Lorista

Leaflet attached to the packaging: patient information

Lorista, 25 mg, film-coated tablets

Lorista, 50 mg, film-coated tablets

Lorista, 100 mg, film-coated tablets

Losartan potassium

Read the 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.
• In case of any doubts, 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 their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Lorista and what is it used for

Lorista belongs to a group of medicines called angiotensin II receptor antagonists.
Angiotensin II is a substance produced in the body that, by binding to receptors in blood vessel walls, causes them to narrow. This results in increased blood pressure.
Losartan, the active substance of Lorista, prevents angiotensin II from binding to these receptors, causing blood vessels to widen and, as a result, lowering blood pressure.
Losartan slows down the deterioration of kidney function in patients with high blood pressure and type 2 diabetes.
Lorista is used:

• to treat high blood pressure (hypertension) in adults and in children and adolescents from 6 to 18 years old;
• to protect the kidneys in patients with high blood pressure and type 2 diabetes, with laboratory-confirmed kidney function disorders and proteinuria ≥0.5 g/day (a condition in which the urine contains an abnormal amount of protein);
• to treat patients with chronic heart failure, when treatment with certain medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors, drugs used to lower high blood pressure) is not considered appropriate by the doctor. If heart failure has been stabilized with an ACE inhibitor, the medicine should not be switched to losartan.
• in patients with high blood pressure and thickening of the left ventricular wall, as it has been shown that Lorista reduces the risk of stroke (the "LIFE indication").

2. Important information before taking Lorista

When not to take Lorista

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• if the patient is allergic to losartan or any of the other ingredients of this medicine (listed in section 6),
• after the third month of pregnancy (Lorista should also be avoided in early pregnancy, see section "Pregnancy and breastfeeding"),
• if the patient has severe liver function disorders,
• if the patient has diabetes or kidney function disorders and is being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Before starting to take Lorista, the patient should discuss it with their doctor or pharmacist.
The patient should inform their doctor about suspected or planned pregnancy. The doctor will usually recommend stopping Lorista before planned pregnancy or as soon as pregnancy is confirmed, and recommend taking a different medicine instead of Lorista. Lorista should not be taken in early pregnancy and must not be taken after the third month of pregnancy, as it may seriously harm the baby (see section "Pregnancy and breastfeeding").
It is essential to inform the doctor before taking Lorista:

• if the patient has ever had angioedema (swelling of the face, lips, throat, and/or tongue) (see also section 4 "Possible side effects"),
• if the patient has had severe vomiting or diarrhea leading to excessive loss of fluids and/or electrolytes,
• if the patient is taking diuretics (medicines that increase the amount of water excreted by the kidneys) or a low-salt diet leading to excessive loss of fluids and electrolytes (see section 3 "Dosage in special patient groups"),
• if the patient has narrowing or blockage of the blood vessels leading to the kidneys or has recently had a kidney transplant,
• if the patient has liver function disorders (see sections 2 "When not to take Lorista" and 3 "Dosage in special patient groups"),
• if the patient has heart failure, with or without kidney function disorders, or severe, life-threatening arrhythmia. Special caution is necessary when co-administering beta-blockers,
• if the patient has valve or muscle disorders of the heart,
• if the patient has coronary heart disease (caused by reduced blood flow in the coronary arteries) or cerebrovascular disorders (caused by reduced blood flow in the brain),
• if the patient has primary hyperaldosteronism (a syndrome caused by increased aldosterone secretion by the adrenal glands, caused by adrenal gland disorders),
• if the patient is taking other medicines that may increase potassium levels in the blood (see section 2 "Lorista and other medicines"),
• if the patient is taking any of the following medicines used to treat high blood pressure:
• angiotensin-converting enzyme inhibitor (ACE inhibitor, e.g., enalapril, lisinopril, ramipril), especially if the patient has kidney function disorders associated with diabetes,
• aliskiren. The doctor may monitor kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood at regular intervals. See also the information under the heading "When not to take Lorista".

Children and adolescents

Studies have been conducted on the use of losartan in children. For more information, patients should consult their doctor.
Losartan is not recommended for use in children and adolescents with kidney or liver function disorders due to limited data available for these patient groups. Losartan is not recommended for use in children under 6 years of age, as its efficacy has not been demonstrated in this age group.
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Lorista and other medicines

Patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might take.
Patient should tell their doctor about any potassium supplements, salt substitutes containing potassium, potassium-sparing diuretics (e.g., amiloride, triamterene, spironolactone), or other medicines that may increase potassium levels in the blood (e.g., heparin, trimethoprim-containing medicines), as co-administration with Lorista is not recommended.
Special caution is necessary when taking the following medicines during treatment with Lorista:

• other blood pressure-lowering medicines, as they may cause additional lowering of blood pressure. Blood pressure may also be lowered by the following medicines/groups of medicines: tricyclic antidepressants, antipsychotics, baclofen, amifostine,
• non-steroidal anti-inflammatory drugs, such as indomethacin, including COX-2 inhibitors (medicines used to reduce inflammation and relieve pain), as they may weaken the blood pressure-lowering effect of losartan. In patients with kidney function disorders, co-administration of these medicines may lead to worsening of kidney function. Lorista should not be taken with lithium without close medical supervision. Periodic blood tests may be necessary. The doctor may need to adjust the dose and/or take other precautions:
• if the patient is taking an ACE inhibitor or aliskiren (see also the information under the headings "When not to take Lorista" and "Warnings and precautions").

