Toramide

Leaflet attached to the packaging: patient information

Toramide, 2.5 mg, tablets

Toramide, 5 mg, tablets

Toramide, 10 mg, tablets

Torasemide

You should read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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 using Toramide
• 3. How to use Toramide
• 4. Possible side effects
• 5. How to store Toramide
• 6. Contents of the packaging 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 using Toramide

When not to use Toramide:

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

Warnings and precautions

Before starting treatment with Toramide, you should discuss it with your doctor. You should be particularly careful when using Toramide:

• during long-term treatment with torasemide - the 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 (excess uric acid in the blood) and gout
• in latent or overt diabetes - the doctor will recommend monitoring carbohydrate metabolism.

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

Children

There is a lack of sufficient data on the use of torasemide in children.

Toramide and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as 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;
• salicylates (e.g., acetylsalicylic acid);
• lithium salts;
• antidiabetic drugs;
• non-steroidal anti-inflammatory drugs (e.g., indomethacin, ibuprofen, naproxen);
• probenecid (a drug used to treat gout);
• cholestyramine (a drug used to reduce blood lipid levels);
• corticosteroids (drugs 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, you should consult your doctor or pharmacist before using this medicine.
Torasemide is contraindicated during pregnancy and breastfeeding.

Driving and operating machinery

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

Toramide contains lactose

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.

3. How to use Toramide

This medicine should always be used as directed by your doctor. If you have any doubts, you should consult your doctor or pharmacist.
The medicine is for oral use.

Use in adults

Primary arterial hypertension:
The recommended dose of torasemide is 2.5 mg once a day. If necessary, the doctor may increase the dose to 5 mg once a day. 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 used once a day. If necessary, the doctor may gradually increase the dose to 5 mg once a day. In individual cases, doses up to 40 mg per day have been administered.

Use in elderly patients (over 65 years old)

Elderly patients do not require special dose adjustments.

Use in children

There is a lack of sufficient data on the use of torasemide in children.

Using a higher dose of Toramide than recommended

If you have taken a higher dose of the medicine than recommended, you should immediately contact your doctor, who will provide appropriate treatment.
A symptom of overdose may be 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 discontinuation of torasemide, along with fluid and electrolyte replacement.

Missing a dose of Toramide

If you miss a dose, you should take it as soon as possible. Do not take a double dose to make up for the missed dose.
If you have any further doubts about using this medicine, you should consult 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 the number of erythrocytes (red blood cells) and leukocytes (white blood cells) and platelets in the peripheral blood,
• paresthesia of the limbs (sensory disturbances),
• 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 hypersensitivity to light,
• urinary retention (in patients with urinary outflow obstruction),
• increased levels of urea and creatinine in the serum.

Diagnostic tests

As with other diuretic drugs, depending on the dose and duration of treatment, disturbances in water and electrolyte balance may occur, especially with significantly restricted salt intake.
Hypokalemia (especially with a diet low in potassium or in case of vomiting, diarrhea, or abuse of laxatives, as well as liver failure) may occur.
If urine production is increased, especially at the beginning of treatment and in elderly patients, symptoms of electrolyte and fluid deficiency may occur, such as:

• headache and dizziness,
• low blood pressure,
• feeling of weakness, drowsiness,
• confusion, loss of appetite, and cramps. If you observe these symptoms, you should consult your doctor, as it may be necessary to adjust the dose of the medicine.

Increased levels of uric acid, glucose, and lipids in the serum may occur.
Metabolic alkalosis may also worsen.
Reporting side effects
If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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 gather more information on the safety of the medicine.

5. How to store Toramide

The medicine should be stored out of 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 entry 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. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Toramide contains

• The active substance of the medicine is torasemide. Each tablet contains 2.5 mg or 5 mg or 10 mg of torasemide.
• The other ingredients of the medicine are: lactose monohydrate, corn starch, colloidal silicon dioxide, magnesium stearate.

What Toramide looks like and what the packaging contains

The 2.5 mg tablets are white, round, and biconvex.
The 5 mg and 10 mg tablets are white, round, and flat, with a score line.
The packaging 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 the last update of the leaflet: