Trifas 20

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Trifas 20 (Trifas 20 mg/4 ml), 5 mg/ml, solution for injection
Torasemidum
Trifas 20 and Trifas 20 mg/4 ml are different trade names for the same medicinal product.
Please read carefully all the information in this leaflet before using this medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet:

1. What Trifas 20 is and what it is used for
2. Important information before using Trifas 20
3. How to use Trifas 20
4. Possible side effects
5. How to store Trifas 20
6. Contents of the pack and other information

1. What Trifas 20 is and what it is used for

Trifas 20 contains the active substance torasemide and belongs to a group of medicines called loop diuretics. Torasemide has a diuretic effect and also lowers blood pressure.
Trifas 20 is used in adults for the treatment of:

• fluid retention in tissues (edema) and/or
• fluid accumulation in body cavities (effusions), which may occur due to heart dysfunction, when intravenous treatment is required (e.g. pulmonary edema caused by acute heart failure).

2. Information before using Trifas 20

When not to use Trifas 20:

• if the patient is allergic to:
• the active substance torasemide;
• substances with a similar chemical structure (sulfonamide derivatives);
• any of the other ingredients of this medicine (listed in section 6);
• if the patient has renal failure (anuria);
• if the patient has severe liver function disorders (hepatic coma or pre-coma state);
• if the patient has low blood pressure (hypotension);
• if the patient has reduced circulating blood volume (hypovolemia);
• if the patient has low sodium and potassium levels in the blood (hyponatremia, hypokalemia);
• if the patient has significant disturbances in bladder emptying (e.g., due to benign prostatic hyperplasia);
• if the patient is breastfeeding.

Warnings and precautions
Before starting treatment with Trifas 20, discuss this with your doctor or pharmacist.
Due to insufficiently documented research results, Trifas 20 should not be used in the following cases:

• gout;
• serious cardiac rhythm disorders, particularly when heartbeats are slow (myocardial stimulation and conduction disturbances, e.g., sinoatrial block, second- or third-degree atrioventricular block);
• acid-base balance disturbances;
• patients concurrently using lithium salts (medicines used in mood disorders and depression);
• patients using certain antibiotics for the treatment of infections, such as: aminoglycosides, cephalosporins;
• patients with blood morphology disorders, e.g., thrombocytopenia or anemia in patients without kidney function disorders;
• patients with kidney function disorders caused by nephrotoxic agents.

Children and adolescents
Trifas 20 should not be used in children and adolescents under 18 years of age due to lack of sufficient data on the use of Trifas 20 in this population.

Effect on anti-doping test results
Use of Trifas 20 may result in positive anti-doping test outcomes.
The effects of using Trifas 20 as a doping agent are difficult to predict; health risks cannot be ruled out.

Trifas 20 and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

• Trifas 20 may affect the action of the following medicines:
  ➢ Blood pressure-lowering medicines, especially ACE inhibitors: administering angiotensin-converting enzyme inhibitors simultaneously or immediately after torasemide treatment may cause a sudden drop in blood pressure.
  ➢ Theophylline (a medicine used in asthma treatment): Trifas 20 may enhance the effect of theophylline.
  ➢ Muscle relaxants (curare-like agents): increased muscle-relaxing effect.
  ➢ Antidiabetic medicines: Trifas 20 may reduce the effectiveness of antidiabetic drugs.
  ➢ Painkillers and rheumatism medicines – when high doses of salicylates are used, torasemide may intensify their toxic effects on the central nervous system.
  ➢ Medicines used in circulatory disorders (epinephrine and norepinephrine): Trifas 20 may reduce the effectiveness of these medicines.

• The following medicines may affect the action of Trifas 20:
  ➢ Probenecid (a medicine used in the treatment of gout): probenecid may inhibit the diuretic and antihypertensive effects of Trifas 20.
  ➢ Some anti-inflammatory medicines (e.g., indomethacin, acetylsalicylic acid): these medicines may inhibit the diuretic and antihypertensive effects of Trifas 20.

• During high-dose treatment (see section 3), Trifas 20 may intensify the following adverse effects:
  ➢ Hearing and kidney damage caused by aminoglycoside antibiotics (e.g., kanamycin, gentamicin, tobramycin) used in the treatment of infections.
  ➢ Hearing and kidney damage caused by cisplatin (used in cancer treatment).
  ➢ Kidney damage caused by cephalosporins (a group of antibiotics) used in the treatment of infections.

