Losartan Vir 100 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Losartán Vir 100 mg film-coated tablets EFG

Read the entire 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 and you should not give it to other people, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

1. What Losartán Vir is and what it is used for
2. Before you take Losartán Vir
3. How to take Losartán Vir
4. Possible side effects
5. How to store Losartán Vir
6. Further information

1. What Losartán Vir 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 angiotensin II from binding to these receptors, resulting in relaxation of the blood vessels and consequently lowering blood pressure. Losartan reduces the worsening of kidney function in patients with high blood pressure and type 2 diabetes.

Losartán Vir 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. Before taking Losartán Vir

Do not take Losartán Vir

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

Take special care with Losartán Vir

Inform your doctor if you are pregnant (or suspect you might be pregnant). The use of Losartán Vir is not recommended during early pregnancy, and under no circumstances should it be administered after the third month of pregnancy, as it may cause serious harm to your baby when used from that point onward (see section Pregnancy).

Before taking Losartán Vir, it is important to inform your doctor:

• If you have a history of angioedema (swelling of the face, lips, tongue, and/or throat) (see also section 4. Possible adverse effects).

• If you are experiencing excessive vomiting or diarrhea, which may lead to excessive loss of fluid and/or salt from your body.

• If you are taking diuretics (medicines that increase the amount of fluid passing through your kidneys) or if you are on a low-salt diet that may cause 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 supplying your kidneys or if you have recently undergone a kidney transplant.

• If your liver function is impaired (see sections 2. Do not take Losartán Vir and 3. Dosage in special patient groups).

• If you have heart failure with or without renal insufficiency or potentially life-threatening concomitant cardiac arrhythmias. Special attention is required if you are also being treated with a beta-blocker.

• If you have heart valve problems or heart muscle disorders.

• 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 dysfunction 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.

  • 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 as monotherapy without medical advice.

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 Losartán Vir”.

Use of other medicines

Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including over-the-counter medicines, herbal medicines, and natural products.

While being treated with Losartán Vir, 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 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.

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 information under the headings “Do not take Losartán Vir” and “Take special care with Losartán Vir”).

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 closely monitors you. Special precautionary measures (e.g., blood tests) may be appropriate.

Taking Losartán Vir with food and drinks

Losartán Vir can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant (or suspect you might be pregnant). Your doctor will generally advise you to stop taking Losartán Vir before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of Losartán Vir. The use of Losartán Vir is not recommended during early pregnancy, and under no circumstances should it be administered after the third month of pregnancy, as it may cause serious harm to your baby when used from that point onward.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to breastfeed. The use of Losartán Vir is not recommended during breastfeeding. Your doctor will choose an alternative treatment for you if you wish to breastfeed, especially if your baby is a newborn or premature.

Consult your doctor or pharmacist before using any medicine.

Use in children and adolescents

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

Driving and using machines

Studies on the effects on the ability to drive and use machines have not been conducted. It is unlikely that Losartán Vir 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 engaging in such activities.

3. How to take Losartán Vir

Follow exactly the administration instructions for Losartán Vir given by your doctor.

Your doctor will determine the appropriate dose of Losartán Vir depending on your condition and whether you are taking other medicines. It is important to keep taking Losartán Vir as prescribed by your doctor in order to maintain consistent blood pressure control.

Patients with high blood pressure

Treatment usually starts with 50 mg of losartan (one Losartán Vir 50 mg 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 (one Losartán Vir 100 mg tablet or two Losartán Vir 50 mg tablets) once daily.

If you feel that the effect of Losartán is too strong or too weak, please inform your doctor or pharmacist.

Patients with high blood pressure and type 2 diabetes

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

Losartan tablets may be taken together with other blood pressure-lowering medicines (e.g. diuretics, calcium antagonists, alpha or beta-blockers, and centrally acting agents), as well as with insulin and other commonly used medicines 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 Losartán 12.5 mg Inicio tablet) 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 Losartán Vir 50 mg 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 to become 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 receiving 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 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 Losartán Vir unless your doctor tells you otherwise.

If you take more Losartán Vir 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 Vir

If you accidentally miss a dose, simply take the next dose as usual. 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, Losartán Vir can cause adverse effects, although not everyone experiences them.

If you experience any of the following, stop taking losartan tablets immediately and contact your doctor 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 in swallowing or breathing).

This is a serious but rare adverse effect, affecting more than 1 in 10,000 patients but less than 1 in 1,000. It may require urgent medical attention or hospitalization.

Adverse effects of medicines are classified as follows:

Very common: affects 1 in 10 patients.
Common: affects 1 to 10 in 100 patients.
Uncommon: affects 1 to 10 in 1,000 patients.
Rare: affects 1 to 10 in 10,000 patients.
Very rare: affects fewer than 1 in 10,000 patients.
Not known: frequency cannot be estimated from available data.

The following adverse effects have been reported with losartan:

Common:

• dizziness,
• low blood pressure,
• weakness,
• fatigue,
• low blood sugar (hypoglycaemia),
• high potassium levels in the blood (hyperkalaemia).

Uncommon:

• drowsiness,
• headache,
• sleep disorders,
• sensation of rapid heartbeat (palpitations),
• severe chest pain (angina pectoris),
• low blood pressure (especially after excessive loss of fluid from blood vessels, e.g. in patients with severe heart failure or receiving high doses of diuretics),
• dose-related orthostatic effects, such as drop in blood pressure upon standing up after lying down or sitting,
• difficulty breathing (dyspnoea),
• abdominal pain,
• chronic constipation,
• diarrhoea,
• nausea,
• vomiting,
• hives (urticaria),
• itching (pruritus),
• skin rash,
• localized swelling (oedema).

Rare:

• inflammation of blood vessels (vasculitis, Schönlein-Henoch purpura),
• numbness or tingling sensation (paraesthesia),
• fainting (syncope),
• very rapid and irregular heartbeat (atrial fibrillation),
• stroke (cerebrovascular accident),
• liver inflammation (hepatitis),
• increased 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 diarrhoea.

Not known:

• reduced number of red blood cells (anaemia),
• 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 renal failure,
• flu-like symptoms,
• increased blood urea, creatinine and plasma potassium levels in patients with heart failure,
• back pain and urinary tract infection.

Reporting of adverse effects:

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 Losartán Vir

Keep out of the reach and sight of children.

Do not use Losartán Vir after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Store Losartán Vir in its original packaging.

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

Medicines must not be disposed of via wastewater drains or household waste. Return unused medicines and their containers to a SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This helps protect the environment.

6. Additional Information

Composition of Losartán Vir

The active substance in Losartán Vir is potassium losartan.

Each Losartán Vir 100 mg tablet contains 100 mg of potassium losartan.

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

Losartán Vir 100 mg contains potassium in the following amount: 8.48 mg (0.216 mEq).

The other components of the coating are microcrystalline cellulose, hypromellose, polyethylene glycol 40 stearate, and titanium dioxide (E171).

Appearance of the medicinal product and content of the container

Losartán Vir 100 mg is supplied as white, oval-shaped, biconvex, film-coated tablets without a break line.

Losartán Vir is available in the following pack sizes: PVC/PE/PVDC/Al blisters, packs containing 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 up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.