PATIENT INFORMATION LEAFLET

Losartán KERN PHARMA 50 mg Film-Coated Tablets

Read this leaflet carefully before you start taking this medicine.

• 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. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If you think you have suffered a side effect, you can report it directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Losartán belongs to a group of medications 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 renal function in patients with high blood pressure and type 2 diabetes.

Losartán Kern Pharma is used for

• treatment of patients with elevated blood pressure (hypertension),
• protection of the kidney 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),
• treatment of patients with chronic heart failure, when their doctor considers that treatment with specific medications, called angiotensin-converting enzyme inhibitors (ACE inhibitors, medications used to reduce elevated blood pressure) are not suitable. If their heart failure has been stabilized with an ACE inhibitor, they should not switch to losartán,
• in patients with elevated blood pressure and left ventricular hypertrophy of the heart, losartán has demonstrated that it reduces the risk of stroke (LIFE indication).

Do not take Losartán Kern Pharma

• if you are allergic (hypersensitive) to losartan or any of the other components of Losartán Kern Pharma,
• if your liver function is severely impaired,
• if you are more than 3 months pregnant. (It is best to avoid Losartán Kern Pharma during the first months of pregnancy – see Pregnancy section)
• if you have diabetes or kidney failure and are being treated with a blood pressure medication that contains aliskirén

Be especially careful with Losartán Kern Pharma

Inform your doctor if you are pregnant (or if you suspect you may be). Losartán Kern Pharma is not recommended for use at the beginning of pregnancy, and in no case should it be administered if you are more than three months pregnant, as it may cause serious damage to your baby when administered from that point onwards (see Pregnancy section).

Before taking Losartán Kern Pharma, it is essential to 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 (medications 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 patient groups),
• if you know you have narrowing or blockage of the blood vessels leading to your kidneys or if you have recently undergone a kidney transplant,
• if your liver function is altered (see sections 2. Do not take Losartán Kern Pharma and 3. Dosage in special patient groups),
• if you have heart failure with or without kidney failure or potentially fatal cardiac arrhythmias. Special attention is required when 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 elevated secretion of the aldosterone hormone by the adrenal gland due to an alteration of this gland)
• if you are taking any of the following medications used to treat high blood pressure (hypertension):
• • a converting enzyme inhibitor (ACEI) (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
  • aliskirén

Your doctor may monitor your renal function, blood pressure, and blood electrolyte levels (e.g. potassium), at regular intervals.

See also the information under the heading “Do not take Losartan Kern Pharma”.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Losartán Kern Pharma. Your doctor will decide whether to continue treatment. Do not stop taking Losartán Kern Pharma in monotherapy.

Use of other medications

Inform your doctor or pharmacist if you are taking or have recently taken other medications, including over-the-counter medications, herbal remedies, and natural products.

While taking Losartán Kern Pharma, be particularly cautious if you are taking any of the following medications:

• other medications that lower blood pressure, as they may produce additional blood pressure reduction. Blood pressure may also decrease with some of the following medications/classes of medications: tricyclic antidepressants, antipsychotics, baclofen, amifostine,
• medications that retain potassium or that may increase potassium levels (e.g. potassium supplements, salt substitutes containing potassium, or potassium-sparing medications such as certain diuretics [amiloride, triamterene, spironolactone] or heparin),
• nonsteroidal anti-inflammatory drugs (NSAIDs), 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.

Your doctor may need to adjust your dosage and/or take other precautions:

If you are taking an ACEI or aliskirén (see also the information under the headings “Do not take Losartan Kern Pharma” and “Be especially careful with Losartán Kern Pharma”).

If your renal function is impaired, the concomitant use of these medications may worsen renal function.

Lithium-containing medications 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).

Taking Losartán Kern Pharma with food and beverages

Losartán Kern Pharma can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you are pregnant (or if you suspect you may be). Your doctor will usually recommend that you stop taking Losartán Kern Pharma before becoming pregnant or as soon as you know you are pregnant and will recommend that you take another medication instead of Losartán Kern Pharma. Losartán Kern Pharma is not recommended for use at the beginning of pregnancy, and in no case should it be administered if you are more than three months pregnant, as it may cause serious damage to your baby when administered from that point onwards.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start. Losartán Kern Pharma is not recommended for use during breastfeeding, and your doctor will choose another treatment for you if you wish to breastfeed, especially if your baby is newborn or premature.

Consult your doctor or pharmacist before using any medication.

Use in children and adolescents

Losartán has been studied in children. For more information, speak with your doctor.

Driving and operating machinery

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

It is unlikely that Losartán Kern Pharma will affect your ability to drive or operate machinery. However, as 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 engaging in these activities.

Important information about some of the components of Losartán Kern Pharma

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

Follow exactly the administration instructions for Losartán Kern Pharma as indicated by your doctor.

