Trifas 200

Package Leaflet: Information for the User

Trifas 200;10 mg/ml, solution for infusion
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.

Contents of the Package Leaflet:

• 1. What Trifas 200 is and what it is used for
• 2. Important information before using Trifas 200
• 3. How to use Trifas 200
• 4. Possible side effects
• 5. How to store Trifas 200
• 6. Contents of the pack and other information

1. What Trifas 200 is and what it is used for

Trifas 200 contains the active substance torasemide and belongs to a group of medicines called loop diuretics.
Torasemide acts as a diuretic and also lowers blood pressure.
Trifas 200 is indicated for use, for a maximum period of 1 week, exclusively for the treatment of
patients with severe renal impairment (creatinine clearance less than 20 ml/min and/or serum creatinine greater than 6 mg/dl). The doctor can determine the degree of renal impairment through blood analysis.
In patients with severe renal impairment, Trifas 200 enables sufficient excretion of the appropriate amount of
urine. The medicine is also effective in dialysed patients. However, in this case, the patient should still excrete 200 ml/24h (residual amount) of urine.
Trifas 200 is used in adults for the treatment of:

• fluid retention in tissues (edema) and/or
• fluid retention in body cavities (effusions),
• high blood pressure

Warning:
Trifas 200 should only be used in cases of severe renal impairment, it is not suitable for use in cases of normal renal function!

2. Important information before using Trifas 200

When not to use Trifas 200

• 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 liver dysfunction with impaired consciousness (hepatic coma or pre-coma);
• if the patient has low blood pressure (hypotension);
• if the patient has a decrease in blood volume (hypovolemia);
• if the patient has low sodium and potassium levels in the blood (hyponatremia, hypokalemia);
• if the patient has significant urinary retention (e.g. due to prostate hypertrophy);
• if the patient is breastfeeding;
• in patients with normal or only mildly impaired renal function (creatinine clearance from 30 ml/min and/or serum creatinine below 3.5 mg/100 ml) due to the risk of excessive water and electrolyte loss. The doctor should analyze the blood test results in this regard.

Warnings and precautions

Before starting treatment with Trifas 200, you should discuss it with your doctor or pharmacist.
Due to insufficiently documented results, Trifas 20 should not be used in cases of:

• gout,
• severe heart rhythm disorders, when heartbeats are slowed, excited myocardium 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);
• 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 impairment;
• patients with renal impairment caused by nephrotoxic compounds.
• in patients with creatinine clearance from 20 to 30 ml/min and/or serum creatinine from 3.5 to 6 mg/100 dl.

Children and adolescents

Trifas 200 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 200 in children and adolescents under 18 years of age.

Impact on doping tests

The use of Trifas 200 may result in positive doping test results.
The consequences of using Trifas 200 as a doping agent are unpredictable; health risks cannot be ruled out.

Trifas 200 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.

• The use of Trifas 200 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 200 may increase the effect of theophylline.
• Muscle relaxants: increased muscle relaxant effect.
• Antidiabetic medicines: Trifas 200 may reduce the effect of antidiabetic medicines.
• Pain and rheumatic medicines - in the case of high doses of salicylates, torasemide may increase their toxic effect on the central nervous system.
• Medicines used to treat circulatory disorders (epinephrine and norepinephrine). Trifas 200 may reduce the effect of these medicines.
• The following medicines have an impact on the action of Trifas 200
• Probenecid (a medicine used to treat gout): Probenecid may inhibit the diuretic and antihypertensive effect of Trifas 200.
• Certain anti-inflammatory medicines (e.g. indomethacin, acetylsalicylic acid): these medicines may inhibit the diuretic and antihypertensive effect of Trifas 200.
• During treatment with high doses (see section 3), Trifas 200 may lead to an increase in the following 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 200 and other medicines
• The reduction of potassium levels caused by Trifas 200 may increase the side effects of concurrently used digitalis glycosides (used to treat heart failure).
• Laxatives may increase potassium loss caused by Trifas 200.
• Adrenal cortex hormones (mineralo- and glucocorticoids, e.g. cortisone), used concurrently with Trifas 200, may increase the potassium loss caused by it.
• Concomitant treatment with Trifas 200 and lithium salts (used to treat mood and depression disorders) may cause an increase in lithium levels in the blood and thus increase the toxic effect of lithium on the heart and kidneys.

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 200 may only be used during pregnancy if it is absolutely necessary. Only the smallest dose should be used.
There is insufficient clinical data on the effect of Trifas 200 on the unborn child.
Breastfeeding
It is not known whether the active substance of Trifas 200 passes into breast milk. Therefore, Trifas 200 should not be used during breastfeeding. If the use of the medicine during breastfeeding is necessary, breastfeeding should be stopped.

Driving and using machines

Trifas 200 may affect your reaction time. Trifas 200 may impair your ability to actively participate in 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 replacement with another medicine,
• the period after starting concurrent treatment with another product

Alcohol may enhance this effect. During treatment with Trifas 200, you should not consume alcohol.

3. How to use Trifas 200

This medicine should always be used exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Dosage

The dosage should be determined individually for each patient depending on the degree of renal impairment.
The recommended initial dose is a single dose of 5 ml of Trifas 200 per day (which corresponds to 50 mg of torasemide). If diuresis is insufficient, the dose may be increased to 10 to 20 ml of Trifas 200 per day (which corresponds to 100-200 mg of torasemide per day).

Patients with liver impairment

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

Trifas 200 solution for infusion should be administered intravenously in a slow infusion, usually using an infusion pump. The infusion rate should not exceed 0.4 ml of Trifas 200 solution per minute (which corresponds to 4 mg of torasemide).
If necessary, Trifas 200 can be diluted with the following solutions, which are compatible with it:
Depending on the needs, the contents of one ampoule of Trifas 200 can be diluted with 30 ml, 125 ml, 250 ml or 500 ml of 0.9% isotonic sodium chloride solution or 5% glucose solution.
The prepared solution should be used immediately!
Trifas 200 must notbe used in infusions together with other medicines.
Only clear solutions should be administered!
It should not be administered intra-arterially!
Unused solution should be discarded.

Administration

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

By shaking or tapping the ampoule, you should

The ampoule should be held with the colored end up

cause the solution to flow from the end of the ampoule
to its base
The end of the ampoule should be
broken off.

Duration of treatment

The duration of treatment with Trifas 200 is determined by the doctor.
Trifas 200 should not be administered intravenously for more than 1 week.
During treatment with Trifas 200, the doctor should closely monitor the patient.
In case of continued treatment, it is recommended to switch to the oral form of the product as soon as possible.

Use of a higher than recommended dose of Trifas 200

Use of a higher than recommended dose of Trifas 200 may cause:

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

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Trifas 200 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 dysfunction
• Depending on the dose and duration of treatment, water and electrolyte balance disorders 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 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 retention 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 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 cannot be ruled out
• Blood clots in blood vessels (thromboembolic complications)
• Confusional states
• Low blood pressure (hypotension)
• Disorders of coronary or central circulation (including myocardial ischemia and cerebral ischemia). These conditions may lead to cardiac arrhythmias (arrhythmia), 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 side effects, please inform your doctor immediately. The doctor will assess the severity of the symptoms and decide what tests should be performed.
In case of side effects that occur suddenly and have a severe course, you should 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 you experience any allergic reactions (e.g. severe allergic skin reaction), Trifas 200 must notbe used again.

Procedure in case of an allergic reaction

Severe, potentially life-threatening allergic reactions (anaphylactic shock) may occur, which require appropriate action. You should lay the patient on a flat surface in a position with elevated legs, clear the airways, administer oxygen therapy, insert an intravenous line and administer epinephrine (adrenaline), glucocorticosteroids and, if possible, fluid replacement.

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,
tel.: + 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 200

Keep the medicine out of the sight and reach of children.
Store in a temperature below 30°C.
Only clear solutions should be administered.
The infusion solution should be used immediately after opening. Leftovers should be discarded.
Do not use this medicine after the expiry date (EXP) stated on the carton and ampoules. The expiry date refers to the last day of the 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 pack and other information

What Trifas 200 contains

The active substance of Trifas 200 is torasemide.
Each ampoule with 20 ml of solution for infusion contains 212.62 mg of torasemide sodium salt, which corresponds to 200 mg of torasemide.
The other ingredients of the medicine are: sodium hydroxide, trometamol, macrogol 400, water for injections.
The pH of Trifas 200 is between 8.7 and 9.7.

What Trifas 200 looks like and contents of the pack

The ampoules contain a clear and colorless solution.
Trifas 200 is available in packs containing 5 ampoules of 20 ml each.

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