TORASEMIDE STADAFARMA 10 mg TABLETS

Introduction

Package Leaflet: Information for the User

Torasemide Stadafarma 10 mg Tablets EFG

Read this package leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Torasemide Stadafarma and what is it used for

Torasemide Stadafarma contains torasemide, which belongs to a group of medicines called antihypertensive diuretics.

Torasemide 10 mg is indicated for the treatment and prevention of edema (fluid retention) due to congestive heart failure, hepatic and renal disease.

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

Do not take Torasemide Stadafarma

• 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

Talk to your doctor or pharmacist before you start taking Torasemide Stadafarma.

• 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, 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 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 the patient's age.

Other Medicines and Torasemide Stadafarma

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 torasemide:

• Cardiac glycosides such as digoxin (heart medicines), which may have more side effects.
• Antidiabetic medicines, whose action may be reduced.
• Aminoglycoside antibiotics, platinum-based 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 renal failure.
• Antihypertensives (particularly ACE inhibitors) may produce 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 the adverse effects of lithium.
• Colestyramine (medicine to reduce blood cholesterol levels): may decrease the effect of torasemide.

Taking Torasemide Stadafarma 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, 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 any 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 Stadafarma 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 Stadafarma

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

Remember to take your medicine.

It can be administered at any time regarding meals, at your convenience. It is 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 hepatic 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.

Dividing the Tablet

The tablet can be divided into equal doses.

If you Take More Torasemide Stadafarma than you Should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or go to the nearest hospital, or call the Toxicology Information Service, phone (91) 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the package and the package leaflet of the medicine to the healthcare professional.

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

If you Forget to Take Torasemide Stadafarma

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.

Side effects may appear with the following frequencies:

Very common: affects more than 1 in 10 patients treated. Common: affects between 1 and 10 in 100 patients treated.

Uncommon: affects between 1 and 10 in 1,000 patients treated. Rare: affects between 1 and 10 in 10,000 patients treated.

Very rare: affects less than 1 in 10,000 patients treated.

Frequency not known: cannot be estimated from the available data.

The following side effects have been reported:

Common:

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:

Increased liver enzymes, urinary retention, increased gallbladder volume, increased uric acid, glucose, and lipids such as triglycerides or cholesterol in the blood.

Rare

Increased urea and/or creatinine in the blood.

Very rare:

Allergic skin reactions (itching and skin spots), sensitivity to sunlight.

Frequency not known

Severe skin reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis), decreased platelet and/or white blood cell count in 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. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare 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 Torasemide Stadafarma

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 packaging after EXP. The expiry date refers to the last day of the month shown.

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 Stadafarma

• The active substance is torasemide. It contains 10 mg of torasemide as the active substance.
• The other ingredients are lactose monohydrate, magnesium stearate, cornstarch, anhydrous colloidal silica.

Appearance of the Product and Contents of the Pack

Torasemide 10 mg are round, white or almost white tablets, with a cross-shaped score line on one side and a cross-shaped score line on the other side, approximately 8.5 mm in diameter and 4.2 mm in height.

The tablets are presented in PVC/Aluminum or OPA/Aluminum/PVC blisters sealed with an aluminum foil and each pack contains 30 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer:

STADA Arzneimittel AG

Stadastrasse 2 -18

61118 Bad Vilbel

Germany

Date of the Last Revision of this Package Leaflet: February 2024

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