TORASEMIDE Aurovitas 5 mg Tablets

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

Do not take Torasemide Aurovitas

• If you are allergic to torasemide, 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

Consult your doctor or pharmacist before taking Torasemide Aurovitas:

• During long-term treatment and especially in elderly patients, your doctor will perform periodic blood tests to check different 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 alter 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 torasemide 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.

Taking Torasemide Aurovitas with Other Medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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

• Cardiac glycosides such as digoxin (heart medicine), which 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 torasemide.
• Muscle relaxants and theophylline.
• Lithium, as torasemide may increase the adverse effects of lithium.
• Cholestyramine (medicine to decrease blood cholesterol levels): may decrease the effect of torasemide.

Taking Torasemide 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 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 torasemide is not recommended during pregnancy or in breastfeeding women, as it is not known whether torasemide passes into breast milk.

Driving and Using Machines

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

Torasemide Aurovitas Contains 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.

3. How to Take Torasemide Aurovitas

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

Remember to take your medicine.

The tablets can be administered at any time regarding meals, as convenient. They are swallowed without chewing, with a little liquid, preferably with breakfast.

Your doctor will indicate the duration of your treatment with torasemide. Do not stop treatment before, as it could worsen your disease.

The recommended dose in adults is:

In edema associated with congestive heart failure, renal 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 up to approximately double 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 additional antihypertensive.

If You Take More Torasemide Aurovitas 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.

In case of overdose, it may produce a greater amount of urine and cause somnolence, confusion, weakness, and dizziness.

If You Forget to Take Torasemide Aurovitas

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):

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), sensation of numbness in the body (paresthesia), confusional state, visual disturbance, ear noises (tinnitus), deafness, infarction (acute myocardial infarction), 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. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly to the Spanish Medicines Agency (AEMPS) at www.notificaram.es. By reporting side 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 which is stated on the carton after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Torasemide Aurovitas

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

Appearance of the Product and Contents of the Pack

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

The tablet can be divided into equal doses.

Torasemide Aurovitas 5 mg tablets EFG are available in blister packs of 30 and 500 tablets (clinical packaging).

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 Last Revision of this Package Leaflet:November 2020

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