Tolurindo

Package leaflet: Information for the patient

Tolurindo, 40 mg + 1.5 mg, modified-release tablets
Tolurindo, 80 mg + 1.5 mg, modified-release tablets
Telmisartan + Indapamide
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm individuals even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What Tolurindo is and what it is used for

Tolurindo contains two active substances: telmisartan and indapamide.
Telmisartan belongs to a group of medicines known as angiotensin II receptor antagonists.
Angiotensin II is a substance produced by the body that causes blood vessels to narrow, leading to increased blood pressure. Telmisartan blocks the action of angiotensin II, allowing blood vessels to relax and blood pressure to decrease.
Indapamide belongs to a group of medicines called diuretics, which are used to remove excess fluid from the body. However, indapamide differs from other diuretics because it only slightly increases urine production. In addition, indapamide widens blood vessels, allowing blood to flow more easily, which helps lower blood pressure.
This medicine is used to treat high blood pressure (hypertension) in adults.
Untreated high blood pressure may damage blood vessels in various organs and may eventually lead to heart attack, heart or kidney failure, stroke, or loss of vision. Usually, there are no symptoms of high blood pressure before such complications occur. Therefore, it is important to have your blood pressure checked regularly to ensure it remains 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 more than 3 months pregnant. (Tolurindo should also be avoided in early pregnancy – see section “Pregnancy”);
• if the patient has severe liver function disorders, such as cholestasis or biliary obstruction (problems with bile flow from the liver and gallbladder), or any other severe liver disease;
• if the patient has hepatic encephalopathy (a brain dysfunction caused by liver disease);
• if the patient has diabetes or kidney problems 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 Tolurindo, discuss with your doctor if the patient has or has had any of the following conditions or diseases:

• kidney disease or status post kidney transplant;
• renal artery stenosis (narrowing of the blood vessels supplying one or both kidneys);
• liver disease;
• heart-related disorders;
• elevated aldosterone levels (water and salt retention in the body, accompanied by disturbances in the balance of various blood minerals);
• low blood pressure (hypotension), which is more likely if the patient is dehydrated (excessive loss of body water) or has salt deficiency due to diuretic use, low-salt diet, diarrhoea, or vomiting;
• high potassium levels in the blood;
• diabetes;
• gout.

Before starting Tolurindo, discuss with your doctor or pharmacist:

• if the patient is taking any of the following medicines used to treat high blood pressure:
• an angiotensin-converting enzyme (ACE) inhibitor (e.g. enalapril, lisinopril, ramipril), particularly if the patient has kidney problems related to diabetes.
• aliskiren. The treating physician may monitor kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals. See also section “When not to take Tolurindo”.
• if the patient is taking digoxin;
• if the patient experiences worsening of vision or eye pain. These may be symptoms of fluid accumulation in the choroid layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur within hours or weeks after taking Tolurindo. Untreated, these symptoms may lead to permanent vision loss. If the patient has previously had an allergic reaction to penicillin or sulfonamides, the risk of these disorders is higher.
• if the patient has muscle disorders, including muscle pain, tenderness, weakness, or cramps;
• if the patient is scheduled for a test assessing parathyroid function.

If the patient experiences abdominal pain, nausea, vomiting, or diarrhoea after taking Tolurindo, discuss this with the doctor. The doctor will decide on further treatment. Do not make independent decisions about stopping Tolurindo.
Inform the doctor about suspected (or planned) pregnancy. Tolurindo is not recommended during early pregnancy and must not be taken if the patient is more than 3 months pregnant, as it may seriously harm the unborn child (see section “Pregnacy”).
If undergoing planned surgery or anaesthesia, inform the doctor about taking Tolurindo.
Inform the doctor if the patient has a light allergy reaction.
The doctor may recommend blood tests to monitor electrolyte levels.
Tolurindo may be less effective in lowering blood pressure in Black patients.
If the patient believes any of the above situations apply, or has questions or concerns about using Tolurindo, they should contact their doctor or pharmacist.

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

Tolurindo with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take. The doctor may decide to adjust the dose of these medicines or take other precautions. In some cases, it may be necessary to discontinue one of the medicines. This particularly applies when Tolurindo is taken together 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 may 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, NSAIDs (non-steroidal anti-inflammatory drugs, e.g. acetylsalicylic acid or ibuprofen), heparin, immunosuppressive medicines (e.g. cyclosporine or tacrolimus), and the antibiotic trimethoprim;
• diuretics (water tablets), especially when taken in high doses together with Tolurindo, as they may lead to excessive loss of body water and reduced blood pressure (hypotension);
• if the patient is taking an ACE inhibitor or aliskiren (see also sections “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 psychiatric disorders such as depression, anxiety, schizophrenia (e.g. tricyclic antidepressants, antipsychotics, neuroleptics such as amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol);
• bepridil (used to treat ischemic heart disease causing chest pain);
• cisapride (used to treat reduced oesophageal and gastric motility);
• difemanil (used to treat gastrointestinal disorders);
• antibiotics used to treat bacterial infections (e.g. sparfloxacin, moxifloxacin, intravenous erythromycin);
• intravenous vinpocetine (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);
• intravenous amphotericin B (used to treat fungal infections);
• corticosteroids, used to treat various diseases including severe asthma and rheumatoid arthritis (systemic administration);
• stimulant laxatives;
• baclofen (used to treat muscle stiffness occurring in diseases such as multiple sclerosis);
• allopurinol (used to treat gout);
• metformin (used to treat diabetes);
• iodine-containing contrast agents (used during diagnostic X-ray procedures);
• calcium tablets or other calcium supplements;
• cyclosporine, tacrolimus, or other medicines that suppress the immune system after organ transplantation or used to treat autoimmune diseases or severe rheumatic or dermatological diseases;
• tetracosactide (used to treat Crohn’s disease);
• methadone (used to treat addiction).

