Trifas 10

Patient Information Leaflet

Trifas 10; 10 mg, tablets
Torasemidum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• 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 personally. 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Trifas 10 is and what it is used for
2. What you need to know before you take Trifas 10
3. How to take Trifas 10
4. Possible side effects
5. How to store Trifas 10
6. Contents of the pack and other information

1. What Trifas 10 is and what it is used for
Trifas 10 contains the active substance torasemid and belongs to a group of medicines called loop diuretics.
Torasemid acts as a diuretic and also lowers blood pressure.
Trifas 10 is used in adults for the treatment and prevention of recurrence of:

• fluid retention in tissues (oedema) and/or
• fluid accumulation in body cavities (effusions), which may occur due to impaired heart function (heart muscle weakness).

2. What you need to know before you take Trifas 10

Do not take Trifas 10 if:

• you are allergic to:
  • the active substance torasemid;
  • substances with a similar chemical structure (sulfonylurea derivatives);
  • any of the other ingredients of this medicine (listed in section 6);
• you have renal failure with anuria;
• you have severe liver dysfunction with impaired consciousness (hepatic coma or pre-coma state);
• you have low blood pressure (hypotension);
• you have reduced circulating blood volume (hypovolemia);
• you have low levels of sodium and potassium in the blood (hyponatremia, hypokalemia);
• you have significant impairment of bladder emptying (e.g. due to benign prostatic hyperplasia);
• you are breastfeeding.

Warnings and precautions
Before starting treatment with Trifas 10, discuss it with your doctor or pharmacist.
Due to insufficiently documented research results, Trifas 10 should not be used in cases of:

• gout;
• serious cardiac arrhythmias with slow heart rate;
• acid-base balance disorders;
• patients concurrently taking lithium salts (medicines used in mood disorders and depression);
• patients taking certain antibiotics for infections, 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.

Children and adolescents
Trifas 10 should not be used in children and adolescents under 18 years of age due to lack of sufficient data on the use of Trifas 10 in this age group.
Effect on doping tests
The use of Trifas 10 medicinal product may result in positive anti-doping test results.
The effects of using Trifas 10 as a doping agent are difficult to predict; health risks cannot be excluded.
Trifas 10 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.

• Use of TRIFAS 10 may affect the action of the following medicines:

• Blood pressure-lowering medicines, especially angiotensin-converting enzyme (ACE) inhibitors: concomitant administration or administration immediately after treatment with torasemid may cause a sudden drop in blood pressure. If you are unsure whether your medicine is an ACE inhibitor, ask your doctor or pharmacist.

• Theophylline (a medicine used to treat asthma): Trifas 10 may increase the effect of theophylline.

• Neuromuscular blocking agents: increased muscle-relaxing effect.

• Antidiabetic medicines: Trifas 10 may reduce the effectiveness of antidiabetic medicines.

• Painkillers and rheumatic medicines – when high doses of salicylates are used, torasemid may enhance their toxic effects on the central nervous system.

• Medicines used in the treatment of circulatory disorders (epinephrine and norepinephrine): Trifas 10 may reduce the effectiveness of these medicines.

• The following medicines may affect the action of Trifas 10:

• Probenecid (a medicine used to treat gout): probenecid may inhibit the diuretic and antihypertensive effects of torasemid.

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

• Cholestyramine (a medicine used to lower cholesterol levels): concomitant use of cholestyramine may reduce the gastrointestinal absorption of Trifas 10, thereby reducing its effectiveness.

• During treatment with high doses (see section 3), Trifas 10 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 10 with other medicines:

• Potassium depletion caused by Trifas 10 may increase the adverse effects of concurrently administered digitalis glycosides (used in heart failure treatment).

• Laxatives may increase potassium loss caused by Trifas 10.

• Adrenal cortex hormones (mineralo- and glucocorticoids, e.g. cortisone), when used concomitantly with Trifas 10, may increase potassium loss caused by the medicine.

• Concurrent treatment with Trifas 10 and lithium salts (used in the treatment of acute mood disorders and various types of depression) may increase lithium serum levels and thus intensify the heart- and kidney-damaging 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, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Trifas 10 may be used during pregnancy only if absolutely necessary. The lowest possible dose should be used.
There is insufficient clinical knowledge regarding the effects 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 must not be used during breastfeeding. If treatment with the medicine during breastfeeding is necessary, breastfeeding must be discontinued.
Driving and using machines
Trifas 10 may alter reaction time. Trifas 10 may impair your ability to actively participate in road traffic, operate machinery, or work without safe foot support.
This particularly applies during:

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

Alcohol may intensify this effect. Do not consume alcohol during treatment with Trifas 10.
Trifas 10 contains lactose
If you have been previously diagnosed with an intolerance to certain sugars, you should consult your doctor before taking this medicine.

