Losartan Krka

Leaflet accompanying the packaging: patient information

Losartan Krka, 25 mg, film-coated tablets

Losartan Krka, 50 mg, film-coated tablets

Losartan Krka, 100 mg, film-coated tablets

Losartan potassium

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

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given 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

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

1. What is Losartan Krka and what is it used for

Losartan, the active substance of Losartan Krka, belongs to a group of medicines called angiotensin II receptor antagonists.
Angiotensin II is a substance produced in the body that binds to receptors in the walls of blood vessels, causing them to narrow. This results in increased blood pressure.
Losartan prevents angiotensin II from binding to these receptors, causing the 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.
Losartan Krka is used:

• to treat high blood pressure (hypertension) in adults and children and adolescents from 6 to 18 years of age;
• 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 per 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, medicines 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 Krka;
• in patients with high blood pressure and thickening of the left ventricular wall, as it has been shown that Losartan Krka reduces the risk of stroke.

2. Important information before taking Losartan Krka

When not to take Losartan Krka

• if the patient is allergic to losartan or any of the other ingredients of this medicine (listed in section 6),
• after the 3rd month of pregnancy (Losartan Krka 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 Losartan Krka, the doctor or pharmacist should be consulted.
The doctor should be informed of any suspected (or planned) pregnancy. The doctor will usually recommend stopping Losartan Krka before planned pregnancy or immediately after confirmation of pregnancy and recommend taking another medicine instead of Losartan Krka. Losartan Krka should not be taken in early pregnancy and should not be taken after the 3rd month of pregnancy, as it may seriously harm the baby (see section "Pregnancy and breastfeeding").
It is important to inform the doctor:

• if the patient has ever had angioedema (swelling of the face, lips, throat, and/or tongue), see also section 4,
• if the patient has severe vomiting or diarrhea leading to excessive loss of fluids and/or electrolytes from the body,
• 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 from the body (see section 3 "Dosage in special patient groups"),
• if the patient has narrowing or blockage of the blood vessels leading to the kidneys or if the patient has recently had a kidney transplant,
• if the patient has liver function disorders (see sections 2 "When not to take Losartan Krka" and 3 "Dosage in special patient groups"),
• if the patient has heart failure, with or without kidney function disorders, or severe, life-threatening heart rhythm disorders - special caution is necessary when taking ß-adrenolytics concomitantly,
• if the patient has valve or heart muscle disorders,
• if the patient has coronary artery disease (caused by reduced blood flow in the blood vessels of the heart) 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 abnormalities),
• if the patient is taking other medicines that may increase potassium levels in the blood (see section 2 "Losartan Krka 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), such as enalapril, lisinopril, ramipril, especially if the patient has kidney function disorders associated with diabetes,
• aliskiren.

The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood.
See also section "When not to take Losartan Krka".
If, after taking Losartan Krka, the patient experiences abdominal pain, nausea, vomiting, or diarrhea. The doctor will decide on further treatment. The patient should not stop taking Losartan Krka on their own.

Children and adolescents

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

Losartan Krka and other medicines

The doctor or pharmacist should be told about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
The doctor should be told 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 concomitant use with Losartan Krka is not recommended.
Special caution should be exercised when taking the following medicines during treatment with Losartan Krka:

• other blood pressure-lowering medicines, as they may further lower blood pressure. Blood pressure may also be lowered by the following medicines/groups of medicines: tricyclic antidepressants, antipsychotics, baclofen, amifostine,
• non-steroidal anti-inflammatory medicines, such as indomethacin, including COX-2 inhibitors (medicines that reduce inflammation and are used to relieve pain), as they may weaken the blood pressure-lowering effect of losartan.

The doctor may recommend a dose change and/or take other precautions:

• if the patient is taking an ACE inhibitor or aliskiren (see also sections "When not to take Losartan Krka" and "Warnings and precautions").

In case of kidney function disorders, concomitant use of these medicines may lead to worsening of kidney function.
Lithium-containing medicines should not be taken in combination with losartan without close medical supervision (e.g., blood tests).

Losartan Krka with food and drink

Losartan Krka can be taken with or without food.
Grapefruit juice should be avoided during treatment with Losartan Krka.

