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Prospect: information for the user

Losartán Viatris 12.5 mg Film-Coated Tablets

potassium losartan

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

2.What you need to know before starting to take Losartán Viatris

3.How to take Losartán Viatris

4.Possible adverse effects

5Storage of Losartán Viatris

6.Contents of the pack and additional information

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

Losartán is used:

• To treat patients with elevated 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 situation in which the urine contains an abnormal amount of proteins).
• To treat 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 been shown to reduce the risk of stroke (LIFE indication).

Do not take Losartán Viatris

• If you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6).
• If your liver function is severely damaged.
• If you have diabetes or kidney insufficiency and are being treated with a medication to lower blood pressure that contains aliskirén.
• If you are more than 3 months pregnant. (It is also recommended to avoid losartan during the first months of pregnancy – see pregnancy section).

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to take Losartán Viatris.

Consult your doctor if you experience abdominal pain, nausea, vomiting or diarrhea after taking losartan. Your doctor will decide whether to continue treatment. Do not stop taking losartan on your own.

Inform your doctor if you are pregnant (or if you suspect you may be). Losartan is not recommended for use at the beginning of pregnancy, and in any case should not 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).

It is essential to inform your doctor before taking:

• 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 follow 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 Viatris and 3. Dosage in special patient groups).
• If you have heart failure with or without kidney insufficiency 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):
• 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 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 Losartán Viatris”.

Other medications and Losartán Viatris

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication.

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

• Other medications that lower blood pressure, as they may cause additional reduction in blood pressure. 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, 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.

If your renal function is altered, the concomitant use of these medications may cause worsening of 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).

Your doctor may need to modify 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 Viatris” and “Warnings and precautions”).

Taking Losartán Viatris with food and beverages

Losartan can be taken with or without food.

Avoid grapefruit juice while taking losartan.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant or in the lactation period, consult your doctor or pharmacist before taking this medication. Your doctor will usually recommend that you stop taking losartan before becoming pregnant or as soon as you know you are pregnant and will recommend that you take another medication instead of losartan. Losartan is not recommended for use at the beginning of pregnancy, and in any case should not 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 breastfeeding. Losartan is not recommended for use during breastfeeding, and your doctor will choose another treatment if you wish to breastfeed, especially if your baby is newborn or premature.

Consult your doctor or pharmacist before using any medication.

Children and adolescents

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

Losartan is not recommended for use in children with kidney or liver problems, as there are limited available data in these patient groups. Losartan is not recommended for use in children under 6 years of age, as it has not been shown to be effective in this age group.

Driving and operating machinery

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

It is unlikely that losartan 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.

Losartán Viatris contains lactose

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 of this medication as indicated by your doctor.In case of doubt, consult your doctor or pharmacist again.

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

Hypertensive patients

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

If you estimate that the losartan effect is too strong or too weak, please inform your doctor or pharmacist.

Use in children and adolescents

Children under 6 years old

Losartan is not recommended for use in children under 6 years old, as it has not been shown to be effective in this age group.

Children aged 6-18 years

The recommended starting dose in patients weighing between 20 and 50 kg is 0.7 mg of losartan per kg of body weight, administered once a day (up to 25 mg of losartan). Your doctor may increase the dose if your blood pressure is not controlled.

Other pharmaceutical forms of this medication may be more suitable for children; ask your doctor or pharmacist.

Hypertensive patients with type 2 diabetes

Typically, treatment begins with 50 mg of losartan (one losartan 50 mg tablet) once a day. Subsequently, the dose may be increased to 100 mg of losartan (two losartan 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 reduce blood glucose levels (e.g., sulfonylureas, glitazones, and glucosidase inhibitors).

Patients with heart failure

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

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 Losartan Viatris").

Administration

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 losartan until your doctor tells you otherwise.

If you take more Losartan Viatris than you should

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

If you forgot to take Losartan Viatris

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, this medication may cause side effects, although not everyone will experience them.

If you experience any of the following, stop taking losartan 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 (may affect up to 1 in 1,000 people). You may need urgent medical attention or hospitalization.

The following side effects have been reported with Losartan:

Frequent(may affect up to 1 in 10 people)

Infrequent(may affect up to 1 in 100 people)

Rare(may affect up to 1 in 1,000 people)

Unknown frequency(frequency cannot be estimated from available data)

Side effects in children are similar to those observed in adults.

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Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD or EXP. The expiration date is the last day of the month indicated.

Store this medication in the original packaging.

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE drop-off point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Losartán Viatris

The active ingredient is losartan (as potassium salt).

Each tablet contains 12.5 mg of losartan (as potassium salt). It contains potassium in the following amount: 1.06 mg (0.027 mEq).

The other components are lactose monohydrate, cornstarch pregelatinized, microcrystalline cellulose (E-460), magnesium stearate (E-470B), hydroxypropyl cellulose (E-463), hydroxypropyl methylcellulose (E-464), titanium dioxide (E-171), and blue lac.

Appearance of the product and contents of the packaging

Losartán Viatris are film-coated tablets without score.

They are presented in blisters with 7 film-coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Responsible for manufacturing

Laboratorios Liconsa, S.A.

Avda. Miralcampo, Nº 7, Pol. Ind. Miralcampo

19200 - Azuqueca de Henares (Guadalajara)

Spain

Last review date of this leaflet:March 2025

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