Trifas 10

Package Leaflet: Information for the User

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Trifas 10, Solution for Injection, 5 mg/ml

Torasemide

Before using the medicine, carefully read the contents of the leaflet, as it contains important information for the patient.

• The leaflet should be kept so that it can be read again if necessary.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for one person. 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 inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

• 1. What is Trifas 10 and what is it used for
• 2. Important information before using Trifas 10
• 3. How to use Trifas 10
• 4. Possible side effects
• 5. How to store Trifas 10
• 6. Contents of the packaging and other information

1. What is Trifas 10 and what is it used for

Trifas 10 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 10 is used in adults to treat:

• fluid retention in tissues (edema) and/or
• fluid retention in body cavities (effusions) that may occur in connection with heart function disorders, if intravenous treatment is necessary (e.g., pulmonary edema caused by sudden heart failure).

2. Important information before using Trifas 10

When not to use Trifas 10

• if the patient is allergic to:
• the active substance torasemide;
• substances with a similar chemical structure (sulfonylurea derivatives);
• any of the other ingredients of this medicine (listed in section 6);
• if the patient has renal failure (with anuria);
• if the patient has severe liver dysfunction with impaired consciousness (hepatic coma or pre-coma);
• if the patient has low blood pressure (hypotension);
• if the patient has a decreased circulating blood volume (hypovolemia);
• if the patient has low sodium and potassium levels in the blood (hyponatremia, hypokalemia);
• if the patient has significant urinary retention disorders (e.g., due to prostate hypertrophy);
• if the patient is breastfeeding.

Warnings and precautions

Before starting treatment with Trifas 10, discuss it with your doctor or pharmacist.
Due to insufficiently documented results, Trifas 10 should not be used in:

• gout,
• severe heart rhythm disorders, when heartbeats are slowed down (atrioventricular block II° or III°),
• acid-base balance disorders,
• patients taking lithium salts (medicines used to treat mood disorders and depression);
• patients taking certain antibiotics for infection treatment, such as aminoglycosides, cephalosporins;
• patients with blood morphology disorders, e.g., thrombocytopenia or anemia in patients without renal function disorders;
• patients with renal function disorders caused by nephrotoxic compounds.

Children and adolescents

Trifas 10 should not be used in children and adolescents under 18 years of age, due to the lack of data on the use of torasemide in children and adolescents under 18 years of age.

Effect on doping tests

The use of Trifas 10 may result in positive doping test results.
It is difficult to predict the effects of using Trifas 10 as a doping agent; the risk to health cannot be ruled out.

Trifas 10 and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Trifas 10 may affect the action of the following medicines

• Blood pressure-lowering medicines, especially ACE inhibitors: administering ACE inhibitors simultaneously or immediately after torasemide treatment may cause a sudden drop in blood pressure.
• Theophylline (a medicine used to treat asthma): Trifas 10 may increase the effect of theophylline.
• Muscle relaxants: increased muscle relaxant effect.
• Antidiabetic medicines: Trifas 10 may reduce the effect of antidiabetic medicines.
• Pain and rheumatic medicines - in the case of high doses of salicylates, torasemide may enhance their toxic effect on the central nervous system.
• Medicines used to treat circulation disorders (epinephrine and norepinephrine). Trifas 10 may reduce the effect of these medicines.

Medicines that affect Trifas 10

• Probenecid (a medicine used to treat gout): Probenecid may inhibit the diuretic and antihypertensive effects of Trifas 10.
• Certain anti-inflammatory medicines (e.g., indomethacin, acetylsalicylic acid): these medicines may inhibit the diuretic and antihypertensive effects of Trifas 10.

During treatment with high doses (see section 3), Trifas 10 may lead to increased side effects

• Hearing and kidney damage caused by aminoglycoside antibiotics (e.g., kanamycin, gentamicin, tobramycin) used to treat infections.
• Hearing and kidney damage caused by cisplatin (used to treat cancer).
• Kidney damage caused by cephalosporins (a group of antibiotics) used to treat infections.