Your doctor will decide the appropriate dose of Losartán Kern Pharma based on your condition and if you are taking other medications. It is essential to continue taking Losartán Kern Pharma as prescribed by your doctor to maintain consistent blood pressure control.

Patients with high blood pressure

Typically, treatment begins with 50 mg of losartan (one Losartán Kern Pharma 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 Kern Pharma 50 mg tablets) once a day.

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

Patients with high blood pressure and type 2 diabetes

Typically, treatment begins with 50 mg of losartan (one Losartán Kern Pharma 50 mg tablet) once a day. The dose may then be increased to 100 mg of losartan (two Losartán Kern Pharma 50 mg tablets) 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).

Patients with heart failure

Typically, treatment begins with 12.5 mg of losartan once a day. The dose is usually increased gradually, weekly (i.e., 12.5 mg per day for the first week, 25 mg per day for the second week, and 50 mg per day for the third week), to a maintenance dose of 50 mg of losartan (one Losartán Kern Pharma 50 mg tablet) once a day, as needed.

In the treatment of heart failure, losartan is usually 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 Kern Pharma").

Administration

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

If you take more Losartán Kern Pharma than you should

If you accidentally take too many tablets, or if a child swallows some, contact your doctor immediately.

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

The symptoms of overdose are low blood pressure, increased heart rate, and possibly decreased heart rate.

If you forget to take Losartán Kern Pharma

If you accidentally forget a dose, simply take the next dose as usual. Do not take a double dose to compensate for the missed tablet.

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

Like all medicines, Losartán Kern Pharma can cause side effects, although not everyone will experience them.

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

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

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

Medicine side effects are classified as follows:

Very common:Affect more than 1 in 10 patients.

Common:Affect 1 to 10 patients in 100.

Uncommon:Affect 1 to 10 patients in 1,000.

Rare:Affect 1 to 10 patients in 10,000.

Very rare:Affect less than 1 in 10,000 patients.

Unknown:The frequency cannot be estimated from available data.

The following side effects have been reported with losartán:

Common:

• Dizziness,
• Low blood pressure,
• Weakness,
• Fatigue,
• Low blood sugar (hypoglycemia),
• High potassium levels in the blood (hyperkalemia).

Uncommon:

• Drowsiness,
• Headache,
• Sleep disorders
• Feeling of very rapid heartbeats (palpitations),
• Severe chest pain (angina pectoris),
• Low blood pressure (especially after excessive loss of body water from the blood vessels, e.g. in patients with severe heart failure or on high doses of diuretics),
• Orthostatic effects related to the dose, such as a decrease in blood pressure after standing up from lying or sitting,
• Difficulty breathing (dyspnea),
• Abdominal pain,
• Chronic constipation,
• Diarhea,
• Nausea
• Vomiting,
• Hives (urticaria)
• Itching (pruritus),
• Localised swelling (edema).

Rare:

• Inflammation of the blood vessels (vasculitis, Schoenlein Henoch purpura),
• Numbness or tingling (paresthesia),
• Fainting (syncope),
• 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 when treatment is stopped.
• Intestinal angioedema: swelling in the intestine presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Unknown:

• Reduced number of red blood cells (anemia),
• Reduced number of platelets,
• Migraine,
• Cough,
• Liver function abnormalities,
• Muscle and joint pain,
• Changes in kidney function (may be reversible when treatment is stopped), including kidney failure,
• Symptoms similar to the flu,
• Increased urea, creatinine, and potassium levels in the blood in patients with heart failure,
• Back pain and urinary tract infection.

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the 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 out of the reach and sight of children.

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

Do not store above 25 °C.

Store Losartán Kern Pharma in the original packaging.

Do not open the blister until you are ready to take the medication.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

Composition of Losartán Kern Pharma

The active ingredient of Losartán Kern Pharma is losartan potassium. Each Losartán Kern Pharma 50 mg tablet contains 50 mg of losartan potassium.

The other components are: microcrystalline cellulose (E460), pregelatinized cornstarch, lactose monohydrate, sodium starch glycolate, povidone, silicon dioxide, magnesium stearate (E572), hydroxypropyl cellulose (E463), hypromellose (E464), and titanium dioxide (E171).

Losartán Kern Pharma 50 mg contains potassium in the following amount: 4.24 mg (0.108 mEq).

Appearance of the Product and Contents of the Package

Losartán Kern Pharma is supplied as film-coated, white, round, and scored tablets.

Losartán Kern Pharma 50 mg is presented in PVC/PE/PVDC blisters with an aluminum foil, in packs of 28 tablets.

Holder of the Marketing Authorization and Responsible for Manufacturing

KERN PHARMA, S.L.

Polígono Ind. Colón II

Venus, 72

08228 Terrassa (Barcelona)

This leaflet was approved in February 2025.

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es