3. How to use Trifas 10

This medicine should always be used as directed by the physician or pharmacist. In case of doubt, consult
your physician or pharmacist.
Follow the instructions in this leaflet to ensure proper effectiveness of Trifas 10.

Dosage
The recommended initial dose is 1/2 tablet of Trifas 10 per day (corresponding to 5 mg of torasemide).
This initial dose may usually be used as the maintenance dose.
The 5 mg dose is available under the name Trifas Cor.
If the effect of the medicine is inadequate, and depending on the clinical condition, the dose may be
increased to 1 tablet of Trifas 10 per day (corresponding to 10 mg of torasemide). Subsequently, depending
on the clinical condition, the dose may be increased up to a maximum of 2 tablets of Trifas 10 per day,
corresponding to 20 mg of torasemide.

• Tablet splitting The tablet can be easily divided into two doses (a division line is present on one side of the tablet), allowing dosing according to individual requirements. Hold the tablet between the index fingers and thumbs of both hands, with the score line facing upwards, then break it into halves along the score line by pressing downwards with the thumbs.

• Patients with hepatic impairment Treatment should be conducted with particular caution due to the possibility of increased blood concentration of torasemide.
• Elderly patients Dose adjustment is not required in elderly patients.

Administration method
Tablets should be taken in the morning, swallowed whole with a small amount of liquid. The medicine may
be taken with or without food.
Duration of treatment
The duration of treatment with Trifas 10 is determined by the treating physician.
Use of a higher than recommended dose of Trifas 10
Taking a higher than recommended dose of Trifas 10 may cause:

• increased urination, potentially leading to dangerous fluid and electrolyte loss,
• disturbances in consciousness,
• confusion,
• drop in blood pressure,
• circulatory collapse,
• gastrointestinal disturbances. You should immediately contact your physician, who will recommend appropriate management.

Missed dose of Trifas 10
Taking a lower than prescribed dose reduces the medicine's effectiveness. Missing a dose of Trifas 10
also reduces efficacy and 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, do not take the missed dose if it is almost
time for the next scheduled dose. Do not take a double dose to make up for the missed dose.
Discontinuation of Trifas 10
Stopping or prematurely ending therapy may lead to worsening of symptoms. Under no circumstances
should you change or discontinue treatment prescribed by your physician without prior consultation.
In case of any doubts regarding the use of the medicine, consult your physician or pharmacist.

4. Possible adverse effects

Like all medicines, Trifas 10 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 the blood
• Potassium deficiency (hypokalaemia), particularly 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 reduced circulating blood volume (hypovolaemia), 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, 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 (a muscle protein) and urea in blood. In patients with impaired urine excretion (e.g. due to prostate enlargement), urinary retention may occur. In such cases, urination becomes difficult or impossible.
• Dryness of the mouth
• Sensation of numbness and coldness in the extremities (paraesthesia)

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

• Decreased blood cell count (red blood cells, white blood cells, and platelets (thrombocytes))
• Allergic reactions, for example itching, rash, photosensitivity, severe allergic skin reactions
• Blood clot formation in blood vessels (thromboembolic complications)
• Confusion
• Low blood pressure (hypotension)
• Disorders in coronary or cerebral circulation (including myocardial and cerebral ischaemia). These conditions may lead to cardiac arrhythmias, 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 the symptoms and decide which tests are necessary.
In the event of sudden and severe adverse effects, immediate medical consultation is required. This is very important, as some adverse effects may potentially be life-threatening. The doctor will decide which analyses should be performed and whether treatment should be continued.
If any hypersensitivity reactions occur (e.g. severe allergic skin reaction), Trifas 10 must not be used again.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform 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 collect more information on the safety of the medicine.

5. How to store Trifas 10

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the outer carton and blister.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Trifas 10 contains
The active substance is torasemide.
Each tablet contains 10 mg of torasemide.
Other ingredients are: monohydrate lactose, maize starch, colloidal silicon dioxide, magnesium stearate.

What Trifas 10 looks like and contents of the pack
White, round, slightly convex tablets with a division line on one side.
The pack contains 10, 20, 30, 50 or 100 tablets.
Not all pack sizes may be marketed.

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:
Berlin-Chemie/Menarini Polska Sp. z o.o.
Tel: (22) 566 2100
Fax: (22) 566 2101