TORASEMIDE CINFA 10 mg TABLETS

Introduction

Package Leaflet: Information for the User

torasemida cinfa 10 mg tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is torasemida cinfa and what is it used for
2. What you need to know before taking torasemida cinfa
3. How to take torasemida cinfa
4. Possible side effects
5. Storage of torasemida cinfa
6. Package Contents and Additional Information

1. What is torasemida cinfa and what is it used for

torasemida cinfa belongs to the group of medications called antihypertensive diuretics.

torasemida cinfa is indicated for the treatment and prevention of edema (fluid retention) due to congestive heart failure, liver, and kidney disease.

2. What you need to know before taking torasemida cinfa

Do not take torasemida cinfa

• If you are allergic to torasemida, sulfonamides (medications for treating diabetes), 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, it should be treated.
• If you have severe liver disease, especially if it has affected the brain.
• This medication may affect muscle cells in the heart, skeleton, 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 (uric acid accumulation in the body).
• If you are allergic to sulfonamides.

Children

Since the safety and efficacy of torasemida in children (<18 years) have not been established, its use is not recommended in this population group.

Use in Elderly Patients

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

Other Medications and torasemida cinfa

Inform your doctor or pharmacist if you are taking, have recently taken, 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 side effects.
• Antidiabetic medications, whose action may be reduced.
• Antibiotics from the aminoglycoside group, platinum-derived cytostatics such as cisplatin (cancer medication), and cephalosporins: may increase kidney or ear toxicity.
• Salicylates, as they may increase the risk of gout attacks.
• Coumarin derivatives.
• Non-steroidal anti-inflammatory medications (e.g., ibuprofen, indomethacin), which may reduce the effect of diuretics and increase the risk of renal failure.
• Antihypertensives (particularly ACE inhibitors) may produce 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.
• Colestyramine (medication to decrease blood cholesterol levels): may decrease 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, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

The use of torasemida is not recommended during pregnancy or in breastfeeding women, as it is unknown whether torasemida passes into breast milk.

Driving and Using Machines

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

torasemida cinfacontains 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".

3. How to Take torasemida cinfa

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

Remember to take your medication.

Your doctor will indicate the duration of your treatment with torasemida. Do not stop treatment before this time, as your condition may worsen.

The score line is only for breaking the tablet if you find it difficult to swallow it whole.

The recommended dose in adults is

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

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.

Method of Administration

torasemida tablets are for oral administration.

The tablets can be administered at any time regarding meals, as convenient. They are swallowed 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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the package leaflet of the medication to the healthcare professional.

In case of overdose, an increased amount of urine may be produced, and drowsiness, confusion, weakness, and dizziness may occur.

If you forget to take torasemida cinfa

Do not take a double dose to make up 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.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The following side effects have been reported:

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 disorders (e.g., loss of appetite, abdominal pain, nausea, vomiting, diarrhea, constipation), muscle spasms, fatigue, tiredness.

Uncommon (may affect up to 1 in 100 people)

Increased liver enzymes, urinary retention, increased gallbladder volume, increased uric acid, glucose, and lipids (such as triglycerides or cholesterol) in the blood.

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

Increased urea and/or creatinine in the blood.

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

Allergic skin reactions (itching and skin rashes), sensitivity to sunlight.

Frequency not known (cannot be estimated from available data)

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

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of torasemida cinfa

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

Do not store above 30°C.

Do not use this medication after the expiration date shown 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 you have any doubts, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of torasemida cinfa

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

Appearance of the Product and Package Contents

White or almost white, biconvex, round, scored tablets, marked with "916" on one side.

They come in PVC-PVDC/Aluminum blister packs.

Each pack contains 30 tablets.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the Last Revision of this Package Leaflet:July 2021

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

You can access detailed and updated information about this medication by scanning the QR code included in the package 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