Losartan/hydrochlorothiazide Vir 50 mg/12.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Losartan/Hydrochlorothiazide VIR 50 mg/12.5 mg film-coated tablets EFG

Losartan/Hydrochlorothiazide

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

• 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 only, and you should not give it to other people, even if they have the same symptoms as you, because it may 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 Losartan/Hydrochlorothiazide VIR is and what it is used for
2. Before you take Losartan/Hydrochlorothiazide VIR
3. How to take Losartan/Hydrochlorothiazide VIR
4. Possible side effects
5. How to store Losartan/Hydrochlorothiazide VIR
6. Contents of the pack and other information

1. What Losartán/Hidroclorotiazida VIR is and what it is used for

Losartán/Hidroclorotiazida is a combination of an angiotensin II receptor antagonist (losartán) and a diuretic (hidroclorotiazida). Angiotensin II is a substance produced in the body that binds to receptors located in blood vessels, causing them to narrow. This leads to an increase in blood pressure. Losartán prevents angiotensin II from binding to these receptors, resulting in relaxation of the blood vessels, thereby lowering blood pressure. Hidroclorotiazida causes the kidneys to eliminate increased amounts of water and salts. This also helps reduce blood pressure.

Losartán/Hidroclorotiazida VIR is indicated for the treatment of essential hypertension (high blood pressure).

2. What you need to know before taking Losartán/Hidroclorotiazida VIR

Do not take Losartán/Hidroclorotiazida VIR

• if you are allergic to losartan, hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6).

• if you are allergic (hypersensitive) to other sulfonamide-derived substances (e.g. other thiazides, certain antibiotics such as cotrimoxazole; consult your doctor if you are unsure).

• if you are more than 3 months pregnant. (It is also best to avoid Losartán/Hidroclorotiazida VIR during the first months of pregnancy – see Pregnancy section)

• if you have severe liver failure.

• if you have severe kidney failure or your kidneys are not producing urine.

• if you have low levels of potassium or sodium, or high levels of calcium that cannot be corrected with treatment.

• if you have gout.

• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Losartán/Hidroclorotiazida VIR.

Inform your doctor if you are pregnant (or think you might be). Use of Losartán/Hidroclorotiazida VIR is not recommended during early pregnancy, and you must not take it after the third month of pregnancy, as it may cause serious harm to your baby when used from that stage onward (see Pregnancy section).

It is important that you inform your doctor before taking Losartán/Hidroclorotiazida VIR:

• if you have previously experienced swelling of the face, lips, tongue, or throat.

• if you are taking diuretics (medicines to increase urine output).

• if you are on a low-salt diet.

• if you have or have had excessive vomiting and/or diarrhea.

• if you have heart failure.

• if you have narrowing of the arteries leading to the kidneys (renal artery stenosis).

• if you have only one functioning kidney or have recently undergone a kidney transplant.

• if you have narrowing of arteries (atherosclerosis), angina pectoris (chest pain due to poor heart function).

• if you have aortic or mitral valve stenosis (narrowing of heart valves) or hypertrophic cardiomyopathy (a condition causing thickening of the heart muscle).

• if you are diabetic.

• if you have had gout.

• if you have or have had an allergic disorder, asthma, or a condition causing joint pain, skin rashes, and fever (systemic lupus erythematosus).

• if you have high levels of calcium or low levels of potassium, or if you are on a low-potassium diet.

• if you require anesthesia (even at the dentist) or before surgery, or if you are undergoing tests to assess parathyroid function, you must inform your doctor or healthcare provider that you are taking losartan potassium and hydrochlorothiazide tablets.

• 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 electrolyte levels (e.g. potassium) at regular intervals.

See also the information under the heading “Do not take Losartán/Hidroclorotiazida VIR”.

• if you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Losartán/Hidroclorotiazida VIR.
• if you experience vision changes or eye pain, which could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure. These may occur within hours to one week after taking Losartán/Hidroclorotiazida VIR.
• if you have had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you develop shortness of breath or severe difficulty breathing after taking Losartán/Hidroclorotiazida VIR, contact your doctor immediately.
• 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.

