Toralis

Package Leaflet: Information for the Patient

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

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

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

Contents of the Package 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 pack 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 medicines called angiotensin-converting enzyme inhibitors, which prevent 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.
Toralis, 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),
• with heart disease called congestive heart failure and high blood pressure.

2. Important information before taking Toralis

When not to take Toralis:

• if you are allergic to lisinopril, torasemide, sulfonylurea derivatives, or any of the other ingredients of this medicine (listed in section 6),
• if you are pregnant or breastfeeding,
• if you have 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 you have hereditary angioedema or angioedema has occurred for any reason,
• if you have diabetes or kidney problems and are being treated with aliskiren,
• if you have severe kidney problems and are unable to urinate,
• if you have severe liver problems,
• if you have very low blood pressure (hypotension),
• if you have low blood volume,
• if you have low sodium or potassium levels in the blood,
• if you have significant difficulty urinating, e.g., due to prostate enlargement.

Warnings and precautions

Before starting to take Toralis, discuss 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 cases, 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 medicines, 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 signs of infection due to a low white blood cell count),
• if you are undergoing desensitization treatment for 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 stop 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 white blood cell count,
• 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 II receptor antagonist (especially if you have diabetic kidney problems), potassium supplements, potassium-sparing diuretics, potassium-containing salt substitutes, lithium, aminoglycoside antibiotics, or cefalosporins,
• 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 tissue under the skin in areas such as the throat):
• sirolimus, everolimus, and other mTOR inhibitors (used to avoid rejection of a transplanted organ),
• if you are pregnant, think you may be pregnant, or plan to become pregnant.

In black patients, angioedema may occur more frequently; additionally, 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), blood count, and glucose and lipid levels in the blood.
Torasemide may cause positive results in doping tests.

Children and adolescents

Toralis is not recommended for use in children and adolescents.

Toralis with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take.
Your doctor may recommend a dose change and/or take other precautions. In some cases, it may be necessary to stop one of the medicines.
This is especially true for the following medicines: aliskiren, angiotensin II 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 cefalosporins.
Caution should be exercised when using:

• 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 worsening 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 cause a decrease in the white blood cell count (leukocytes),
• corticosteroids and laxatives, as torasemide may enhance 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 treatment 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 their ototoxic and nephrotoxic effects,
• 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 blood clots, usually administered in a hospital), as they may increase the risk of angioedema,
• medicines 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, consult 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, consult your doctor or pharmacist before taking this medicine.
Your doctor will usually recommend stopping Toralis treatment before planned pregnancy or as soon as pregnancy is confirmed and recommend taking a different medicine instead of Toralis. Women of childbearing age who do not plan to become pregnant should use effective contraception.
Inform your doctor about breastfeeding or intending to breastfeed. Do not take Toralis while breastfeeding. Your doctor will recommend a different 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. Do not drive or operate machinery until you know how Toralis affects you.

3. How to take Toralis

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor. This will help you get the best results from your treatment and reduce the risk of side effects.
The recommended dose is one tablet per day.

• It is recommended to take the tablet at the same time every day, e.g., in the morning.
• Swallow the tablet whole with 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, contact your doctor immediately.

Patients with kidney problems

In patients with kidney problems, your doctor may adjust the dose of Toralis depending on 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 Toralis depending on 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 more than the recommended dose of Toralis

Do not take more than the recommended dose. If you have taken too many Toralis tablets, 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 miss a dose, take it as soon as possible, and take the next dose at the usual time. However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for the missed tablet.

Stopping Toralis treatment

Stopping Toralis treatment may worsen your condition. Continue taking the medicine and attending follow-up appointments with your doctor, even if you feel well. Do not stop treatment unless your doctor tells you to.
If you have any further questions about taking this medicine, ask 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 regular blood and/or urine tests to check if Toralis treatment has caused certain side effects.
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 you experience them, contact your doctor immediately:

Common (may affect up to 1 in 10 people):dizziness (may be caused by too low blood pressure), worsening of metabolic alkalosis (symptoms include apathy, confusion, arrhythmias, 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 affect up to 1 in 100 people):chest pain, inability to urinate in patients with urinary retention, circulatory disorders in the fingers and toes with a change in their color and pain (Raynaud's phenomenon).
Rare (may affect up to 1 in 1,000 people):excessive lowering of blood pressure, fainting, angioedema, significant 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, or coma).
Very rare (may affect up to 1 in 10,000 people):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), liver function disorders, bronchospasm, bone marrow disorders, very low red blood cell count (symptoms include pale skin, dizziness, feeling of tiredness, 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:

Common (may affect up to 1 in 10 people):headache, feeling of tiredness, 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 affect up to 1 in 100 people):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 affect up to 1 in 1,000 people):urinary tract infections; 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, digestive disorders, changes in 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.
Very rare (may affect up to 1 in 10,000 people):decreased or absent urine output, ringing in the ears, hearing loss, sinusitis, infection, or allergic inflammation of the lungs, lymph node enlargement, autoimmune disease; decreased platelet, red blood cell, or white blood cell count (leukocytes).
Lisinopril increases potassium levels in the blood, and thus may reduce potassium loss caused by torasemide.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: ndl@urpl.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 Toralis

Keep this medicine out of the 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. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Toralis contains

• The active substances of Toralis 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.
• Other ingredients are: mannitol E421, maize starch, maize starch pregelatinised, 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 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 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, tablets, Tolirasim, 10mg/10mg, tablets, Tolirasim, 20mg/5mg, tablets, Tolirasim, 20mg/10mg, tablets
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