LOSARTAN/HYDROCHLOROTHIAZIDE VIR 100 MG/25 MG FILM-COATED TABLETS EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Losartan/Hydrochlorothiazide VIR 100 mg/25 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 must not be given 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 present 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 starting to take 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 antibacterial agents such as cotrimoxazole; ask 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 impairment.

• if you have severe renal impairment or your kidneys are not producing urine.

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

• if you have gout.

• if you have diabetes or renal impairment 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 suspect you may be pregnant). Use of Losartán/Hidroclorotiazida VIR is not recommended during early pregnancy, and must be avoided after the third month of pregnancy as it may cause serious harm to the unborn baby 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 production).

• 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 supplying the kidneys (renal artery stenosis).

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

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

• if you have aortic or mitral valve stenosis (narrowing of the 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 calcium levels or low potassium levels, 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 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.

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, and may occur within hours to a week after taking Losartán/Hidroclorotiazida VIR.
• if you have previously experienced respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking Losartán/Hidroclorotiazida VIR, seek medical attention 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 closely monitors you. 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 (tablets for increasing urine), certain laxatives, medicines for treating gout, medicines to control heart rhythm, or medicines for diabetes (oral medications or insulin). It is also important that your doctor knows if you are taking other blood pressure-lowering medicines, steroids, cancer treatments, pain medications, antifungal medicines, arthritis medications, 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 class, 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 inhibitor (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 iodinated 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 increase each other's effects.

Excessive dietary salt intake may counteract the effect 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 suspect you may be pregnant). 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 the unborn baby when used from that stage.

Breastfeeding:

Inform your doctor if you are breastfeeding or plan 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 VIR in children. Therefore, Losartán/Hidroclorotiazida VIR should not be administered to children.

Use in elderly patients

Losartán/Hidroclorotiazida VIR is equally effective and well tolerated by 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 components of Losartán/Hidroclorotiazida VIR

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

Use in athletes:

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

3. How to take Losartán/Hidroclorotiazida VIR

Follow exactly the administration instructions for Losartán/Hidroclorotiazida VIR given to you by your doctor. Your doctor will decide the appropriate dose of Losartán/Hidroclorotiazida VIR based on your condition and whether you are taking other medications. It is important to keep taking Losartán/Hidroclorotiazida VIR as prescribed by your doctor in order 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. The 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 the event of an 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 can cause adverse effects, although not everyone experiences them.

If you experience the following, stop taking Losartán/Hidroclorotiazida VIR tablets and contact your doctor immediately 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 100 patients):

• Cough, respiratory infection, nasal congestion, sinusitis, sinus disorder,
• Diarrhoea, 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 haemoglobin levels.

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

• Anaemia, 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 cells, blood clotting problems 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, somnolence, memory disturbance,
• Tingling or similar sensations, limb pain, tremor, migraine, fainting,
• Blurred vision, burning or itching in the eyes, conjunctivitis, worsening of vision, seeing things 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 upon standing), angina (chest pain), abnormal heartbeats, stroke (transient ischaemic attack, "mini-stroke"), heart attack, palpitations,
• Inflammation of blood vessels often associated with a 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, inflammation 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, hip, knee or other joints, joint swelling, stiffness, muscle weakness,
• Frequent urination, even at night, abnormal kidney function including kidney inflammation, urinary tract infection, sugar in the urine,
• Decreased sexual appetite, impotence,
• Facial swelling, fever.

Rare (may affect between 1 and 10 out of 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 diarrhoea.

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 adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects 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/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 in the original packaging.

Keep the blister pack in the outer packaging. Do not open the blister until ready to take the tablet.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. If you are in doubt, please consult your pharmacist on how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Losartan/Hydrochlorothiazide VIR

The active substances are potassium losartan and hydrochlorothiazide.

Each Losartan/Hydrochlorothiazide VIR tablet contains, as active substances, 100 mg of potassium losartan and 25 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 medicine and contents of the pack

Losartan/Hydrochlorothiazide VIR 100 mg/25 mg tablets are yellow, film-coated tablets.

Losartan/Hydrochlorothiazide VIR 100 mg/25 mg tablets are supplied in PVC/PE/PVDC blisters with an aluminum foil lid, in pack sizes of 28 and 500 tablets.

Only some pack sizes may be commercially available.

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/.