Tolurindo

Leaflet accompanying the packaging: patient information

Tolurindo, 40 mg + 1.5 mg, tablets with modified release

Tolurindo, 80 mg + 1.5 mg, tablets with modified release

Telmisartan + Indapamide

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 necessary.
• In case of any doubts, you should consult a 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 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 tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Tolurindo and what is it used for
• 2. Important information before taking Tolurindo
• 3. How to take Tolurindo
• 4. Possible side effects
• 5. How to store Tolurindo
• 6. Package contents and other information

1. What is Tolurindo and what is it used for

Tolurindo contains two active substances: telmisartan and indapamide.
Telmisartan belongs to a group of medicines called angiotensin II receptor antagonists.
Angiotensin II is a substance produced by the body that causes blood vessels to constrict, leading to increased blood pressure. Telmisartan blocks the action of angiotensin II, causing blood vessels to relax and blood pressure to decrease.
Indapamide belongs to a group of diuretic medicines used to remove water from the body.
However, indapamide differs from other diuretic medicines in that it only slightly increases the amount of urine produced. Additionally, indapamide dilates blood vessels, making it easier for blood to flow through them. This helps to lower blood pressure.
This medicine is used to treat high blood pressure (hypertension) in adults.
Untreated high blood pressure can cause damage to blood vessels in various organs, which can sometimes lead to heart attack, heart failure, or kidney failure, stroke, or vision loss. Usually, before the above complications occur, no symptoms of high blood pressure are observed. Therefore, it is essential to regularly measure blood pressure to check if it is within the normal range.

2. Important information before taking Tolurindo

When not to take Tolurindo

• if the patient is allergic to telmisartan, indapamide, other sulfonamides, or any of the other ingredients of this medicine (listed in section 6);
• if the patient is pregnant for more than 3 months. (It is also recommended to avoid taking Tolurindo in early pregnancy - see "Pregnancy");
• if the patient has severe liver function disorders, such as bile stasis or bile duct obstruction (problems with bile flow from the liver and gallbladder) or any other severe liver disease;
• if the patient has hepatic encephalopathy (a brain function disorder caused by liver disease);
• if the patient has diabetes or kidney function disorders and is being treated with a blood pressure-lowering medicine containing aliskiren;
• if the patient has severe kidney disease;
• if the patient has low potassium levels in the blood.

Warnings and precautions

Before starting to take Tolurindo, the patient should discuss with their doctor if they have or have had any of the following conditions or diseases:

• kidney disease or a history of kidney transplantation;
• renal artery stenosis (narrowing of the blood vessels supplying one or both kidneys);
• liver disease;
• heart rhythm disorders;
• increased aldosterone levels (water and salt retention in the body, accompanied by mineral balance disorders in the blood);
• low blood pressure (hypotension), which is more likely if the patient is dehydrated (excessive water loss from the body) or has a salt deficiency due to the use of diuretics (diuretics), a low-salt diet, diarrhea, or vomiting;
• high potassium levels in the blood;
• diabetes;
• gout.

Before starting to take Tolurindo, the patient should discuss with their doctor or pharmacist:

• if the patient is taking any of the following medicines used to treat high blood pressure:
• angiotensin-converting enzyme (ACE) inhibitors (e.g., enalapril, lisinopril, ramipril), especially if the patient has diabetes-related kidney function disorders.
• aliskiren. The doctor may monitor kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood at regular intervals. See also "When not to take Tolurindo" and "Warnings and precautions".
• if the patient is taking digoxin;
• if the patient experiences vision loss or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which can occur within a few hours or weeks of taking Tolurindo. Untreated symptoms can lead to permanent vision loss. If the patient has previously been allergic to penicillin or sulfonamides, there is a higher risk of these disorders.
• if the patient has muscle disorders, including pain, tenderness, weakness, or muscle cramps
• if the patient is to undergo a test to assess parathyroid function.

If the patient experiences stomach pain, nausea, vomiting, or diarrhea after taking Tolurindo, they should discuss this with their doctor. The doctor will decide on further treatment. The patient should not stop taking Tolurindo on their own.
The patient should inform their doctor if they suspect (or plan) pregnancy. It is not recommended to take Tolurindo in early pregnancy, and it should not be taken if the patient is pregnant for more than 3 months, as it may seriously harm the fetus (see "Pregnancy").
In case of planned surgery or anesthesia, the patient should inform their doctor about taking Tolurindo.
The patient should inform their doctor if they experience a light sensitivity reaction.
The doctor may recommend blood tests to assess electrolyte levels.
Tolurindo may be less effective in lowering blood pressure in black patients.
If the patient thinks they are affected by any of the above situations or has questions or doubts about taking the medicine, they should contact their doctor or pharmacist.

Children and adolescents

Tolurindo is not recommended for children and adolescents under 18 years of age.

Tolurindo and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The doctor may decide to change the dose of these medicines or take other precautions. In some cases, it may be necessary to stop taking one of the medicines. This applies especially to the simultaneous use of Tolurindo with the following medicines:

• lithium-containing medicines used to treat certain types of depression; due to the risk of increased lithium levels in the blood;
• medicines that can increase potassium levels in the blood, such as potassium-containing salt substitutes, potassium-sparing diuretics (some diuretics, e.g., amiloride, spironolactone, triamterene), ACE inhibitors (used to treat hypertension and heart failure), angiotensin II receptor antagonists, non-steroidal anti-inflammatory drugs (NSAIDs, e.g., acetylsalicylic acid or ibuprofen), heparin, immunosuppressive drugs (e.g., cyclosporine or tacrolimus), and the antibiotic trimethoprim;
• diuretics (diuretic medicines), especially when taken in high doses with Tolurindo, as they can lead to excessive water loss from the body and decreased blood pressure (hypotension);
• if the patient is taking an ACE inhibitor or aliskiren (see also "When not to take Tolurindo" and "Warnings and precautions");
• other antihypertensive medicines;
• digoxin;
• medicines used to treat heart rhythm disorders (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, digitalis preparations, bretylium);
• medicines used to treat mental disorders, such as depression, anxiety, schizophrenia (e.g., tricyclic antidepressants, antipsychotic drugs, neuroleptics (such as amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol));
• bepridil (used to treat coronary heart disease, which causes chest pain);
• cisapride (used to treat reduced esophageal and gastric motility);
• difemanil (used to treat gastrointestinal disorders);
• antibiotics used to treat bacterial infections (e.g., sparfloxacin, moxifloxacin, erythromycin given by injection);
• vincamine given by injection (used to treat symptomatic cognitive disorders in elderly patients, including memory loss);
• halofantrine (an antiparasitic medicine used to treat certain types of malaria);
• pentamidine (used to treat certain types of pneumonia);
• antihistamines used to treat allergic reactions, such as hay fever (e.g., mizolastine, astemizole, terfenadine);
• amphotericin B given by injection (a medicine used to treat fungal infections);
• corticosteroids used to treat various diseases, including severe asthma and rheumatoid arthritis (given systemically);
• laxatives that stimulate peristalsis;
• baclofen (used to treat muscle stiffness, which occurs in diseases such as multiple sclerosis);
• allopurinol (used to treat gout);
• metformin (used to treat diabetes);
• iodine-containing contrast agents (used in diagnostic tests using X-rays);
• calcium-containing tablets or other calcium supplements;
• cyclosporine, tacrolimus, or other immunosuppressive drugs used after organ transplantation or to treat autoimmune diseases, severe rheumatic diseases, or dermatological diseases;
• tetracosactide (used to treat Crohn's disease);
• methadone (used to treat drug addiction).

The effect of Tolurindo may be reduced when the patient takes non-steroidal anti-inflammatory drugs (NSAIDs, e.g., acetylsalicylic acid or ibuprofen) or corticosteroids.
Tolurindo may enhance the blood pressure-lowering effect of other medicines used to treat hypertension or medicines that can cause a decrease in blood pressure (e.g., baclofen, amifostine). Additionally, low blood pressure may be further reduced by:
alcohol, barbiturates, narcotics, or antidepressants. The symptom is dizziness when standing up. If it is necessary to adjust the dose of another medicine taken by the patient while taking Tolurindo, they should consult their doctor.

