TORASEMIDE STADAFARMA 5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Torasemide Stadafarma 5 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 Torasemide Stadafarma is and what it is used for
2. What you need to know before taking Torasemide Stadafarma
3. How to take Torasemide Stadafarma
4. Possible side effects
5. Storage of Torasemide Stadafarma
6. Package Contents and Additional Information

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

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

Torasemide Stadafarma 5 mg is indicated for:

• Treatment of essential arterial hypertension.
• Treatment and prevention of edema (swelling due to fluid retention) due to congestive heart failure, liver and kidney disease.

2. What you need to know before taking Torasemide Stadafarma

Do not take Torasemide Stadafarma

• If you are allergic to torasemide, sulfonylureas (medicines for treating diabetes) or any of the other ingredients of this medicine (listed in section 6).
• If you have anuria (absence of urine production) due to renal failure.
• If you have severe liver function impairment.

Warnings and Precautions

Consult your doctor or pharmacist before 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 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 recommended in this population.< p>

Use in Elderly Patients

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

Other Medicines and Torasemide Stadafarma

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 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 kidney failure.
• Antihypertensives (particularly ACE inhibitors) 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.
• 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 some sugars, consult them before taking this medicine.

3. How to Take Torasemide Stadafarma

Follow the administration instructions of this medicine exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Remember to take your medicine.

It can be administered at any time regarding meals, as convenient. 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, kidney 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 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.

Tablet Division

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 take the package and 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 further 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 can occur 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, 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 Side Effects

If you experience any side effects, talk to 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 ingredient is torasemide. It contains 5 mg of torasemide as the active substance.
• The other ingredients are lactose monohydrate, magnesium stearate, cornstarch, anhydrous colloidal silica.

Appearance of the Product and Package Contents

Torasemide 5 mg are round, biconvex, white or almost white tablets, with a division line on one side, approximately 7 mm in diameter and 2.5 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 on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es