Trifas 200

Patient Information Leaflet

Trifas 200; 200 mg, tablets
Torasemidum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Leaflet Contents:

1. What Trifas 200 is and what it is used for
2. What you need to know before you take Trifas 200
3. How to take 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 torasemid and belongs to a group of medicines called loop diuretics.
Torasemid has diuretic action and also lowers blood pressure.
This medicine is intended exclusively for use in patients with severe renal impairment (creatinine clearance less than 20 ml/min and/or creatinine concentration greater than 6 mg/100 dl). Your doctor can determine the degree of renal impairment by blood tests.
In patients with severe renal impairment, Trifas 200 enables sufficient excretion of an adequate amount of urine. The medicine is also effective in dialysed patients. However, in such cases the patient should still excrete at least 200 ml/24h of residual urine.
Trifas 200 is used in adults to treat:

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

Note: Trifas 200 may only be used in cases of severe renal dysfunction, not in cases of normal kidney 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 to torasemide (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 accompanied by impaired consciousness (hepatic pre-coma or hepatic coma);
• if the patient has low blood pressure;
• if the patient has reduced circulating blood volume (hypovolemia);
• if the patient has low levels of sodium and potassium in the blood (hyponatremia, hypokalemia);
• if the patient has significant disorders in bladder emptying (e.g., due to benign prostatic hyperplasia);
• if the patient is breastfeeding;
• in cases of normal or only mildly impaired kidney function: creatinine clearance above 30 ml/min and (or) serum creatinine concentration below 3.5 mg/100 ml, due to the risk of excessive loss of water and electrolytes. The physician should consider this when interpreting blood test results.

Warnings and precautions
Before starting treatment with Trifas 200, discuss this with your doctor or pharmacist.
Due to insufficiently documented research results, Trifas 200 should not be used in the following cases:

• gout,
• severe cardiac arrhythmias with bradycardia (myocardial conduction disturbances, e.g., sinoatrial block, second- or third-degree atrioventricular block);
• acid-base balance disorders,
• patients concurrently using lithium salts (medications used in mood disorders and depression);
• patients using certain antibiotics for infection treatment, such as: aminoglycosides, cephalosporins;
• patients with blood morphology disorders, e.g.: thrombocytopenia or anemia in patients without kidney dysfunction;
• patients with kidney dysfunction caused by nephrotoxic agents;
• patients with moderate to severe kidney dysfunction (creatinine clearance from 20 to 30 ml/min and/or serum creatinine concentration from 3.5 mg/dl to 6 mg/dl).

Children and adolescents
Trifas 200 should not be used in children and adolescents under 18 years of age due to lack of data on the use of torasemide in this age group.

Effect on anti-doping test results
The use of Trifas 200 may lead to positive anti-doping test results.
The effects of using Trifas 200 as a doping agent are difficult to predict; health risks cannot be ruled out.

Trifas 200 and other medicines
Always inform your doctor about all medicines you are currently taking, including those available without a prescription.

• Medicines whose effects may be influenced by Trifas 200

• Blood pressure-lowering medicines, particularly angiotensin-converting enzyme (ACE) inhibitors: simultaneous or immediate administration following treatment with Trifas 200 may cause a sudden drop in blood pressure. If uncertain whether a medicine belongs to ACE inhibitors, consult your doctor or pharmacist.

• Theophylline (used in asthma treatment): Trifas 200 may enhance the effects of theophylline.

• Neuromuscular blocking agents: Trifas 200 enhances muscle-relaxing effects.

• Antidiabetic medicines (used in diabetes treatment): Trifas 200 may weaken the effects of these medicines.

• Analgesic and anti-rheumatic medicines: when high doses of salicylate analgesics and anti-rheumatic medicines are used, Trifas 200 may enhance their toxic effects on the central nervous system.

• Medicines used in circulatory disorders (e.g., epinephrine and norepinephrine): Trifas 200 may weaken their effects.

• Medicines that affect the action of Trifas 200

• Probenecid (used in gout treatment): Probenecid may inhibit the diuretic and antihypertensive effects of Trifas 200.

• Certain non-steroidal anti-inflammatory drugs (e.g., indomethacin, acetylsalicylic acid): these medicines may inhibit the diuretic and antihypertensive effects of Trifas 200.

• Cholestyramine (a cholesterol-lowering medicine): concomitant use may reduce the absorption of orally administered torasemide, thereby weakening its effectiveness.

• During high-dose treatment (see section 3), Trifas 200 may intensify the following adverse 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 in cancer treatment).

• Kidney damage caused by cephalosporins (a group of antibiotics) used to treat infections.

• Other interactions of Trifas 200 with other medicines

• Decreased potassium levels caused by Trifas 200 may intensify adverse effects of concurrently used digitalis glycosides (used in heart failure treatment).

• Laxatives may increase potassium loss caused by Trifas 200.

• Adrenal cortex hormones (mineralo- and glucocorticoids, e.g., cortisone), when used concurrently with Trifas 200, may increase potassium loss induced by the medicine.

• Concurrent treatment with Trifas 200 and lithium salts (used in 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 is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Torasemide may be used during pregnancy only if absolutely necessary. Only the lowest possible dose should be used.
There is insufficient clinical knowledge regarding the effects of Trifas 200 on unborn children.

Breastfeeding
It is not known whether the active substance of Trifas 200 passes into breast milk. Therefore, Trifas 200 must not be used during breastfeeding. If treatment with Trifas 200 during breastfeeding is necessary, breastfeeding must be discontinued.