Tolurindo with food and drink and alcohol

Tolurindo can be taken with or without food.
Alcohol may cause a greater decrease in blood pressure and (or) increase the risk of dizziness or fainting.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
The patient should inform their doctor about suspected (or planned) pregnancy. Usually, the doctor will recommend stopping Tolurindo before planned pregnancy or as soon as pregnancy is confirmed and recommend taking another medicine instead of Tolurindo. Before planned pregnancy or as soon as pregnancy is confirmed, the patient should switch to another treatment as soon as possible. It is not recommended to take Tolurindo in early pregnancy, and it should not be taken after the third month of pregnancy, as it may seriously harm the fetus if taken after the third month of pregnancy.
Breastfeeding
The patient should inform their doctor about breastfeeding or intending to breastfeed. The active substance passes into breast milk. It is not recommended to take Tolurindo during breastfeeding. The doctor may choose another treatment during breastfeeding, especially in the case of breastfeeding newborns and premature babies.

Driving and using machines

This medicine may cause side effects related to lowering blood pressure, such as dizziness or fatigue (see section 4). The patient should not drive or operate machines if they experience dizziness or fatigue.

Tolurindo contains lactose and sodium

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking Tolurindo.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Tolurindo

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
The recommended dose of Tolurindo is one tablet per day, preferably in the morning. The patient should try to take Tolurindo at the same time every day.
Tolurindo can be taken with or without food. The tablets should be swallowed whole, with water or another non-alcoholic liquid. The tablets should not be crushed or chewed.
It is essential to take Tolurindo every day, unless the doctor recommends otherwise. If the patient feels that the effect of Tolurindo is too strong or too weak, they should consult their doctor or pharmacist. The treatment of hypertension is usually long-term.
In case of liver function disorders, the doctor will adjust the dose accordingly.

Taking a higher dose of Tolurindo than recommended

If the patient accidentally takes too many tablets, they should immediately contact their doctor or pharmacist or the nearest hospital emergency department.
Very high doses of Tolurindo may cause nausea, vomiting, low blood pressure, muscle cramps, dizziness, drowsiness, disorientation, and changes in the amount of urine produced by the kidneys.

Missing a dose of Tolurindo

If the patient misses a dose, they should take it as soon as they remember, and then continue taking the medicine as before. If the tablet is not taken within a day, the patient should take the usual dose the next day. The patient should not take a double dose to make up for the missed tablet.

Stopping Tolurindo

Since the treatment of high blood pressure usually lasts a lifetime, the patient should consult their doctor before stopping the medicine.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Tolurindo can cause side effects, although not everybody gets them.

If the patient experiences any of the following serious side effects, they should stop taking the medicine and contact their doctor immediately:

• sepsis (often referred to as "blood poisoning", a severe infection with a systemic inflammatory response), which may have occurred by chance or may be related to an unknown mechanism (rare - may occur in less than 1 in 1,000 people);
• sudden swelling of the skin on the limbs or face, swelling of the lips or tongue, mucous membranes of the throat or respiratory tract, causing shortness of breath or difficulty swallowing (angioedema). (Rare - may occur in less than 1 in 1,000 patients). If

these symptoms are not treated, they can be life-threatening.

• severe skin reactions, including severe rash, redness of the skin all over the body, severe itching, blistering, peeling, and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome) or other allergic reactions (very rare - may occur in less than 1 in 10,000 patients);
• life-threatening heart rhythm disorders (frequency not known);
• pancreatitis, which can cause severe abdominal pain, radiating to the back, and very poor general condition (very rare - may occur in less than 1 in 10,000 patients);
• liver disease caused by liver disease (encephalopathy) (frequency not known);
• liver inflammation (frequency not known);
• muscle weakness, cramps, tenderness, or pain, especially if the patient feels unwell or has a high temperature, which may be caused by abnormal muscle breakdown (frequency not known).

Possible side effects of Tolurindo:

Common(may occur in up to 1 in 10 people):

• allergic reactions, mainly affecting the skin, such as rash, in people prone to allergies and asthmatic reactions
• red, raised rash
• low potassium levels in the blood

Uncommon(may occur in up to 1 in 100 people):

• urinary tract infections, upper respiratory tract infections
• reduced red blood cell count (anemia)
• difficulty sleeping
• low mood (depression)
• fainting
• dizziness (peripheral vertigo)
• slow heart rate (bradycardia)
• low blood pressure (hypotension), dizziness when standing up (orthostatic hypotension)
• shortness of breath, cough
• abdominal pain, diarrhea, discomfort in the abdominal cavity, bloating, vomiting
• red spots on the skin (petechiae), itching, excessive sweating, rash, allergic rash
• back pain, muscle cramps, muscle pain
• kidney function disorders, including acute kidney failure
• chest pain, feeling of weakness
• increased creatinine levels in the blood
• high potassium levels in the blood
• low sodium levels in the blood, which can lead to dehydration and low blood pressure
• impotence (erectile dysfunction)