Other interactions between Trifas 10 and other medicines

• Potassium level reduction caused by Trifas 10 may increase the side effects of concurrently used digitalis glycosides (used to treat heart failure).
• Laxatives may increase potassium loss caused by Trifas 10.
• Adrenal cortex hormones (mineralo- and glucocorticoids, e.g., cortisone), used concurrently with Trifas 10, may increase potassium loss caused by it.
• Concomitant treatment with Trifas 10 and lithium salts (used to treat sudden mood changes and various types of depression) may increase lithium levels in the blood and thus enhance the cardiotoxic and nephrotoxic effects of lithium salts.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Pregnancy
Trifas 10 should only be used during pregnancy if absolutely necessary.
Only the smallest dose should be used. There is insufficient clinical data on the effect of Trifas 10 on unborn children.
Breastfeeding
It is not known whether the active substance of Trifas 10 passes into breast milk. Therefore, Trifas 10 should not be used during breastfeeding. If the use of the medicine during breastfeeding is necessary, breastfeeding should be stopped.

Driving and operating machinery

Trifas 10 may affect reaction time. Trifas 10 may impair the ability to actively participate in road traffic, operate machinery, or work without safe support for the feet.
This applies especially to:

• the initial treatment period,
• the period after dose increase,
• the period after replacing another medicine,
• the period of starting concurrent treatment with another product.

Alcohol may enhance this effect.
During treatment with Trifas 10, alcohol should not be consumed.

3. How to use Trifas 10

This medicine should always be used as directed by a doctor or pharmacist. In case of doubts, consult a doctor or pharmacist.

Dosage

The dosage should be determined based on the severity of renal function disorders.
The recommended initial dose is 2 ml of Trifas 10 per day (corresponding to 10 mg of torasemide).
If the therapeutic effect is not satisfactory, the dose can be increased to 4 ml of Trifas 10 (corresponding to 20 mg of torasemide) per day. If this still does not produce the desired effect, short-term treatment for no more than 3 days can be used, consisting of administering 8 ml of Trifas 10 (corresponding to 40 mg of torasemide) per day.
In the case of acute pulmonary edema, treatment should be started with an intravenous dose of 4 ml of Trifas 10 (corresponding to 20 mg of torasemide). Then, depending on the clinical picture, the dose can be repeated every 30 minutes. A dose greater than 20 ml of Trifas 10 (corresponding to 100 mg of torasemide) per day should not be used.

Patients with liver failure

Treatment should be carried out with special caution, due to the possibility of increased torasemide levels in the blood.

Patients of advanced age

No dose modification is required in patients of advanced age.

Method of administration

The solution is administered by slow intravenous injection.
Only clear solution should be injected!
It should not be administered intra-arterially!
Trifas 10 should not be used in injections and infusions together with other medicines.

Handling of one-point-cut (OPC) ampoules

Warning: It is not necessary to file the ampoule!

The ampoule should be held with the colored end up

By shaking or tapping the ampoule, the solution should be made to flow from the end of the ampoule to its base

The ampoule should be held with the colored end up

The end of the ampoule should be broken off.

Treatment duration

The duration of treatment with Trifas 10 is determined by the doctor. Trifas 10 should not be administered intravenously for more than 1 week.
In the case of continued treatment, it is recommended to switch to the oral form of the medicine as soon as possible.
During treatment, the doctor should closely monitor the patient.

Using more than the recommended dose of Trifas 10

Using more than the recommended dose of Trifas 10 may cause:

• increased, potentially life-threatening diuresis with fluid and electrolyte loss,
• disorders of consciousness,
• confusion,
• drop in blood pressure,
• circulatory collapse,
• gastrointestinal disorders. You should immediatelycontact a doctor, who will recommend the appropriate course of action.

In case of questions or doubts, consult a doctor or pharmacist.

