Toralis

Leaflet accompanying the packaging: patient information

Toralis, 10 mg+5 mg, tablets

Toralis, 10 mg+10 mg, tablets

Toralis, 20 mg+5 mg, tablets

Toralis, 20 mg+10 mg, tablets

Lisinopril+Torasemide

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

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you specifically. 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 any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Toralis is and what it is used for

Toralis tablets contain two active substances - lisinopril and torasemide, which help control high blood pressure and symptoms of heart failure, such as swelling caused by fluid accumulation in the body. Lisinopril belongs to a group of angiotensin-converting enzyme inhibitors, which inhibit the production of a substance that increases blood pressure, resulting in the dilation of blood vessels and making it easier for the heart to pump blood to all parts of the body. Torasemide belongs to a group of loop diuretics, which increase the amount of water excreted in the urine, reducing the amount of fluid in the blood vessels. The Toralis medicine, which contains lisinopril and torasemide in one tablet, is used in patients who have previously taken lisinopril and torasemide in the same doses as in Toralis, but in separate tablets (Toralis is used instead of these tablets). This reduces the number of tablets taken by the patient. Toralis can be used in patients with heart disease called congestive heart failure (a condition in which the heart does not pump enough blood to meet the body's needs), and in patients with heart disease called congestive heart failure and high blood pressure.

2. Important information before taking Toralis

When not to take Toralis:

• if the patient is allergic to lisinopril, torasemide, sulfonylurea derivatives, or any of the other ingredients of this medicine (listed in section 6),
• if the patient is pregnant or breastfeeding,
• if the patient has ever had allergic reactions with symptoms such as swelling of the face, lips, tongue, throat, legs, and hands, difficulty swallowing or breathing (angioedema) while being treated with a medicine from the same group as lisinopril,
• if the patient has hereditary angioedema or angioedema has occurred for any reason,
• if the patient has diabetes or kidney problems and is being treated with aliskiren,
• if the patient has severe kidney problems and is unable to urinate,
• if the patient has severe liver problems,
• if the patient has very low blood pressure (hypotension),
• if the patient has a low blood volume,
• if the patient has low sodium or potassium levels in the blood,
• if the patient has significant difficulty urinating, e.g., due to prostate enlargement.

Warnings and precautions

Before starting to take Toralis, you should discuss it with your doctor or pharmacist:

• if you have low blood pressure (you may experience symptoms such as dizziness or a feeling of "emptiness" in the head, especially when standing up quickly - in such a case, you should lie down on your back with your legs raised); the occurrence of transient hypotension does not contraindicate continued use of this medicine,
• if you are dehydrated due to treatment with diuretics, dialysis, a low-sodium diet, or prolonged, severe vomiting or diarrhea,
• if you have coronary artery disease, cerebrovascular disease, aortic stenosis, significantly thickened heart muscle, or heart rhythm disorders,
• if you have kidney problems, including those caused by medications, unilateral or bilateral narrowing of the renal arteries, or require hemodialysis,
• if you have jaundice,
• if you have collagen vascular disease,
• if you have ever had angioedema,
• if you have a high fever, sore throat, or swollen lymph nodes (these may be symptoms of an infection due to a decrease in the number of white blood cells),
• if you are being desensitized due to an allergy (e.g., to bee or wasp venom) or are undergoing a procedure called LDL apheresis (removal of cholesterol from the blood) - your doctor may discontinue Toralis treatment to prevent a possible allergic reaction,
• if you have abnormal potassium, sodium, uric acid, creatinine, glucose, cholesterol, or triglyceride levels, or an abnormal number of blood cells,
• if you have diabetes or gout,
• if you have a dry, persistent cough, worsening at night (may be caused by lisinopril),
• if you are taking any of the following medicines: aliskiren, angiotensin receptor antagonist (especially if you have diabetic kidney problems), potassium supplements, potassium-sparing diuretics, potassium-containing salt substitutes, as well as other medicines that may increase potassium levels in the blood (such as heparin and cotrimoxazole, a combination of trimethoprim and sulfamethoxazole), lithium, aminoglycoside antibiotics, or cephalosporins,
• if surgery is planned (including dental surgery) - the anesthetics used may cause excessive lowering of blood pressure,
• if you are taking any of the following medicines, as the risk of angioedema may increase (sudden swelling of the subcutaneous tissue in areas such as the throat):
• sirolimus, everolimus, and other mTOR inhibitors (used to avoid rejection of a transplanted organ),
• if you are pregnant, suspect you may be pregnant, or plan to become pregnant.

