Leaflet: information for the user

Torasemide Aurovitas 10 mg tablets EFG

Read this 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, consult your doctor or pharmacist.

-This medicine has been prescribedonlyfor you, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

-Ifyou experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Torasemida Aurovitascontains torasemida, which belongs to a group of medications called diuretic anti-hypertensive drugs.

Torasemida is indicated for:

• Treatment of essential hypertension.

Treatment and prevention of edemas (swelling due to fluid retention) caused by congestive heart failure, liver, and kidney insufficiency.

Do not take Torasemida Aurovitas

•If you are allergic totorasemida,to sulfonylureas (medicines for treating diabetes)or to any of the other components 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

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

•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 medicine.

•If you have kidney disease, you should be treated.

•If you have severe liver disease, especially if it has affected the brain.

•This medicine may alter heart, skeletal, and intestinal muscle cells. 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

Due to the lack of establishedsecurity and efficacy of torasemida in children (<18>, it is not recommended to usein this age group.

Use in elderly patients

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

Taking Torasemida Aurovitas with other medicines

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine.

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

•Cardiac glycosides such as digoxin (heart medicine), which may have more adverse effects.

•Antidiabetic medicines, whose action may be reduced.

•Aminoglycoside antibiotics, platinum-derived cytostatics, such as cisplatin (cancer treatment medicine), and cephalosporins: may increase the toxicity to the kidneys or ears.

•Salicylates, which may increase the risk of gout attacks.

•Coumarin derivatives.

•Non-steroidal anti-inflammatory drugs (e.g. ibuprofen, indomethacin), which may reduce the effect of diuretics and increase the risk of renal failure.

•Antihypertensives (particularly IECA), which 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 (medicine to lower blood cholesterol levels): may reduce the effect of torasemida.

Taking Torasemida Aurovitas with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

If you are pregnantor breastfeeding, consult your doctor or pharmacist before using this medicine.

Torasemida is not recommended during pregnancyor in breastfeeding women, asit is unknown whether torasemida passes into breast milk.

Driving and operating machines

This medicine may affect your ability to drive or operate machines, especially if taken simultaneously with alcohol.

Torasemida Aurovitas contains lactose

This medicine contains lactose. If your doctor has told you that you have intolerance to certain sugars, consult with him before taking this medicine.

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

Remember to take your medication.

The tablets can be taken at any time in relation to meals, at your convenience. They are swallowed whole, with a little liquid, preferably with breakfast.

Your doctor will indicate the duration of your treatment with torasemida. Do not discontinue treatment beforehand, as this could worsen your condition.

The recommended dose in adults is:

In edema associated with congestive heart failure, renal or hepatic disease:The initial dose ranges from 5 mg to 20 mg per day,in a single dose,but your doctor may increase it up to approximatelytwice as much if deemed necessary.

In hypertension:The usual initial dose is 2.5 to 5 mg per day,in a single dose,but your doctor may increase it up to 10 mg per day or prescribe another antihypertensive medication in addition.

If you take more Torasemida Aurovitas 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.

In case of overdoseit may produce an increased amount of urine and appear drowsiness, confusion, weakness, and dizziness.

If you forgot to take Torasemida Aurovitas

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 time it is due.

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

Like all medications, this medication may produce adverse effects, although not everyone will 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, lethargy.

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, cardiac 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: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 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.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the 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 the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Torasemida Aurovitas

-The active ingredient is torasemide. Each tablet contains 10 mg of torasemide.

-The other components (excipients) are: lactose monohydrate, microcrystalline cellulose, crospovidone, povidone (Kollidon 30) and magnesium stearate.

Appearance of the product and contents of the packaging

White or almost white, oval, biconvex tablets with a “C” engraved on one face and a line of division between the numbers “4” and “2” on the other.

The tablet can be divided into equal doses.

Torasemida Aurovitas 10 mg tablets EFG are presented in blister packs of 30 and 500 tablets (clinical packaging).

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible for manufacturing

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Last review date of this leaflet:November 2020

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http:\\www.aemps.gob.es).