4. Possible side effects

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

Common (may affect up to 1 in 10 people)

• Acid-base balance disorders (metabolic alkalosis)
• Muscle cramps (especially at the beginning of treatment)
• Increased levels of uric acid, glucose, and lipids in the blood (triglycerides, cholesterol)
• Potassium deficiency (hypokalemia) when using a low-potassium diet, vomiting, diarrhea, excessive use of laxatives, in patients with chronic liver function disorders)
• Depending on the dose used and the duration of treatment, disorders of water and electrolyte balance may occur, in particular decreased circulating blood volume (hypovolemia), potassium and sodium loss (hypokalemia and/or hyponatremia)
• Gastrointestinal disorders (e.g., loss of appetite, abdominal pain, nausea, vomiting, diarrhea, constipation), especially at the beginning of treatment
• Increased activity of certain liver enzymes (gamma-GT) in the blood
• Headache and dizziness, feeling of fatigue, weakness (especially at the beginning of treatment)

Uncommon (may affect up to 1 in 100 people)

• Increased levels of urea and creatinine (muscle protein) and urea in the blood. In patients with urinary disorders (e.g., due to prostate hypertrophy), urinary retention may occur. In such cases, urination is impaired or impossible.
• Dryness in the mouth,
• Feeling of numbness and cold in the limbs (paresthesia)

Rare (may affect up to 1 in 10,000 people)

• Decreased number of red and white blood cells (erythrocytes and lymphocytes) and decreased number of platelets (thrombocytopenia)
• Allergic reactions, such as itching, rash, photosensitivity, severe allergic skin reactions. In the case of intravenous administration, it cannot be ruled out that acute, potentially life-threatening anaphylactic reactions may occur
• Blood clots in blood vessels (thromboembolic complications)
• Confusional states
• Low blood pressure (hypotension)
• Disorders of coronary or cerebral circulation (including myocardial ischemia and cerebral ischemia). These conditions may lead to arrhythmias, feeling of pressure in the chest (angina pectoris), acute myocardial infarction, or, for example, sudden loss of consciousness (syncope).
• Pancreatitis.
• Visual disturbances.
• Tinnitus.
• Hearing loss.

If any of the above side effects occur, inform your doctor immediately. The doctor will assess the severity of the symptoms and decide what tests should be performed.
In case of sudden and severe side effects, immediatelyconsult a doctor. This is very important, as some side effects may potentially be life-threatening. The doctor will decide what tests should be performed and whether treatment should be continued.
If an allergic reaction occurs (e.g., severe allergic skin reaction), Trifas 10 should not be used again.

Procedure in case of an allergic reaction

Severe, potentially life-threatening allergic reactions (anaphylactic shock) may occur, which require appropriate action. The patient should be laid down on a flat surface with their legs elevated, the airways should be cleared, oxygen therapy should be started, an intravenous line should be inserted, and epinephrine (adrenaline), glucocorticoids, and fluids should be administered as needed.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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:
Aleje Jerozolimskie 181C, 02-222 Warsaw
tel.: +48 22 49 21 301, fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Trifas 10

The medicine should be stored out of sight and reach of children.
Store at a temperature below 30°C.
Only clear solution should be injected. The solution for injection should be used immediately after opening. The remainder should be discarded.
Do not use this medicine after the expiry date stated on the carton and ampoules. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. 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 Trifas 10 contains

The active substance of Trifas 10 is torasemide.
Each ampoule with 2 ml of solution for injection contains 10.631 mg of torasemide sodium, corresponding to 10 mg of torasemide.
Other ingredients of the medicine are: sodium hydroxide, trometamol, macrogol 400, water for injection.
The pH of Trifas 10 is between 8.5 and 9.5.

What Trifas 10 looks like and what the pack contains

Trifas 10 ampoules contain a clear and colorless solution.
The pack contains 5 ampoules of 2 ml each.
For more detailed information, consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Bulgaria, the 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:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Authorization number in Bulgaria, the country of export: 20020611

Parallel import authorization number: 175/25

Date of leaflet approval: 14.05.2025

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