In black patients, angioedema may occur more frequently; furthermore, lisinopril may be less effective in lowering blood pressure. Your doctor may recommend regular monitoring of kidney function, blood pressure, electrolyte levels (e.g., potassium, sodium) in the blood, blood morphology, and glucose and lipid levels in the blood. The use of torasemide may result in positive doping test results.

Children and adolescents

Toralis is not recommended for use in children and adolescents.

Toralis and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. Your doctor may recommend a dose change and/or take other precautions. In some cases, it may be necessary to discontinue one of the medicines. This is especially true for the following medicines: aliskiren, angiotensin receptor antagonists, potassium supplements, potassium-sparing diuretics, potassium-containing salt substitutes, and other medicines that may increase potassium levels in the blood (such as heparin and cotrimoxazole, a combination of trimethoprim and sulfamethoxazole), lithium, aminoglycoside antibiotics, or cephalosporins.

• diuretics (thiazides), blood pressure-lowering medicines, or medicines used for chest pain (e.g., glyceryl trinitrate), as hypotension may occur,
• non-steroidal anti-inflammatory drugs (NSAIDs), as they may weaken the effect of lisinopril and torasemide; their concurrent use may lead to impaired kidney function and increased potassium levels in the blood, and in the case of high doses of salicylates, torasemide may enhance their toxic effect on the central nervous system,
• aspirin in doses greater than 3 g per day,
• gold salts for injection, as they may cause sudden flushing (especially of the face), nausea, vomiting, and excessive lowering of blood pressure,
• sympathomimetics, such as pseudoephedrine or adrenaline, as they may weaken the effect of lisinopril; torasemide may reduce the vasoconstriction caused by these medicines,
• cytotoxic medicines (e.g., methotrexate) or systemic corticosteroids, as they may lead to a decrease in the number of white blood cells (leukocytes),
• corticosteroids and laxatives, as torasemide may enhance the potassium loss caused by these medicines,
• oral antidiabetic medicines (e.g., metformin) or insulin, as lisinopril may cause further lowering of blood sugar levels, especially in the first few weeks of its use and in patients with kidney problems; torasemide may weaken the effect of these medicines,
• digitalis glycosides,
• probenecid, as it may weaken the effect of torasemide,
• aminoglycosides or cisplatin preparations, as torasemide, especially in high doses, may enhance the ototoxic and nephrotoxic effects of these medicines,
• cephalosporins, as torasemide may enhance their nephrotoxic effect,
• theophylline or muscle relaxants containing curare, as torasemide may enhance their effect,
• cholestyramine, as it may reduce the absorption and thus the effect of torasemide,
• tissue plasminogen activators (medicines used to dissolve clots, usually administered in a hospital), as they may increase the risk of angioedema,
• medicines most commonly used to avoid rejection of a transplanted organ (sirolimus, everolimus, and other mTOR inhibitors) - see "Warnings and precautions".

Toralis with food, drink, and alcohol

Toralis can be taken with or without food. Excessive sodium intake may weaken the effect of the medicine. If you have any doubts about the amount of alcohol allowed while taking Toralis, you should discuss it with your doctor, as blood pressure-lowering medicines and alcohol may enhance each other's effects.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan to have a baby, you should consult your doctor or pharmacist before taking this medicine. Your doctor will usually recommend stopping Toralis before planned pregnancy or as soon as pregnancy is confirmed and recommend taking another medicine instead of Toralis. Women of childbearing age who do not plan to become pregnant should use effective contraception. You should inform your doctor about breastfeeding or intending to breastfeed. You should not take Toralis while breastfeeding. Your doctor will recommend taking another medicine if you want to breastfeed.

Driving and using machines

This medicine may occasionally cause dizziness, blurred vision, or even fainting, especially at the beginning of treatment, when changing the dose, or in combination with alcohol. You should not drive or operate machinery until you know how Toralis affects you.

3. How to take Toralis

This medicine should always be taken exactly as prescribed by your doctor. If you have any doubts, you should consult your doctor. This will ensure the best results and minimize the risk of side effects. The recommended dose is one tablet per day.

