LOSARTAN VIR 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Losartan Vir 50 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine.

• 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 pack

1. What is Losartan Vir and what is it used for
2. Before taking Losartan Vir
3. How to take Losartan Vir
4. Possible side effects
5. Storage of Losartan Vir
6. Further information

1. What is Losartan Vir 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, which causes the blood vessels to relax, thereby lowering blood pressure. Losartan reduces the worsening of kidney function in patients with high blood pressure and type 2 diabetes.

Losartan Vir 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 your 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. Before taking Losartan Vir

Do not take Losartan Vir

• If you are allergic (hypersensitive) to losartan or any of the other ingredients of Losartan Vir.
• If your liver function is severely impaired.
• If you are more than 3 months pregnant. (It is also recommended to avoid Losartan Vir during the first months of pregnancy – see section Pregnancy).
• If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medication containing aliskiren.

Be cautious when taking Losartan Vir

Tell your doctor if you are pregnant (or if you think you might be). Your doctor will generally advise you to stop taking Losartan Vir before you become pregnant or as soon as you know you are pregnant and will recommend that you take another medication instead of Losartan Vir. Losartan Vir should not be used at the start of pregnancy, and in no case should it be administered after the third month of pregnancy, as it may cause serious harm to your baby when administered from that time on (see section Pregnancy).

Before taking Losartan Vir, it is important that you inform your doctor:

• 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 (medications 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 in 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 Vir and 3. Dosage in special patient groups).
• If you have heart failure with or without kidney failure or life-threatening heart rhythm disorders. Special attention is necessary when you are 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 medications used to treat high blood pressure (hypertension):

• An angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• Aliskiren.
• 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.

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 Vir”.

Use of other medications

Tell your doctor or pharmacist if you are taking or have recently taken any other medications, including those obtained without a prescription, herbal medicines, and natural products.

While you are being treated with Losartan Vir, 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 be lowered by some of the following medications/classes of medications: tricyclic antidepressants, antipsychotics, baclofen, amifostine.
• Medications that retain potassium or may increase potassium levels (e.g., potassium supplements, salt substitutes containing potassium, or potassium-sparing diuretics such as amiloride, triamterene, spironolactone) or heparin.
• Non-steroidal anti-inflammatory medications, such as indomethacin, including COX-2 inhibitors (medications that reduce inflammation and may be used to relieve pain), as they may decrease 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 the information under the headings “Do not take Losartan Vir” and “Be cautious when taking Losartan Vir”).

If your kidney function is impaired, concomitant use of these medications may worsen kidney function.

Medications containing lithium should not be used in combination with losartan without your doctor performing careful monitoring. It may be appropriate to take special precautions (e.g., blood tests).

Taking Losartan Vir with food and drinks

Losartan Vir can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you are pregnant (or if you think you might be). Your doctor will generally advise you to stop taking Losartan Vir before you become pregnant or as soon as you know you are pregnant and will recommend that you take another medication instead of Losartan Vir. Losartan Vir should not be used at the start of pregnancy, and in no case should it be administered 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 plan to breastfeed. Losartan Vir is not recommended during breastfeeding, and your doctor will choose another treatment for you if you want 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, talk to your doctor.

Driving and using machines

No studies have been conducted on the effects on the ability to drive and use machines. It is unlikely that Losartan Vir will affect your ability to drive or use machines. However, as with 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 performing these activities.

3. How to take Losartan Vir

Follow the instructions for administration of Losartan Vir indicated by your doctor.

Your doctor will decide the appropriate dose of Losartan Vir, depending on your condition and whether you are taking other medications. It is important to continue taking Losartan Vir as long as your doctor prescribes it to maintain constant control of your blood pressure.

Patients with high blood pressure

Normally, treatment starts with 50 mg of losartan (one Losartan Vir 50 mg 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 Losartan Vir 50 mg tablets or one Losartan Vir 100 mg tablet) once a day.

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

Patients with high blood pressure and type 2 diabetes

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

Losartan tablets can be administered with other medications that lower blood pressure (e.g., diuretics, calcium antagonists, alpha or beta blockers, and centrally acting agents), as well as with insulin and other medications commonly used to lower blood glucose levels (e.g., sulfonylureas, glitazones, and glucosidase inhibitors).

Patients with heart failure

Normally, treatment starts with 12.5 mg of losartan (one Losartan 12.5 mg Initiation 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 Losartan Vir 50 mg tablet) once a day, depending on your condition.

In the treatment of heart failure, losartan is normally 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-dose diuretics, patients with liver failure, or patients over 75 years of age. Losartan should not be used in patients with severe liver failure (see section "Do not take Losartan Vir").

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 Vir until your doctor tells you to stop.

If you take more Losartan Vir 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 medication and the amount ingested.

If you forget to take Losartan Vir

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 medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Losartan Vir can cause side effects, although not everyone gets 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 side effect, which affects more than 1 patient in 10,000 but less than 1 patient in 1,000. You may need urgent medical attention or hospitalization.

Medication side effects are classified as follows:

Very common:affects 1 in 10 patients.

Common:affects 1 to 10 patients in 100.

Uncommon:affects 1 to 10 patients in 1,000.

Rare:affects 1 to 10 patients in 10,000.

Very rare:affects less than 1 patient in 10,000.

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

Uncommon:

• drowsiness,
• headache,
• sleep disorders,
• palpitations (feeling of rapid heartbeats),
• severe chest pain (angina pectoris),
• 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-dose diuretics),
• dose-related orthostatic effects, 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 the blood vessels (vasculitis, Schonlein-Henoch purpura),
• numbness or tingling (paresthesia),
• fainting (syncope),
• 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 discontinuation of treatment.
• Intestinal angioedema: swelling in the intestine that presents with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Unknown:

• reduced number of red blood cells (anemia),
• reduced number of platelets,
• migraine,
• cough,
• abnormalities in liver function,
• muscle and joint pain,
• changes in kidney function (may be reversible upon discontinuation of treatment), including kidney failure,
• flu-like symptoms,
• increased urea, creatinine, and potassium levels in the blood in patients with heart failure,
• back pain and urinary tract infection.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for human use medications: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Losartan Vir

Keep out of the reach and sight of children.

Do not use Losartan Vir after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Store Losartan Vir in its original packaging.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Additional Information

Composition of Losartán Vir

The active ingredient of Losartán Vir is losartan potassium.

Each Losartán Vir 50 mg tablet contains 50 mg of losartan potassium.

The other components of the core are microcrystalline cellulose, sodium stearyl fumarate, sodium croscarmellose, and anhydrous colloidal silica.

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

The other components of the coating are microcrystalline cellulose, hydroxypropyl methylcellulose, polyoxyethylene 40 stearate, and titanium dioxide (E171).

Appearance of the Product and Packaging Contents

Losartán Vir 50 mg is supplied as film-coated tablets, white, oval, and biconvex with a score.

Losartán Vir is supplied in the following package sizes: PVC/PE/PVDC/Al blister packs, in packs of 28 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Industria Química y Farmacéutica VIR, S.A.

C/Laguna 66-68-70

Polígono Industrial Urtinsa II

28923 Alcorcón-Madrid (Spain)

Manufacturer:

Sofarimex Lda.

Av. Indústrias, Alto do Colaride

Agualva 2735-213 Cacém – Portugal

or

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-68-70

Polígono Industrial Urtinsa II

28923 Alcorcón-Madrid (Spain)

This leaflet was approved in February 2025

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