Losartan Kern Pharma 100 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Losartan KERN PHARMA 100 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you think any of the side effects you experience is serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Losartan KERN PHARMA is and what it is used for
2. Before you take Losartan KERN PHARMA
3. How to take Losartan KERN PHARMA
4. Possible side effects
5. How to store Losartan KERN PHARMA
6. Further information

1. What Losartán Kern Pharma is and what it is 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 blocks angiotensin II from binding to these receptors, resulting in relaxation of the blood vessels, which in turn lowers blood pressure. Losartan slows the progression of renal impairment in patients with high blood pressure and type 2 diabetes.

Losartán Kern Pharma is used

• to treat patients with high blood pressure (hypertension),
• 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 condition in which the urine contains an abnormally high amount of protein),
• to treat patients with chronic heart failure when your doctor considers that treatment with specific medicines called angiotensin-converting enzyme (ACE) inhibitors (medicines 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 thickening of the left ventricle of the heart, losartan has been shown to reduce the risk of stroke (LIFE indication).

2. Before taking Losartán Kern Pharma

Do not take Losartán Kern Pharma

• if you are allergic (hypersensitive) to losartan or to 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 renal impairment and are being treated with an antihypertensive medicine containing aliskiren

Take special care with Losartán Kern Pharma

Tell your doctor if you are pregnant (or think you might be). Use of Losartán Kern Pharma is not recommended during early pregnancy, and it must not be used after the third month of pregnancy, as it may cause severe harm to your baby when used from that stage onward (see Pregnancy section).

Before taking Losartán 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 diarrhoea, causing excessive loss of fluid and/or salt from your body,
• if you are taking diuretics (medicines that increase the amount of fluid passing through your kidneys) or are on a low-salt diet that may cause excessive loss of fluid 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 to your kidneys or if you have recently had a kidney transplant,
• if your liver function is impaired (see sections 2. Do not take Losartán Kern Pharma and 3. Dosage in special patient groups),
• if you have heart failure with or without renal impairment or potentially life-threatening concomitant cardiac arrhythmias. Special attention is required if you are also being treated with a beta-blocker,
• if you have heart valve problems or heart muscle disease,
• 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 excessive secretion of the hormone aldosterone by the adrenal gland due to a disorder of this gland),
• if you are taking any of the following medicines for 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 Losartán Kern Pharma”.

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

Use of other medicines

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

While being treated with Losartán Kern Pharma, take particular care if you are taking any of the following medicines:

• other medicines that lower blood pressure, as they may cause an additional decrease in blood pressure. Blood pressure may also be lowered by some of the following medicines/classes of medicines: tricyclic antidepressants, antipsychotics, baclofen, amifostine,
• medicines that retain potassium or may increase potassium levels (e.g. potassium supplements, potassium-containing salt substitutes, or potassium-sparing medicines such as certain diuretics [amiloride, triamterene, spironolactone] or heparin),
• non-steroidal anti-inflammatory drugs (NSAIDs), such as indomethacin, 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.

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 information under the headings “Do not take Losartán Kern Pharma” and “Take special care with Losartán Kern Pharma”).

If your kidney function is impaired, concomitant use of these medicines may lead to worsening of kidney function.

Medicines containing lithium should not be used in combination with losartan without careful monitoring by your doctor. Special precautionary measures (e.g. blood tests) may be appropriate.

Taking Losartán Kern Pharma with food and drink

Losartán Kern Pharma may be taken with or without food.

Pregnancy and breast-feeding

Pregnancy

Inform your doctor if you are pregnant (or think you might be). Your doctor will usually advise you to stop taking Losartán Kern Pharma before becoming pregnant or as soon as you know you are pregnant, and will recommend another medicine instead of Losartán Kern Pharma. Use of Losartán Kern Pharma is not recommended during early pregnancy, and must not be used from the third month of pregnancy onward, as it may cause severe harm to your baby when used from that stage.

Breast-feeding

Inform your doctor if you are breast-feeding or plan to breast-feed. Use of Losartán Kern Pharma is not recommended during breast-feeding, and your doctor will choose another treatment for you if you intend to breast-feed, especially if your baby is a newborn or premature.

Consult your doctor or pharmacist before using any medicine.

Use in children and adolescents

Losartan has been studied in children. For further information, speak with your doctor.

Driving and using machines

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

It is unlikely that Losartán Kern Pharma will affect your ability to drive or use machines. However, like many medicines used to treat high blood pressure, losartan may cause dizziness or somnolence in some people. If you experience dizziness or somnolence, consult your doctor before performing such activities.

Important information about some of the components of Losartán Kern Pharma

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

3. How to take Losartán Kern Pharma

Follow exactly the instructions for using Losartán Kern Pharma provided by your doctor.

Your doctor will decide the appropriate dose of Losartán Kern Pharma depending on your condition and whether you are taking other medicines. It is important to keep taking Losartán Kern Pharma as prescribed by your doctor to maintain consistent blood pressure control.

