Trifas Cor

Package Leaflet: Information for the User

TRIFAS COR; 5mg, tablets
Torasemidum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

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

Trifas Cor 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 Cor is used in adults for the treatment of:
primary hypertension and
treatment and prevention of recurrences 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 Cor

When not to take Trifas Cor

• 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 severe liver function disorders with impaired consciousness (hepatic coma or pre-coma);
• if the patient has low blood pressure (hypotension);
• if the patient has a decreased circulating blood volume (hypovolemia);
• if the patient has low sodium or 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

Due to insufficiently documented results, Trifas Cor should not be used in the case of:

• gout,
• serious heart rhythm disorders, when heartbeats are slowed down,
• acid-base balance disorders,
• patients taking lithium salts (medicines used in mood and depression disorders) 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 Cor 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 Cor in children and adolescents under 18 years of age.

Impact on doping tests

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

Trifas Cor and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.

• Taking Trifas Cor 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, ask your doctor or pharmacist.
• Theophylline (medicines used in the treatment of asthma): Trifas Cor may enhance the action of these medicines.
• Muscle relaxants: increased muscle relaxant effect.
• Antidiabetic medicines: Trifas Cor may reduce the effect of antidiabetic medicines.
• Painkillers and rheumatic medicines - in the case of taking high doses of salicylates, torasemide may enhance their toxic effect on the central nervous system.
• Medicines used in the treatment of circulation disorders (epinephrine and norepinephrine). Trifas Cor may reduce the effect of these medicines.
• The following medicines affect the action of Trifas Cor
• Probenecid (a medicine used in the treatment of 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 for lowering cholesterol levels): concurrent use of cholestyramine may reduce the absorption of Trifas Cor from the gastrointestinal tract, thereby reducing its effectiveness.
• During treatment with high doses (see section 3), Trifas Cor may lead to an increase in the following side effects
• Hearing and kidney damage caused by aminoglycoside antibiotics (e.g. kanamycin, gentamicin, tobramycin) used in the treatment of infections.
• Hearing and kidney damage caused by cisplatin (used in the treatment of tumors).
• Kidney damage caused by cephalosporins (a group of antibiotics) used in the treatment of infections.
• Other interactions between Trifas Cor and other medicines
• Potassium level reduction caused by Trifas Cor may enhance the side effects of concurrently used digitalis glycosides (used in the treatment of heart failure).
• Laxatives may increase potassium loss caused by Trifas Cor.
• Adrenal cortex hormones (mineralo- and glucocorticoids, e.g. cortisone), taken concurrently with Trifas Cor, may increase the potassium loss caused by it.
• Concurrent treatment with Trifas Cor and lithium salts (used in the treatment of mood swings and depression) may cause an increase in lithium levels in the blood and thus enhance the toxic effect of lithium on the heart and kidneys.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects that she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before taking this medicine.
Pregnancy
Trifas Cor may be used during pregnancy only after consulting a doctor. Only the lowest dose should be used.
There is insufficient clinical data on the effect of Trifas Cor on unborn children.
Breastfeeding
It is not known whether the active substance of Trifas Cor passes into breast milk. Therefore, Trifas Cor should not be used during breastfeeding. If the use of the medicine during breastfeeding is necessary, breastfeeding should be stopped.

Driving and operating machinery

Trifas Cor may affect reaction time. Trifas Cor may impair the ability to actively participate in road traffic, operate mechanical devices, or work without safe support for the 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 of starting concurrent treatment with another product. Alcohol may enhance this effect. During treatment with Trifas Cor, alcohol should not be consumed.

Trifas Cor contains lactose

If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact their doctor before taking the medicine.

3. How to take Trifas Cor

This medicine should always be taken as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
Follow the instructions in the leaflet to ensure that Trifas Cor works properly.

Dosage

Primary hypertension
The recommended initial dose is ½ tablet of Trifas Cor per day, which corresponds to 2.5 mg of torasemide.
The blood pressure lowering effect of Trifas Cor starts slowly in the first week of treatment and reaches its maximum effect no later than after about 12 weeks. If blood pressure does not normalize after 12 weeks of treatment with Trifas Cor at a dose of ½ tablet (corresponding to 2.5 mg of torasemide) per day, the dose can be increased to 1 tablet of Trifas Cor per day (corresponding to 5 mg of torasemide).
A stronger antihypertensive effect is achieved with a higher dose when the initial blood pressure is very high and in patients with kidney function disorders.
The dose should not be increased to more than one tablet of Trifas Cor (corresponding to 5 mg of torasemide) per day, as this will not lead to further lowering of blood pressure.
Edema and effusions
The recommended initial dose is 1 tablet of Trifas Cor (corresponding to 5 mg of torasemide) per day.
Usually, this dose is used as a maintenance dose.
If the effect of the medicine is not satisfactory and depending on the clinical picture, the dose can be increased to 2 tablets of Trifas Cor per day, corresponding to 10 mg of torasemide, or up to a maximum of 4 tablets of Trifas Cor per day, corresponding to 20 mg of torasemide.
If the dose to be used is 10 mg of torasemide or more, Trifas 10 (10 mg of torasemide) can be used.

Dividing tablets

The tablet can be divided into two dose parts by pressing the break line on the tablet. This allows for dose adjustment to individual patient requirements.
Hold the tablet between the index fingers and thumbs of both hands, with the break line facing up, and break the tablet into two halves along the break line, pressing down with your thumbs.

Patients with liver failure

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 taken 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 Cor is decided by the doctor.

Use of a higher than recommended dose of Trifas Cor

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

• excessive urine excretion, potentially life-threatening 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 Cor

Taking a lower dose of the medicine reduces its effectiveness. Missing a dose of Trifas Cor also 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 the next dose is approaching. You should not take a double dose to make up for the missed dose.

Stopping treatment with Trifas Cor

Stopping or prematurely ending therapy may lead to worsening of symptoms. In no case should the treatment prescribed by the doctor be changed or stopped without prior consultation.
If you have any doubts about taking the medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Trifas Cor can cause side effects, although they may not occur in every patient.
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 concurrent use of a low-potassium diet, vomiting, diarrhea, excessive use of laxatives, in patients with chronic liver function disorders)
• Depending on the dose and duration of treatment, electrolyte and water balance disorders may occur, in particular decreased circulating 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 retention 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 (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 may lead to arrhythmias, feelings of chest pressure (angina pectoris), acute myocardial infarction, or sudden loss of consciousness (syncope)
• Pancreatitis
• Visual disturbances
• Tinnitus
• Hearing loss

If any of the above side effects occur, you should inform your doctor immediately. The doctor will assess the severity of the symptoms and decide what tests should be performed.
In the event of sudden and severe side effects, you should consult your doctor immediately. This is very important, as some side effects may be life-threatening. The doctor will decide what tests should be performed and whether treatment should be continued.
If an allergic reaction occurs (e.g. severe allergic skin reaction), Trifas Cor should not be used again.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, you should inform your doctor or pharmacist, or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje 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 Cor

The medicine should be stored out of sight and reach of children.
This medicine does not require special storage conditions.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the 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 needed. This will help protect the environment.

6. Contents of the pack and other information

What Trifas Cor contains

The active substance of Trifas Cor is torasemide.
Each tablet contains 5 mg of torasemide.
Other ingredients of the medicine are: lactose monohydrate, cornstarch, colloidal silicon dioxide, magnesium stearate.

What Trifas Cor looks like and what the pack contains

White, round, slightly convex tablets with a break line on one side.
The pack contains 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 update of the leaflet: