DILUTOL HTA 2.5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Dilutol HTA 2.5 mg tablets

Torasemide

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

• Keep this 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Dilutol HTA 2.5 mg is and what it is used for.
2. What you need to know before you take Dilutol HTA 2.5 mg.
3. How to take Dilutol HTA 2.5 mg.
4. Possible side effects.

5. Storage of Dilutol HTA 2.5 mg tablets.

1. Contents of the pack and other information.

1. What Dilutol HTA 2.5 mg is and what it is used for

Dilutol HTA 2.5 mg contains torasemide, which belongs to a group of medicines called antihypertensive diuretics.

Dilutol HTA 2.5 mg is indicated for the treatment of essential arterial hypertension.

2. What you need to know before taking Dilutol HTA 2.5 mg tablets

Do not take Dilutol HTA 2.5 mg

• 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) due to renal failure.
• If you have severe liver function impairment.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Dilutol HTA.

• During long-term treatment and especially in elderly patients, your doctor will perform periodic blood tests to monitor different 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 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 (under 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 HTA 2.5 mg with other medicines

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 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.
• Cholestyramine (medicine to decrease blood cholesterol levels): may decrease the effect of torasemide.

Taking Dilutol HTA 2.5 mg with food and drinks

The tablets can be taken with or without food. They should be 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.

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.

Dilutol HTA 2.5 mg 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 Dilutol HTA 2.5 mg tablets

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.

They can be administered at any time regarding meals, at your convenience. They should be 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 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 Dilutol HTA 2.5 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 medicine and the amount taken. It is recommended to take the package and the 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 Dilutol HTA 2.5 mg

Do not take a double dose to make up for the forgotten dose.

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 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this 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 Dilutol HTA 2.5 mg tablets

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 pack after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dilutol HTA 2.5 mg tablets

The active substance is torasemide.

The other ingredients are lactose monohydrate, corn starch, colloidal silicon dioxide, and magnesium stearate.

Appearance of the product and pack contents

Dilutol HTA 2.5 mg are white or almost white round tablets. The tablets are presented in PVC-aluminum blisters, and each pack contains 30 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer:

Madaus GmbH

51101 Cologne

Germany

You can obtain further information on this medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Date of last revision of this leaflet:July 2018

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