Interaction of Losartán/Hidroclorotiazida VIR with other medicines

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

Diuretics such as hydrochlorothiazide contained in Losartán/Hidroclorotiazida VIR may interact with other medicines. Preparations containing lithium should not be taken with Losartán/Hidroclorotiazida VIR unless your doctor performs careful monitoring. Special precautionary measures (e.g. blood tests) may be appropriate if you are taking potassium supplements, potassium-containing salt substitutes, or potassium-sparing medicines, diuretics (water tablets), certain laxatives, medicines for gout, medicines to control heart rhythm, or medicines for diabetes (oral agents or insulin). It is also important that your doctor knows if you are taking other blood pressure-lowering medicines, steroids, cancer treatments, pain medicines, antifungal medicines, arthritis medicines, cholesterol-lowering resins such as cholestyramine, muscle relaxants, sleeping tablets, opioid medicines such as morphine, "pressor amines" such as adrenaline or other medicines in the same group, or oral antidiabetic medicines or insulin.

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/Hidroclorotiazida VIR” and “Warnings and precautions”).

Please inform your doctor if you are scheduled to receive iodine-containing contrast media while taking Losartán/Hidroclorotiazida VIR.

Losartán/Hidroclorotiazida VIR with food, drinks, and alcohol

You are advised not to drink alcohol while taking these tablets: alcohol and Losartán/Hidroclorotiazida VIR tablets may enhance each other's effects.

Excessive dietary salt intake may reduce the effectiveness of Losartán/Hidroclorotiazida VIR tablets.

Losartán/Hidroclorotiazida VIR may be taken with or without food.

Pregnancy and breastfeeding

Pregnancy:

Inform your doctor if you are pregnant (or think you might be). Your doctor will usually advise you to stop taking Losartán/Hidroclorotiazida VIR before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Use of Losartán/Hidroclorotiazida VIR is not recommended during early pregnancy, and must not be used from the third month of pregnancy onward, as it may cause serious harm to your baby when administered from that time.

Breastfeeding:

Inform your doctor if you are breastfeeding or planning to breastfeed. Use of Losartán/Hidroclorotiazida VIR during breastfeeding is not recommended, and your doctor will choose an alternative treatment if you wish to breastfeed.

Consult your doctor or pharmacist before using any medicine.

Use in children and adolescents

There is no experience with the use of Losartán/Hidroclorotiazida in children. Therefore, Losartán/Hidroclorotiazida VIR should not be given to children.

Use in elderly patients

Losartán/Hidroclorotiazida VIR is equally effective and well tolerated in most elderly and younger patients. Most elderly patients require the same dose as younger patients.

Driving and using machines

When starting treatment with this medicine, do not perform tasks that require special attention (e.g. driving a car or operating dangerous machinery) until you know how you react to the medicine.

Important information about some of the ingredients of Losartán/Hidroclorotiazida VIR

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

Use in athletes:

This medicine contains hydrochlorothiazide, which may lead to a positive result in doping control tests.

3. How to take Losartán/Hidroclorotiazida VIR

Follow exactly the administration instructions for Losartán/Hidroclorotiazida VIR given by your doctor. Your doctor will decide the appropriate dose of Losartán/Hidroclorotiazida VIR depending on your condition and whether you are taking other medicines. It is important to keep taking Losartán/Hidroclorotiazida VIR as prescribed by your doctor to maintain consistent blood pressure control.

High blood pressure

For most patients with high blood pressure, the usual dose is 1 tablet of losartan/hydrochlorothiazide 50 mg/12.5 mg once daily to control blood pressure over 24 hours. This dose may be increased to 2 film-coated tablets of losartan/hydrochlorothiazide 50 mg/12.5 mg per day or changed to 1 film-coated tablet of losartan/hydrochlorothiazide 100 mg/25 mg (a stronger dose) per day. The maximum daily dose is 2 tablets of 50 mg losartan/12.5 mg hydrochlorothiazide per day or 1 tablet of 100 mg losartan/25 mg hydrochlorothiazide per day.

If you take more Losartán/Hidroclorotiazida VIR than you should

In case of overdose, contact your doctor immediately or go directly to the hospital to receive immediate medical attention.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount taken.

Overdose may cause low blood pressure, palpitations, slow pulse, changes in blood composition, and dehydration.

If you forget to take Losartán/Hidroclorotiazida VIR

Try to take Losartán/Hidroclorotiazida VIR each day as prescribed. Do not take a double dose to make up for missed doses. Simply return to your regular dosing schedule.

If you stop taking Losartán/Hidroclorotiazida VIR

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/Hidroclorotiazida VIR may cause adverse effects, although not everyone experiences them.

If you experience any of the following, stop taking Losartán/Hidroclorotiazida VIR 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 rare but serious 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.