• It is recommended to take the tablet every day at the same time, e.g., in the morning.
• You should swallow the tablet whole, with a glass of water.
• Toralis can be taken with or without food.

Your doctor will determine the dose individually, depending on your clinical condition and other medicines you are taking. The response to treatment will be monitored based on blood pressure values and the results of some blood tests. Depending on the results, your doctor may recommend a higher or lower dose. If you feel that the effect of Toralis is too strong or too weak, you should contact your doctor immediately.

Patients with kidney problems

In patients with kidney problems, your doctor may adjust the dose of the medicine depending on the blood pressure values and the degree of kidney problems. If you are undergoing dialysis, it may be necessary to modify the daily dose of Toralis.

Patients with liver problems

In patients with liver problems, your doctor may adjust the dose of the medicine depending on the blood pressure values and the degree of liver problems.

Use in children and adolescents

Toralis is not recommended for use in children and adolescents.

Taking a higher dose of Toralis than recommended

You should not take a dose higher than recommended. If you have taken too many Toralis tablets, you should contact your doctor immediately. Medical attention may be necessary. The following symptoms may occur: dizziness due to excessive lowering of blood pressure, shortness of breath, rapid or slow heart rate, palpitations, feeling of anxiety, cough, stomach upset. You may urinate excessively, feel sleepy or confused.

Missing a dose of Toralis

If you forget to take a dose, you should take it as soon as possible, and the next dose should be taken at the usual time. However, if it is almost time for the next dose, you should skip the missed dose. You should not take a double dose to make up for the missed tablet.

Stopping Toralis treatment

Stopping Toralis treatment may lead to worsening of the disease. You should continue taking the medicine and attending follow-up appointments with your doctor even if you feel well. You should not stop treatment unless your doctor recommends it. If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Toralis can cause side effects, although not everybody gets them. Toralis contains two active substances - lisinopril and torasemide, which you have previously taken in the form of separate tablets. Side effects related to each active substance may occur. Your doctor may recommend periodic blood and/or urine tests to check if Toralis has caused certain side effects. The side effects reported for lisinopril and torasemide are listed below and may occur during Toralis treatment.

The following side effects may be serious, so if they occur, you should immediately consult your doctor:

Frequent (may occur in less than 1 in 10 patients):dizziness (may be caused by too low blood pressure), worsening of metabolic acidosis (symptoms include apathy, confusion, heart rhythm disorders, seizures, breathing difficulties), decreased blood volume (symptoms include dizziness, excessive thirst, severe dryness of the mucous membranes, decreased urine output, dark urine, or constipation). Uncommon (may occur in less than 1 in 100 patients):chest pain, inability to urinate in patients with urination problems, impaired blood circulation in the fingers and toes with a change in their color and pain (Raynaud's phenomenon). Rare (may occur in less than 1 in 1,000 patients):excessive lowering of blood pressure, fainting, angioedema, severe decrease in urine output, syndrome of inappropriate antidiuretic hormone secretion (symptoms include weakness, muscle cramps, headaches, dark urine, or changes in urine volume, decreased appetite, excessive thirst, diarrhea, or constipation, nausea, or vomiting, low mood, confusion, stupor, or coma). Very rare (may occur in less than 1 in 10,000 patients):severe skin reactions (toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, cutaneous lymphoma), a syndrome of symptoms (several or all of the following symptoms: fever, muscle and joint pain, arthritis, rash, skin changes, also after exposure to light), myocardial infarction, or stroke, pancreatitis (symptoms include severe abdominal pain radiating to the back, with very poor general condition), acute abdominal pain with cramps, nausea, and vomiting (symptoms of angioedema of the intestines), impaired liver function, bronchospasm, impaired bone marrow function, very low red blood cell count (symptoms include pale skin, dizziness, feeling of fatigue, shortness of breath, rapid heart rate, yellowing of the skin and eyes, dark urine), very low platelet count (symptoms include easy bruising, spontaneous bleeding, small red spots on the skin), very low white blood cell count (symptoms include weakness, fever, frequent infections).

