Toramide

Package Leaflet: Information for the Patient

Toramide, 20 mg, Tablets

Torasemidum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Toramide and what is it used for
• 2. Important information before taking Toramide
• 3. How to take Toramide
• 4. Possible side effects
• 5. How to store Toramide
• 6. Contents of the pack and other information

1. What is Toramide and what is it used for

Toramide is a loop diuretic.
Toramide is indicated for the treatment of:

• hepatic and renal edema
• edema associated with congestive heart failure and pulmonary edema.

2. Important information before taking Toramide

When not to take Toramide:

• if you are allergic to torasemide, sulfonylurea derivatives or any of the other ingredients of this medicine (listed in section 6);
• if you have renal failure with anuria (lack of urine production);
• if you have hepatic coma or pre-coma;
• if you have low blood pressure;
• if you have heart rhythm disorders;
• if you are pregnant or breastfeeding;
• if you are taking aminoglycoside antibiotics or cephalosporins, or if you have developed renal failure after taking other nephrotoxic drugs.

Warnings and precautions

Before starting treatment with Toramide, discuss it with your doctor or pharmacist.

Be particularly cautious when taking Toramide:

• during long-term treatment with torasemide - your doctor will recommend regular monitoring of electrolyte balance, glucose, uric acid, creatinine, and lipid levels in the blood;
• in patients with a tendency to hyperuricemia (elevated uric acid levels in the blood) and gout;
• in latent or overt diabetes - your doctor will recommend monitoring carbohydrate metabolism.

Before starting treatment, your doctor will recommend correcting hypokalemia (low potassium levels in the blood), hyponatremia (low sodium levels in the blood), and urinary disorders.

Children

There is no sufficient data on the use of torasemide in children.

Toramide and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about any medicines you plan to take, especially:

• cardiac glycosides (e.g., digoxin);
• muscle relaxants containing curare;
• theophylline (used in the treatment of asthma);
• antihypertensive drugs, e.g., angiotensin inhibitors (enalapril, ramipril);
• certain antibiotics (aminoglycosides and cephalosporins);
• cisplatin (used in cancer treatment);
• salicylates (e.g., acetylsalicylic acid);
• lithium salts (used in anxiety treatment);
• antidiabetic drugs;
• non-steroidal anti-inflammatory drugs (e.g., indomethacin, ibuprofen, naproxen);
• probenecid (used in gout treatment);
• cholestyramine (used in high cholesterol treatment);
• corticosteroids (used as anti-inflammatory and antiallergic drugs, as well as in hormonal disorder treatment);
• laxatives;
• drugs that increase blood pressure, e.g., adrenaline and noradrenaline.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.
Torasemide is contraindicated during pregnancy and breastfeeding.

Driving and using machines

As with other medicines that can cause changes in blood pressure, do not drive or operate machinery if you experience dizziness or other similar symptoms.

Toramide contains lactose

If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Toramide

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Adult administration

Usually, 5 mg is taken once a day. If necessary, your doctor may gradually increase the dose up to 20 mg once a day. In individual cases, doses up to 40 mg per day have been administered.

Administration in elderly patients (over 65 years of age)

Elderly patients do not require special dose adjustments.

Administration in children

There is no sufficient data on the use of torasemide in children.

Method of administration

Oral administration.
Tablets should be taken in the morning, without chewing, with a small amount of liquid.

Overdose of Toramide

If you take more of this medicine than you should, contact your doctor immediately.
Signs of overdose may include increased urine production, which can lead to drowsiness, confusion, low blood pressure, and circulatory collapse. Gastrointestinal disorders may also occur. There is no specific antidote. Overdose symptoms require reduction of the dose or withdrawal of torasemide, along with fluid and electrolyte replacement.

Missed dose of Toramide

If you miss a dose, take it as soon as possible. Do not take a double dose to make up for the missed dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Toramide can cause side effects, although not everybody gets them.

Toramide may cause the following side effects:

• decrease in red blood cell, white blood cell, and platelet count;
• paresthesia (abnormal sensations) of the limbs;
• visual disturbances;
• tinnitus and hearing loss;
• thromboembolic complications and circulatory disorders related to blood thickening;
• dry mouth;
• gastrointestinal disorders;
• pancreatitis;
• increased activity of certain liver enzymes, e.g., gamma-glutamyltransferase (GGT);
• allergic reactions, such as itching, rash, and photosensitivity;
• urine retention (in patients with urinary outflow obstruction);
• increased levels of urea and creatinine in the blood.

Diagnostic tests

As with other diuretics, depending on the dose and duration of treatment, water and electrolyte balance disorders may occur, especially with significantly restricted salt intake.
Hypokalemia (especially with a potassium-poor diet or in case of vomiting, diarrhea, or laxative abuse, as well as liver failure) may occur.
If urine production is increased, signs of electrolyte and fluid deficiency, such as:

• headache and dizziness;
• low blood pressure;
• weakness, drowsiness;
• confusion, loss of appetite, and cramps, may occur, especially at the beginning of treatment and in elderly patients. If you observe these symptoms, consult your doctor, as it may be necessary to adjust the dose.

Increased levels of uric acid, glucose, and lipids in the blood may occur.
Metabolic alkalosis may also be exacerbated.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181C,
02-222 Warsaw,
Phone: +48 22 49 21 301,
Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Toramide

Keep this medicine out of the sight and reach of children.
There are no special storage instructions for this medicine.
Do not use this medicine after the expiry date stated on the carton and blister after EXP.
The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
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

What Toramide contains

• The active substance is torasemide. Each tablet contains 20 mg of torasemide.
• The other ingredients are: lactose monohydrate, corn starch, colloidal silica, magnesium stearate.

What Toramide looks like and contents of the pack

Toramide 20 mg are white or almost white, round, biconvex tablets with a cross-shaped engraving on one side. The tablet can be divided into equal doses.
The pack contains 30 tablets.

Marketing authorization holder and manufacturer

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
Phone: +48 22 364 61 01

Date of the last revision of the leaflet: