Torasemide Aurovitas 5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Torasemide Aurovitas 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 others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Torasemida Aurovitas is and what it is used for

Torasemida Aurovitas contains torasemide, which belongs to a group of medicines called antihypertensive diuretics.

Torasemide is indicated for:

• Treatment of essential arterial hypertension.

Treatment and prevention of oedema (swelling due to fluid retention) caused by congestive cardiac, hepatic, and renal failure.

2. What you need to know before starting to take Torasemide Aurovitas

Do not take Torasemide Aurovitas

• 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

Consult your doctor or pharmacist before starting to take Torasemide Aurovitas:

• 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 a kidney disease, it should be treated.
• If you have a severe liver disease, especially if it has affected the brain.
• This medicine may affect muscle cells of the heart, skeleton, and intestine. 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

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

Use in elderly people

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

Taking Torasemide Aurovitas with other medicines

Inform 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 (a heart medicine), which may have increased adverse effects.
• Antidiabetic medicines, whose action may be reduced.
• Aminoglycoside antibiotics, platinum-derived cytostatic agents such as cisplatin (a medicine for cancer treatment), 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, indometacin), which may reduce the effect of diuretics and increase the risk of kidney failure.
• Antihypertensive medicines (particularly ACE inhibitors), which may cause hypotension and increase the risk of kidney failure.
• Probenecid, which may reduce the effect of torasemide.
• Muscle relaxants and theophylline.
• Lithium, as torasemide may increase the adverse effects of lithium.
• Cholestyramine (a medicine to lower blood cholesterol levels): may reduce the effect of torasemide.

Taking Torasemide Aurovitas with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

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 affect your ability to drive or operate machinery, especially if taken simultaneously with alcohol.

Torasemide Aurovitas 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 Torasemida Aurovitas

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are unsure, please consult your doctor or pharmacist again.

Remember to take your medicine.

The tablets can be taken at any time in relation to meals, as convenient. Swallow them whole with some liquid, preferably with breakfast.

Your doctor will determine how long your treatment with torasemide should last. Do not stop treatment prematurely, as this could worsen your condition.

The recommended dose in adults is:

For oedema associated with congestive heart failure, renal 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.

For hypertension: the usual initial dose is 2.5 to 5 mg once daily. Your doctor may increase it up to 10 mg daily or prescribe an additional antihypertensive.

If you take more Torasemida Aurovitas than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

In case of overdose, you may experience increased urine output and symptoms such as drowsiness, confusion, weakness, and dizziness.

If you forget to take Torasemida Aurovitas

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

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

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 may cause adverse effects, although not everyone experiences them.

The following adverse effects have been reported:

Common (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 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 disturbance, noises in the ears (tinnitus), deafness, infarction (acute myocardial infarction), lack of 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 Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Torasemide Aurovitas

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

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.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Torasemide Aurovitas

• The active substance is torasemide. Each tablet contains 5 mg of torasemide.
• The other components (excipients) are: lactose monohydrate, microcrystalline cellulose, crospovidone, povidone (Kollidon 30) and magnesium stearate.

Nature and contents of the container

White or almost white, oval, biconvex tablets, with a "C" engraved on one side and a division line between the numbers "4" and "1" on the other.

The tablet can be divided into equal doses.

Torasemide Aurovitas 5 mg tablets EFG is available in blister packs containing 30 and 500 tablets (hospital pack).

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Date of the most recent revision of this leaflet: November 2020

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http:\www.aemps.gob.es).