LOSARTAN VIATRIS 12.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Losartan Viatris 12.5 mg, Film-Coated Tablets EFG

potassium losartan

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Losartan Viatris and what is it used for
2. What you need to know before you take Losartan Viatris
3. How to take Losartan Viatris
4. Possible side effects

5 Conservation of Losartan Viatris

1. Contents of the pack and further information

1. What is Losartan Viatris and what is it 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 in blood vessels, causing them to narrow. This results in an increase in blood pressure.

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

Losartan 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 kidney failure 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 their doctor considers that treatment with specific medications called angiotensin-converting enzyme inhibitors (ACE inhibitors, medications 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 increased thickness 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 you take Losartan Viatris

Do not take Losartan Viatris

• If you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• If your liver function is severely impaired.
• If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains aliskiren.
• If you are more than 3 months pregnant. (It is also recommended to avoid losartan during the first months of pregnancy – see section pregnancy).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Losartan 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 think you might be). Losartan is not recommended during the first trimester of pregnancy, and should not be taken after the third month of pregnancy, as it may cause serious harm to your baby when administered from that time on (see section pregnancy).

It is essential that you inform your doctor before taking Losartan Viatris:

• 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 (medicines 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 from your body (see section 3. Dosage in special patient groups).
• If you know you have narrowing or blockage of the blood vessels that supply your kidneys or if you have recently undergone a kidney transplant.
• If your liver function is impaired (see sections 2. Do not take Losartan Viatris 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 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 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 Losartan Viatris”.

Other medicines and Losartan Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

While being treated with Losartan Viatris, be particularly cautious if you take any of the following medicines:

• Other medicines that lower blood pressure, as they may cause additional blood pressure reduction. 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, salt substitutes that contain potassium, or potassium-sparing diuretics [e.g., amiloride, triamterene, spironolactone] or heparin).
• Non-steroidal anti-inflammatory medicines, 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.

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

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

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 Viatris” and “Warnings and precautions”).

Taking Losartan Viatris with food and drinks

Losartan can be taken with or without food.

Grapefruit juice should be avoided while taking losartan.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will generally advise you to stop taking losartan before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of losartan. Losartan is not recommended during the first trimester of pregnancy, and should not be taken after the third month of pregnancy, as it may cause serious harm to your baby when administered from that time on.

Breastfeeding

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

Ask your doctor or pharmacist for advice before taking any medicine.

Children and adolescents

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

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

Driving and using machines

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

Losartan is unlikely to affect your ability to drive or use machines. However, as with 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.

Losartan Viatris contains lactose

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

3. How to take Losartan Viatris

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

Your doctor will decide the appropriate dose of losartan, depending on your condition and whether you are taking other medicines. It is essential to keep taking losartan while your doctor prescribes it to maintain constant blood pressure control.

Patient with high blood pressure

Normally, treatment starts with 50 mg of losartan (one 50 mg losartan 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 50 mg losartan tablets) once a day.

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

Use in children and adolescents

Children under 6 years

Losartan is not recommended for use in children under 6 years of age, as it has not been shown to work 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, given once a day (up to 25 mg of losartan). The doctor may increase the dose if blood pressure is not controlled.

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

Patient with high blood pressure and type 2 diabetes

Normally, treatment starts with 50 mg of losartan (one 50 mg losartan tablet) once a day. After that, the dose may be increased to 100 mg of losartan (two 50 mg losartan tablets) once a day, depending on the response of your blood pressure.

Losartan tablets can be administered 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 lower blood glucose levels (e.g., sulfonylureas, glitazones, and glucosidase inhibitors).

Patient with heart failure

Normally, treatment starts with 12.5 mg of losartan (one 12.5 mg losartan starting tablet) 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 50 mg losartan tablet) once a day, 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 that passes through your kidneys) and/or digitalis (a medicine 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 of age. Losartan is not recommended for use in patients with severe liver failure (see section "Do not take Losartan Viatris").

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 essential to keep taking losartan until your doctor tells you to stop.

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. 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 Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Losartan Viatris

If you accidentally miss a dose, simply take the next dose as normal. Do not take a double dose to make up for the missed tablet. If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from 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 adverse effect (it can affect up to 1 in 1,000 people). You may need urgent medical attention or hospitalization.

The following adverse effects have been reported with Losartan:

Frequent(may affect up to 1 in 10 people)

• Dizziness.
• 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 doses of diuretics).
• Dose-related orthostatic effects, such as a decrease in blood pressure that occurs after standing up from lying down or sitting.
• Weakness.
• Fatigue.
• Low blood sugar (hypoglycemia).
• High potassium levels in the blood (hyperkalemia).
• Changes in renal function, including renal failure.
• Reduced number of red blood cells (anemia).
• Increased urea in blood, serum creatinine, and serum potassium in patients with heart failure.

Uncommon(may affect up to 1 in 100 people)

• Somnolence.
• Headache.
• Sleep disorders.
• Feeling of very rapid heartbeats (palpitations).
• Severe chest pain (angina pectoris).
• Difficulty breathing (dyspnea).
• Abdominal pain.
• Constipation.
• Diarrhea.
• Nausea.
• Vomiting.
• Hives (urticaria).
• Itching (pruritus).
• Rash.
• Localized swelling (edema).
• Cough.

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

• Hypersensitivity.
• Angioedema.
• Inflammation of the blood vessels (vasculitis, including Schönlein-Henoch purpura).
• Numbness or tingling sensation (paresthesia).
• Fainting (syncope).
• Very rapid and irregular heartbeats (atrial fibrillation).
• Stroke (ictus).
• Inflammation of the liver (hepatitis).
• Elevation of alanine aminotransferase (ALT) levels in blood, which usually resolves upon discontinuation of treatment.
• Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Frequency not known(frequency cannot be estimated from the available data)

• Reduced number of platelets.
• Migraine.
• Abnormalities in liver function.
• Muscle and joint pain.
• Flu-like symptoms.
• Back pain and urinary tract infection.
• Increased sensitivity to sunlight (photosensitivity).
• Muscle pain of unknown origin with dark-colored urine (tea-colored) (rhabdomyolysis).
• Impotence.
• Inflammation of the pancreas (pancreatitis),
• Low sodium levels in blood (hyponatremia).
• Depression.
• Generally feeling unwell (malaise).
• Ringing, buzzing, noise, or clicking in the ears (tinnitus).
• Altered taste (dysgeusia).

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

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Reporting of Adverse Effects

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

5. Storage of Losartan Viatris

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

Do not use this medicine 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 medicine in its original packaging.

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines at the SIGRE collection point in your pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Packaging Contents and Additional Information

Composition of Losartan 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 ingredients are lactose monohydrate, pregelatinized corn starch, microcrystalline cellulose (E-460), magnesium stearate (E-470B), hydroxypropylcellulose (E-463), hydroxypropylmethylcellulose (E-464), titanium dioxide (E-171), and blue lacquer.

Appearance of the Product and Packaging Contents

Losartan Viatris are film-coated tablets without scoring.

They are presented in blister packs containing 7 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Manufacturer

Laboratorios Liconsa, S.A.

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

19200 - Azuqueca de Henares (Guadalajara)

Spain

Date of the Last Revision of this Leaflet:March 2025

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