• Other interactions of Trifas 20 with other medicines:
  ➢ Potassium depletion caused by Trifas 20 may intensify adverse effects of concurrently administered digitalis glycosides (used in heart failure treatment).
  ➢ Laxatives may increase potassium loss caused by Trifas 20.
  ➢ Adrenal cortex hormones (mineralo- and glucocorticoids, e.g., cortisone), when used concurrently with Trifas 20, may increase potassium loss induced by this medicine.
  ➢ Concurrent treatment with Trifas 20 and lithium salts (used in the treatment of acute mood disorders and various types of depression) may increase serum lithium concentration, thereby intensifying the cardiotoxic and nephrotoxic effects of lithium salts.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Trifas 20 may be used during pregnancy only if absolutely necessary. The lowest possible dose should be used.
There is insufficient clinical data on the effects of Trifas 20 on the unborn child.

Breastfeeding
It is unknown whether the active substance of Trifas 20 passes into human milk. Therefore, Trifas 20 must not be used during breastfeeding. If use of the medicine during breastfeeding is necessary, breastfeeding must be discontinued.

Driving and operating machinery
Trifas 20 may alter reaction time. Trifas 20 may impair the ability to actively participate in road traffic, operate machinery, or perform work without secure foot support. This particularly applies to:

• the initial treatment period;
• the period following dose increase;
• the period following substitution of another medicine;
• the period following initiation of concurrent treatment with another product.

Alcohol may intensify this effect. Alcohol should not be consumed during treatment with Trifas 20.

3. How to use Trifas 20

This medicine should always be used as directed by the physician. If in doubt, consult your
doctor or pharmacist.
Dosage
Dosage should be individually adjusted according to the severity of renal function impairment.
The recommended initial dose is 2 ml of Trifas 20 per day (equivalent to 10 mg of torasemide). After
using 2 ml of the solution, any remaining solution must be discarded.
If the therapeutic effect is unsatisfactory, the dose may be increased to 4 ml of Trifas 20 (equivalent
to 20 mg of torasemide) per day. If this still does not produce the desired therapeutic effect, short-term
treatment for no longer than 3 days may be administered, consisting of 8 ml of Trifas 20 (equivalent
to 40 mg of torasemide) per day.
In acute pulmonary edema, treatment should begin with a single intravenous dose of 4 ml of Trifas 20
(equivalent to 20 mg of torasemide). Subsequently, depending on the clinical picture, the dose may be
repeated every 30 minutes.
The daily dose must not exceed 20 ml of Trifas 20 (equivalent to 100 mg of torasemide).

• Patients with hepatic impairment Treatment should be conducted with particular caution due to the possibility of increased blood concentration of torasemide.
• Elderly patients Dose adjustment is not required in elderly patients.

Method of administration
The solution should be administered intravenously by slow injection.
Only a clear, transparent solution should be injected!
Do not administer intra-arterially!
Trifas 20 must not be mixed with other medicinal products in an injection or infusion.
Handling of OPC-type (one-point-cut) ampoules. Note: It is not necessary to score the ampoule!

Hold the ampoule with the Hold the ampoule with the
coloured mark facing upwards coloured mark facing upwards
Shake or tap the ampoule gently to ensure Break off the tip of the ampoule.
that the solution flows from the tip to the base of the ampoule.

Duration of treatment
The duration of treatment with Trifas 20 is determined by the attending physician. Trifas 20 should
not be administered intravenously for longer than 1 week.
If treatment needs to be continued, switching as soon as possible from the intravenous formulation
to an oral formulation is recommended.
During treatment with Trifas 20, the physician should closely monitor the patient.
Use of a higher than recommended dose of Trifas 20
Administration of a higher than recommended dose of Trifas 20 may cause:

• pronounced, potentially dangerous diuresis with loss of fluids and electrolytes,
• disturbances of consciousness,
• confusion,
• drop in blood pressure,
• circulatory collapse,
• gastrointestinal disturbances. You should immediately contact your doctor, who will advise appropriate management.

If you have any questions or doubts, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Trifas 20 may cause adverse effects, although not everyone experiences them.