The effect of Tolurindo may be reduced when the patient takes NSAIDs (non-steroidal anti-inflammatory drugs, e.g. acetylsalicylic acid or ibuprofen) or corticosteroids.
Tolurindo may enhance the blood pressure-lowering effect of other medicines used to treat high blood pressure or medicines that may cause reduced blood pressure (e.g. baclofen, amifostine). Additionally, low blood pressure may be further reduced by:
alcohol, barbiturates, narcotics, or antidepressants. A symptom is dizziness upon standing.
If dose adjustment of another medicine taken during Tolurindo treatment is needed, consult the doctor.

Tolurindo with food, drink, and alcohol
Tolurindo can be taken with food or independently of meals.
Alcohol may cause a greater reduction in blood pressure and/or increase the risk of dizziness or fainting.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Inform the doctor about suspected (or planned) pregnancy. Usually, the doctor will recommend stopping Tolurindo before planned pregnancy or immediately after confirming pregnancy, and will recommend an alternative medicine. Tolurindo should be replaced with another treatment as soon as possible before planned pregnancy or after confirming pregnancy. Tolurindo is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may seriously harm the unborn child if used after the third month.

Breastfeeding
Inform the doctor about breastfeeding or plans to breastfeed. The active substance passes into breast milk. Tolurindo is not recommended during breastfeeding. The doctor may choose an alternative treatment during breastfeeding, especially when feeding newborns or preterm infants.

Driving and operating machinery
This medicine may cause side effects related to lowering blood pressure, such as dizziness or fatigue (see section 4). Do not drive or operate machinery if the patient experiences dizziness or fatigue.

Tolurindo contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered “sodium-free”.

3. How to take Tolurindo

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in
doubt, consult your doctor or pharmacist.
The recommended dose of Tolurindo is one tablet per day, preferably in the morning. Try to take
Tolurindo at the same time each day.
Tolurindo may be taken during or between meals. Swallow the tablets whole with water or another
non-alcoholic drink. Do not crush or chew the tablets.
It is important to take Tolurindo every day, unless otherwise advised by your doctor. If you feel
that the effect of Tolurindo is too strong or too weak, consult your doctor or pharmacist. Treatment
of high blood pressure is usually long-term.
If you have impaired liver function, your doctor will adjust the dose accordingly.
Taking more Tolurindo than recommended
If you accidentally take too many tablets, contact your doctor or pharmacist immediately, or go to
the nearest hospital emergency department.
Very high doses of Tolurindo may cause nausea, vomiting, low blood pressure, muscle cramps,
dizziness, drowsiness, confusion, and changes in the amount of urine produced by the kidneys.
Missing a dose of Tolurindo
If you miss a dose, take it as soon as you remember, then continue taking the medicine as before.
If you do not take a tablet within the same day, take your usual dose the next day. Do not take a
double dose to make up for a missed tablet.
Stopping Tolurindo
Since treatment of high blood pressure is usually lifelong, you should consult your doctor before
stopping this medicine.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If the patient experiences any of the following adverse reactions, which may be serious, treatment must be discontinued and immediate contact with a physician is required:

• Septicaemia (often called "blood poisoning", a severe infection causing systemic inflammation), which may have occurred coincidentally or may be related to an unknown mechanism (rare – may occur in no more than 1 in 1,000 people);

• Sudden swelling of the skin of the limbs or face, swelling of the lips or tongue, mucous membranes of the throat or airways, causing shortness of breath or difficulty swallowing (angioedema). (rare – may occur in no more than 1 in 1,000 patients). If
  these symptoms are not treated, they may lead to death.

• Severe skin reactions, including severe rash, redness of the entire skin surface, intense itching, blistering, peeling and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome) or other allergic reactions (very rare – may occur in fewer than 1 in 10,000 patients);

• Life-threatening heart rhythm disturbances (frequency unknown);

• Pancreatitis, which may cause severe upper abdominal pain radiating to the back and general malaise (very rare – may occur in fewer than 1 in 10,000 patients);

• Brain disease caused by liver disease (hepatic encephalopathy) (frequency unknown);

• Inflammation of the liver (frequency unknown);

• Muscle weakness, cramps, tenderness or muscle pain, particularly when the patient also feels unwell or has a high temperature, which may be due to abnormal muscle breakdown (frequency unknown).

Possible adverse reactions of Tolurindo:
Common (may occur in no more than 1 in 10 people):

• Allergic reactions, mainly affecting the skin, such as rash, in individuals prone to allergies and asthmatic reactions
• Red, raised rash
• Low blood potassium levels

Uncommon (may occur in no more than 1 in 100 people):

• Urinary tract infections, upper respiratory tract infections
• Decreased number of red blood cells (anaemia)
• Difficulty falling asleep
• Low mood (depression)
• Fainting
• Sensation of spinning (peripheral vertigo)
• Slow heart rate (bradycardia)
• Low blood pressure (hypotension), dizziness upon standing (orthostatic hypotension)
• Shortness of breath, cough
• Abdominal pain, diarrhoea, abdominal discomfort, bloating, vomiting
• Small red spots on the skin (petechiae), itching, excessive sweating, drug rash
• Back pain, muscle cramps, muscle pain
• Kidney dysfunction, including acute kidney failure
• Chest pain, feeling of weakness
• Increased blood creatinine levels
• High potassium levels in plasma
• Low blood sodium levels, which may lead to dehydration and low blood pressure
• Impotence (inability to achieve or maintain erection)

Rare (may occur in no more than 1 in 1,000 people):

• Increased number of certain white blood cells (eosinophilia)
• Low platelet count (thrombocytopenia)
• Severe allergic reaction (anaphylactic reaction)
• Allergic reaction (e.g. rash, itching, breathing difficulties, wheezing, facial swelling)
• Feeling of restlessness
• Feeling of fatigue, headache, tingling (paraesthesia)
• Drowsiness
• Visual disturbances
• Fast heart rate (tachycardia)
• Nausea, constipation, dryness of the oral mucosa, gastritis, taste disturbances
• Liver function disorders (more common in patients of Japanese origin)
• Eruptions (skin disease), redness of the skin, urticaria, severe drug rash
• Joint pain, limb pain, tendon pain
• Influenza-like symptoms
• Decreased haemoglobin concentration (a protein in the blood)
• Increased uric acid levels, a substance which may cause gout or worsen existing gout (joint pain)
• Increased liver enzyme or creatine phosphokinase activity in blood
• Low blood sugar levels (in patients with diabetes)
• Low chloride levels in blood
• Low magnesium levels in blood

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

• Agranulocytosis, aplastic anaemia, haemolytic anaemia
• Decreased number of white blood cells, which may cause fever, redness of the throat or other influenza-like symptoms (leukopenia)
• Heart rhythm disturbances (causing palpitations and sensation of rapid heartbeat)
• Cases of progressive lung tissue fibrosis (interstitial lung disease) have been reported during telmisartan treatment, although it is not known whether telmisartan was the cause
• High calcium levels in blood

Frequency unknown (cannot be estimated from available data):

• Myopia
• Blurred vision, visual disturbance
• Worsening of vision or eye pain due to high pressure (possible symptoms of fluid accumulation in the choroidal layer of the eye (choroidal effusion) or acute angle-closure glaucoma)
• Abnormal electrocardiogram (ECG) findings
• Possible worsening of systemic lupus erythematosus symptoms (a type of collagenosis)
• Photosensitivity reaction (skin changes) following exposure to sunlight or artificial UVA radiation
• Increased blood glucose levels in patients with diabetes
• Intestinal angioedema – following administration of similar products, intestinal swelling with symptoms such as abdominal pain, nausea, vomiting and diarrhoea has occurred

Reporting of adverse reactions
If any adverse reactions occur, including any not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can
be reported directly to the Department of Monitoring 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Tolurindo

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton after EXP. The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from moisture and light.
No special temperature storage requirements for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Tolurindo contains

• The active substances are telmisartan and indapamide.
  Tolurindo 40 mg + 1.5 mg modified-release tablets
  Each modified-release tablet contains 40 mg telmisartan and 1.5 mg indapamide.
  Tolurindo 80 mg + 1.5 mg modified-release tablets
  Each modified-release tablet contains 80 mg telmisartan and 1.5 mg 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, colloidal anhydrous 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 modified-release tablets
Capsule-shaped, two-layer, biconvex tablets. One layer of the tablet is orange, mottled. The other layer is white to brownish-yellowish-white, mottled, with the imprint TI1.
Tablet dimensions: approximately 18 mm x 8 mm.

Tolurindo 80 mg + 1.5 mg modified-release tablets
Capsule-shaped, two-layer, biconvex tablets. One layer of the tablet is brownish-yellow, mottled. The other layer is white to brownish-yellowish-white, mottled, with the imprint TI2.
Tablet dimensions: approximately 18 mm x 8 mm.

Tolurindo is available in cardboard packaging containing:

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

Marketing Authorisation 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 medicinal product is authorised in the Member States of the European Economic Area under the following names:

For more detailed information about this medicinal product, please contact the local representative of the marketing authorisation holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw
Phone: +48 22 57 37 500