Rare(may occur in up to 1 in 1,000 people):

• increased white blood cell count (eosinophilia)
• low platelet count (thrombocytopenia)
• severe allergic reaction (anaphylactic reaction)
• allergic reaction (e.g., rash, itching, difficulty breathing, wheezing, swelling of the face)
• feeling of restlessness
• feeling of fatigue, headache, tingling (paresthesia)
• drowsiness
• vision disturbances
• rapid heart rate (tachycardia)
• nausea, constipation, dry mouth, gastritis, taste disturbances
• liver function disorders (more common in patients of Japanese origin)
• skin eruptions (skin disease), redness of the skin, hives, severe allergic rash
• joint pain, limb pain, tendon pain
• flu-like symptoms
• reduced hemoglobin levels (a protein in the blood)
• increased uric acid levels, a substance that can cause gout or worsen it (joint pain)
• increased liver enzyme activity or creatine phosphokinase in the blood
• low blood sugar levels (in patients with diabetes)
• low chloride levels in the blood
• low magnesium levels in the blood

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

• agranulocytosis, aplastic anemia, hemolytic anemia
• reduced white blood cell count, which can cause fever, sore throat, or other flu-like symptoms (leukopenia)
• heart rhythm disorders (causing palpitations and feeling of heartbeat)
• progressive scarring of lung tissue (interstitial lung disease) has been reported in patients taking telmisartan, but it is not known if it was caused by telmisartan
• high calcium levels in the blood

Frequency not known(cannot be estimated from the available data):

• myopia
• blurred vision, vision disturbances
• worsening of vision or eye pain due to high pressure (possible symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)
• abnormal ECG recording
• possibility of exacerbating symptoms of systemic lupus erythematosus (a type of collagen disease)
• light sensitivity reaction (change in skin appearance) after exposure to sunlight or artificial UVA radiation
• increased blood sugar levels in patients with diabetes
• intestinal angioedema - after using similar products, intestinal edema occurred with symptoms such as abdominal pain, nausea, vomiting, and diarrhea

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Tolurindo

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after "EXP". The expiry date refers to the last day of the month.
Store in the original packaging to protect from moisture and light.
There are no special storage temperature recommendations for the medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Tolurindo contains

• The active substances of Tolurindo are telmisartan and indapamide. Tolurindo, 40 mg + 1.5 mg, tablets with modified release Each tablet with modified release contains 40 mg of telmisartan and 1.5 mg of indapamide. Tolurindo, 80 mg + 1.5 mg, tablets with modified release Each tablet with modified release contains 80 mg of telmisartan and 1.5 mg of indapamide.
• The other ingredients (excipients) are: lactose monohydrate, meglumine, sodium hydroxide, povidone K30, microcrystalline cellulose, sodium croscarmellose, iron oxide yellow (E 172), iron oxide red (E 172), sodium stearyl fumarate, magnesium stearate, hypromellose, anhydrous colloidal silica, and carbomers. See section 2 "Tolurindo contains lactose and sodium".

What Tolurindo looks like and contents of the pack

Tolurindo, 40 mg + 1.5 mg, tablets with modified release
The tablets are capsule-shaped, two-layered, and biconvex. One layer of the tablet is orange, speckled. The other layer of the tablet is white to yellowish-white, speckled, with the marking TI1.
Tablet dimensions: approximately 18 mm x 8 mm.
Tolurindo, 80 mg + 1.5 mg, tablets with modified release
The tablets are capsule-shaped, two-layered, and biconvex. One layer of the tablet is yellowish-brown, speckled. The other layer of the tablet is white to yellowish-white, speckled, with the marking TI2.
Tablet dimensions: approximately 18 mm x 8 mm.
Tolurindo is available in a carton containing:

• 10, 30, 60, 90, or 100 tablets with modified release, in blisters.
• 14, 28, 56, 84, or 98 tablets with modified release, in blisters, calendar packaging. Not all pack sizes may be marketed.

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

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

In order to obtain more detailed information on this medicine, the patient should contact their local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warszawa
tel. +48 22 57 37 500

Date of last revision of the leaflet: 24.01.2025