Toramide

Package Leaflet: Information for the Patient

Toramide, 2.5 mg, tablets

Toramide, 5 mg, tablets

Toramide, 10 mg, tablets

Torasemide

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 tell 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. It contains torasemide as the active substance.
Toramide is indicated for the treatment of:

• primary arterial hypertension
• 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 cardiac arrhythmias;
• 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. 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 insufficient data on the use of torasemide in children.

Toramide and other medicines

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

• cardiac glycosides (e.g., digoxin);
• muscle relaxants containing curare;
• theophylline (used to treat asthma);
• antihypertensive drugs, e.g., angiotensin inhibitors (enalapril, ramipril);
• certain antibiotics (aminoglycosides and cephalosporins);
• cisplatin;
• salicylates (e.g., acetylsalicylic acid);
• lithium salts;
• antidiabetic drugs;
• non-steroidal anti-inflammatory drugs (e.g., indomethacin, ibuprofen, naproxen);
• probenecid (used to treat gout);
• cholestyramine (used to reduce blood lipid levels);
• corticosteroids (used to reduce inflammation);
• 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, consult your doctor or pharmacist 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 has told you. If you are not sure, ask your doctor or pharmacist.
The medicine is for oral use.

Adults

Primary arterial hypertension:
The recommended dose of torasemide is 2.5 mg once daily. If necessary, your doctor may increase the dose to 5 mg once daily. Studies have shown that doses above 5 mg per day do not lead to further reduction in blood pressure. The maximum effect is achieved after about twelve weeks of continuous treatment.
Edema:
Usually, 5 mg is taken once daily. If necessary, your doctor may gradually increase the dose to 5 mg once daily. In individual cases, doses up to 40 mg per day have been administered.

Elderly patients (over 65 years)

Elderly patients do not require special dose adjustments.

Children

There is insufficient data on the use of torasemide in children.

Overdose

If you take more than the prescribed dose, contact your doctor immediately, who will provide appropriate treatment.
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. Symptoms of overdose require reduction of the dose or withdrawal of torasemide, along with fluid and electrolyte replacement.

Missed dose

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 counts,
• 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,
• urinary retention (in patients with urinary outflow obstruction),
• increased urea and creatinine levels in the blood.

Diagnostic tests

As with other diuretics, depending on the dose and duration of treatment, electrolyte and water balance disorders may occur, especially with significantly restricted salt intake.
Hypokalemia (especially with a potassium-poor diet or in case of vomiting, diarrhea, or abuse of laxatives, 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 in the elderly. If you experience these symptoms, consult your doctor, as it may be necessary to adjust the dose.

Increased uric acid, glucose, and lipid levels in the blood may occur.
Metabolic alkalosis may also occur.
Reporting side effects
If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Toramide

Keep this medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Do not use this medicine after the expiry date stated on the label 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 2.5 mg, 5 mg, or 10 mg of torasemide.
• The other ingredients are: lactose monohydrate, maize starch, colloidal anhydrous silica, magnesium stearate.

What Toramide looks like and contents of the pack

The 2.5 mg tablets are white, round, and biconvex.
The 5 mg and 10 mg tablets are white, round, flat, with a score line.
The pack contains 30 tablets.

Marketing authorization holder and manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01

Date of last revision of the leaflet: