Trifas 10

Leaflet attached to the packaging: information for the user

Trifas 10;10 mg, tablets
Torasemide

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

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given 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 or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Trifas 10 and what is it used for
• 2. Important information before taking Trifas 10
• 3. How to take 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 for the treatment and prevention of:

• fluid retention in tissues (edema) and (or)
• fluid retention in body cavities (effusions) that may occur in connection with heart function disorders (heart failure).

2. Important information before taking Trifas 10

When not to take 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 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 enlargement);
• if the patient is breastfeeding.

Warnings and precautions

Before starting to take Trifas 10, you should 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,
• acid-base balance disorders,
• patients taking lithium salts (medicines used to treat mood disorders and depression) 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 10 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 10 in children and adolescents under 18 years of age.

Impact on doping tests

Taking Trifas 10 may result in positive doping test results.
It is difficult to predict the effects of taking Trifas 10 as a doping agent; health risks cannot be ruled out.

Trifas 10 and other medicines

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

• Taking Trifas 10 may affect the action of the following medicines
• Blood pressure lowering medicines, especially angiotensin-converting enzyme inhibitors: taking angiotensin-converting enzyme inhibitors at the same time, or immediately after torasemide treatment, may cause a sudden drop in blood pressure. If you are unsure whether the medicine you are taking is an ACE inhibitor, you should ask your doctor or pharmacist.
• 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.
• Painkillers and rheumatic medicines - in the case of taking high doses of salicylates, torasemide may increase 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.
• The following medicines have an impact on the action of Trifas 10
• Probenecid (a medicine used to treat gout): Probenecid may inhibit the diuretic and antihypertensive effect of torasemide.
• Certain anti-inflammatory medicines (e.g. indomethacin, acetylsalicylic acid): these medicines may inhibit the diuretic and antihypertensive effect of torasemide.
• Cholestyramine (a medicine to lower cholesterol levels): taking cholestyramine at the same time may reduce the absorption of Trifas 10 from the gastrointestinal tract. This may reduce the effectiveness of its action.
• During treatment with high doses (see section 3), Trifas 10 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 10 and other medicines
• The decrease in potassium levels caused by Trifas 10 may increase the side effects of digitalis glycosides (used to treat heart failure) taken at the same time.
• Laxatives may increase the potassium loss caused by Trifas 10.
• Adrenal cortex hormones (mineralo- and glucocorticoids, e.g. cortisone), taken at the same time as Trifas 10, may increase the potassium loss caused by it.
• Taking Trifas 10 and lithium salts (used to treat mood swings and various types of depression) at the same time may increase the lithium level 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 child, you should consult your doctor or pharmacist before taking this medicine.
Pregnancy
Trifas 10 may 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 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 it is necessary to use the medicine during breastfeeding, you should stop breastfeeding.

Driving and operating machinery

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

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

Alcohol may increase this effect. You should not drink alcohol during treatment with Trifas 10.

Trifas 10 contains lactose

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Trifas 10

This medicine should always be taken according to the doctor's or pharmacist's recommendations. In case of doubts, you should consult a doctor or pharmacist.
You should follow the instructions in the leaflet so that the action of Trifas 10 is proper.

Dosage

The recommended initial dose is 1/2 tablet of Trifas 10 per day (which corresponds to 5 mg of torasemide).
Usually, the initial dose can be used as a maintenance dose.
Then, a dose of 5 mg can be used under the name Trifas Cor.
In case of insufficient effect of the medicine and depending on the clinical picture, the dose can be increased to 1 tablet of Trifas 10 per day (which corresponds to 10 mg of torasemide). Then, depending on the clinical picture, the dose can be increased to a maximum of 2 tablets of Trifas 10 per day, which corresponds to 20 mg of torasemide.

Dividing tablets

The tablet can be easily divided into two doses (score line on one side of the tablet), which allows for dosing according to individual requirements. The tablet should be held between the index fingers and thumbs of both hands, with the score line facing up, and then broken in half along the score line by pressing the thumbs down.

Patients with liver failure

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

Patients in old age

No dose modification is required in elderly patients.

Method of administration

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

Duration of treatment

The duration of treatment with Trifas 10 is decided by the attending physician.

Using a higher dose of Trifas 10 than recommended

Taking a higher dose of Trifas 10 than recommended may cause:

• increased urine excretion, potentially life-threatening with fluid and electrolyte loss,
• disturbances of consciousness,
• confusion,
• decreased blood pressure,
• circulatory collapse,
• gastrointestinal disorders. You should immediatelycontact a doctor, who will recommend the appropriate procedure.

Missing a dose of Trifas 10

Taking a lower dose of the medicine reduces its effectiveness. Also, missing a dose of Trifas 10 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, you should not take the missed dose if it is close to the time of taking the next dose of the medicine. You should not take a double dose to make up for the missed dose.

Stopping treatment with Trifas 10

Stopping or prematurely ending therapy may lead to an increase in symptoms. In no case should the treatment prescribed by the doctor be changed or interrupted without prior consultation.
In case of doubts related to the use of the medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Trifas 10 can cause side effects, although they may not occur in everyone.
Common(may occur in less than 1 in 10 patients)

• 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 simultaneous use of 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 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 the blood. In patients with urinary disorders (e.g. due to prostate enlargement), urinary retention may occur. In such cases, urination is difficult or impossible.
• Dryness in the mouth,
• Feeling of numbness and cold in the limbs (paresthesia)

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

• Decreased number of blood cells (red and white blood cells and platelets)
• Allergic reactions, such as itching, rash, hypersensitivity to light, severe allergic skin reactions.
• Formation of 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, feelings 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, you should 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 consult a doctor immediately. 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 hypersensitivity reactions (e.g. severe allergic skin reaction), Trifas 10 should not be used again.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should 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 gather more information on the safety of the medicine.

5. How to store Trifas 10

The medicine should be stored out of sight and reach of children.
This medicine does not require special storage conditions.
You should not use this medicine after the expiry date stated on the carton and blister.
The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer used. 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 tablet contains 10 mg of torasemide.
Other ingredients of the medicine are: lactose monohydrate, cornstarch, colloidal silicon dioxide, magnesium stearate.

What Trifas 10 looks like and what the packaging contains

White, round, slightly convex tablets with a score line on one side.
The packaging contains 10, 20, 30, 50 or 100 tablets
Not all pack sizes may be marketed.

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, you should 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: