Leaflet:informationfor the user

Dilutol 5 mg tablets

Torasemide

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

-Keep this leaflet, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is DILUTOL 5 mg tablets and what it is used for.

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

3.How to take DILUTOL 5 mg tablets.

4.Possible side effects.

5Storage of DILUTOL 5 mg tablets.

6.Contents of the pack and additional information.

DILUTOL 5 mg contains torasemide which belongs to a group of medicines called diuretic anti-hypertensive drugs.

DILUTOL 5 mg is indicated for:

Treatment of essential hypertension.

Treatment and prevention of edema (swelling due to fluid retention) caused by congestive heart failure, liver and kidney insufficiency.

Do not take Dilutol 5 mg

• If you are allergic to torasemide, sulfonylureas (diabetes medications) 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, you should be treated.
• If you have severe liver disease, especially if it has affected the brain.
• This medication may alter heart, skeletal, and intestinal muscle cells. 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 (accumulation of uric acid in the body)
• If you are allergic to sulfonamides.

Children

Due to the lack of established safety and efficacy of torasemide in children (<18 years old)

Use in elderly patients

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

Use of Dilutol 5 mg with other medications

Inform your doctor or pharmacist if you are using, have used recently, 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 adverse effects.
• Antidiabetic medications, whose action may be reduced.
• Aminoglycoside antibiotics, platinum-derived cytostatics, such as cisplatin (cancer treatment medication), and cephalosporins: may increase renal or ototoxicity.
• Salicylates, which may increase the risk of gout attacks.
• Coumarin derivatives.
• Nonsteroidal anti-inflammatory drugs (e.g. ibuprofen, indomethacin), which may reduce the effect of diuretics and increase the risk of renal failure.
• Antihypertensive medications (particularly IECA) 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.
• Cholestyramine (medication to lower blood cholesterol levels): may reduce the effect of torasemide.

Taking Dilutol 5 mg with food and drinks

The tablets can be taken with or without food. They are swallowed whole, with a small amount of liquid, preferably in the morning.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using any medication.

Torsemide is not recommended during pregnancy, nor in women breastfeeding, as it is unknown whether torasemide passes into breast milk.

Driving and operating machinery

This medication may affect your ability to drive or operate machinery, 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 him before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

Remember to take your medication.

They can be taken at any time in relation to meals, as needed. 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 discontinue treatment beforehand, as this could worsen your condition.

The recommended dose in adults is:

Incongestive 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.

Inhypertension: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 another additional antihypertensive.

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 Toxicological Information Service, phone (91) 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

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

If you forgot to take Dilutol 5 mg

Do not take a double dose to compensate for the missed doses.

Take your dose as soon as you remember and, the next day, take it at the time it is due.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience 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 every 100 patients treated.

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

Rare: affects between 1 and 10 in every 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 described:

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 disturbances (e.g. loss of appetite, abdominal pain, nausea, vomiting, diarrhea, constipation), muscle spasms, fatigue, tiredness.

Uncommon:

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

Rare

Increased blood urea and/or creatinine.

Very rare:

Skin allergic reactions (itching and skin spots), photosensitivity reaction.

Frequency not known

Severe skin reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis), decreased platelet and/or leukocyte count in blood, anemia, cerebral ischemia (decreased blood flow to the brain), numbness in the body (paresthesia), confusion, visual disturbances, ear ringing (tinnitus), hearing loss, myocardial infarction, heart ischemia, angina pectoris, loss of consciousness (syncope), hypotension, vascular obstruction (embolism), dry mouth, pancreatitis.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

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

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Dilutol 5 mg tablets

The active ingredient is torasemide.

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

Appearance of the product and contents of the packaging

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

Holder of the marketing authorization and manufacturer responsible

Holder:

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer responsible:

Madaus GmbH

51101 Cologne

Germany

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

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Last review date of this leaflet: July 2018

The detailed and updated information about this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (https://www.aemps.gob.es)