Dilutol 5 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Dilutol 5 mg tablets

Torasemide

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Dilutol 5 mg tablets are and what they are used for.

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

3. How to take Dilutol 5 mg tablets.

4. Possible side effects.

5. How to store Dilutol 5 mg tablets.

6. Contents of the pack and other information.

1. What Dilutol 5 mg tablets are and what they are used for

DILUTOL 5 mg contains torasemide, which belongs to a group of medicines called antihypertensive diuretics.

DILUTOL 5 mg is indicated for:

Treatment of essential arterial hypertension.

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

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

Do not take Dilutol 5 mg

• If you are allergic to torasemide, sulfonylureas (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

Talk to your doctor or pharmacist before starting to take Dilutol.

• During long-term treatment, and especially in elderly patients, your doctor will periodically perform blood tests to monitor various parameters such as potassium, glucose, uric acid, creatinine, and lipids.
• Urinary retention should be corrected before and during treatment with this medicine.
• If you have a kidney disease, it should be treated appropriately.
• If you have severe liver disease, especially if it has affected the brain.
• This medicine may affect muscle cells of the heart, skeleton, and intestine. Potassium levels must 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 levels of sodium, potassium, calcium, and magnesium.
• If you have gout (accumulation of uric acid in the body).
• If you are allergic to sulfonamides.

Children

Since the safety and efficacy of torasemide have not been established in children (< 18 years), its use is not recommended in this population group.

Use in elderly patients

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

Taking Dilutol 5 mg with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

You should also inform your doctor if you are taking any of the following medicines, which may interact with torasemide:

• Cardiac glycosides such as digoxin (a heart medicine), which may have increased adverse effects.
• Antidiabetic medicines, whose action may be reduced.
• Aminoglycoside antibiotics, platinum-derived cytostatics such as cisplatin (a cancer treatment), and cephalosporins: these may increase kidney or ear toxicity.
• Salicylates, as they may increase the risk of gout attacks.
• Coumarin derivatives.
• Non-steroidal anti-inflammatory drugs (e.g., ibuprofen, indomethacin), which may reduce the diuretic effect and increase the risk of renal failure.
• Antihypertensive medicines (particularly ACE inhibitors) which 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 (a medicine used to lower blood cholesterol levels): may reduce the effect of torasemide.

Taking Dilutol 5 mg with food and drink

The tablets may be taken with or without food. Swallow them whole with a little liquid, preferably in the morning.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using any medicine.

The use of torasemide is not recommended during pregnancy or in women who are breast-feeding, as it is unknown whether torasemide passes into breast milk.

Driving and using machines

This medicine may affect your ability to drive or operate machinery, especially if taken simultaneously with alcohol.

Dilutol 5 mg contains lactose.

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Dilutol 5 mg tablets

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Remember to take your medicine.

They can be taken at any time in relation to meals, as convenient. Swallow without chewing, with a little liquid, preferably with breakfast.

Your doctor will tell you how long you should continue treatment with Dilutol. Do not stop treatment earlier, as this could worsen your condition.

The recommended dose in adults is:

In edema associated with congestive heart failure, renal or hepatic disease: The initial dose ranges from 5 mg to 20 mg daily, taken as a single dose, but your doctor may increase it up to approximately double if deemed appropriate.

In hypertension: The usual initial dose is 2.5 mg to 5 mg daily, taken as a single dose, but your doctor may increase it up to 10 mg daily or prescribe an 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, go to the nearest hospital, or call the Toxicology Information Service at telephone (91) 562 04 20, stating the medicine and the amount ingested. It is recommended to take the medicine’s packaging and leaflet to the healthcare professional.

In case of overdose, increased urine output may occur, along with drowsiness, confusion, weakness, and dizziness.

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 following day, take it at the usual time.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Adverse effects may occur with the following frequencies:

Very common: affects more than 1 in 10 treated patients.

Common: affects between 1 and 10 in every 100 treated patients.

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

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

Very rare: affects fewer than 1 in every 10,000 treated patients.

Frequency not known: cannot be estimated from available data.

The following adverse effects have been reported:

Common:

Increase in 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, diarrhoea, constipation), muscle spasms, fatigue, tiredness.

Uncommon:

Increased liver enzymes, urinary retention, gallbladder enlargement, increased blood levels of 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 rashes), photosensitivity reaction.

Frequency not known:

Severe skin reactions (e.g. Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis), decreased number of platelets and/or leucocytes in blood, anaemia, cerebral ischaemia (reduced blood supply to the brain), sensation of numbness in the body (paraesthesia), confusion, visual disturbances, noises in the ears (tinnitus), deafness, heart attack (acute myocardial infarction), lack of blood supply to the heart (myocardial ischaemia), angina pectoris, loss of consciousness (syncope), hypotension, blockage of blood vessels (embolism), dry mouth, inflammation of the pancreas (pancreatitis).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dilutol 5 mg tablets

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

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

6. Contents of the pack and other information

Composition of Dilutol 5 mg tablets

The active substance is torasemide.

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

Appearance of the medicine and contents of the pack

Dilutol 5 mg are round, white or almost white 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

Further information on this medicine is available upon request by contacting the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Date of the most recent revision of this leaflet: July 2018

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (https://www.aemps.gob.es)