The following adverse effects have been reported:

Common (may affect between 1 and 10 out of every 100 patients):

• Cough, respiratory infection, nasal congestion, sinusitis, sinus disorder,
• Diarrhea, abdominal pain, nausea, indigestion,
• Muscle pain or cramps, leg pain, back pain,
• Insomnia, headache, dizziness,
• Weakness, fatigue, chest pain,
• Elevated potassium levels (which may cause abnormal heart rhythm), decreased hemoglobin levels.

Uncommon (may affect between 1 and 10 out of every 1,000 patients):

• Anemia, red or brown spots on the skin (sometimes especially on feet, legs, arms and buttocks, with joint pain, swelling of hands and feet, and abdominal pain), bruising, reduced white blood cell count, bleeding disorders and bruising,
• Loss of appetite, elevated uric acid levels or overt gout, elevated blood glucose levels, abnormal blood electrolyte levels,
• Anxiety, nervousness, panic disorders (recurrent panic attacks), confusion, depression, abnormal dreams, sleep disorders, drowsiness, memory impairment,
• Tingling or similar sensations, limb pain, tremor, migraine, fainting,
• Blurred vision, burning or itching in the eyes, conjunctivitis, worsening of vision, seeing things in yellow, decreased vision or eye pain due to increased pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma],
• Ringing, buzzing, noises or crackling in the ears,
• Low blood pressure which may be associated with postural changes (feeling dizzy or weak when standing up), angina (chest pain), irregular heartbeat, stroke (transient ischemic attack, "mini-stroke"), heart attack, palpitations,
• Inflammation of blood vessels, often associated with skin rash or bruising,
• Sore throat, shortness of breath, bronchitis, pneumonia, fluid in the lungs (which may cause difficulty breathing), nosebleeds, runny nose, congestion,
• Constipation, gas, stomach disorders, stomach spasms, vomiting, dry mouth, swelling of a salivary gland, toothache,
• Jaundice (yellowing of the eyes and skin), inflammation of the pancreas,
• Hives, itching, skin inflammation, skin rash, skin redness, photosensitivity, dry skin, flushing, sweating, hair loss,
• Pain in arms, shoulders, hips, knees or other joints, joint swelling, stiffness, muscle weakness,
• Frequent urination, including at night, abnormal kidney function including kidney inflammation, urinary tract infection, glucose in urine,
• Decreased sexual appetite, impotence,
• Facial swelling, fever.

Rare (may affect between 1 and 10 out of every 10,000 patients):

• Hepatitis (inflammation of the liver), abnormal liver function tests,
• Intestinal angioedema: swelling in the intestine presenting symptoms such as abdominal pain, nausea, vomiting and diarrhea.

Very rare:

Acute breathing difficulty (signs include severe shortness of breath, fever, weakness and confusion).

Frequency not known:

• Skin and lip cancer (non-melanoma skin cancer)

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Reporting of adverse effects:

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through 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/Hydrochlorothiazide Vir

Keep out of sight and reach of children.

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

Store Losartan/Hydrochlorothiazide Vir in the original packaging.

Keep the blister pack inside the outer packaging. Do not open the blister pack until you are ready to take the tablet.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Losartán/Hidroclorotiazida Vir

The active substances are losartan potassium and hydrochlorothiazide.

Each Losartán/Hidroclorotiazida Vir tablet contains, as active substances, 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide.

The other components are:

Core: lactose monohydrate, pregelatinized corn starch, microcrystalline cellulose (E460), magnesium stearate (E572).

Coating: hydroxypropyl cellulose (E463), hypromellose (E464), titanium dioxide (E171), talc, and yellow iron oxide (E172).

Appearance of the product and pack contents

Losartán/Hidroclorotiazida Vir 50 mg/12.5 mg tablets are yellow, film-coated tablets.

Losartán/Hidroclorotiazida Vir 50 mg/12.5 mg tablets are supplied in PVC/PE/PVDC blisters with an aluminum foil lid, in pack sizes of 28 and 500 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A.
C/Laguna, 66-68-70. Poligono Industrial Urtinsa II
28923- Alcorcón (Madrid).
Spain

Manufacturer:

SOFARIMEX
Avda. Das Industrias - Alto do Colaride
P-2735 (Agualva- Cacem)
Portugal

Or

INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A.
C/Laguna, 66-68-70. Poligono Industrial Urtinsa II
28923- Alcorcón (Madrid).
Spain

This patient information leaflet was approved in: February 2025

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