Losartan krka

Patient Information Leaflet

Losartan Krka, 25 mg, film-coated tablets
Losartan Krka, 50 mg, film-coated tablets
Losartan Krka, 100 mg, film-coated tablets
losartanum kalicum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, 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 Losartan Krka is and what it is 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 pack and other information

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

Losartan, the active substance in 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 leads to increased blood pressure.
Losartan prevents angiotensin II from binding to these receptors, resulting in blood vessel dilation and consequently lowering blood pressure.
Losartan slows the progression of kidney function deterioration in patients with high blood pressure and type 2 diabetes.
Losartan Krka is used:

• for the treatment of high blood pressure (hypertension) in adults and in 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 per day (a condition in which the urine contains an abnormal amount of protein);
• for the treatment of patients with chronic heart failure when treatment with certain medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors, drugs used to reduce high blood pressure) is not considered appropriate by the physician. If heart failure has been stabilized with an ACE inhibitor, switching to Losartan Krka is not recommended;
• in patients with high blood pressure and left ventricular hypertrophy (thickening of the wall of the left ventricle of the heart), because Losartan Krka has been shown to reduce the risk of stroke.

2. Information before using Losartan Krka

When not to use Losartan Krka

• if the patient is allergic to losartan or to any of the other ingredients of this medicine (listed in section 6),
• after the 3rd month of pregnancy (use of Losartan Krka should also be avoided during early pregnancy; see section "Pregnancy and breastfeeding"),
• if the patient has severe impairment of liver function,
• if the patient has diabetes or kidney impairment and is being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions
Before starting treatment with Losartan Krka, please discuss this with your doctor or pharmacist.
Inform your doctor if you are pregnant or suspect you may be pregnant, or if you are planning a pregnancy. Use of Losartan Krka is not recommended during early pregnancy and must be avoided after the 3rd month of pregnancy, as it may cause serious harm to the unborn child (see section "Pregnancy and breastfeeding").
It is important to inform your doctor before taking Losartan Krka:

• if the patient has ever experienced angioedema (swelling of the face, lips, throat, and/or tongue); see also section 4,
• if the patient has severe vomiting or diarrhoea leading to excessive loss of fluids and/or salts from the body,
• if the patient is taking diuretics (medicines that increase the amount of urine produced) or a low-salt diet, which may lead to excessive loss of fluids and salts 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 has recently received a kidney transplant,
• if the patient has impaired liver function (see sections 2 "When not to use Losartan Krka" and 3 "Dosage in special patient groups"),
• if the patient has heart failure, with or without kidney impairment, or severe, life-threatening heart rhythm disorders – particular caution is required when treating concomitantly with β-blockers,
• if the patient has heart valve disorders or heart muscle disease,
• 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 to the brain),
• if the patient has primary hyperaldosteronism (a syndrome caused by increased secretion of aldosterone from the adrenal glands due to adrenal gland abnormalities),
• if the patient is taking other medicines that may increase serum potassium levels (see section 2 "Losartan Krka and other medicines"),
• if the patient is taking any of the following medicines used to treat high blood pressure:
• an angiotensin-converting enzyme (ACE) inhibitor, such as enalapril, lisinopril, ramipril, particularly if the patient has kidney impairment related to diabetes,
• aliskiren.

Your doctor may recommend regular monitoring of kidney function, blood pressure, and blood electrolyte levels (e.g. potassium).
See also the subsection "When not to use Losartan Krka".
If abdominal pain, nausea, vomiting, or diarrhoea occur after taking Losartan Krka, inform your doctor. Your doctor will decide whether treatment should continue. Do not stop taking Losartan Krka on your own.

Children and adolescents
Studies on the use of losartan in children have been conducted. For additional information, please consult your doctor.
Use of losartan is not recommended in children and adolescents with kidney or liver impairment due to limited data available for these patient groups. Use of losartan is not recommended in children under 6 years of age, as efficacy has not been demonstrated in this age group.

Losartan Krka and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Inform your doctor about potassium supplements, salt substitutes containing potassium, potassium-sparing medicines such as certain diuretics (e.g. amiloride, triamterene, spironolactone), or other medicines that may increase serum potassium levels (e.g. heparin, medicines containing trimethoprim), as concomitant use with Losartan Krka is not recommended.
Exercise particular caution when using the following medicines during treatment with Losartan Krka:

• other medicines that lower blood pressure, as they may further reduce blood pressure. The following medicines/groups of medicines may also reduce blood pressure: tricyclic antidepressants, antipsychotics, baclofen, amifostine,
• non-steroidal anti-inflammatory drugs (NSAIDs), 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.

Your doctor may recommend adjusting the dose and/or taking other precautions:

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

In patients with impaired kidney function, concomitant use of these medicines may lead to worsening of kidney function.
Do not use lithium-containing medicines concomitantly with losartan without strict medical supervision.
Special precautions (e.g. blood tests) may be necessary.

Losartan Krka with food and drink
Losartan Krka may be taken with or without food.
Avoid drinking grapefruit juice while taking Losartan Krka.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Inform your doctor if you are pregnant or suspect you may be pregnant, or if you are planning a pregnancy. Your doctor will usually advise stopping treatment with Losartan Krka before planning a pregnancy or immediately after pregnancy is confirmed, and will recommend an alternative medicine. Use of Losartan Krka is not recommended during early pregnancy and must be avoided after the 3rd month of pregnancy, as it may cause serious harm to the unborn child.
Breastfeeding
Inform your doctor if you are breastfeeding or plan to breastfeed. Use of Losartan Krka is not recommended during breastfeeding, especially when breastfeeding a newborn or preterm infant. Your doctor may recommend using another medicine.
Always consult your doctor or pharmacist before taking any medicine.

Driving and using machines
Studies on the effect of this medicine on the ability to drive and operate machinery have not been conducted.
It is unlikely that losartan affects this ability. However, as with many medicines used to treat high blood pressure, losartan may cause dizziness or drowsiness in some people. If dizziness or drowsiness occurs, consult your doctor before performing such activities.

Losartan Krka contains lactose
If the patient has been previously diagnosed with an intolerance to certain sugars, consult your doctor before starting treatment with this medicine.

3. How to use Losartan Krka

This medicine should always be taken as directed by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.
Your doctor will determine the appropriate dose of Losartan Krka depending on your condition and
other medicines you are taking. It is important to take Losartan Krka for as long as your doctor has
recommended, in order to maintain consistent control of blood pressure.
Losartan Krka is available in the following strengths: 25 mg, 50 mg and 100 mg.
The 25 mg Losartan Krka tablet may 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 between 3 and 6 weeks after starting
treatment. In some patients, the dose may then be increased to 100 mg losartan (two 50 mg Losartan Krka tablets) once daily.
If you feel that the effect of losartan is too strong or too weak, you should consult your 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 aged 6 to 18 years
The recommended initial dose for patients with body weight between 20 kg and 50 kg is 0.7 mg
losartan per kg of body weight, taken once daily (up to 25 mg of Losartan Krka). Your doctor may
increase the dose if blood pressure is not well controlled.
Another formulation/formulations of this medicine may be more suitable for children. Please consult
your 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 then be increased to 100 mg losartan (two 50 mg Losartan Krka tablets) once daily,
depending on achieved blood pressure values.
Losartan may be used together with other antihypertensive medicines (e.g. diuretics, calcium channel
blockers, alpha- or beta-blockers, and centrally acting antihypertensives), as well as with insulin and
other commonly used glucose-lowering medicines (e.g. sulfonylureas, glitazones, and alpha-glucosidase
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.
Your doctor will usually increase this 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.
A maximum daily dose of 150 mg losartan may be used (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 used in combination with diuretics (medicines that
increase the amount of water excreted by the kidneys) and (or) digitalis glycosides (medicines that
increase the force of heart contractions and improve heart function) and (or) beta-blockers.

Dosing in special patient groups
Your doctor may recommend a lower dose, especially when starting treatment in certain patients, such
as those taking high-dose diuretics, patients with impaired liver function, or patients over 75 years of
age. Losartan should not be used in patients with severe hepatic impairment (see section “When not to
use Losartan Krka”).

Method of administration
Tablets should be swallowed with a glass of water. Try to take the daily dose at the same time each
day. It is important to continue taking Losartan Krka for as long as your doctor has instructed.

Taking more Losartan Krka than prescribed
If you accidentally take too many tablets, contact your doctor immediately. Symptoms of overdose
include low blood pressure, rapid heartbeat, and possibly slow heartbeat.

If you miss a dose of Losartan Krka
If you miss a dose, take the next dose at your usual time. Do not take a double dose to make up for a
missed dose.

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 any of the following adverse reactions occur, stop taking Losartan Krka and consult a doctor immediately or go to the emergency department of the nearest hospital:
Severe allergic reaction (rash, itching, swelling of the face, lips, mouth or throat, which may cause difficulty in swallowing or breathing).
This is a serious, but rare adverse reaction occurring in at least 1 in 10,000 patients, but less than 1 in 1,000 patients. Immediate medical assistance or hospitalization may be required.

The following adverse reactions have been reported for losartan:

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

• dizziness,
• low blood pressure (especially after excessive fluid loss, e.g. in patients with severe heart failure or treated with high doses of diuretics),
• dose-dependent orthostatic symptoms, such as reduced blood pressure upon standing up from lying or sitting position,
• weakness,
• fatigue,
• low blood glucose levels (hypoglycaemia),
• high potassium levels in blood (hyperkalaemia),
• changes in kidney function, including kidney failure,
• reduced number of red blood cells (anaemia),
• increased levels of blood urea, creatinine and serum potassium in patients with heart failure.

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

• drowsiness,
• headache,
• sleep disorders,
• sensation of rapid heartbeat (palpitations),
• severe chest pain (angina pectoris),
• shortness of breath,
• abdominal pain,
• constipation,
• diarrhoea,
• nausea,
• vomiting,
• urticaria,
• itching,
• rash,
• localised swelling,
• cough.

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

• hypersensitivity reactions,
• angioedema,
• vasculitis (including Henoch-Schönlein purpura),
• sensation of numbness or tingling (paraesthesia),
• fainting,
• very rapid and irregular heartbeat (atrial fibrillation),
• stroke,
• intestinal angioedema: intestinal swelling with symptoms such as abdominal pain, nausea, vomiting and diarrhoea,
• hepatitis,
• increased alanine aminotransferase (AlAT) activity in blood, usually resolving after discontinuation of treatment.

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

• reduced number of platelets (thrombocytopenia),
• migraine,
• liver function disorders,
• joint and muscle pain,
• influenza-like symptoms,
• back pain and urinary tract infection,
• increased sensitivity to sunlight,
• unexplained muscle pain and dark (tea-coloured) urine (rhabdomyolysis),
• impotence,
• pancreatitis,
• low sodium levels in blood (hyponatraemia),
• depression,
• general malaise,
• ringing, buzzing, humming or pulsating sounds in the ears (tinnitus),
• taste disturbances.

Adverse reactions occurring in children are similar to those observed in adults.
Reporting of adverse reactions
If any symptoms of adverse reactions occur, including any adverse reactions 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 to provide more information on the safety of the medicine.

5. How to store Losartan Krka

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following EXP.
The expiry date refers to the last day of the specified month.
Do not store above 30°C.
Store the blister in the outer packaging to protect from moisture.
Medicines should 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 Losartan Krka contains

• The active substance is losartan potassium. Each coated tablet contains 25 mg of losartan potassium, equivalent to 22.9 mg of losartan. Each coated tablet contains 50 mg of losartan potassium, equivalent to 45.8 mg of losartan. Each coated tablet contains 100 mg of losartan potassium, equivalent to 91.5 mg of losartan.
• The other ingredients of Losartan Krka 25 mg, coated tablets are: celactose (lactose monohydrate, cellulose, powder), maize starch pregelatinized, maize starch, 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, coated tablets and Losartan Krka 100 mg, coated tablets are: celactose (lactose monohydrate, cellulose, powder), maize starch pregelatinized, maize starch, 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, 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, coated tablets: white, round (7.9 mm x 8.2 mm), slightly convex on both sides, with bevelled edges and a score line. The division line on the tablet is not intended for breaking the tablet.
Losartan Krka 100 mg, coated tablets: white, oval (15 mm x 8 mm), slightly convex on both sides.

Losartan Krka 25 mg, coated tablets
Aluminium/PVC/PVDC foil blisters in a cardboard box.
Packs: 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100 coated tablets in blisters containing 7, 10, 14 or 15 tablets per outer pack.

Losartan Krka 50 mg, coated tablets
Aluminium/PVC/PVDC foil blisters in a cardboard box.
Packs: 10, 14, 15, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100 coated tablets in blisters containing 7, 10, 14 or 15 tablets per outer pack.

Losartan Krka 100 mg, coated tablets
Aluminium/PVC/PVDC foil blisters in a cardboard box.
Packs: 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100 coated tablets in blisters containing 7, 10, 14 or 15 tablets per outer pack.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer/Importer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

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 authorization holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw
Poland
Telephone: +48 22 573 75 00