Patient Information Leaflet: Package Insert

Losartán Uxa 50 mg Film-Coated Tablets EFG

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. By reporting side effects, you can help provide more information on the safety of this medicine.

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

2.Before taking Losartán Uxa

3.How to take Losartán Uxa

4.Possible side effects

5Storage of Losartán Uxa

6.Further information

Losartan 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. Losartan prevents the binding of angiotensin II to these receptors, causing blood vessels to relax, which in turn reduces blood pressure. Losartan reduces the worsening of renal function in patients with high blood pressure and type 2 diabetes.

Losartan UXAis used

• to treat patients with elevated blood pressure (hypertension).
• to protect the kidney in hypertensive patients with type 2 diabetes and laboratory test results indicating renal insufficiency and proteinuria ≥0.5 gper day (a situationin which the urine contains an abnormal amount of proteins).
• to treat patients with chronic heart failure, when their doctor considersthat 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 losartan.

in patients with elevated blood pressure and left ventricular hypertrophy of the heart, losartan hasbeen shown to reduce the risk of stroke (LIFE indication).

Do not take Losartán Uxa

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

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 in monotherapy.

Be especially careful with Losartán Uxa

Inform your doctor if you are pregnant (or if you suspect you may be). Losartán Uxa 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 harm to your baby when administered from that point onwards (see Pregnancy section).

Before taking Losartán Uxa, 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 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 Uxa 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 heart valve problems or heart muscle problems,
• 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 high secretion of the hormone aldosterone by the adrenal gland due to an alteration of this gland).
• if you are taking any of the following blood pressure medications:
• - an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• - aliskirén

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

See also the information under the heading “Do not take Losartán Uxa”

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 Uxa, be particularly cautious if you take any of the following medications:

• other medications that lower blood pressure, as they may cause 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 ACE inhibitor or aliskirén (see also the information under the headings “Do not take Losartán Uxa” and “Be especially careful with Losartán Uxa”

If your kidney function is impaired, the concomitant use of these medications may cause a worsening of kidney function.

Medications containing lithium 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 Uxa with food and drinks

Losartán Uxa 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 Uxa before becoming pregnant or as soon as you know you are pregnant and will recommend that you take another medication instead of Losartán Uxa. Losartán Uxa 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 harm to your baby when administered from that point onwards.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start. Losartán Uxa 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

Losartan 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 Uxa 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..

Follow exactly the administration instructions for Losartán Uxaas indicated by your doctor.

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

Patients with high blood pressure

Typically, treatment begins with 50mg of losartan (one Losartán Uxa 50mg 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 100mg of losartan (two Losartán Uxa 50mg tablets) once a day.

If you estimate that the action of Losartán 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 50mg of losartan (one Losartán Uxa 50mg tablet) once a day. Subsequently, the dose may be increased to 100mg of losartan (two Losartán Uxa 50mg 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 frequently used medications to decrease blood glucose levels (e.g., sulfonylureas, glitazones, and glucosidase inhibitors).

Patients with heart failure

Typically, treatment begins with 12.5mg of losartan once a day. Typically, the dose is gradually increased weekly (i.e., 12.5mg per day for the first week, 25mg per day for the second week, and 50mg per day for the third week), up to a maintenance dose of 50mg of losartan (one Losartán Uxa 50mg tablet) once a day, depending on your condition.

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.

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 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 Uxa").

Administration

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 essential to continue taking Losartán Uxa until 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 some, contact your doctor immediately. The symptoms of overdose are 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Losartán Uxa

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 medications,Losartán Uxacan cause side effects, although not everyone will experience them.

If you experience the following, stop taking 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 fewer than 1 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 between 1 and 10 patients in 100

Uncommon:affect between 1 and 10 patients in 1,000

Rare:affect between 1 and 10 patients in 10,000

Very rare:affect fewer than 1 in 10,000 patients

Unknown:the frequency cannot be estimated from 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 (hyperkalemia).

Uncommon:

• drowsiness,
• headache,
• sleep disturbances,
• sensation 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 those taking high doses of diuretics),
• orthostatic effects related to the dose, 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 blood vessels (vasculitis, Schonlein-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.
• 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,
• kidney function changes (may be reversible upon discontinuing treatment), including renal insufficiency,
• flu-like symptoms,
• increased urea levels in the blood, creatinine, and potassium in patients with heart failure,
• back pain and urinary tract infection.

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

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep out of the sight and reach of children.

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

No special storage conditions are required.

Store Losartán Uxa 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 Uxa

The active ingredient of Losartán Uxa is losartan potassium.

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

The other components aremicrocrystalline cellulose, stearate of sodium and fumarate, and croscarmellose sodium.

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

Losartán Uxa 50mg tablets also containmicrocrystalline cellulose, colloidal anhydrous silica, hydroxypropylmethylcellulose, polyoxyl 40 stearate, and titanium dioxide (E171)

Appearance of the product and contents of the packaging

Losartán Uxais supplied as film-coated, white, oval, biconvex tablets with a score.

Losartán UXAis supplied in the following packaging sizes:

PVC/PE/PVDC-Aluminium blisters, in packs of 28 tablets.

Marketing Authorization Holder andResponsible for Manufacturing

Last review date of this leaflet: January 2025

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