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
The doctor should be informed of any suspected (or planned) pregnancy. The doctor will usually recommend stopping Losartan Krka before planned pregnancy or immediately after confirmation of pregnancy and recommend taking another medicine instead of Losartan Krka. Losartan Krka should not be taken in early pregnancy and should not be taken after the 3rd month of pregnancy, as it may seriously harm the baby.
Breastfeeding
The doctor should be informed of breastfeeding or intention to breastfeed. Losartan Krka is not recommended during breastfeeding, especially in the case of breastfeeding a newborn or premature baby. The doctor may recommend taking another medicine.
Before taking any medicine, the doctor or pharmacist should be consulted.

Driving and using machines

No studies have been conducted on the effect of the preparation on the ability to drive and use machines.
It is unlikely that losartan will affect this ability. However, like many medicines used to treat high blood pressure, losartan may cause dizziness or drowsiness. If dizziness or drowsiness occurs, the doctor should be consulted before performing such activities.

Losartan Krka contains lactose

If the patient has been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to take Losartan Krka

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the doctor or pharmacist should be consulted.
The doctor will determine the appropriate dose of Losartan Krka, depending on the patient's condition and other medicines being taken. It is important to take Losartan Krka for as long as the doctor recommends, in order to maintain constant control of blood pressure.
Losartan Krka is available in the following strengths: 25 mg, 50 mg, and 100 mg.
Losartan Krka 25 mg can be divided into two equal doses.
Adult patients with high blood pressure
Treatment usually starts with a dose of 50 mg of losartan (one tablet of Losartan Krka 50 mg) once a day. The maximum blood pressure-lowering effect should occur within 3 to 6 weeks of starting treatment. In some patients, the dose may then be increased to 100 mg of losartan (two tablets of Losartan Krka 50 mg) once a day.
If the patient feels that the effect of losartan is too strong or too weak, they should consult their doctor or pharmacist.

Use in children and adolescents

Children under 6 years of age
Losartan Krka is not recommended for 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 for patients with a body weight of 20 kg to 50 kg is 0.7 mg of losartan per kilogram of body weight, taken once a day (up to 25 mg of Losartan Krka). The doctor may increase the dose if blood pressure is not well controlled.
A different formulation of this medicine may be more suitable for children. The doctor or pharmacist should be consulted.
Adult patients with high blood pressure and type 2 diabetes
Treatment usually starts with a dose of 50 mg of losartan (one tablet of Losartan Krka 50 mg) once a day. The dose may then be increased to 100 mg of losartan (two tablets of Losartan Krka 50 mg) once a day, depending on the blood pressure values obtained.
Losartan can be taken concomitantly with other blood pressure-lowering medicines (e.g., diuretics, calcium antagonists, alpha- or beta-adrenolytics, and centrally acting medicines), as well as with insulin and other commonly used medicines to lower blood glucose levels (e.g., sulfonylurea derivatives, glitazones, and glucose inhibitors).
Adult patients with heart failure
Treatment usually starts with a dose of 12.5 mg of losartan (half a tablet of Losartan Krka 25 mg) once a day. The 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.
The maximum dose is 150 mg of losartan (e.g., three tablets of Losartan Krka 50 mg or one tablet of Losartan Krka 100 mg and one tablet of Losartan Krka 50 mg) once a day.
In the treatment of heart failure, losartan is usually taken in combination with diuretics (medicines that increase the amount of water excreted by the kidneys) and/or digitalis glycosides (medicines that increase the strength of heart contractions and improve its efficiency) and/or beta-adrenolytics.

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 Losartan Krka").

Method of administration

The tablets should be swallowed with a glass of water. The patient should try to take the daily dose at the same time every day. It is important to take Losartan Krka for as long as the doctor recommends.

Taking a higher than recommended dose of Losartan Krka

In case of accidental ingestion of too many tablets, the doctor should be contacted immediately. Symptoms of overdose are low blood pressure, rapid heart rate, and possibly slow heart rate.

Missing a dose of Losartan Krka

If a dose is missed, the next dose should be taken at the usual time. A double dose should not be taken to make up for the missed dose.
In case of any further doubts about taking this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Losartan Krka can cause side effects, although not everybody gets them.
In case of the following side effects, the patient should stop taking Losartan Krka and consult their doctor or go to the emergency department of the nearest hospital immediately:
Severe allergic reaction (rash, itching, swelling of the face, lips, mouth, or throat, which may cause difficulty swallowing or breathing).
This is a serious but rare side effect, occurring in at least 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:

• dizziness,
• low blood pressure (especially after excessive loss of fluids from the body, 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),
• increased levels of urea, creatinine, and potassium in the blood in patients with heart failure.