Other possible side effects of Toralis:

Frequent (may occur in less than 1 in 10 patients):headache, feeling of fatigue, weakness, cough, diarrhea, stomach pain, nausea, vomiting, constipation, decreased appetite, muscle cramps, low potassium levels in the blood (due to torasemide), low sodium levels in the blood, increased uric acid, glucose, triglycerides, and cholesterol levels in the blood, or increased activity of certain liver enzymes in the blood. Uncommon (may occur in less than 1 in 100 patients):high potassium levels in the blood (due to lisinopril), feeling of spinning, rapid or irregular heart rate, hallucinations, feeling of tingling, runny nose, dryness of the mucous membranes, impotence, increased urea or creatinine levels in the blood. Rare (may occur in less than 1 in 1,000 patients):urinary tract infection; high urea levels in the blood; abnormal blood test results (decreased hemoglobin or hematocrit levels); low blood sugar levels in patients with diabetes treated with oral medicines or insulin, increased bilirubin levels in the blood, mood changes, confusion, decreased libido, depression, insomnia, excessive sleepiness, loss of appetite, taste disorders, indigestion, bloating, impaired sense of smell, blurred vision, flushing, rash, hives, itching, excessive sweating, hair loss, increased sensitivity to light, psoriasis, shortness of breath, lung infiltrates, laryngitis, bronchitis, nasal congestion, sore throat, back pain, joint pain, shoulder pain, gout, breast enlargement in men. Very rare (may occur in less than 1 in 10,000 patients):decreased or absent urine output, ringing in the ears, hearing loss, sinusitis, infection, or inflammation of the lungs due to hypersensitivity, lymph node enlargement, autoimmune disease; decreased platelet count, red blood cell count, or white blood cell count (leukocytes). Lisinopril increases potassium levels in the blood, and thus may reduce the potassium loss caused by torasemide.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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, e-mail: [email protected]. 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 Toralis

The medicine should be stored out of sight and reach of children. 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. There are no special storage instructions for this medicine. 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 packaging and other information

What Toralis contains

• The active substances of the medicine are lisinopril and torasemide. Each Toralis 10 mg + 5 mg tablet contains 10 mg of lisinopril (as lisinopril dihydrate) and 5 mg of torasemide. Toralis 10 mg+10 mg tablets: Each tablet contains 10 mg of lisinopril (as lisinopril dihydrate) and 10 mg of torasemide. Toralis 20 mg+5 mg tablets: Each tablet contains 20 mg of lisinopril (as lisinopril dihydrate) and 5 mg of torasemide. Toralis 20 mg+10 mg tablets: Each tablet contains 20 mg of lisinopril (as lisinopril dihydrate) and 10 mg of torasemide.
• The other ingredients are: mannitol E421, corn starch, corn starch pregelatinized, microcrystalline cellulose, magnesium stearate.

What Toralis looks like and contents of the pack

Toralis 10 mg+5 mg tablets: White or almost white, round, biconvex tablets, smooth on both sides, with a diameter of 8.2 mm. Toralis 10 mg+10 mg tablets: White or almost white, round, biconvex tablets with the inscription "L10T10" on one side and smooth on the other side, with a diameter of 11.0 mm. Toralis 20 mg+5 mg tablets: White or almost white, round, biconvex tablets with a score, double inscription "LT" on one side, and smooth on the other side, with a diameter of 11.0 mm. Toralis 20 mg+10 mg tablets: White or almost white, round, biconvex tablets with the inscription "L20T10" on one side and smooth on the other side, with a diameter of 11.0 mm. Toralis 10 mg+5 mg tablets: The medicine is available in packs containing 30, 60, or 90 tablets. One blister pack contains 15 tablets. Toralis 10 mg+10 mg, 20 mg+5 mg, 20 mg+10 mg tablets: The medicine is available in packs containing 30, 60, or 90 tablets. One blister pack contains 10 tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Aflofarm Farmacja Polska Sp. z o.o., ul. Partyzancka 133/151, 95-200 Pabianice, tel.: (42) 22-53-100

Manufacturer

Aflofarm Farmacja Polska Sp. z o.o., ul. Szkolna 31, 95-054 Ksawerów

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Czech Republic: Tolirasim, Lithuania: Tolirasim, 10mg/5mg, tabletės, Tolirasim, 10mg/10mg, tabletės, Tolirasim, 20mg/5mg, tabletės, Tolirasim, 20mg/10mg, tabletės, Poland: Toralis, Slovakia: Lisemid 10 mg/5 mg, Lisemid 10 mg/10 mg, Lisemid 20 mg/5 mg, Lisemid 20 mg/10 mg

Date of last revision of the leaflet:05/2024