Taking Lorista with food and drink

Lorista can be taken with or without food.
Patient should avoid drinking grapefruit juice while taking Lorista.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Patient should inform their doctor about suspected or planned pregnancy. The doctor will usually recommend stopping Lorista before planned pregnancy or as soon as pregnancy is confirmed, and recommend taking a different medicine instead of Lorista. Lorista should not be taken in early pregnancy and must not be taken after the third month of pregnancy, as it may seriously harm the baby.
Breastfeeding
Patient should inform their doctor about breastfeeding or intention to breastfeed. Lorista is not recommended during breastfeeding, especially in newborns or premature babies. The doctor may recommend a different medicine.

Driving and using machines

No studies have been conducted on the effects of Lorista on the ability to drive and use machines. It is unlikely that Lorista will affect the ability to drive and use machines. However, as with many medicines used to treat high blood pressure, losartan may cause dizziness or drowsiness.
In case of dizziness or drowsiness, patient should consult their doctor before performing such activities.

Lorista contains lactose monohydrate

3. How to take Lorista

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, patient should consult their doctor or pharmacist.
The doctor will determine the appropriate dose of Lorista, depending on the patient's condition and other medicines being taken. It is essential to take Lorista for as long as the doctor recommends to maintain constant blood pressure control.
Adult patients with high blood pressure
Treatment usually starts with a dose of 50 mg of losartan (one 50 mg Lorista tablet) once a day. The maximum blood pressure-lowering effect should occur within 3 to 6 weeks after starting treatment. In some patients, the dose may be increased to 100 mg of losartan (two 50 mg Lorista tablets) once a day.
In case of feeling that the effect of losartan is too strong or too weak, patient should consult their doctor or pharmacist.

Dosage in children and adolescents

Children under 6 years of age
Lorista is not recommended for use in children under 6 years of age, as its efficacy has not been demonstrated in this age group.
Children from 6 to 18 years of age
The recommended initial dose is 0.7 mg of losartan per kilogram of body weight, given once a day (up to 25 mg of Lorista). The doctor may increase the dose if blood pressure is not well controlled.
Adult patients with high blood pressure and type 2 diabetes
Treatment usually starts with a dose of 50 mg of losartan (one 50 mg Lorista tablet) once a day. The dose may be increased to 100 mg of losartan (two 50 mg Lorista tablets) once a day, depending on the blood pressure response.
Losartan can be taken with other blood pressure-lowering medicines (e.g., diuretics, calcium channel blockers, alpha- or beta-blockers) and with insulin and other commonly used medicines to lower blood glucose levels (e.g., sulfonylurea derivatives, glitazones, and glucosidase inhibitors).
Adult patients with heart failure
Treatment usually starts with a dose of 12.5 mg of losartan (half a 25 mg Lorista tablet) once a day. This dose is usually increased gradually at weekly intervals (i.e., 12.5 mg per day during the first week, 25 mg per day during the second week, 50 mg per day during the third week, 100 mg per day during the fourth week, 150 mg per day during the fifth week) until the maintenance dose is reached, as recommended by the doctor.
The maximum recommended dose is 150 mg of losartan (e.g., three 50 mg Lorista tablets or one 100 mg Lorista tablet and one 50 mg Lorista tablet) once a day.
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In the treatment of heart failure, losartan is usually taken with diuretics (medicines that increase the amount of water excreted by the kidneys) and/or digitalis glycosides (medicines that strengthen the heart and improve its efficiency) and/or beta-blockers.

Dosage in special patient groups

The doctor may recommend a lower dose, especially when starting treatment in certain patients, such as those taking high doses of diuretics, patients with liver function disorders, or patients over 75 years of age. Losartan should not be taken by patients with severe liver function disorders (see section "When not to take Lorista").

Method of administration

The tablets should be swallowed with a glass of water. Patient should try to take their daily dose of Lorista at the same time every day. It is essential to take Lorista for as long as the doctor recommends.

Overdose

In case of accidental overdose, patient should immediately consult their doctor. Symptoms of overdose are low blood pressure, rapid heartbeat, and possibly slow heartbeat.

Missed dose

In case of a missed dose, the next dose should be taken at the usual time. Patient should not take a double dose to make up for the missed dose.
In case of any further doubts about taking this medicine, patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Lorista can cause side effects, although not everybody gets them.
In case of the following side effects, patient should stop taking losartan and immediately consult their doctor or go to the emergency department of the nearest hospital:
Severe allergic reactions (rash, itching, swelling of the face, lips, tongue, or throat, which may cause difficulty swallowing or breathing).
This is a severe but rare side effect, occurring in more than 1 in 10,000 patients but less than 1 in 1,000 patients. Immediate medical attention or hospitalization may be necessary.
The following side effects have been reported for losartan:
Common (may affect up to 1 in 10 people):

• dizziness,
• low blood pressure (especially after excessive fluid loss, e.g., in patients with severe heart failure or those taking high doses of diuretics),
• dose-dependent orthostatic symptoms, such as decreased blood pressure when standing up from a lying or sitting position,
• weakness,
• fatigue,
• low blood glucose levels (hypoglycemia),
• high potassium levels in the blood (hyperkalemia),
• changes in kidney function, including kidney failure,
• decreased red blood cell count (anemia),

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• increased levels of urea, creatinine, and potassium in the blood in patients with heart failure. Uncommon (may affect up to 1 in 100 people):
• drowsiness,
• headache,
• sleep disorders,
• palpitations (feeling of rapid or irregular heartbeat),
• severe chest pain (angina pectoris),
• shortness of breath (dyspnea),
• abdominal pain,
• constipation,
• diarrhea,
• nausea,
• vomiting,
• hives,
• itching,
• rash,
• local swelling,
• cough. Rare (may affect up to 1 in 1,000 people):
• hypersensitivity reactions,
• angioedema,
• vasculitis (including Henoch-Schönlein purpura),
• numbness or tingling (paresthesia),
• fainting,
• very rapid and irregular heartbeat (atrial fibrillation),
• stroke,
• hepatitis,
• increased alanine aminotransferase (ALT) activity in the blood, usually resolving after discontinuation of treatment. Frequency not known (cannot be estimated from the available data):
• decreased platelet count (thrombocytopenia),
• migraine,
• liver function disorders,
• joint and muscle pain,
• flu-like symptoms,
• back pain and urinary tract infections,
• increased sensitivity to sunlight,
• unexplained muscle pain and dark urine (rhabdomyolysis),
• impotence,
• pancreatitis,
• low sodium levels in the blood (hyponatremia),
• depression,
• general malaise,
• ringing, buzzing, booming, or hissing in the ears (tinnitus),
• taste disorders. Side effects in children are similar to those observed in adults.

Reporting side effects

If patient experiences any side effects, including those not listed in the 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:
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Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Lorista

The medicine should be stored out of sight and reach of children.
Do not take this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Store in a temperature below 30°C, in the original packaging.
Medicines should not be disposed of via wastewater or household waste. Patient should ask their 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 Lorista contains

• The active substance of Lorista is losartan potassium. Each film-coated tablet contains 25 mg, 50 mg, or 100 mg of losartan potassium.
• The other ingredients are: Lorista, 25 mg, film-coated tablets: cornstarch, pregelatinized cornstarch, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, cellactose (lactose monohydrate and cellulose); coating: hypromellose, talc, propylene glycol, titanium dioxide (E 171), quinoline yellow (E 104). Lorista, 50 mg, film-coated tablets: cornstarch, pregelatinized cornstarch, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, cellactose (lactose monohydrate and cellulose); coating: hypromellose, talc, propylene glycol, titanium dioxide (E 171). Lorista, 100 mg, film-coated tablets: cornstarch, pregelatinized cornstarch, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, cellactose (lactose monohydrate and cellulose); coating: hypromellose, talc, propylene glycol, titanium dioxide (E 171). See section 2 "Lorista contains lactose monohydrate".

What Lorista looks like and contents of the pack

Lorista, 25 mg: yellow, oval, slightly convex film-coated tablets with a dividing line on one side. The tablet can be divided into equal doses.
Lorista, 50 mg: white, round, slightly convex film-coated tablets with a dividing line on one side. The dividing line is not intended for breaking the tablet.
Lorista, 100 mg: white, oval, slightly convex film-coated tablets.

Packaging

Lorista, 25 mg:28 or 56 film-coated tablets in blisters, in a cardboard box
Lorista, 50 mg, 100 mg:28, 56, or 84 film-coated tablets in blisters, in a cardboard box

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
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Manufacturer/Importer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany (only for Lorista, 50 mg)
KRKA-POLSKA Sp. z o.o., ul. Równoległa 5, 02-235 Warsaw (only for Lorista, 50 mg and 100 mg)
For more information about this medicine, patient should contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Phone: 22 57 37 500
Date of last revision of the leaflet:16.02.2024
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