DILUTOL 5 mg TABLETS

2. What you need to know before taking DILUTOL 5 mg tablets

Do not take Dilutol 5 mg

• If you are allergic to torasemide, sulfonamides (medications for treating diabetes), or any of the other components of this medication (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 Dilutol.

• 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 medication.
• If you have kidney disease, it should be treated.
• If you have severe liver disease, especially if it has affected the brain.
• This medication may affect muscle cells in the heart, skeleton, and intestine. Potassium levels should be monitored during treatment with this medication.
• Sodium levels should be monitored before or during treatment.
• In patients with reduced blood volume, this medication should be administered under medical supervision.
• If you have hypotension, it should be corrected before or during treatment with this medication.
• 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.

Use of Dilutol 5 mg with other medications

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

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

• Cardiac glycosides such as digoxin (heart medication), which may have more side effects.
• Antidiabetic medications, whose action may be reduced.
• Antibiotics from the aminoglycoside group, cytostatic platinum derivatives, such as cisplatin (cancer medication), and cephalosporins: may increase kidney or ear toxicity.
• Salicylates, as they may increase the risk of gout attacks.
• Coumarin derivatives.
• Non-steroidal anti-inflammatory medications (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.
• Colestryamine (medication to decrease blood cholesterol levels): may reduce the effect of torasemide.

Taking Dilutol 5 mg with food and beverages

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 any medication.

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

Dilutol 5 mg contains lactose.

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Dilutol 5 mg tablets

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Remember to take your medication.

The tablets 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 Dilutol. Do not stop treatment before, as it may worsen your condition.

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 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 to 10 mg per day or prescribe an additional antihypertensive medication.

If you take more Dilutol 5 mg 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 medication and the amount ingested. It is recommended to bring the packaging and the leaflet of the medication to the healthcare professional.

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

If you forget to take Dilutol 5 mg

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 doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Side effects may 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 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 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 side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Dilutol 5 mg tablets

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Dilutol 5 mg tablets

The active ingredient is torasemide.

The other components are lactose monohydrate, cornstarch, colloidal silicon dioxide, and magnesium stearate.

Appearance of the product and package contents

Dilutol 5 mg are white or almost white round tablets. The tablets are presented in PVC-aluminum blisters, and each package contains 30 tablets.

Marketing authorization holder and manufacturer

Holder:

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer:

Madaus GmbH

51101 Cologne

Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Date of the last revision of this leaflet:July 2018

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (https://www.aemps.gob.es)