Package Insert: Information for the Patient

Losartán/Hidroclorotiazida VIR 50 mg/12.5 mg Film-Coated Tablets

Losartán/Hidroclorotiazida

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you only, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What isLosartán/Hidroclorotiazida VIRand for what it is used

2. Before taking Losartán/Hidroclorotiazida VIR

3. How to take Losartán/Hidroclorotiazida VIR

4. Possible adverse effects

5. Storage of Losartán/Hidroclorotiazida VIR

6. Contents of the package and additional information

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 constrict. This results in an increase in blood pressure. Losartán prevents the binding of angiotensin II to these receptors, causing blood vessels to relax, which in turn reduces blood pressure. Hidroclorotiazida causes the kidneys to eliminate a greater amount of water and salts. This also helps to reduce blood pressure.

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

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, some antibacterials 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 failure.
• If you have severe kidney failure or your kidneys do not produce urine.
• If you have low levels of potassium or sodium, 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 that contains aliskiren

Warnings and precautions

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

Inform your doctor if you are pregnant (or if you suspect that you may be). Losartán/Hidroclorotiazida VIR is not recommended for use at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant as it may cause serious harm to your baby when administered from that point onwards (see Pregnancy section).

It is important to 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 (urine medicines)
• If you are following a low-sodium diet
• If you have had excessive vomiting and/or diarrhea
• If you have heart failure
• If you have narrowed arteries leading to the kidney (renal artery stenosis)
• If you only have one functioning kidney or have recently had a kidney transplant
• If you have atherosclerosis (narrowing of the arteries), angina (chest pain due to poor heart function)
• If you have aortic or mitral valve stenosis (narrowing of the heart valves) or hypertrophic cardiomyopathy (a disease that causes thickening of the heart valves)
• If you are diabetic
• If you have had gout
• If you have or have had an allergic reaction, asthma, or a condition that causes 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 following a low-potassium diet
• If you need anesthesia (even for dental procedures) or before surgery, or if you are having tests to determine your parathyroid function, inform your doctor or healthcare professional that you are taking losartan potassium and hydrochlorothiazide tablets
• If you have primary aldosteronism (a syndrome associated with an elevated secretion of aldosterone hormone by the adrenal gland due to a glandular alteration).
• If you are taking any of the following blood pressure-lowering medicines:

- 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 electrolyte levels in the blood (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 if you develop an unexpected skin lesion during treatment. The treatment with hydrochlorothiazide, particularly its long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking Losartán/Hidroclorotiazida VIR
• If you experience a decrease in vision or eye pain, which may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure and may occur within a few hours to a week after taking Losartan/Hidroclorotiazida VIR.
• If you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience 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

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

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 without your doctor's careful monitoring. Special precautions may be necessary (e.g. blood tests) if you take potassium supplements, salt substitutes containing potassium, or potassium-sparing medicines, diuretics (urine tablets), some laxatives, medicines for gout treatment, heart rhythm control medicines, or diabetes medicines (oral or insulin).

It is also important for your doctor to know if you are taking other blood pressure-lowering medicines, steroids, cancer medicines, pain medicines, fungal infection medicines, or arthritis medicines, cholesterol-lowering resins such as cholestyramine, muscle relaxants, sleeping pills; opioid medicines such as morphine, "pressor amines" such as adrenaline, or other medicines in the same group; (oral diabetes medicines or insulin).

Your doctor may need to modify 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 Losartán/Hidroclorotiazida VIR” and “Warnings and precautions”).

Please inform your doctor when you plan to have a contrast agent with iodine.

Losartán/Hidroclorotiazida VIR with food, drinks, and alcohol

It is recommended that you do not drink alcohol while taking these tablets: alcohol and Losartán/Hidroclorotiazida VIR tablets may increase the effects of each other.

Excessive salt in the diet may counteract the effect of Losartán/Hidroclorotiazida VIR tablets.

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

Pregnancy and breastfeeding

Pregnancy:

You must inform your doctor if you are pregnant (or if you suspect that you may be). Your doctor will usually recommend that you stop taking Losartán/Hidroclorotiazida VIR before becoming pregnant or as soon as you know you are pregnant and will recommend that you take another medicine instead of Losartán/Hidroclorotiazida VIR. Losartán/Hidroclorotiazida VIR is not recommended for use at the beginning of pregnancy, and in any case, it should not be administered from the third month of pregnancy as it may cause serious harm to your baby when administered from that point onwards.

Breastfeeding:

Inform your doctor if you are breastfeeding or plan to start. Losartán/Hidroclorotiazida VIR is not recommended for use during breastfeeding, and your doctor will choose another treatment for you 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 administered to children.