Common (may affect up to 1 in 10 patients)

• Acid-base imbalance (metabolic alkalosis).
• Muscle cramps (especially at the beginning of treatment).
• Increased blood levels of uric acid, glucose, and lipids (triglycerides, cholesterol).
• Potassium deficiency (hypokalaemia) when combined with a low-potassium diet, vomiting, diarrhoea, overuse of laxatives, or in patients with chronic liver dysfunction.
• Depending on the dose used and duration of treatment, disturbances in water and electrolyte balance may occur, particularly a reduction in circulating blood volume (hypovolaemia), loss of potassium and sodium (hypokalaemia and/or hyponatraemia).
• Gastrointestinal disturbances (e.g. loss of appetite, abdominal pain, nausea, vomiting, diarrhoea, constipation), especially at the beginning of treatment.
• Increased activity of certain liver enzymes (gamma-GT) in blood.
• Headaches and dizziness, feeling of fatigue, weakness (especially at the beginning of treatment).

Uncommon (may affect up to 1 in 100 patients)

• Elevated levels of urea and creatinine (a muscle protein) and urea in blood. In patients with impaired urine excretion (e.g. due to benign prostatic hyperplasia), urinary retention may occur. In such cases, urination is impaired or impossible.
• Dryness of the mouth.
• Sensation of numbness and coldness in the extremities (paraesthesia).

Very rare (may affect up to 0.01% of patients, i.e. less than 1 in 10,000 patients)

• Decreased number of red and white blood cells (erythrocytes and lymphocytes) and reduced platelet count (thrombocytes).
• Allergic reactions, for example itching, rash, photosensitivity, severe allergic skin reactions. When administered intravenously, acute, even potentially fatal hypersensitivity reactions (anaphylactic shock) cannot be excluded.
• Formation of blood clots in blood vessels (thromboembolic complications).
• Confusion.
• Low blood pressure (hypotension).
• Disorders in coronary or central circulation (including myocardial and cerebral ischaemia). These conditions may lead to cardiac arrhythmias, chest tightness (angina pectoris), acute myocardial infarction, or, for example, sudden loss of consciousness (syncope).
• Pancreatitis.
• Visual disturbances.
• Tinnitus.
• Hearing loss.

If any of the adverse effects listed above occur, inform your doctor immediately. The doctor will assess the severity of symptoms and decide which tests should be performed. In case of sudden onset of severe adverse effects, consult a doctor immediately. This is very important, as some side effects may potentially be life-threatening. The doctor will decide which laboratory tests are necessary and whether treatment should be continued.

If any hypersensitivity reactions occur (e.g. severe allergic skin reaction), Trifas 20 must not be used again.

Management in case of hypersensitivity reactions

Severe, potentially life-threatening hypersensitivity reactions (anaphylactic shock) may occur and require immediate intervention. The patient should be placed flat on their back with legs elevated, airways should be cleared, oxygen therapy initiated, intravenous access established, and intravenous epinephrine (adrenaline), glucocorticosteroids, and fluid replacement as appropriate should be administered.

Reporting of adverse effects

If any adverse effects occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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.

Reporting adverse effects helps to collect more information on the safety of the medicine.

5. How to store Trifas 20

Keep this medicine out of sight and reach of children.
Do not store above 30°C.
Only inject a clear solution. The injection solution should be used immediately after opening.
Any unused portion should be discarded. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
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 packaging and other information

What Trifas 20 contains
The active substance in this medicine is torasemide.
Each ampoule containing 4 ml of injection solution includes 21,262 mg of sodium torasemide,
corresponding to 20 mg of torasemide.
Other components of the medicine are: sodium hydroxide, trometamol, macrogol 400, water for injections.

What Trifas 20 looks like and contents of the packaging
Trifas 20 ampoules contain a clear, colourless solution.
The packaging contains 5 ampoules with a volume of 4 ml each.
For further detailed information about this medicine, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Lithuania, country of export:
Menarini International Operations Luxembourg S.A.
1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg

Manufacturer:
A. Menarini Manufacturing Logistics and Services S.r.l.
Via Sette Santi 3
50131 Florence, Italy

Parallel Importer:
InPharm Sp. z o.o.
Strumykowa Street 28/11
03-138 Warsaw, Poland

Relabelled and repackaged by:
InPharm Sp. z o.o. Services sp. k.
Chełmżyńska Street 249
04-458 Warsaw, Poland

Marketing Authorisation Number in Lithuania, country of export: LT/1/98/0029/007
Parallel Import Authorisation Number: 57/26