LOSARTAN KRKA 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Losartan Krka 50 mg Film-Coated Tablets EFG

potassium losartan

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Losartan Krka and what is it used for
2. What you need to know before you take Losartan Krka
3. How to take Losartan Krka
4. Possible side effects
5. Storing Losartan Krka
6. Package Contents and Additional Information

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

Losartan belongs to a group of medicines called angiotensin II receptor antagonists.

Angiotensin II is a substance produced in the body that binds to receptors present in blood vessels, causing them to narrow. This leads to an increase in blood pressure. Losartan prevents angiotensin II from binding to these receptors, which causes the blood vessels to relax, thereby lowering blood pressure. Losartan reduces the worsening of kidney function in patients with high blood pressure and type 2 diabetes.

Losartan Krka is used

• to treat patients with high blood pressure (hypertension) in adults and in children and adolescents between 6 and 18 years.
• to protect the kidneys in hypertensive patients with type 2 diabetes and laboratory test results indicating kidney failure and proteinuria ≥ 0.5 g per day (a condition where the urine contains an abnormal amount of protein).
• to treat patients with chronic heart failure, when your doctor considers that treatment with specific medications called angiotensin-converting enzyme inhibitors (ACE inhibitors, medications used to lower high blood pressure) is not suitable. If your heart failure has been stabilized with an ACE inhibitor, you should not switch to losartan.
• in patients with high blood pressure and increased thickness of the left ventricle of the heart, losartan has been shown to reduce the risk of stroke (LIFE indication).

2. What you need to know before you take Losartan Krka

Do not take Losartan Krka

• if you are allergic to losartan or any of the other ingredients of this medicine (listed in section 6),
• if your liver function is severely impaired,
• if you are pregnant more than 3 months (do not take Losartan Krka in the first 3 months either – see also "Pregnancy and Breastfeeding"),
• if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Losartan Krka.

If you are pregnant or think you may be (or are planning to), you should inform your doctor. Losartan Krka is not recommended at the beginning of pregnancy, and it should not be taken if you are pregnant more than 3 months, as it may cause serious harm to your child (see section Pregnancy and Breastfeeding).

Before taking Losartan Krka, it is important that you inform your doctor:

• if you have a history of angioedema (swelling of the face, lips, tongue, and/or throat) (see also section 4. Possible Side Effects),
• if you have excessive vomiting or diarrhea that causes excessive loss of fluid and/or salt from your body,
• if you are taking diuretics (medicines that increase the amount of water that passes through your kidneys) or if you are on a low-salt diet that causes excessive loss of fluids or salt in your body (see section 3. Dosage in Special Patient Groups),
• if you know you have narrowing or blockage of the blood vessels that supply your kidneys or if you have recently undergone a kidney transplant,
• if your liver function is impaired (see sections 2. Do not take Losartan Krka and 3. Dosage in Special Patient Groups),
• if you have heart failure with or without kidney failure or potentially life-threatening heart rhythm disorders. Special attention is needed when being treated at the same time with a beta-blocker,
• if you have problems with the valves in your heart or with the heart muscle,
• if you have coronary heart disease (caused by reduced blood flow in the blood vessels of the heart) or cerebrovascular disease (caused by reduced blood circulation in the brain),
• if you have primary hyperaldosteronism (a syndrome associated with high secretion of the hormone aldosterone by the adrenal gland due to a disorder of this gland),
• if you are taking other medications that may increase serum potassium (see section 2 "Other Medications and Losartan Krka"),
• if you are taking any of the following medications used to treat high blood pressure:

• an ACE inhibitor (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• aliskiren.

Your doctor may monitor your kidney function, blood pressure, and the amount of electrolytes (e.g., potassium) in your blood at regular intervals.

See also the information under the heading "Do not take Losartan Krka".

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking losartan. Your doctor will decide whether to continue treatment. Do not stop taking losartan on your own.

Children and Adolescents

Losartan has been studied in children. For more information, consult your doctor.

Losartan Krka is not recommended for use in children with kidney or liver problems, as there is limited data available in these patient groups. Losartan Krka is not recommended for use in children under 6 years of age, as it has not been shown to be effective in this age group.

Other Medications and Losartan Krka

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Tell your doctor if you are taking potassium supplements, salt substitutes that contain potassium, or potassium-sparing medications such as certain diuretics (e.g., amiloride, triamterene, spironolactone) or other medications that may increase serum potassium (e.g., heparin, trimethoprim-containing medications), as combination with Losartan Krka is not recommended.