Driving and operating machinery
Trifas 200 may affect reaction time. Trifas 200 may impair the ability to actively participate in road traffic, operate machinery, or work without safe foot support. This particularly applies to:

• the initial treatment period,
• the period during dose increase,
• the period after switching from another medicine,
• the period when starting concomitant treatment with another product.

Alcohol may intensify this effect. Alcohol should not be consumed during treatment with Trifas 200.

Trifas 200 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 Trifas 200

This medicine should always be used as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist before using this medicine. Follow the instructions in the leaflet to ensure proper effectiveness of Trifas 200.

Dosage

The dosage should be individually adjusted for each patient depending on the degree of renal impairment.

The recommended initial dose is ¼ of a Trifas 200 tablet per day (corresponding to 50 mg of torasemide). If diuresis is insufficient, the dose may be increased to ½ of a Trifas 200 tablet per day (corresponding to 100 mg of torasemide), up to a maximum of 1 tablet per day (corresponding to 200 mg of torasemide).

Treatment with Trifas 200 should be carried out under strict medical supervision.

Tablet division

The tablet has a cross-scored surface to facilitate division.

The tablet can be easily divided into two or four parts, allowing for dosage adjustment according to individual requirements.

• Place the tablet on a hard surface (e.g. a table or worktop), with the scored side facing upwards.
• Then break the tablet by pressing with one thumb on the right side and the other thumb on the left side of the break line, splitting it into two halves (Fig. 1 and 2).
• To obtain quarters, break each half in the same manner (Fig. 3 and 4).

Figure 1 and 2: dividing tablets into two parts, along the break line

Figure 3 and 4: dividing tablets into four parts, along the break line

• Patients with hepatic impairment Treatment should be conducted with particular caution due to the potential for increased blood concentrations of torasemide.
• Elderly patients Dosage adjustment is not required in elderly patients.

Administration method

The tablets should be taken in the morning, with a small amount of liquid. The medicine may be taken with or without food.

Duration of treatment

The duration of treatment with Trifas 200 is determined by the treating physician.

Use of a higher than recommended dose of Trifas 200

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

• excessive urination, potentially dangerous, with loss of fluids and electrolytes,
• disturbances in consciousness,
• confusion,
• drop in blood pressure,
• circulatory collapse,
• gastrointestinal disturbances.

Immediately contact a doctor, who will recommend appropriate management.

Missed dose of Trifas 200

Taking a lower than recommended dose reduces the medicine's effectiveness. Similarly, missing a dose of Trifas 200 leads to reduced efficacy. This may manifest as, among others:

• increased body weight,
• increased fluid retention in the body (edema).

The missed dose should be taken as soon as possible. However, if the next scheduled dose is approaching, the missed dose should not be taken. Do not take a double dose to make up for a missed dose.

Stopping treatment with Trifas 200

Discontinuing or prematurely ending therapy may lead to worsening of symptoms. Under no circumstances should treatment prescribed by a doctor be interrupted or stopped prematurely without prior consultation.

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

4. Possible adverse effects

Like all medicines, Trifas 200 may cause adverse effects, although not everyone experiences them.

Common (may occur in less than 1 in 10 patients)

• Acid-base imbalance (metabolic alkalosis),
• Muscle cramps (especially at the beginning of treatment),
• Increased levels of uric acid, glucose and lipids (triglycerides, cholesterol) in blood,
• Potassium deficiency (hypokalaemia) when combined with a low-potassium diet, vomiting, diarrhoea, laxative abuse, 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), and 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,
• Headache and dizziness, feeling of fatigue, weakness (especially at the beginning of treatment).

Uncommon (may occur in less than 1 in 100 patients)

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

Very rare (may occur in less than 1 in 10,000 patients)

• Decreased number of blood cells (red and white blood cells) and platelets (thrombocytes),
• Allergic reactions, for example itching, rash, photosensitivity, severe allergic skin reactions,
• Formation of blood clots in blood vessels (thromboembolic complications),
• Confusional states,
• Low blood pressure (hypotension),
• Circulatory disturbances in coronary or cerebral vessels (including myocardial and cerebral ischaemia). These conditions may lead to cardiac rhythm disturbances (arrhythmia), feeling of 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 as quickly as possible. This is very important, as some adverse effects may potentially be life-threatening. The doctor will decide which analyses should be carried out and whether treatment should be continued.
If any hypersensitivity reactions occur (e.g. severe allergic skin reaction), Trifas 200 must not be used again.

Reporting of adverse effects

If any adverse effects occur, including any adverse effects not listed in this leaflet, tell your doctor, pharmacist, or nurse.
Adverse effects can be reported directly to the Department of Monitoring of 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
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to gather further information on the safety of the medicine.

5. How to store Trifas 200

Store below 25°C.
Keep the medicine in a place out of sight and reach of children.
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 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 package and other information

What Trifas 200 contains
The active substance is torasemide.
Each tablet contains 200 mg of torasemide.
Other ingredients are: lactose monohydrate, microcrystalline cellulose, povidone K 25, crospovidone,
magnesium stearate.

What Trifas 200 looks like and contents of the pack
White, round, slightly convex tablets with bevelled edges and a cross-shaped notch on both sides.
The pack contains 20, 30, 50 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Menarini International Operations Luxembourg S.A.
1, Avenue de la Gare,
L-1611 Luxembourg, Luxembourg

Manufacturer
Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin, Germany

For further information, contact the Marketing Authorisation Holder's representative:
Berlin-Chemie/Menarini Polska Sp. z o.o.
Tel: (22) 566 2100
Fax: (22) 566 2101