warnings and precautions

Consult your doctor or pharmacist before starting to take torasemida cinfa.

• During long-term treatment and especially in elderly patients, your doctor will perform periodic blood tests to monitor various values such as potassium, glucose, uric acid, creatinine, and lipids.
• Urinary retention should be corrected before and during treatment with this medication.
• If you have kidney disease, you should be treated.
• If you have severe liver disease, especially if it has affected the brain.
• This medication may alter the skeletal muscle cells of the heart and intestines. Potassium levels should be monitored during treatment with this medication.
• Sodium levels should be monitored before or during treatment.
• In patients with reduced blood volume, this medication should be administered under medical supervision.
• If you have hypotension, it should be corrected before or during treatment with this medication.
• If you have arrhythmias, blood tests should be performed to monitor sodium, potassium, calcium, and magnesium levels.
• If you have gout (accumulation of uric acid in the body).
• If you are allergic to sulfonamides.

Children

Due to the lack of established safety and efficacy of torasemida in children (<18 years old).

Use in elderly patients

No differences in efficacy or safety have been observed according to patient age.

Other medications and torasemida cinfa

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

You should also inform your doctor if you are taking any of the following medications that may interact with torasemida:

• Cardiac glycosides such as digoxin (heart medications) that may have more adverse effects.
• Antidiabetic medications, whose action may be reduced.
• Aminoglycoside antibiotics, platinum-derived cytostatics, such as cisplatin (cancer treatment medication) and cephalosporins: may increase the toxicity to the kidneys or ears.
• Salicylates, which may increase the risk of gout attacks.
• Cumarinic derivatives.
• Non-steroidal anti-inflammatory drugs (e.g. ibuprofen, indomethacin),which may reduce the action of diuretics and increase the risk of renal failure.
• Antihypertensive medications (particularly IECA) may cause hypotension and increase the risk of renal failure.
• Probenecid,which may reduce the effect of torasemida.
• Muscle relaxants and theophylline.
• Lithium, as torasemida may increase the adverse effects of lithium.
• Colestiramine (medication to reduce blood cholesterol levels): may reduce the effect of torasemida.

Taking torasemida cinfa with food and drinks

The tablets can be taken with or without food. They are swallowed without chewing, with a little liquid, preferably in the morning.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Torasemida is not recommended during pregnancy, nor in women breastfeeding, as it is unknown whether torasemida passes into breast milk.

Driving and operating machinery

This medication may cause dizziness or drowsiness. This may occur more frequently at the beginning of treatment, when your doctor increases your dose, or if you consume alcohol. Do not drive or operate tools or machinery if you feel dizzy or drowsy.

Torasemida cinfa 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.

Torasemida cinfa contains sodium.

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions for this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medication.

Your doctor will indicate the duration of your treatment with Torasemida. Do not suspend treatment beforehand, as it may worsen your condition.

The groove is only for breaking the tablet if it is difficult to swallow whole.

The recommended dose in adults is

In congestive heart failure, kidney disease, or liver disease associated with edema:

The initial dose ranges from 5 mg to 20 mg per day, in a single dose, but your doctor may increase it to approximately double if deemed necessary.

Administration form

Torasemida tablets are for oral administration.

Torsemide tablets can be taken at any time in relation to meals, at your convenience. It is ingested without chewing, with a little liquid, preferably with breakfast.

If you take more Torasemida Cinfa than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

In case of overdose, it may cause increased urine production and appear drowsiness, confusion, weakness, and dizziness.

If you forgot to take Torasemida Cinfa

Do not take a double dose to compensate for the missed doses.

Take your dose as soon as you remember and, the next day, take it at the corresponding time.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

The following adverse effects have been described:

Frequent (may affect up to 1 in 10 people)

Increased blood pH (metabolic alkalosis), electrolyte and fluid imbalance (e.g. decreased total blood volume, decreased sodium and/or potassium in blood), headache, dizziness, gastrointestinal disturbances (e.g. loss of appetite, abdominal pain, nausea, vomiting, diarrhea, constipation), muscle spasms, fatigue, tiredness.

Infrequent (may affect up to 1 in 100 people)

Increased liver enzymes, urinary retention, gallbladder enlargement, increased blood uric acid, glucose, and lipids such as triglycerides or cholesterol.

Rare (may affect up to 1 in 1,000 people)

Increased blood urea and/or creatinine.

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

Skin allergic reactions (itching and skin patches), photosensitivity reaction.

Unknown frequency (cannot be estimated from available data)

Severe skin reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis), decreased platelet and/or leukocyte count in blood, anemia, cerebral ischemia (decreased blood flow to the brain), numbness in the body (paresthesia), confusion, visual disturbances, ear ringing (tinnitus), hearing loss, myocardial infarction, heart ischemia, angina pectoris, loss of consciousness (syncope), hypotension, vascular obstruction (embolism), dry mouth, pancreatitis.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not store at a temperature above 30°C.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Torsemide cinfa composition

• The active ingredient is torsemide. Each tablet contains 10 mg of torsemide.
• The other components are: lactose monohydrate, cornstarch, carboxymethylcellulose sodium (type A) (from potato), anhydrous colloidal silica, and magnesium stearate (E-470b).

Product appearance and packaging contents

White or almost white, biconvex, round, scored on one face, and marked with “916” on the other.

Presented in PVC-PVDC/Aluminum blister packaging.

Each package contains 30 tablets.

Marketing authorization holder and responsible manufacturer

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:July 2021

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

You can access detailed and updated information about this medication by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/66315/P_66315.html

QR code to:https://cima.aemps.es/cima/dochtml/p/66315/P_66315.html