Toramide

Patient Information Leaflet

Toramide 2.5 mg tablets
Toramide 5 mg tablets
Toramide 10 mg tablets
Torasemide
Please read the entire leaflet before taking this medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are similar.
• If the patient experiences any adverse reactions, including those not listed in this leaflet, inform a doctor or pharmacist immediately. See section 4.

Table of Contents

1. What Toramide is and what it is 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 Toramide is and what it is used for

Toramide is a loop diuretic. It contains torasemide as the active substance.
Toramide is indicated for the treatment of:

• essential 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 (absence of urine production);
• if the patient has hepatic coma or pre-coma state;
• if the patient has low arterial blood pressure;
• if the patient has cardiac arrhythmias;
• if the patient is pregnant or breastfeeding;
• if the patient is concurrently using aminoglycoside antibiotics or cephalosporins, or if the patient has developed renal failure after using other drugs causing kidney damage.

Warnings and precautions
Before starting treatment with Toramide, discuss this with your doctor. Exercise particular caution when using 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 manifest diabetes – your doctor will recommend monitoring carbohydrate metabolism.

Before starting treatment, your doctor should correct hypokalemia (low potassium levels in the blood), hyponatremia (low sodium levels in the blood), and micturition disorders (urination problems).
Children
There is insufficient data on the use of torasemide in children.
Toramide and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans 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 medicine used in the treatment of gout);
• cholestyramine (a medicine used to reduce blood lipid levels);
• corticosteroids (medicines used to reduce inflammation);
• laxatives;
• drugs that increase blood pressure, e.g. adrenaline and noradrenaline.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Torasemide is contraindicated during pregnancy and breastfeeding.
Driving and operating machinery
As with other medicines that may cause changes in blood pressure, do not drive or operate machinery if dizziness or other similar symptoms occur.
Toramide contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Toramide

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
This is an oral medicine.
Use in adults
Essential 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 indicate that doses above 5 mg daily do not lead to further
reduction in blood pressure. Maximum effect is achieved after approximately twelve
weeks of continuous treatment.
Edema:
The usual dose is 5 mg once daily. If necessary, your doctor may gradually increase the dose
up to 20 mg once daily. In individual cases, doses up to 40 mg daily have been administered.
Use in elderly patients (aged over 65 years)
Elderly patients do not require specific dose adjustments.
Use in children
There is insufficient data on the use of torasemide in children.
Taking more Toramide than recommended
If you take more medicine than recommended, contact your doctor immediately. The doctor will
initiate appropriate treatment.
Symptoms of overdose may include excessive urine production, which may lead to drowsiness,
confusion, hypotension, and circulatory collapse. Gastrointestinal disturbances may also occur.
There is no known specific antidote. Symptoms of overdose require dose reduction or discontinuation
of torasemide, together with fluid and electrolyte replacement.
Missing a dose of Toramide
If you miss a dose, take it as soon as possible. Do not take a double dose to make up for a
missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Toramide may cause the following adverse effects:

• reduction in the number of erythrocytes (red blood cells), leukocytes (white blood cells), and platelets in peripheral blood,
• limb paresthesia (sensory disturbances),
• visual disturbances,
• tinnitus and hearing loss,
• thromboembolic complications and circulatory disorders related to blood concentration,
• dryness of the mouth,
• gastrointestinal disturbances,
• pancreatitis,
• increased activity of certain liver enzymes, e.g. gamma-glutamyl transferase (GGT),
• allergic reactions such as itching, rash, and photosensitivity,
• urinary retention (urinary stasis) (in patients with urinary outflow obstruction),
• increased plasma urea and creatinine concentrations.

Diagnostic investigations
As with other diuretic medicines, disturbances in water and electrolyte balance may occur, depending on dose and duration of treatment, particularly when dietary salt intake is significantly restricted.
Hypokalemia may occur (especially in cases of potassium-deficient diet, or in case of vomiting, diarrhea, or overuse of laxatives, as well as liver insufficiency).
If diuresis is pronounced, symptoms of electrolyte and fluid deficiency may occur, especially at the beginning of treatment and in elderly patients, such as:

• headaches and dizziness,
• low blood pressure,
• weakness, drowsiness,
• confusion, loss of appetite, and cramps.

If any of the described symptoms are observed, medical advice should be sought, as dose adjustment may be necessary.

Increased plasma concentrations of uric acid, glucose, and lipids may also occur.
Metabolic alkalosis may also be exacerbated.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Toramide

Keep this medicine out of sight and reach of children.
Store 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 specified month.
The packaging label shows the expiry date after the abbreviation EXP, and the batch number after the abbreviation Lot/LOT.
Medicines must 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 packaging and other information

What Toramide contains

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

What Toramide looks like and contents of the pack
2.5 mg tablets are white, round, biconvex tablets.
5 mg and 10 mg tablets are white, round, flat tablets with a score line.
The pack contains 30 tablets.
Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01