LOSARTAN KERN PHARMA 50 mg FILM-COATED TABLETS

2. Before taking Losartan Kern Pharma

Do not take Losartan Kern Pharma

• if you are allergic (hypersensitive) to losartan or any of the other ingredients of Losartan Kern Pharma,
• if your liver function is severely impaired,
• if you are pregnant for more than 3 months. (It is better to avoid Losartan Kern Pharma during the first months of pregnancy – see section on Pregnancy)
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medication containing aliskiren

Be especially careful with Losartan Kern Pharma

Tell your doctor if you are pregnant (or if you think you might be). Your doctor will generally advise you to stop taking Losartan Kern Pharma before you become pregnant or as soon as you know you are pregnant and will recommend that you take another medication instead of Losartan Kern Pharma. It is not recommended to use Losartan Kern Pharma at the start of pregnancy, and in no case should it be administered after the third month of pregnancy, as it may cause serious harm to your baby when administered from that time onwards (see section on Pregnancy).

Before taking Losartan Kern Pharma, 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, which causes 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 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 go to your kidneys or if you have recently undergone a kidney transplant,
• if your liver function is altered (see sections 2. Do not take Losartan Kern Pharma 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 necessary when you are 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 any of the following medications used to treat high blood pressure (hypertension):
• • an angiotensin-converting enzyme inhibitor (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 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 Losartan Kern Pharma. Your doctor will decide whether to continue treatment. Do not stop taking Losartan Kern Pharma on your own.

Use of other medications

Tell your doctor or pharmacist if you are taking or have recently taken any other medications, including those obtained without a prescription, herbal medicines, and natural products.

While you are being treated with Losartan Kern Pharma, be particularly careful 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,
• medications that retain potassium or that may increase potassium levels (e.g. potassium supplements, salt substitutes containing potassium, or potassium-sparing diuretics [e.g. amiloride, triamterene, spironolactone] or heparin),
• non-steroidal anti-inflammatory medications, such as indomethacin, including COX-2 inhibitors (medications that reduce inflammation and that may be used to relieve pain), as they may reduce the blood pressure-lowering effect of losartan.

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

If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also the information under the headings “Do not take Losartan Kern Pharma” and “Be especially careful with Losartan Kern Pharma”).

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

Medications containing lithium should not be used in combination with losartan without your doctor performing careful monitoring. It may be appropriate to take special precautions (e.g. blood tests).

Taking Losartan Kern Pharma with food and drinks

Losartan Kern Pharma can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you are pregnant (or if you think you might be). Your doctor will generally advise you to stop taking Losartan Kern Pharma before you become pregnant or as soon as you know you are pregnant and will recommend that you take another medication instead of Losartan Kern Pharma. It is not recommended to use Losartan Kern Pharma at the start of pregnancy, and in no case should it be administered after the third month of pregnancy, as it may cause serious harm to your baby when administered from that time onwards.

Breastfeeding

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

Consult your doctor or pharmacist before using any medication.

Use in children and adolescents

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

Driving and using machines

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

It is unlikely that Losartan Kern Pharma 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.

Important information about some of the ingredients of Losartan Kern Pharma

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

3. How to take Losartan Kern Pharma

Follow your doctor's instructions for taking Losartan Kern Pharma exactly.

Your doctor will decide the appropriate dose of Losartan Kern Pharma, depending on your condition and whether you are taking other medications. It is important to keep taking Losartan Kern Pharma as long as your doctor prescribes it to maintain constant control of your blood pressure.

Patients with high blood pressure

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

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

Patients with high blood pressure and type 2 diabetes

Normally, treatment starts with 50 mg of losartan (one Losartan Kern Pharma 50 mg tablet) once a day. After that, the dose may be increased to 100 mg of losartan (two Losartan 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 antagonists, alpha or beta blockers, and centrally acting medications), as well as with insulin and other medications commonly used to lower blood sugar levels (e.g. sulfonylureas, glitazones, and glucosidase inhibitors).

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, and 50 mg per day during the third week), up to a maintenance dose of 50 mg of losartan (one Losartan Kern Pharma 50 mg tablet) once a day, depending on your condition.

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 old. It is not recommended to use losartan in patients with severe liver failure (see section "Do not take Losartan Kern Pharma").

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 Kern Pharma until your doctor tells you to stop.

If you take more Losartan 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 Toxicology 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 Losartan Kern Pharma

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

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

4. Possible side effects

Like all medications, Losartan Kern Pharma can cause side effects, although not everyone gets them.

If you experience the following, stop taking the losartan tablets and inform your doctor immediately or go to the emergency department of your 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 but rare side effect, affecting more than 1 patient in 10,000 but less than 1 patient in 1,000. You may need urgent medical attention or hospitalization.

Medication 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 patient in 10,000.

Unknown:the frequency cannot be estimated from the available data.

The following side effects have been reported with losartan:

Common:

• dizziness,
• low blood pressure,
• weakness,
• fatigue,
• low blood sugar (hypoglycemia),
• high potassium levels in the blood (hyperkalemia).

Uncommon:

• drowsiness,
• headache,
• sleep disorders
• palpitations (feeling of rapid heartbeats),
• chest pain (angina pectoris),
• low blood pressure (especially after excessive loss of water from the body within the blood vessels, e.g. in patients with severe heart failure or on high-dose diuretic therapy),
• dose-related orthostatic effects, such as decreased blood pressure after standing up from lying down or sitting,
• difficulty breathing (dyspnea),
• abdominal pain,
• chronic constipation,
• diarrhea,
• nausea
• vomiting,
• hives (urticaria)
• itching (pruritus),
• skin rash,
• localized swelling (edema).

Rare:

• inflammation of the blood vessels (vasculitis, Schoenlein-Henoch purpura),
• numbness or tingling (paresthesia),
• fainting (syncope),
• 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 discontinued.
• Intestinal angioedema: swelling in the intestine that presents with 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 discontinued), including kidney failure,
• flu-like symptoms,
• increased urea, creatinine, and potassium levels in the blood in patients with heart failure,
• back pain and urinary tract infection.

If you think any of the side effects you are experiencing is serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Reporting 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 not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Losartan Kern Pharma

Keep out of the reach and sight of children.

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

Do not store above 25°C.

Keep Losartan Kern Pharma in its original packaging.

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

Medications should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Additional Information

Composition of Losartán Kern Pharma

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

The other components are: microcrystalline cellulose (E460), pregelatinized corn starch, 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 Packaging Contents

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

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

Marketing Authorization Holder and Manufacturer

KERN PHARMA, S.L.

Polígono Ind. Colón II

Venus, 72

08228 Terrassa (Barcelona)

This leaflet was approved in February 2025.

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