While being treated with Losartan Krka, be particularly cautious if you take any of the following medications:

• other medications that lower blood pressure, as they may produce an additional reduction in blood pressure. Blood pressure may also be lowered by some of the following medications/classes of medications: tricyclic antidepressants, antipsychotics, baclofen, amifostine,
• non-steroidal anti-inflammatory medications, such as indomethacin, including COX-2 inhibitors (medications that reduce inflammation and may be used to relieve pain), as they may reduce the blood pressure-lowering effect of losartan.

If your kidney function is impaired, concomitant use of these medications may cause worsening of kidney function.

Medications containing lithium should not be used in combination with losartan without careful monitoring by your doctor. Special precautions may be necessary (e.g., blood tests).

Your doctor may need to change your dose and/or take other precautions:

If you are taking ACE inhibitors or aliskiren (see also the information under the heading "Do not take Losartan Krka" and "Warnings and Precautions").

Taking Losartan Krka with Food, Drinks, and Alcohol

Losartan Krka can be taken with or without food.

Grapefruit juice should be avoided while taking Losartan Krka.

Pregnancy, Breastfeeding, and Fertility

Consult your doctor or pharmacist before taking any medication.

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medication. Normally, your doctor will advise you to stop taking Losartan Krka before becoming pregnant or as soon as you know you are pregnant and will recommend a different treatment instead of Losartan Krka. Losartan Krka is not recommended at the beginning of pregnancy, and it should not be taken if you are pregnant more than 3 months, as it may cause serious harm to your child if used after the third month of pregnancy.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. Losartan Krka is not recommended for breastfeeding mothers, and your doctor may choose a different treatment for you if you wish to breastfeed. Especially if your child is a newborn or was born prematurely.

Driving and Using Machines

No studies have been performed on the ability to drive and use machines.

It is unlikely that Losartan Krka will affect your ability to drive or use machines. However, as with many medications used to treat high blood pressure, losartan may cause dizziness or drowsiness in some people. If you experience dizziness or drowsiness, consult your doctor before performing these activities.

Losartan Krka Contains Lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medication.

3. How to Take Losartan Krka

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Your doctor will decide the appropriate dose of Losartan Krka, depending on your condition and whether you are taking other medications. It is important to keep taking Losartan Krka as long as your doctor prescribes it to maintain constant control of your blood pressure.

Losartan Krka is available in doses of 25 mg, 50 mg, and 100 mg.

Adult Patients with High Blood Pressure

Normally, treatment starts with 50 mg of losartan (one Losartan Krka 50 mg tablet) once a day. The maximum blood pressure-lowering effect is achieved within 3-6 weeks of starting treatment. Afterward, in some patients, the dose may be increased to 100 mg of losartan (two Losartan Krka 50 mg tablets or one Losartan Krka 100 mg tablet) once a day.

If you think the effect of Losartan Krka is too strong or too weak, please inform your doctor or pharmacist.

Use in Children and Adolescents

Children Under 6 Years

Losartan Krka is not recommended for use in children under 6 years of age, as it has not been shown to be effective in this age group.

Children Between 6-18 Years

The recommended starting dose in patients weighing between 20 and 50 kg is 0.7 mg of losartan per kg of body weight, administered once a day (up to 25 mg of Losartan Krka). The doctor may increase the dose if blood pressure is not controlled.

Other pharmaceutical forms of this medication may be more suitable for children; ask your doctor or pharmacist.

Adult Patients with High Blood Pressure and Type 2 Diabetes

Normally, treatment starts with 50 mg of losartan (one Losartan Krka 50 mg tablet) once a day. Afterward, the dose may be increased to 100 mg of losartan (two Losartan Krka 50 mg tablets or one Losartan Krka 100 mg tablet) once a day, depending on the response of your blood pressure.

Losartan tablets can be administered with other medications that lower blood pressure (e.g., diuretics, calcium antagonists, alpha or beta blockers, and centrally acting medications), as well as with insulin and other medications frequently used to lower blood glucose levels (e.g., sulfonylureas, glitazones, and glucosidase inhibitors).

Adult Patients with Heart Failure

Normally, treatment starts with 12.5 mg of losartan once a day. Normally, the dose is gradually increased weekly (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), up to a maintenance dose determined by your doctor. A maximum dose of 150 mg of losartan (e.g., three Losartan Krka 50 mg tablets or one Losartan Krka 100 mg tablet and one Losartan Krka 50 mg tablet) once a day can be used.

In the treatment of heart failure, losartan is normally combined with a diuretic (a medication that increases the amount of water that passes through your kidneys) and/or digitalis (a medication that helps your heart be stronger and more efficient) and/or a beta-blocker.

Dosage in Special Patient Groups

Your doctor may recommend a lower dose, especially when starting treatment in certain patients, such as those treated with high-dose diuretics, patients with liver failure, or patients over 75 years of age. The use of losartan is not recommended in patients with severe liver failure (see section "Do not take Losartan Krka").

Administration

The tablets should be taken with a glass of water. You should try to take your daily dose at approximately the same time each day. It is important that you keep taking Losartan Krka until your doctor tells you to stop.

If You Take More Losartan Krka Than You Should

If you accidentally take too many tablets, or if a child swallows some, contact your doctor immediately. The symptoms of overdose are low blood pressure, increased heart rate, and possibly decreased heart rate.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to Take Losartan Krka

Do not take a double dose to make up for forgotten doses.

If you accidentally miss a dose, simply take the next dose as normal.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

If you experience the following, stop taking the losartan tablets and inform your doctor immediately or go to the emergency department of the nearest hospital:

A severe allergic reaction (skin rash, itching, swelling of the face, lips, mouth, or throat that can cause difficulty swallowing or breathing).

This is a serious, though rare, adverse effect that affects more than 1 in 10,000 patients but less than 1 in 1,000 patients. You may need urgent medical attention or hospitalization.

The following adverse effects have been reported with losartan:

Frequent (may affect more than 1 in 10 people):

• dizziness,
• low blood pressure (especially after excessive loss of body water from blood vessels, e.g., in patients with severe heart failure or under treatment with high doses of diuretics),
• dose-dependent orthostatic effects such as a decrease in blood pressure that occurs when standing up from a lying or sitting position,
• weakness,
• fatigue,
• low blood sugar (hypoglycemia),
• high potassium levels in the blood (hyperkalemia),
• changes in kidney function including kidney failure,
• reduced number of red blood cells (anemia),
• increased urea, creatinine, and potassium levels in the blood in patients with heart failure.

Uncommon (may affect more than 1 in 100 people):

• drowsiness,
• headache,
• sleep disorders,
• feeling of very rapid heartbeats (palpitations),
• severe chest pain (angina pectoris),
• difficulty breathing (dyspnea),
• abdominal pain,
• chronic constipation,
• diarrhea,
• nausea,
• vomiting,
• hives,
• itching (pruritus),
• skin rash,
• localized swelling (edema),
• cough.

Rare (may affect more than 1 in 1,000 people):

• hypersensitivity,
• angioedema,
• inflammation of blood vessels (vasculitis, Schoenlein-Henoch purpura),
• numbness or tingling sensation (paresthesia),
• fainting (syncope),
• very rapid and irregular heartbeats (atrial fibrillation),
• stroke (cerebrovascular accident),
• intestinal angioedema: swelling in the intestine that occurs with symptoms such as abdominal pain, nausea, vomiting, and diarrhea,
• inflammation of the liver (hepatitis),
• elevation of alanine aminotransferase (ALT) levels in the blood, which usually resolves when treatment is discontinued.

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

• reduced number of platelets,
• migraine,
• abnormalities in liver function,
• muscle and joint pain,
• flu-like symptoms,
• back pain and urinary tract infection,
• increased sensitivity to the sun (photosensitivity),
• unexplained muscle pain with dark urine (tea-colored) (rhabdomyolysis),
• impotence,
• inflammation of the pancreas (pancreatitis),
• low sodium levels in the blood (hyponatremia),
• depression,
• feeling of general discomfort,
• ringing, buzzing, roaring, or clicking in the ears (tinnitus),
• altered taste (dysgeusia).

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Losartan Krka

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Losartan Krka

• The active ingredient is losartan potassium. Each film-coated tablet contains 50 mg of losartan potassium, equivalent to 45.8 mg of losartan.
• The other ingredients are: lactose monohydrate and cellulose powder, pregelatinized corn starch, corn starch, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate in the tablet core, and hypromellose, talc, propylene glycol, and titanium dioxide (E171) in the coating. See section 2 "Losartan Krka contains lactose".

Appearance and Package Contents

Round, convex, white film-coated tablet, scored on one side with beveled edges. The score is not designed to break the tablet.

Blister Pack (PVC/PVDC//Al)

10, 14, 15, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100, 112 film-coated tablets, in a cardboard box.

High-Density Polyethylene (HDPE) Bottle with Polypropylene Closure. Desiccant of Silica Gel Filled Polyethylene.

250 film-coated tablets, in a cardboard box.

Only some pack sizes may be marketed.

Marketing Authorization 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

You can request more information about this medicine from the Local Representative of the Marketing Authorization Holder:

Krka Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

This medicine is authorized in the Member States of the European Economic Area and the United Kingdom (Northern Ireland) under the following names:

Date of the Last Revision of this Prospectus:May 2025

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/