TORASEMIDE CINFA 5 mg TABLETS

2. What you need to know before you take torasemida cinfa

Do not take torasemida cinfa

• If you are allergic to torasemida, sulfonamides (medicines used to treat diabetes) or any of the other ingredients of this medicine (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

Talk to your doctor or pharmacist before taking torasemida cinfa.

• During long-term treatment and especially in elderly patients, your doctor will perform periodic blood tests to check various values such as potassium, glucose, uric acid, creatinine, lipids.
• Urinary retention should be corrected before and during treatment with this medicine.
• If you have kidney disease, it should be treated.
• If you have severe liver disease, especially if it has affected the brain.
• This medicine may affect muscle cells in the heart, skeleton, and intestine. Potassium levels should be monitored during treatment with this medicine.
• Sodium levels should be monitored before or during treatment.
• In patients with reduced blood volume, this medicine should be administered under medical supervision.
• If you have hypotension, it should be corrected before or during treatment with this medicine.
• 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.

Use in elderly patients

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

Other medicines and torasemida cinfa

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

• Cardiac glycosides such as digoxin (heart medicines) that may have more side effects.
• Antidiabetic medicines, whose action may be reduced.
• Aminoglycoside antibiotics, platinum-derived cytostatics such as cisplatin (cancer treatment medicine), and cephalosporins: may increase kidney or ear toxicity.
• Salicylates, as they may increase the risk of gout attacks.
• Coumarin derivatives.
• Non-steroidal anti-inflammatory medicines (e.g., ibuprofen, indomethacin), which may reduce the effect of diuretics and increase the risk of kidney failure.
• Antihypertensives (particularly ACE inhibitors) may produce hypotension and increase the risk of kidney failure.
• Probenecid, which may reduce the effect of torasemida.
• Muscle relaxants and theophylline.
• Lithium, as torasemida may increase the adverse effects of lithium.
• Colestyramine (medicine to reduce 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

Driving and using machines

This medicine 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 medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

torasemida cinfa contains sodium.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially “sodium-free”.

3. How to take torasemida cinfa

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Your doctor will tell you how long to take torasemida. Do not stop treatment before, as it may worsen your condition.

The score line is only to facilitate breaking the tablet if you have difficulty swallowing 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.

Inhypertension:

The initial dose is 2.5 mg to 5 mg per day, in a single dose, but your doctor may increase it to 10 mg per day or prescribe another additional antihypertensive.

Method of administration

torasemida tablets are for oral administration.

The tablets can be administered at any time regarding meals, at convenience. 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 medicine and the amount taken. It is recommended to take the package and the package leaflet of the medicine 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 forgotten doses.

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been reported:

Common (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 the available data)

Severe skin reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis), decreased platelet and/or white blood cell count in the 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 of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Health Products Agency (AEMPS) through the website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of torasemida cinfa

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

Do not store above 30°C.

Do not use this medicine after the expiry date stated on the package after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. If you are in doubt, ask your pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of torasemida cinfa

• The active substance is torasemida. Each tablet contains 5 mg of torasemida.
• The other ingredients are: lactose monohydrate, corn starch, sodium carboxymethyl starch (type A) (potato), colloidal anhydrous silica, and magnesium stearate (E-470b).

Appearance of the product and pack contents

White or almost white, biconvex, round, scored on one side and marked with “915” on the other side tablets.

They are presented 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 last revision of this leaflet:July 2021

Detailed information on this medicine 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 on this medicine 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/66314/P_66314.html

QR code to: https://cima.aemps.es/cima/dochtml/p/66314/P_66314.html