Patients with high blood pressure

Treatment usually starts with 50 mg of losartan (one tablet of Losartán Kern Pharma 50 mg) once daily. The maximum blood pressure-lowering effect is reached within 3 to 6 weeks after starting treatment. Afterwards, in some patients, the dose may be increased to 100 mg of losartan (one tablet of Losartán Kern Pharma 100 mg) once daily.

If you feel that the effect 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

Treatment usually starts with 50 mg of losartan (one tablet of Losartán Kern Pharma 50 mg) once daily. Afterwards, the dose may be increased to 100 mg of losartan (one tablet of Losartán Kern Pharma 100 mg) once daily, depending on your blood pressure response.

Losartan tablets may be taken together with other medicines that lower blood pressure (e.g. diuretics, calcium antagonists, alpha or beta blockers, and centrally acting agents), as well as with insulin and other medicines commonly used to reduce blood glucose levels (e.g. sulfonylureas, glitazones, and alpha-glucosidase inhibitors).

Patients with heart failure

Treatment usually starts with 12.5 mg of losartan once daily. The dose is usually gradually increased on a weekly basis (i.e., 12.5 mg daily during the first week, 25 mg daily during the second week, and 50 mg daily during the third week), up to a maintenance dose of 50 mg of losartan (one tablet of Losartán Kern Pharma 50 mg) once daily, depending on your condition.

In the treatment of heart failure, losartan is usually combined with a diuretic (a medicine that increases the amount of water passing through your kidneys) and/or digitalis (a medicine that helps your heart become 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 hepatic impairment, or patients over 75 years of age. The use of losartan is not recommended in patients with severe hepatic impairment (see section "Do not take Losartán 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 continue taking Losartán Kern Pharma unless 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 any, contact your doctor immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

Symptoms of overdose include low blood pressure, increased heart rate, and possibly decreased heart rate.

If you forget to take Losartán Kern Pharma

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

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

4. Possible adverse effects

Like all medicines, Losartán Kern Pharma can cause adverse effects, although not everyone experiences them.

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

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

This is a serious but rare adverse effect, affecting more than 1 in 10,000 patients but less than 1 in 1,000. It may require urgent medical attention or hospitalization.

Adverse effects of medicines are classified as follows:

Very common: affects more than 1 in 10 patients.
Common: affects 1 to 10 in 100 patients.
Uncommon: affects 1 to 10 in 1,000 patients.
Rare: affects 1 to 10 in 10,000 patients.
Very rare: affects fewer than 1 in 10,000 patients.
Not known: frequency cannot be estimated from available data.

The following adverse effects have been reported with losartan:

Common:

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

Uncommon:

• drowsiness,
• headache,
• sleep disorders,
• sensation of very rapid heartbeat (palpitations),
• severe chest pain (angina pectoris),
• low blood pressure (especially after excessive loss of fluid in the blood vessels, e.g. in patients with severe heart failure or on high-dose diuretics),
• dose-related orthostatic effects, such as drop in blood pressure upon standing up from a lying or sitting position,
• difficulty breathing (dyspnoea),
• abdominal pain,
• chronic constipation,
• diarrhoea,
• nausea,
• vomiting,
• hives (urticaria),
• itching (pruritus),
• skin rash,
• localized swelling (oedema).

Rare:

• inflammation of blood vessels (vasculitis, Henoch-Schönlein purpura),
• numbness or tingling sensation (paraesthesia),
• fainting (syncope),
• very rapid and irregular heartbeat (atrial fibrillation), stroke (cerebrovascular accident),
• inflammation of the liver (hepatitis),
• increased levels of alanine aminotransferase (ALT) in blood, which usually resolves upon discontinuation of treatment,
• intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting, and diarrhoea.

Not known:

• reduced number of red blood cells (anaemia),
• reduced number of platelets,
• migraine,
• cough,
• abnormalities in liver function,
• muscle and joint pain,
• changes in kidney function (may be reversible upon discontinuation of treatment), including renal failure,
• flu-like symptoms,
• increased blood urea, creatinine, and plasma potassium levels in patients with heart failure,
• back pain and urinary tract infection.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Losartán Kern Pharma

Keep out of the reach and sight of children.

Do not use Losartán Kern Pharma after the expiry date which is stated on the packaging after EXP. The expiry 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 pack until ready to take the medicine.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Information for the user

Composition of Losartán Kern Pharma

The active substance in Losartán Kern Pharma is potassium losartan. Each Losartán Kern Pharma 100 mg tablet contains 100 mg of potassium losartan.

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

Losartán Kern Pharma 100 mg contains potassium in the following amount: 8.48 mg (0.216 mEq).

Appearance of the medicinal product and contents of the pack

Losartán Kern Pharma is supplied as white, round, film-coated tablets without a break line.

Losartán Kern Pharma 100 mg is available in PVC/PE/PVDC blisters with an aluminum foil lid, in pack sizes of 28 tablets.

Marketing Authorization Holder and Manufacturer

KERN PHARMA, S.L.

Polígono Ind. Colón II

Venus, 72

08228 Terrassa (Barcelona)

This patient information leaflet was approved in February 2025.

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