Package Leaflet: Information for the Patient

Losartán Krka 100 mg Film-Coated Tablets

losartan potassium

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

Losartán 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 constrict. This results in an increase in blood pressure. Losartán prevents the binding of angiotensin II to these receptors, causing blood vessels to relax, which in turn reduces blood pressure. Losartán reduces the worsening of kidney function in patients with high blood pressure and type 2 diabetes.

Losartán 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 renal insufficiency and proteinuria ≥ 0.5 g per day (a situation in which the urine contains an abnormal amount of proteins).
• to treat patients with chronic heart failure, when their doctor considers that treatment with specific medicines, called angiotensin-converting enzyme inhibitors (ACE inhibitors, medicines used to reduce high blood pressure) are not suitable. If their heart failure has been stabilized with an ACE inhibitor, they should not switch to losartan.
• in patients with high blood pressure and left ventricular hypertrophy of the heart, losartan has been shown to reduce the risk of stroke (LIFE indication).

Do not take Losartán 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 damaged,
• if you are more than 3 months pregnant (do not take Losartán Krka in the first 3 months – see also "Pregnancy and breastfeeding"),
• if you have diabetes or damaged kidney function and are being treated with a blood pressure-lowering medicine that contains aliskireno.

Warnings and precautions

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

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

Before taking Losartán Krka, it is essential that you inform your doctor:

• if you have had 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, which cause 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 following a low-sodium diet that causes excessive loss of fluids or salt from your body (see section 3. Dosage in special groups of patients),
• if you know that you have narrowing or blockage of the blood vessels that go to your kidneys or if you have recently had a kidney transplant,
• if your liver function is altered (see sections 2. Do not take Losartán Krka and 3. Dosage in special groups of patients),
• if you have heart failure with or without kidney failure or potentially fatal cardiac arrhythmias. Special attention is required when you are being treated at the same time with a beta-blocker,
• if you have problems with your heart valves or heart muscle,
• if you have coronary heart disease (caused by reduced blood flow in the heart's blood vessels) or cerebrovascular disease (caused by reduced blood circulation in the brain),
• if you have primary aldosteronism (a syndrome associated with an elevated secretion of aldosterone hormone by the adrenal gland due to an alteration of this gland),
• if you are taking other medicines that may increase serum potassium (see section 2 "Other medicines and Losartán Krka"),
• if you are taking any of the following medicines used to treat high blood pressure:

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

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 title "Do not take Losartán Krka".

Children and adolescents

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

Losartán Krka is not recommended for use in children with kidney or liver problems, as there are limited data available for these patient groups. Losartán 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 medicines and Losartán Krka

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

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

While taking Losartán Krka, be particularly cautious if you take any of the following medicines:

• other medicines that lower blood pressure, as they may cause an additional reduction in blood pressure. Blood pressure may also decrease with some of the following medicines/classes of medicines: tricyclic antidepressants, antipsychotics, baclofen, amifostine,
• non-steroidal anti-inflammatory medicines, such as indometacin, including COX-2 inhibitors (medicines 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, the concomitant use of these medicines may cause a worsening of kidney function.

Lithium-containing medicines should not be used in combination with losartan without your doctor's careful monitoring. It may be necessary to take special precautions (e.g. blood tests).

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

If you are taking ACE inhibitors or aliskireno (see also the information under the title "Do not take Losartán Krka" and "Warnings and precautions").

Taking Losartán Krka with food, drinks, and alcohol

Losartán Krka can be taken with or without food.

Avoid grapefruit juice while taking Losartán Krka.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medicine.

Pregnancy

If you are pregnant or think you may be pregnant (or are planning to become pregnant), consult your doctor or pharmacist before using this medicine. Normally, your doctor will recommend that you stop taking Losartán Krka before becoming pregnant or as soon as you know you are pregnant and advise you to take another treatment different from Losartán Krka. Losartán Krka is not recommended in the early stages of pregnancy, and should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your child if used after the third month of pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding. Losartán Krka is not recommended for breastfeeding mothers, and your doctor may choose another treatment for you if you want to breastfeed. Especially if your child is a newborn or premature.

Driving and operating machinery

No studies have been conducted on the ability to drive and operate machinery.

It is unlikely that Losartán Krka will affect your ability to drive or operate machinery. However, as many medicines 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.

