Losartan Krka

Package Leaflet: Information for the Patient

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 Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet, as you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this package leaflet, they should inform 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. Package Contents and Other Information

1. What is Losartan Krka and What is it Used For

Losartan, the active substance in Losartan Krka, belongs to a group of medications called angiotensin II receptor antagonists.
Angiotensin II is a substance produced in the body that binds to receptors in blood vessel walls, causing them to constrict. This results in increased blood pressure.
Losartan prevents angiotensin II from binding to these receptors, causing blood vessels to dilate and thereby reducing blood pressure.
Losartan slows the progression of kidney disease 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 aged 6 to 18 years;
• to protect the kidneys in patients with high blood pressure and type 2 diabetes, with laboratory-confirmed kidney function impairment 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 medications called angiotensin-converting enzyme inhibitors (ACE inhibitors, medications used to lower high blood pressure) is not considered appropriate by the doctor. If heart failure has been stabilized with an ACE inhibitor, it should not be switched to Losartan Krka;
• in patients with high blood pressure and left ventricular hypertrophy, as Losartan Krka has been shown to reduce 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 medication (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 impairment,
• if the patient has diabetes or kidney function impairment and is being treated with a blood pressure-lowering medication containing aliskiren.

Warnings and Precautions

Before starting to take Losartan Krka, 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 advise stopping Losartan Krka before planned pregnancy or as soon as pregnancy is confirmed, and will advise taking a different medication instead of Losartan Krka. Losartan Krka should not be taken during early pregnancy and must not be taken after the 3rd month of pregnancy, as it may cause serious harm to the fetus (see section "Pregnancy and Breastfeeding").
It is essential 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 had severe vomiting or diarrhea leading to excessive loss of fluids and/or electrolytes,
• if the patient is taking diuretics (medications that increase urine production) or is on 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 blood vessels leading to the kidneys or has recently had a kidney transplant,
• if the patient has liver function impairment (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 impairment, or severe, life-threatening heart rhythm disturbances - special caution is required when co-administering beta-blockers,
• if the patient has heart valve problems or heart muscle problems,
• if the patient has coronary artery disease (caused by reduced blood flow in the heart's blood vessels) or cerebrovascular disorders (caused by reduced blood flow in the brain's blood vessels),
• if the patient has primary hyperaldosteronism (a condition caused by excessive aldosterone production by the adrenal glands, caused by adrenal gland abnormalities),
• if the patient is taking other medications that may increase potassium levels in the blood (see section 2 "Losartan Krka and Other Medications"),
• if the patient is taking any of the following medications for high blood pressure:
• angiotensin-converting enzyme inhibitors (ACE inhibitors, e.g., enalapril, lisinopril, ramipril), particularly if the patient has kidney function impairment 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 without consulting their doctor or pharmacist.

Children and Adolescents

Studies have been conducted on the use of losartan in children. For more information, the patient should consult their doctor.
Losartan is not recommended for children and adolescents with kidney or liver function impairment, 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 established in this age group.

Losartan Krka and Other Medications

The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take.
The patient should inform their doctor about any potassium supplements, salt substitutes containing potassium, potassium-sparing diuretics (e.g., amiloride, triamterene, spironolactone), or other medications that may increase potassium levels in the blood (e.g., heparin, trimethoprim-containing medications), as concurrent use with Losartan Krka is not recommended.
Special caution is required when taking the following medications during Losartan Krka treatment:

• other blood pressure-lowering medications, as they may further lower blood pressure. The following medications/drug classes may also lower blood pressure: tricyclic antidepressants, antipsychotics, baclofen, amifostine,
• non-steroidal anti-inflammatory medications, such as indomethacin, including COX-2 inhibitors (medications 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 impairment, concurrent use of these medications may lead to worsening of kidney function.
Lithium-containing medications 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.
The patient should avoid drinking grapefruit juice while taking 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 medication.
Pregnancy
The patient should inform their doctor about suspected or planned pregnancy. The doctor will usually advise stopping Losartan Krka before planned pregnancy or as soon as pregnancy is confirmed, and will advise taking a different medication instead of Losartan Krka. Losartan Krka should not be taken during early pregnancy and must not be taken after the 3rd month of pregnancy, as it may cause serious harm to the fetus.
Breastfeeding
The patient should inform their doctor about breastfeeding or intention to breastfeed. Losartan Krka is not recommended during breastfeeding, especially in newborns or premature infants. The doctor may recommend a different medication.
Before taking any medication, the patient should consult their doctor or pharmacist.

Driving and Using Machines

No studies have been conducted on the effects of Losartan Krka on the ability to drive and use machines.
It is unlikely that losartan will affect this ability. However, as with many medications used to treat high blood pressure, losartan may cause dizziness or drowsiness in some individuals. If the patient experiences dizziness or drowsiness, they should consult their doctor before performing such activities.

Losartan Krka Contains Lactose

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

3. How to Take Losartan Krka

This medication should always be taken exactly as advised by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
The doctor will determine the appropriate dose of Losartan Krka, depending on the patient's condition and other medications being taken. It is essential to take Losartan Krka for as long as the doctor recommends, to maintain consistent blood pressure control.
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 losartan (one 50 mg Losartan Krka tablet) once daily. 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 losartan (two 50 mg Losartan Krka tablets) once daily.
If the patient feels that the effect of losartan is too strong or too weak, they should consult their doctor or pharmacist.

Dosage 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 established in this age group.
Children aged 6 to 18 years
The recommended initial dose for patients with a body weight of 20 kg to 50 kg is 0.7 mg losartan per kg body weight, taken once daily (up to 25 mg Losartan Krka). The doctor may increase the dose if blood pressure is not well controlled.
A different formulation of this medication may be more suitable for children. The patient should consult their doctor or pharmacist.
Adult patients with high blood pressure and type 2 diabetes
Treatment usually starts with a dose of 50 mg losartan (one 50 mg Losartan Krka tablet) once daily. The dose may be increased to 100 mg losartan (two 50 mg Losartan Krka tablets) once daily, depending on blood pressure values.
Losartan can be taken in combination with other blood pressure-lowering medications (e.g., diuretics, calcium channel blockers, alpha- or beta-blockers) and with insulin and other commonly used medications 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 losartan (half a 25 mg Losartan Krka tablet) once daily. The doctor will usually increase the dose gradually at weekly intervals (i.e., 12.5 mg daily during the first week, 25 mg daily during the second week, 50 mg daily during the third week, 100 mg daily during the fourth week, 150 mg daily during the fifth week), until the maintenance dose is reached.
The maximum recommended dose is 150 mg losartan (e.g., three 50 mg Losartan Krka tablets or one 100 mg Losartan Krka tablet and one 50 mg Losartan Krka tablet) once daily.
In the treatment of heart failure, losartan is usually taken in combination with diuretics (medications that increase urine production) and/or digitalis glycosides (medications that increase the heart's contractile force 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 impairment, or patients over 75 years of age. Losartan should not be taken by patients with severe liver function impairment (see section "When Not to Take Losartan Krka").

Method of Administration

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

Overdose of Losartan Krka

In case of accidental overdose, the patient should immediately consult their doctor. Symptoms of overdose include low blood pressure, rapid heart rate, and possibly slow heart rate.

Missed Dose of Losartan Krka

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

4. Possible Side Effects

Like all medications, 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 required.
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),
• 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 disturbances,
• rapid heart rate (palpitations),
• severe chest pain (angina pectoris),
• shortness of breath,
• abdominal pain,
• constipation,
• diarrhea,
• nausea,
• vomiting,
• hives,
• itching,
• rash,
• localized swelling,
• cough.

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

• 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 intestine: intestinal swelling 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 impairment,
• joint and muscle pain,
• flu-like symptoms,
• back pain and urinary tract infection,
• increased sensitivity to sunlight,
• unexplained muscle pain and dark-colored urine (rhabdomyolysis),
• impotence,
• pancreatitis,
• low sodium levels in the blood (hyponatremia),
• depression,
• general feeling of being unwell,
• ringing, buzzing, or other persistent noise in the ears (tinnitus),
• taste disturbances.

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

Reporting Side Effects

If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring, 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 medication.

5. How to Store Losartan Krka

The medication should be stored out of sight and reach of children.
Do not use this medication after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the month.
Do not store above 30°C.
Store the blister pack in the outer packaging to protect from moisture.
Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications they no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Losartan Krka Contains

• The active substance in Losartan Krka is losartan potassium. Each film-coated tablet contains 25 mg losartan potassium, equivalent to 22.9 mg losartan. Each film-coated tablet contains 50 mg losartan potassium, equivalent to 45.8 mg losartan. Each film-coated tablet contains 100 mg losartan potassium, equivalent to 91.5 mg losartan.
• Other ingredients in Losartan Krka 25 mg film-coated tablets are: cellulose (lactose monohydrate, cellulose powder), maize starch, maize starch paste, microcrystalline cellulose, silicon dioxide, magnesium stearate, hypromellose, talc, propylene glycol, quinoline yellow (E104), titanium dioxide (E171).
• Other ingredients in Losartan Krka 50 mg and 100 mg film-coated tablets are: cellulose (lactose monohydrate, cellulose powder), maize starch, maize starch paste, microcrystalline cellulose, silicon dioxide, 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 Package

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
Aluminum/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
Aluminum/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
Aluminum/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/Importer

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

This Medication is Authorized in the Member States of the European Economic Area Under the Following Names:

For more information about this medication, the patient should contact their local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5
02-235 Warsaw

Phone: +48 22 573 75 00
Date of Last Revision of the Package Leaflet:22.05.2025