TRIFAS 200 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Package Leaflet:
2. What is Trifas 200 and what is it used for
3. Important information before taking Trifas 200
   1. When not to take Trifas 200
   2. Warnings and precautions
   3. Children and adolescents
   4. Impact on doping tests
   5. Trifas 200 and other medicines
   6. Pregnancy and breastfeeding
   7. Driving and using machines
4. How to take Trifas 200
   1. Dividing tablets
   2. Patients with liver impairment
   3. Patients in old age
   4. Method of administration
   5. Duration of treatment
   6. Taking a higher dose of Trifas 200 than recommended
   7. Missing a dose of Trifas 200
   8. Stopping treatment with Trifas 200
5. Possible side effects
   1. Reporting side effects
6. How to store Trifas 200
7. Contents of the pack and other information
   1. What Trifas 200 contains
   2. What Trifas 200 looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. Date of last revision of the leaflet:

Package Leaflet: Information for the User

Trifas 200;200 mg, tablets
Torasemidum

Read the package leaflet carefully before taking 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 Package Leaflet:

• 1. What is Trifas 200 and what is it used for
• 2. Important information before taking 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 is Trifas 200 and what is it 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.
The medicine is intended for use only in patients with severe renal impairment (creatinine clearance less than 20 ml/min and/or serum creatinine greater than 6 mg/100 ml). The doctor can determine the degree of renal impairment by analyzing the blood test results.
In patients with severe renal impairment, Trifas 200 allows for sufficient excretion of the appropriate amount of urine. The medicine is also effective in dialyzed patients. However, in this case, the patient should still excrete 200 ml/24h (residual amount) of urine.
Trifas 200 is used in adults to treat:

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

Note: Trifas 200 should only be used in cases of severe renal impairment, not in cases of normal renal function!

2. Important information before taking Trifas 200

When not to take Trifas 200

• 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);

Warnings and precautions

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

• gout,
• severe 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 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 impairment;
• patients with renal impairment caused by nephrotoxic compounds;
• patients with moderate to severe renal impairment (creatinine clearance from 20 to 30 ml/min and/or serum creatinine 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 the lack of data on the use of torasemide in children and adolescents under 18 years of age.

Impact on doping tests

Taking Trifas 200 may result in positive doping test results.
It is difficult to predict the effects of taking Trifas 200 as a doping agent; health risks cannot be ruled out.

Trifas 200 and other medicines

Always inform your doctor about all medicines you have taken recently, including those that are available without a prescription.

• Medicines whose effects may be influenced by Trifas 200
• Blood pressure lowering medicines, in particular angiotensin-converting enzyme inhibitors: taking angiotensin-converting enzyme inhibitors at the same time or immediately after treatment with Trifas 200 may cause a sudden drop in blood pressure. If you are unsure whether the medicine you are taking is an ACE inhibitor, ask your doctor or pharmacist.
• Theophylline (used to treat asthma): Trifas 200 may enhance the effect of theophylline.
• Muscle relaxants: Trifas 200 enhances muscle relaxant effects.
• Antidiabetic medicines (used to treat diabetes): Trifas 200 may reduce the effect of these medicines.
• Pain and anti-rheumatic medicines: when taking high doses of pain and anti-rheumatic medicines from the salicylate group, Trifas 200 may enhance their toxic effects on the central nervous system.
• Medicines used to treat circulation disorders (e.g. epinephrine and norepinephrine): Trifas 200 may reduce their effect.
• Medicines that affect the action of Trifas 200
• Probenecid (used to treat gout): Probenecid may inhibit the diuretic and antihypertensive effects of Trifas 200.
• Certain non-steroidal anti-inflammatory medicines (e.g. indomethacin, acetylsalicylic acid): these medicines may inhibit the diuretic and antihypertensive effects of Trifas 200.
• Cholestyramine (a cholesterol-lowering medicine): taking this medicine at the same time may reduce the absorption of orally administered torasemide, thereby reducing its effectiveness.
• 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
• Potassium loss caused by Trifas 200 may enhance 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), taken concurrently with Trifas 200, may increase the potassium loss caused by it.
• Concomitant treatment with Trifas 200 and lithium salts (used to treat mood disorders and depression) may increase the lithium level in the blood and thus enhance the toxic effects 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 child, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Torasemide may be used during pregnancy only if it is absolutely necessary. Only the lowest 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 road traffic, operate machinery or work without safe support for your feet.
This applies in particular to:

• the initial treatment period,
• the period during which the dose is increased,
• the period after replacing another medicine,
• the period when starting concurrent treatment with another product.