Losartán Krka contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Your doctor will decide on the appropriate dose of Losartán Krka, depending on your condition and if you are taking other medications. It is essential to continue taking Losartán Krka as prescribed by your doctor to maintain consistent blood pressure control.

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

Adult patients with high blood pressure

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

If you estimate that the action of Losartán Krka is too strong or too weak, please inform your doctor or pharmacist.

Use in children and adolescents

Children under 6 years

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

Children aged 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 Losartán Krka). Your 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

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

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

Adult patients with heart failure

Typically, treatment begins 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), to a maintenance dose determined by your doctor. A maximum dose of 150 mg of losartan (e.g., three Losartán Krka 50 mg tablets or one Losartán Krka 100 mg tablet and one Losartán Krka 50 mg tablet) once a day may be used.

In the treatment of heart failure, losartan is typically 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.

Posology in special patient groups

Your doctor may recommend a lower dose, especially when starting treatment in certain patients, such as those treated with high doses of diuretics, patients with liver insufficiency, or patients over 75 years old. Losartan is not recommended for use in patients with severe liver insufficiency (see "Do not take Losartán Krka").

Administration

Tablets should be taken with a glass of water. Try to take your daily dose approximately at the same time each day. It is essential to continue taking Losartán Krka until your doctor tells you otherwise.

If you take more Losartán Krka than you should

If you accidentally take too many tablets, or if a child swallows some, contact your doctor immediately. Symptoms of overdose include 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 Losartán Krka

Do not take a double dose to compensate for the missed doses.

If you accidentally forget a dose, simply take the next dose as usual.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

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

The following side effects have been reported with losartan:

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

• dizziness,
• low blood pressure (especially after excessive water loss from blood vessels, for example, 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 appears when standing from a lying or sitting position,
• weakness,
• fatigue,
• low blood sugar (hypoglycemia),
• high potassium levels in the blood (hyperkalemia),
• changes in kidney function, including renal insufficiency,
• reduced red blood cell count (anemia),
• increased urea, creatinine, and plasma potassium levels in patients with heart failure.

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

• drowsiness,
• headache,
• sleep disturbances,
• feeling of very rapid heartbeats (palpitations),
• severe chest pain (angina pectoris),
• difficulty breathing (dyspnea),
• abdominal pain,
• chronic constipation,
• diarrhea,
• nausea,
• vomiting,
• urticaria,
• 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 (paresthesia),
• syncope (fainting),
• very rapid and irregular heartbeats (atrial fibrillation),
• stroke (cerebrovascular accident),
• inflammation of the liver (hepatitis),
• elevation of alanine aminotransferase (ALT) levels in the blood, which usually resolves upon discontinuing treatment.

Unknown frequency (cannot be estimated from available data):

• reduced platelet count,
• migraine,
• liver function abnormalities,
• 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,
• pancreatitis,
• low sodium levels in the blood (hyponatremia),
• depression,
• general feeling of discomfort,
• tinnitus (ringing, buzzing, roaring, or clicking in the ears),
• altered taste (dysgeusia).

The side effects in children are similar to those observed in adults.

Reporting side effects

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

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Polyethylene (HDPE) bottle with polypropylene (PP) tamper-evident closure.

Losartán Krka 100 mg: After the first opening of the packaging, the medication must be used within the following 100 days.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Losartán Krka

• The active ingredient is losartan potassium. Each film-coated tablet contains 100 mg of losartan potassium, equivalent to 91.5 mg of losartan.
• The other components are: lactose monohydrate and cellulose powder (contains lactose), pregelatinized maize starch, maize starch, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate in the tablet core, hypromellose, talc, propylene glycol, and titanium dioxide (E171) in the coating. See section 2 “Losartán Krka contains lactose”.

Appearance of the product and contents of the pack

Film-coated, oval, convex, white tablet.

Blister (PVC/PVDC//Al)

7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100, 112 film-coated tablets, in a cardboard box.

Polyethylene terephthalate (HDPE) bottle with a polypropylene (PP) closure.

100 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

For further information about this medicinal product, please contact 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 medicinal product is authorized in the Member States of the European Economic Area and the United Kingdom (Northern Ireland) with the following names:

Last update of this leaflet:March 2024

Further information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/