Frequent (may occur in less than 1 in 10 patients):

• dizziness,
• low blood pressure (especially after excessive loss of fluids from the body, 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),
• increased levels of urea, creatinine, and potassium in the blood in patients with heart failure.

Uncommon (may occur in less than 1 in 100 patients):

• drowsiness,
• headache,
• sleep disorders,
• palpitations (feeling of rapid heart rate),
• severe chest pain (angina pectoris),
• shortness of breath,
• abdominal pain,
• constipation,
• diarrhea,
• nausea,
• vomiting,
• hives,
• itching,
• rash,
• local swelling,
• cough.

Rare (may occur in less than 1 in 1,000 patients):

• allergic reactions,
• angioedema,
• vasculitis (including Henoch-Schönlein purpura),
• numbness or tingling (paresthesia),
• fainting,
• very rapid and irregular heart rate (atrial fibrillation),
• stroke,
• angioedema of the intestines: swelling in the intestine with symptoms such as abdominal pain, nausea, vomiting, and diarrhea,
• hepatitis,
• increased alanine aminotransferase (ALT) activity in the blood, usually resolving after discontinuation of treatment.

Frequency not known (frequency 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 infection,
• 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 ticking in the ears (tinnitus),
• taste disorders.

Side effects in children are similar to those observed in adults.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the doctor or pharmacist should be told. 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:
Jerozolimskie Avenue 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 Losartan Krka

The medicine should be stored out of sight and reach of children.
The medicine should not be taken after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the month.
The medicine should not be stored above 30°C.
The blister should be stored in the outer packaging to protect it from moisture.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked 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 Losartan Krka contains

• The active substance of Losartan Krka is losartan potassium. Each film-coated tablet contains 25 mg of losartan potassium, which corresponds to 22.9 mg of losartan. Each film-coated tablet contains 50 mg of losartan potassium, which corresponds to 45.8 mg of losartan. Each film-coated tablet contains 100 mg of losartan potassium, which corresponds to 91.5 mg of losartan.
• The other ingredients of Losartan Krka 25 mg film-coated tablets are: cellulose (lactose monohydrate, cellulose, powder), maize starch, maize starch paste, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, hypromellose, talc, propylene glycol, quinoline yellow (E104), titanium dioxide (E171).
• The other ingredients of Losartan Krka 50 mg and 100 mg film-coated tablets are: cellulose (lactose monohydrate, cellulose, powder), maize starch, maize starch paste, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, hypromellose, talc, propylene glycol, titanium dioxide (E171). See section 2 "Losartan Krka contains lactose".

What Losartan Krka looks like and contents of the pack

Losartan Krka 25 mg film-coated tablets: yellow, oval (8.5 mm x 4.5 mm), slightly convex on both sides with a score line. The tablet can be divided into two equal doses.
Losartan Krka 50 mg film-coated tablets: white, round (7.9 mm x 8.2 mm), slightly convex on both sides with a score line. The score line is not intended for breaking the tablet.
Losartan Krka 100 mg film-coated tablets: white, oval (15 mm x 8 mm), slightly convex on both sides.
Losartan Krka 25 mg film-coated tablets
Aluminium/PVC/PVDC blisters in a cardboard box.
Packaging: 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100 film-coated tablets in blisters of 7, 10, 14, or 15 tablets in the outer packaging.
Losartan Krka 50 mg film-coated tablets
Aluminium/PVC/PVDC blisters in a cardboard box.
Packaging: 10, 14, 15, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100 film-coated tablets in blisters of 7, 10, 14, or 15 tablets in the outer packaging.
Losartan Krka 100 mg film-coated tablets
Aluminium/PVC/PVDC blisters in a cardboard box.
Packaging: 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100 film-coated tablets in blisters of 7, 10, 14, or 15 tablets in the outer packaging.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

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

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

For more information about this medicine, the local representative of the marketing authorization holder should be contacted:
KRKA-POLSKA Sp. z o.o.
Równoległa 5
02-235 Warsaw

phone: +48 22 573 75 00
Date of last revision of the leaflet:22.05.2025