TORASEMIDE STADAFARMA 2.5 mg TABLETS

2. What you need to know before taking Torasemide Stadafarma

Do not take Torasemide Stadafarma

• If you are allergic to torasemide, sulfonamides (medicines for treating diabetes), or 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 Torasemide Stadafarma.

• During long-term treatment, 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, 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 recommended in this population group.< p>

Use in Elderly Patients

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

Other Medicines and Torasemide Stadafarma

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

You should also inform your doctor if you are using 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 renal failure.
• Antihypertensives (particularly ACE inhibitors), 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 the adverse effects of lithium.
• Colestyramine (cholesterol-lowering medicine): may reduce 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

The use of torasemide is not recommended during pregnancy or in breastfeeding women, as it is unknown 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 certain sugars, consult with them before taking this medicine.

3. How to Take Torasemide Stadafarma

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

Remember to take your medicine.

They can be administered at any time regarding meals, at your convenience. 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 may worsen your disease.

The recommended dose in adults is:

In hypertension:The usual initial dose is 2.5 mg 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 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 ingested. It is recommended to take the package and the package leaflet of the medicine to the healthcare professional.

In case of overdose, an increased amount of urine may be produced, and drowsiness, confusion, weakness, and dizziness may appear.

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 other questions about 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 rashes), 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 disturbance, 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, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) 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 expiration date stated on the package after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Place the packages and medicines you no longer need in the pharmacy's SIGRE point. Ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Torasemide Stadafarma

• The active substance is torasemide. It contains 2.5 mg of torasemide as the active substance.
• The other components are lactose monohydrate, magnesium stearate, cornstarch, anhydrous colloidal silica.

Appearance of the Product and Package Contents

Torasemide 2.5 mg are round, biconvex, white or almost white tablets, approximately 6 mm in diameter and 3.6 mm in height.

The tablets are presented in PVC/Aluminum or OPA/Aluminum/PVC blisters sealed with an aluminum foil and each package 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 about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es