Losartan Viatri 50 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Losartán Viatris 50 mg film-coated tablets EFG

potassium losartan

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• 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 only, and you should not give it to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Losartán Viatris is and what it is used for
2. What you need to know before taking Losartán Viatris
3. How to take Losartán Viatris
4. Possible side effects
5. How to store Losartán Viatris
6. Contents of the pack and other information

1. What Losartán Viatris 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 blocks the binding of angiotensin II 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.

Losartan 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 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. What you need to know before taking Losartán Viatris

Do not take Losartán Viatris

• If you are allergic to the active substance or to 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 containing aliskiren.
• If you are more than 3 months pregnant. (It is also advisable to avoid losartan during the first months of pregnancy – see pregnancy section).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you start taking Losartán Viatris.

Contact 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 suspect you might be). Losartan is not recommended during early pregnancy, and must not be used after the third month of pregnancy, as it may cause serious harm to your baby from that stage onwards (see pregnancy section).

It is important that you inform your doctor before taking Losartán Viatris:

• If you have previously had 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 may cause excessive fluid and/or salt loss 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 fluid or salt loss 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 you have impaired liver function (see sections 2. Do not take Losartán Viatris and 3. Dosage in special patient groups).
• If you have heart failure with or without kidney failure or potentially life-threatening concomitant cardiac arrhythmias. Special care is needed 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 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 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 (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 levels of electrolytes (e.g., potassium) at regular intervals.

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

Other medicines and Losartán Viatris

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

While being treated with Losartán Viatris, 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, salt substitutes containing potassium, 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.

If you have impaired kidney function, concomitant use of these medicines may lead to worsening of kidney function.

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

Your doctor may need to adjust your dose and/or take other precautions:

If you are taking an angiotensin-converting enzyme (ACE) inhibitor or aliskiren (see also information under the headings “Do not take Losartán Viatris” and “Warnings and precautions”).

Taking Losartán Viatris with food and drink

Losartan may 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 plan to become pregnant, consult your doctor or pharmacist before taking this medicine. Your doctor will usually advise you to stop taking losartan before becoming pregnant or as soon as you know you are pregnant, and will recommend another medicine instead of losartan. Losartan is not recommended during early pregnancy, and must not be administered from the third month of pregnancy onwards, as it may cause serious harm to your baby from that stage.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to breastfeed. The use of losartan during breastfeeding is not recommended, and your doctor will choose another treatment if you wish to breastfeed, especially if your baby is a newborn or premature.

Consult your doctor or pharmacist before using any medicine.

Children and adolescents

Losartan has been studied in children. For further information, speak with 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 efficacy has not been demonstrated in this age group.

Driving and using machines

Studies on the effects on the ability to drive and use machines have not been conducted.

It is unlikely that losartan 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 such activities.

Losartán Viatris contains lactose

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

3. How to take Losartán Viatris

Follow exactly the instructions for the use of this medicine provided by your doctor. If in doubt, consult your doctor or pharmacist again.

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

If you feel that 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 of age

Losartan is not recommended for use in children under 6 years of age, as its effectiveness has not been demonstrated in this age group.

Children aged 6 to 18 years

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

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

Patients with high blood pressure and type 2 diabetes

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

Losartan tablets can 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 glucosidase inhibitors).

Patients with heart failure

Treatment usually starts with 12.5 mg of losartan (one 12.5 mg losartan tablet "Inicio") 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 50 mg losartan tablet) 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 fluid passing through your kidneys) and/or digitalis (a medicine that helps your heart beat more strongly and efficiently) 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 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 important that you continue taking losartan unless your doctor tells you otherwise.

If you take more Losartán 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, 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.

If you forget to take Losartán Viatris

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, this medicine can cause adverse effects, although not everyone will experience 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 (may affect up to 1 in 1,000 people). It may require 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 fluid from the blood vessels, e.g. in patients with severe heart failure or those receiving high doses of diuretics).
• Dose-related orthostatic effects, such as a drop in blood pressure occurring after standing up from lying down or sitting.
• Weakness.
• Fatigue.
• Low blood sugar (hypoglycemia).
• High potassium levels in the blood (hyperkalemia).
• Changes in kidney function, including kidney failure.
• Reduced number of red blood cells (anemia).
• Increased blood urea, serum creatinine and serum potassium levels in patients with heart failure.

Uncommon (may affect up to 1 in 100 people)

• Drowsiness.
• Headache.
• Sleep disorders.
• Sensation of very rapid heartbeat (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 blood vessels (vasculitis, including Schönlein-Henoch purpura).
• Numbness or tingling sensation (paresthesia).
• Fainting (syncope).
• Very rapid and irregular heartbeat (atrial fibrillation).
• Stroke (cerebrovascular accident).
• Inflammation of the liver (hepatitis).
• Elevated 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 diarrhea.

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

• Reduced number of platelets.
• Migraine.
• Abnormal liver function.
• Muscle and joint pain.
• Flu-like symptoms.
• Back pain and urinary tract infection.
• Increased sensitivity to sunlight (photosensitivity).
• Unexplained muscle pain with dark-colored (tea-colored) urine (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.

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: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date which is stated on the packaging after CAD or EXP. The expiry date refers to 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 must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at a SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Losartan Viatris

The active substance is losartan (as potassium salt). Each tablet contains 50 mg of losartan (as potassium salt). It contains potassium in the following amount: 4.24 mg (0.108 mEq).

The other components are monohydrate lactose, pregelatinized corn starch, microcrystalline cellulose (E-460), magnesium stearate (E-470B), hydroxypropylcellulose (E-463), hypromellose (E-464), and titanium dioxide (E-171).

Appearance of the product and contents of the pack

Losartan Viatris are film-coated tablets without a breakline.

It is supplied in blisters containing 28 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.

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 most recent revision of this leaflet: March 2025

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