Alcohol may enhance this effect. During treatment with Trifas 200, do not drink alcohol.
Trifas 200 contains lactose. If you have been diagnosed with an intolerance to some sugars, contact your doctor before taking the medicine.

3. How to take Trifas 200

Always take this medicine 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 ¼ tablet of Trifas 200 per day (corresponding to 50 mg of torasemide). If diuresis is insufficient, the dose may be increased to ½ tablet of Trifas 200 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 close medical supervision.

Dividing tablets

The cross-shaped notch on the tablet makes it easier to divide.
The tablet can be easily divided into two or four parts, allowing for dosing according to individual requirements.

• Place the tablet on a hard surface (e.g. a table or work surface) with the notch facing upwards.
• Then break the tablet by pressing the tablet with one thumb on the right and the other thumb on the left side of the dividing line, to break it into two parts (fig. 1 and 2).
• Quarter tablets can be obtained by breaking the halves in the same way (fig. 3 and 4).

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

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

Patients with liver impairment

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

Patients in old age

No dose adjustment is required in elderly patients.

Method of administration

Tablets should be swallowed in the morning, with a small amount of liquid. The medicine can be taken with or without food.

Duration of treatment

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

Taking a higher dose of Trifas 200 than recommended

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

• excessive urine excretion, potentially dangerous, with fluid and electrolyte loss,
• disorders of consciousness,
• confusion,
• low blood pressure,
• circulatory collapse,
• gastrointestinal disorders.

You should immediatelycontact your doctor, who will recommend the appropriate course of action.

Missing a dose of Trifas 200

Taking a lower dose of the medicine reduces its effectiveness. Also, missing a dose of Trifas 200 leads to reduced effectiveness. This may manifest in, among other things, the following symptoms:

• weight gain
• increased fluid retention in the body (edema). You should take the missed dose as soon as possible. However, do not take the missed dose if it is close to the time of taking the next dose of the medicine. Do not take a double dose to make up for the missed dose.

Stopping treatment with Trifas 200

Stopping or prematurely ending therapy may lead to worsening of symptoms. In no case should treatment be stopped or prematurely ended without prior consultation with a doctor.
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) with concurrent use of a low-potassium diet, vomiting, diarrhea, abuse 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 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 excretion disorders (e.g. due to prostate enlargement), urinary retention may occur. In such cases, urination is difficult or impossible
• Dry mouth
• Feeling of numbness and cold in the limbs (paresthesia)

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

• Decreased number of blood cells (red and white blood cells) and platelets (thrombocytopenia)
• Allergic reactions, such as itching, rash, photosensitivity, severe allergic skin reactions.
• Blood clots in blood vessels (thromboembolic complications)
• Confusion
• Low blood pressure (hypotension)
• Disorders of coronary or cerebral circulation (including myocardial ischemia and cerebral ischemia). These conditions can lead to arrhythmias, chest pain (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, inform your doctor immediately. The doctor will assess the severity of the symptoms and decide what tests to perform.
In case of sudden and severe side effects, consult your doctor as soon as possible. This is very important, as some side effects can potentially be life-threatening. The doctor will decide what tests to perform and whether treatment should be continued.
If you experience any allergic reactions (e.g. severe allergic skin reaction), Trifas 200 should not be used again.

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

Store in a temperature below 25°C.
Keep the medicine out of the 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 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 200 contains

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

What Trifas 200 looks like and contents of the pack

White, round, slightly convex tablets with a cross-shaped notch on both sides.
The pack contains 20, 30, 50 or 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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
To obtain more detailed information, please contact the representative of the marketing authorization holder:
Berlin-Chemie/Menarini Polska Sp. z o.o.
Tel: (22) 566 2100
Fax: (22) 566 2101

Date of last revision of the leaflet: