Isodiur HTA 2.5 mg tablets
SpainTable of Contents
Patient Information Leaflet
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Isodiur HTA 2.5 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, since 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:
- What Isodiur HTA is and what it is used for
- What you need to know before taking Isodiur HTA
- How to take Isodiur HTA
- Possible side effects
- How to store Isodiur HTA
- Contents of the pack and other information
1. What Isodiur HTA is and what it is used for
Isodiur HTA contains torasemide, which belongs to a group of medicines called antihypertensive diuretics.
Isodiur HTA is indicated in adults for the treatment of:
Essential arterial hypertension
2. What you need to know before taking Isodiur HTA
Do not take Isodiur HTA
- 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)
Warnings and precautions
Consult your doctor or pharmacist before taking this medicine. If any of the following apply to you, inform your doctor. Your doctor will take these into account during treatment with this medicine:
- If you have kidney problems or difficulty urinating
- If you have severe liver disease, as the use of torasemide could trigger a coma-like state.
- If you have low blood levels of sodium, potassium, or reduced blood volume.
- If you have gout (accumulation of uric acid in the body)
- If you have diabetes mellitus
- If you have heart problems, especially if you are being treated with cardiac glycosides, as this increases the risk of cardiac arrhythmias.
- If you have low blood pressure
Use in children
Because the safety and efficacy of torasemide in children 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 patient age.
Other medicines and Isodiur HTA
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, with which torasemide may interact:
- Cardiac glycosides such as digoxin (heart medications), antihypertensives (particularly ACE inhibitors), theophylline (an asthma medication): the effects of these medicines may be increased.
- Mineralocorticoids, glucocorticoids, and laxatives: may increase potassium loss caused by these medicines.
- Antibiotics of the aminoglycoside group: may increase kidney or ear toxicity.
- Cisplatin (a cancer treatment medicine), lithium (an antidepressant medicine), salicylates, ethacrynic 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 used to treat 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 are planning 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 using machines
This medicine may affect your ability to drive or operate machinery, especially if taken together with alcohol.
Isodiur HTA contains lactose
This medicine 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 ISODIUR HTA
Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist.
Remember to take your medicine.
Your doctor will tell you how long to take this medicine. Do not stop treatment earlier, as your condition may worsen.
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.
In hypertension: The usual initial dose is 2.5 mg to 5 mg once daily, but your doctor may increase it up to 10 mg daily or prescribe an additional antihypertensive.
If you take more Isodiur HTA 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 915620420, stating the medicine and the amount ingested. It is recommended to bring the medicine's packaging and leaflet to the healthcare professional.
If you forget to take Isodiur HTA
Do not take a double dose to make up for missed doses.
Take your dose as soon as you remember, and the next 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 HTA may produce adverse effects, although not everyone will experience them.
With prolonged treatment, disturbances in the body's water and electrolyte balance may occur.
The following adverse effects have been reported with the use of torasemide, especially at the beginning of treatment: headache, dizziness, fatigue, weakness, muscle cramps, and gastrointestinal discomfort (e.g. loss of appetite, stomach pain, nausea, vomiting, diarrhoea, constipation).
In rare cases, dry mouth and discomfort in the extremities may occur. In individual cases, visual disturbances and allergic reactions (e.g. itching, redness, photosensitivity) may be observed.
In patients who have difficulty urinating (e.g. due to prostate hypertrophy), the increased urinary flow may lead to urinary retention.
As a consequence of excessive diuresis (abundant urine secretion), a drop in blood pressure may occur, along with 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 can also report them directly through the Spanish System of Pharmacovigilance of 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 HTA
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 should not be disposed of via wastewater or household waste.
6. Contents of the pack and other information
Composition of Isodiur HTA 2.5 mg tablets.
The active substance is torasemide. Each tablet contains 2.5 mg of torasemide.
The other components (excipients) are monohydrate lactose (see section 2: 'Isodiur HTA contains lactose'), corn starch, colloidal silicon dioxide, and magnesium stearate.
Appearance of the product and contents of the pack
The tablets are round, white or almost white. The tablets are presented in PVC-aluminum blisters. Each pack contains 30 or 500 tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization 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 revision of this leaflet: April 2011
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es