Trifas 20

Package Leaflet: Information for the User

Trifas 20;5 mg/ml, solution for injection
Torasemidum

Read the package leaflet carefully before using 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 those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Trifas 20 and what is it 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 is Trifas 20 and what is it 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 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 acute heart failure).

2. Important 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 (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 function disorders (hepatic coma or pre-coma);
• if the patient has low blood pressure (hypotension);
• if the patient has decreased 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 20, discuss it with your doctor or pharmacist.
Due to insufficiently documented results, Trifas 20 should not be used in the case of:

• gout,
• serious heart rhythm disorders, when heartbeats are slowed down (stimulation of the heart muscle and conduction disorders, e.g. sinoatrial block, atrioventricular block II or III)
• acid-base balance disorders,
• patients taking lithium salts (medicines used in mood and depression disorders) at the same time;
• patients taking certain antibiotics for infection treatment, 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 compounds.

Children and adolescents

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

Impact on doping tests

The use of the medicinal product Trifas 20 may result in positive doping test results.
It is difficult to predict the effects of using the medicinal product Trifas 20 as a doping agent; the risk to health cannot be ruled out.

Trifas 20 and other medicines

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

• The use of Trifas 20 may affect the action of the following medicines
• blood pressure lowering medicines, especially ACE inhibitors: the administration of ACE inhibitors at the same time or immediately after torasemide treatment may cause a sudden drop in blood pressure.
• Theophylline (a medicine used in the treatment of asthma): Trifas 20 may increase the effect of theophylline.
• Muscle relaxants: increased muscle relaxant effect.
• Antidiabetic medicines: Trifas 20 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 in the treatment of circulatory disorders (epinephrine and norepinephrine). Trifas 20 may reduce the effect of these medicines.
• The following medicines have an effect on Trifas 20
• Probenecid (a medicine used in the treatment of gout): probenecid may inhibit the diuretic and antihypertensive effect of Trifas 20.
• Certain anti-inflammatory medicines (e.g. indomethacin, acetylsalicylic acid): these medicines may inhibit the diuretic and antihypertensive effect of Trifas 20.
• During treatment with high doses (see section 3), Trifas 20 may lead to an increase in the following side effects
• Hearing and kidney damage caused by aminoglycoside antibiotics (e.g. kanamycin, gentamicin, tobramycin) used in infection treatment.
• Hearing and kidney damage caused by cisplatin (used in cancer treatment).
• Kidney damage caused by cephalosporins (a group of antibiotics) used in infection treatment.
• Other interactions between Trifas 20 and other medicines
• The reduction of potassium levels caused by Trifas 20 may increase the side effects of concurrently used digitalis glycosides (used in heart failure treatment).
• Laxatives may increase potassium loss caused by Trifas 20.
• Corticosteroids (mineralo- and glucocorticoids, e.g. cortisone), used concurrently with Trifas 20, may increase the potassium loss caused by it.
• Concomitant treatment with Trifas 20 and lithium salts (used in mood and depression disorders) may increase the lithium level in the serum and thus increase the cardiotoxic and nephrotoxic effects of lithium salts.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Trifas 20 should only be used during pregnancy if it is absolutely necessary. Only the lowest dose should be used.
There is insufficient clinical data on the effect of Trifas 20 on the unborn child.
Breastfeeding
It is not known whether the active substance of Trifas 20 passes into breast milk. Therefore, Trifas 20 should not be used during breastfeeding. If the use of the medicine during breastfeeding is necessary, breastfeeding should be discontinued.

Driving and using machines

Trifas 20 may affect your reaction time. Trifas 20 may impair your ability to actively participate in road traffic, operate machinery or work without safe support for your feet.
This is especially true for:

• 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 20, you should not drink alcohol.

3. How to use Trifas 20

This medicine should always be used as directed by your doctor. If you are unsure, ask your doctor or pharmacist.

Dosage

The dosage should be determined individually, depending on the severity of kidney function disorders.
The recommended initial dose is 2 ml of Trifas 20 per day (which corresponds to 10 mg of torasemide). After using 2 ml of the solution, the remaining solution should be discarded.
If the therapeutic effect is not satisfactory, the dose can be increased to 4 ml of Trifas 20 (which corresponds to 20 mg of torasemide) per day. If this does not produce the desired therapeutic effect, short-term treatment for no more than 3 days can be used, consisting of administering 8 ml of Trifas 20 (which corresponds 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 20 (which corresponds 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 20 (which corresponds 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.

Elderly patients

No dose adjustment is required in elderly patients.

Method of administration

The solution is administered intravenously, in slow injection.
Only clear solution should always be injected!
Do not administer intrarterially!
Trifas 20 should not be mixed with other medicines in an injection or infusion.
Handling of one-point-cut (OPC) ampoules.Note: It is not necessary to file the ampoule!

The ampoule should be held with the colored end up

The end of the ampoule should be
broken off.

Duration of treatment

The duration of treatment with Trifas 20 is decided by the attending physician. Trifas 20 should not be administered intravenously for more than 1 week.
If treatment is continued, it is recommended to switch to the oral form of the product as soon as possible.
During treatment with Trifas 20, the doctor should closely monitor the patient.

Use of a higher than recommended dose of Trifas 20

Use of a higher than recommended dose of Trifas 20 may cause:

The ampoule should be held with the colored end up

By shaking or tapping the ampoule, cause the solution to flow from the end of the ampoule to its base

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

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

4. Possible side effects

Like all medicines, Trifas 20 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, abuse 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 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 tiredness, 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 retention disorders (e.g. due to prostate hypertrophy), urinary retention may occur. In such cases, urination is impaired or impossible
• Dryness of 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 platelet count (thrombocytopenia)
• Allergic reactions, such as itching, rash, hypersensitivity to light, severe allergic skin reactions In the case of intravenous administration, acute, potentially life-threatening anaphylactic reactions (anaphylactic shock) cannot be ruled out
• 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 you experience any of the above-mentioned side effects, please inform your doctor immediately. The doctor will assess the severity of the symptoms and decide what tests should be performed.
In the case of sudden and severe side effects, you should immediatelyconsult a doctor. This is very important, as some side effects can potentially be life-threatening. The doctor will decide what tests should be performed and whether treatment should be continued.
If you experience any allergic reactions (e.g. severe allergic skin reaction), Trifas 20 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 raised, the airway 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 you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 Trifas 20

The medicine should be stored out of sight and reach of children.
Store in a temperature below 30°C.
Only clear solution should be injected. The solution for injection should be used immediately after opening. The leftovers 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 pack and other information

What Trifas 20 contains

The active substance of Trifas 20 is torasemide.
Each ampoule of Trifas 20 with 4 ml of solution for injection contains 21.262 mg of torasemide sodium salt, which corresponds to 20 mg of torasemide.
Other ingredients of the medicine are: sodium hydroxide, trometamol, Macrogol 400, water for injection.

What Trifas 20 looks like and contents of the pack

Trifas 20 ampoules contain a clear and colorless solution.
The pack contains 5 ampoules of 4 ml.

Marketing authorization holder and manufacturer

Marketing authorization holder

Menarini International Operations Luxembourg S.A.
1, Avenue de la Gare,
L-1611 Luxembourg, Luxembourg

Manufacturer

• A. Menarini Manufacturing Logistics and Services S.r.I. Via Sette Santi 3, 50131 Florence, Italy