Isodiur 5 mg tablets
SpainTable of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Isodiur 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 as 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 could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents:
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What Isodiur is and what it is used for
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What you need to know before taking Isodiur
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How to take Isodiur
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Possible adverse effects
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Storage of Isodiur
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Contents of the pack and other information
1. What Isodiur is and what it is used for
Isodiur contains torasemide, which belongs to a group of medicines called antihypertensive diuretics.
Isodiur is indicated in adults for the treatment and prevention of oedema (swelling due to fluid retention) associated with congestive heart failure, liver and kidney disease, and for the treatment of hypertension.
2. What you need to know before taking Isodiur
Do not take Isodiur
- If you are allergic to torasemide, to sulfonylureas (medicines for the treatment of diabetes), or to any of the other ingredients of this medicine (listed in section 6).
- If you have anuria (absence of urine production).
Warnings and precautions
Consult your doctor or pharmacist before taking this medicine:
- if you have low blood pressure (hypotension).
- if you have kidney problems or difficulty urinating.
- if you have severe liver function impairment.
- if you have low blood levels of sodium or potassium, or reduced blood volume.
- if you have gout (accumulation of uric acid in the body).
- if you have diabetes mellitus.
Use in children
Since the safety and efficacy of torasemide in children have not been established, 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.
Other medicines and Isodiur
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 using any of the following medicines, with which torasemide may interact:
- Cardiac glycosides such as digoxin (heart medications), antihypertensives (particularly ACE inhibitors), theophylline (asthma medication): the effect of these medicines may be increased.
- Mineralocorticoids, glucocorticoids, and laxatives: may increase potassium loss caused by these medicines.
- Aminoglycoside antibiotics: may increase kidney or ear toxicity.
- Cisplatin (a medicine for cancer treatment), lithium (an antidepressant medicine), salicylates, etacrynic acid: may increase the toxicity of these.
- Non-steroidal anti-inflammatory drugs (e.g., ibuprofen, indomethacin), probenecid (a medicine for gout), cholestyramine (a medicine to lower blood cholesterol levels): may reduce the effect of torasemide.
- Medicines for the treatment of diabetes: may reduce their effectiveness.
Taking Isodiur with food and drink
The tablets may be taken with or without food (see also Section 3: 'How to take Isodiur').
Pregnancy and breastfeeding
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 women who are breastfeeding, as it is unknown whether torasemide passes into breast milk.
Driving and use of machines
This medicine may affect your ability to drive or operate machinery, especially if taken simultaneously with alcohol.
Isodiur contains lactose
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.
3. How to take Isodiur
Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.
Remember to take your medicine.
Your doctor will determine the duration of your treatment with Isodiur. Do not stop treatment prematurely, as this could worsen your condition.
The tablets should be taken orally. They may be taken with or without food. They should be taken in the morning, without chewing, with some liquid.
Adults
In edema associated with congestive heart failure, renal or hepatic disease: The initial dose ranges from 5 mg to 20 mg once daily. However, your doctor may increase it up to approximately double if considered appropriate.
In hypertension: The usual initial dose is 2.5 mg to 5 mg once daily. However, your doctor may increase it up to 10 mg daily or prescribe an additional antihypertensive.
If you take more Isodiur than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, go to the nearest hospital, or call the Toxicology Information Service at telephone 91 562 04 20, stating the name of the medicine and the amount ingested. It is recommended to bring the medicine's packaging and leaflet to the healthcare professional.
In case of overdose, increased urine output may occur, along with somnolence, confusion, weakness, and dizziness.
If you forget to take Isodiur
Do not take a double dose to make up for the forgotten dose.
Take your dose as soon as you remember, and the following day, take it at your 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, Isodiur 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 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.
The following adverse effects have been reported:
With prolonged treatment, disturbances in the body's water and electrolyte balance may occur.
Occasionally, at the beginning of treatment, headache, dizziness, fatigue, weakness, muscle cramps, and gastrointestinal disturbances (e.g. loss of appetite, stomach pain, nausea, vomiting, diarrhoea, constipation) may occur.
In rare cases, dry mouth and discomfort in the limbs may occur; in individual cases, visual disturbances and allergic reactions (e.g. stinging, redness, photosensitivity) may be observed.
In patients with difficulty urinating (e.g. due to prostate enlargement), increased urinary flow may lead to urinary retention.
Due to increased urine production, a drop in blood pressure may occur, along with states of confusion, and, exceptionally, thrombosis, cardiac arrhythmia, angina pectoris, acute myocardial infarction, sudden loss of consciousness (syncope), and circulatory collapse—especially if large amounts of fluid and salts have been lost.
Occasionally, increases in blood levels of uric acid, glucose, triglycerides, and cholesterol have been observed.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
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 may also report them directly through 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 Isodiur
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 refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste.
Dispose of unused medicines and their packaging at the SIGRE collection point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Isodiur 5 mg tablets.
The active substance is torasemide. Each tablet contains 5 mg of torasemide.
The other components (excipients) are monohydrate lactose (see section 2: 'Isodiur contains lactose'), corn starch, colloidal silicon dioxide, and magnesium stearate.
Appearance of the product and contents of the pack
Isodiur tablets are round, white or almost white in colour. The tablets are presented in PVC-aluminium blisters and each pack contains 30 or 500 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
ITALFARMACO S.A.
San Rafael, 3
28108 Alcobendas (Madrid)
Tel.: 91 657 2323
Manufacturer:
KERN PHARMA S.L.
Polígono Industrial Colón II. C/Venus, 72. 08228 Terrassa. Barcelona
Date of the most recent review of this leaflet: April 2011
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es