Losartan Uxa 50 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Losartan Uxa 50 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine

• Keep this leaflet as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

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

1. What Losartán Uxa is and what it is used for

Losartan belongs to a group of medicines known as 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, resulting in relaxation of the blood vessels, which in turn lowers blood pressure. Losartan reduces the progression of renal impairment in patients with high blood pressure and type 2 diabetes.

Losartán UXA is used

• to treat patients with high blood pressure (hypertension).
• to protect the kidney in hypertensive patients with type 2 diabetes and laboratory test results indicating renal impairment and proteinuria ≥ 0.5 g per day (a condition in which the urine contains an abnormal 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. What you need to know before taking Losartán Uxa

Do not take Losartán Uxa

• if you are allergic (hypersensitive) to losartan or any of the other ingredients of Losartán Uxa,
• if your liver function is severely impaired,
• if you are more than 3 months pregnant. (It is also advisable to avoid Losartán Uxa 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.

Warnings and precautions

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

Take special care with Losartán Uxa

Inform your doctor if you are pregnant (or suspect you might be). The use of Losartán Uxa is not recommended at the beginning of pregnancy, and it must under no circumstances be administered 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 Uxa, it is important 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 adverse effects),
• if you have excessive vomiting or diarrhea, leading to 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 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 supplying your kidneys or if you have recently undergone a kidney transplant,
• if your liver function is impaired (see sections 2. Do not take Losartán Uxa 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 issues with your 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 hyperaldosteronism (a syndrome associated with excessive secretion of the hormone aldosterone by the adrenal gland due to adrenal dysfunction),
• if you are taking any of the following medicines 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 Losartán Uxa”.

Use of other medicines

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

While being treated with Losartán Uxa, take particular care if you are taking 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 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 Uxa” and “Take special care with Losartán Uxa”).

If you have impaired kidney function, concomitant use of these medicines may worsen kidney function.

Medicines containing lithium should not be used in combination with losartan unless your doctor carefully monitors you. Special precautionary measures (e.g., blood tests) may be appropriate.

Taking Losartán Uxa with food and drink

Losartán Uxa can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant (or suspect you might be). Your doctor will generally advise you to stop taking Losartán Uxa before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. The use of Losartán Uxa is not recommended at the beginning of pregnancy, and it must under no circumstances be administered after the third month of pregnancy, as it may cause severe harm to your baby when used from that stage onward.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to breastfeed. The use of Losartán Uxa is not recommended during breastfeeding. Your doctor will choose an alternative treatment if you wish to breastfeed, 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 more information, speak with your doctor.

Driving and using machines

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

It is unlikely that Losartán Uxa will affect your ability to drive or use machines. However, like 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.

3. How to take Losartán Uxa

Follow exactly the instructions for use of Losartán Uxa provided by your doctor.

Your doctor will determine the appropriate dose of Losartán Uxa based on your condition and whether you are taking other medications. It is important to continue taking Losartán Uxa 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 Uxa 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 (two tablets of Losartán Uxa 50 mg) once daily.

If you feel that the effect of Losartán 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 Uxa 50 mg) once daily. Afterwards, the dose may be increased to 100 mg of losartan (two tablets of Losartán Uxa 50 mg) once daily, depending on your blood pressure response.

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

Patients with heart failure

Treatment usually starts with 12.5 mg of losartan once daily. The dose is usually increased gradually 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) to a maintenance dose of 50 mg of losartan (one tablet of Losartán Uxa 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 at the beginning of 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 Uxa").

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 Uxa unless your doctor tells you otherwise.

If you take more Losartán Uxa than you should

If you accidentally take too many tablets, or if a child swallows any, 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Losartán Uxa

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 Uxa may produce adverse effects, although not everyone experiences them.

If you experience the following, stop taking losartan tablets immediately and contact your doctor right away 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 less 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 from 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, Schönlein-Henoch purpura),
• numbness or tingling sensation (paraesthesia),
• fainting (syncope),
• very rapid and irregular heartbeat (atrial fibrillation), stroke (cerebrovascular accident),
• liver inflammation (hepatitis),
• increased blood levels of alanine aminotransferase (ALT), 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,
• liver function abnormalities,
• 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 type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Losartán Uxa

Keep out of the sight and reach of children.

Do not use Losartán Uxa after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Store Losartán Uxa in the original container.

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

Medicines must 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. Contents of the pack and other information

Composition of Losartán Uxa

The active substance in Losartán Uxa is potassium losartan.

Each Losartán Uxa 50 mg tablet contains 50 mg of losartan (as potassium salt).

The other components are microcrystalline cellulose, sodium stearyl fumarate, and sodium croscarmellose.

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

Losartán Uxa 50 mg tablets also contain microcrystalline cellulose, colloidal anhydrous silica, hypromellose, polyoxyl 40 stearate, and titanium dioxide (E171).

Appearance of the product and contents of the pack

Losartán Uxa is supplied as white, oval, biconvex, film-coated tablets with a score line.

Losartán Uxa is available in the following pack sizes:

PVC/PE/PVDC-Aluminum blister packs in packs of 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:
[To be completed according to local regulations]

Responsible for Manufacturing:
[To be completed according to local regulations]

Date of the last revision of this leaflet: January 2025

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