Torasemide Cinfa 5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

torasemida cinfa 5 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine because 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, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What torasemida cinfa is and what it is used for
2. What you need to know before taking torasemida cinfa
3. How to take torasemida cinfa
4. Possible side effects
5. How to store torasemida cinfa
6. Contents of the pack and other information

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

Torasemide cinfa belongs to a group of medicines called antihypertensive diuretics.

Torasemide cinfa is indicated for:

• Treatment of essential arterial hypertension.
• Treatment and prevention of oedema (swelling due to fluid retention) caused by congestive heart failure, hepatic and renal insufficiency.

2. What you need to know before taking torasemide cinfa

Do not take torasemide cinfa

• If you are allergic to torasemide, sulfonylureas (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) due to kidney failure.
• If you have severe impairment of liver function.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take torasemide cinfa.

• During long-term treatment, and especially in elderly patients, your doctor will periodically perform blood tests to monitor various parameters such as potassium, glucose, uric acid, creatinine, and lipids.
• Urinary retention should be corrected before and during treatment with this medicine.
• If you have kidney disease, it must be treated.
• If you have severe liver disease, especially if it has affected the brain.
• This medicine may affect muscle cells of the heart, skeletal muscles, and intestines. Potassium levels must 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 levels of sodium, potassium, calcium, and magnesium.
• If you have gout (accumulation of uric acid in the body).
• If you are allergic to sulfonamides.

Children

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

Use in elderly patients

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

Other medicines and torasemide cinfa

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

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 (heart medications), which may have increased adverse effects.
• Antidiabetic medicines, whose action may be reduced.
• Antibiotics of the aminoglycoside group, platinum-derived cytostatics such as cisplatin (a medicine used to treat cancer), and cephalosporins: may increase kidney or ear toxicity.
• Salicylates, as they may increase the risk of gout attacks.
• Coumarin derivatives.
• Non-steroidal anti-inflammatory drugs (e.g., ibuprofen, indomethacin), which may reduce the diuretic effect and increase the risk of renal failure.
• Antihypertensive medicines (particularly ACE inhibitors), which may cause hypotension and increase the risk of renal failure.
• Probenecid, which may reduce the effect of torasemide.
• Muscle relaxants and theophylline.
• Lithium, as torasemide may increase lithium's adverse effects.
• Cholestyramine (a medicine used to lower blood cholesterol levels): may reduce the effect of torasemide.

Taking torasemide cinfa with food and drinks

The tablets may be taken with or without food. They should be swallowed whole with some liquid, preferably in the morning.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Driving and using machines

This medicine may cause dizziness or drowsiness. This is more likely 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.

torasemide cinfa 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.

torasemide cinfa contains sodium.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; i.e., essentially "sodium-free".

3. How to take torasemide cinfa

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Your doctor will tell you how long to take torasemide for. Do not stop treatment earlier, as this could worsen your condition.

The groove is intended only for splitting the tablet if you find it difficult to swallow it whole.

The recommended dose for adults is:

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

The initial dose ranges from 5 mg to 20 mg once daily. However, your doctor may increase it up to approximately double if considered appropriate.

In hypertension:

The initial dose is 2.5 mg to 5 mg once daily. Your doctor may increase it up to 10 mg daily or may prescribe an additional antihypertensive.

Method of administration

Torasemide tablets are for oral use.

The tablets may be taken at any time in relation to meals, according to convenience. Swallow without chewing, with a little liquid, preferably with breakfast.

If you take more torasemide cinfa than you should

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 medicine and the amount ingested. It is recommended to bring the medicine package and leaflet to the healthcare professional.

In case of overdose, increased urine output may occur, along with somnolence, confusion, weakness, and dizziness.

If you forget to take torasemide cinfa

Do not take a double dose to make up for forgotten doses.

Take the missed dose as soon as you remember, and the following day take your dose at the usual time.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The following adverse effects have been reported:

Frequent (may affect up to 1 in 10 people)

Increase in 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, diarrhoea, constipation), muscle spasms, fatigue, tiredness.

Uncommon (may affect up to 1 in 100 people)

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

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

Increased blood levels of urea and/or creatinine.

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

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

Frequency not known (cannot be estimated from the available data)

Severe skin reactions (e.g. Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis), decreased number of platelets and/or white blood cells in blood, anaemia, cerebral ischaemia (reduced blood supply to the brain), sensation of numbness in the body (paraesthesia), confusion, visual disturbances, ringing in the ears (tinnitus), deafness, heart attack (acute myocardial infarction), reduced blood supply to the heart (myocardial ischaemia), angina pectoris, loss of consciousness (syncope), hypotension, blockage of blood vessels (embolism), dry mouth, inflammation of the pancreas (pancreatitis).

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 can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of torasemide 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 packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of torasemide cinfa

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

Appearance of the product and contents of the container

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

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 the most recent revision of this leaflet: July 2021

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. 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