Use in elderly patients

Losartán/Hidroclorotiazida VIR acts with equal efficacy and is equally well tolerated by most elderly patients and young patients. Most elderly patients require the same dose as younger patients.

Driving and operating machinery

When starting treatment with this medicine, you should not perform tasks that may require special attention (e.g. driving a car or operating hazardous machinery) until you know how you tolerate your medicine.

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

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

Use in athletes:

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

Follow exactly the administration instructions for Losartán/Hidroclorotiazida VIR as indicated by your doctor. Your doctor will decide the appropriate dose of Losartán/Hidroclorotiazida VIR based on your condition and if you are taking other medications. It is essential to continue taking Losartán/Hidroclorotiazida VIR as prescribed by your doctor to maintain consistent blood pressure control.

Hypertension

For most patients with high blood pressure, the usual dose is 1 tablet of losartan/hydrochlorothiazide 50 mg/12.5 mg per day to control blood pressure for 24 hours. It can be increased to 2 tablets of losartan/hydrochlorothiazide 50 mg/12.5 mg per day or changed to 1 tablet of losartan/hydrochlorothiazide 100 mg/25 mg (a higher 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 an overdose, contact your doctor immediately or go directly to the hospital for immediate medical attention.

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

An overdose may cause a drop in blood pressure, palpitations, slow pulse, changes in blood composition, and dehydration.

If you forgot to take Losartán/Hidroclorotiazida VIR

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

If you interrupt treatment with Losartán/Hidroclorotiazida VIR

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, Losartán/Hidroclorotiazida VIR can cause side effects, although not everyone will experience them.

If you experience the following, stop taking the Losartán/Hidroclorotiazida VIR tablets and immediately inform your doctor or go to the nearest hospital emergency department:

Severe allergic reaction (skin rash, itching, swelling of the face, lips, mouth, or throat that may cause difficulty swallowing or breathing).

This is a serious but rare side effect that affects more than 1 in 10,000 patients but less than 1 in 1,000. You may need urgent medical attention or hospitalization.

The following side effects have been reported:

Frequent (may affect between 1 and 10 in every 100 patients):

• Cough, respiratory infection, nasal congestion, sinusitis, breast discomfort,
• 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.

Less frequent (may affect between 1 and 10 in every 1,000 patients):

• Anemia, red or brown spots on the skin, (sometimes especially on the feet, legs, arms, and buttocks, with joint pain, swelling of the hands and feet, and abdominal pain), hematoma, reduced white blood cells, coagulation problems, and hematomas,
• Loss of appetite, elevated uric acid levels or overt gout, elevated blood glucose levels, abnormal electrolyte levels in the blood,
• Anxiety, nervousness, panic attacks (recurring panic attacks), confusion, depression, abnormal dreams, sleep disorders, drowsiness, memory impairment,
• Tingling or similar sensations, limb pain, tremor, migraine, fainting,
• Blurred vision, eye itching or stinging, conjunctivitis, worsening vision, seeing things in yellow, decreased vision or eye pain due to high pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma].
• Ringing, buzzing, sounds, or crackling in the ears,
• Low blood pressure that may be associated with changes in posture (feeling dizzy or weak when standing up), angina (chest pain), abnormal heartbeats, transient ischemic attack (mini-stroke), heart attack, palpitations,
• Inflammation of blood vessels that often occurs with a skin rash or hematoma,
• Throat itching, shortness of breath, bronchitis, pneumonia, fluid in the lungs (which may cause difficulty breathing), nasal bleeding, runny nose, congestion,
• Constipation, gas, stomach disorders, stomach spasms, vomiting, dry mouth, salivary gland inflammation, tooth pain,
• Jaundice (yellow discoloration of the eyes and skin), pancreatitis inflammation,
• Hives, itching, skin inflammation, skin rash, skin redness, light sensitivity, dry skin, flushing, sweating, hair loss,
• Pain in the arms, shoulders, hips, knees, 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,
• Swelling of the face, fever.

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

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

Very rare:

Acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion

Unknown frequency:

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

If you experience side effects, consult your doctor or pharmacist, even if they are side effects that do not appear in this prospectus.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is possible side effects that do not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of the sight and reach of children.

Do not use Losartán/Hydrochlorothiazide Vir after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Store Losartán/Hydrochlorothiazide Vir in the original packaging.

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

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE point of the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need.This will help protect the environment.

Composition of Losartán/Hidroclorotiazida Vir

The active principles are losartan potassium and hydrochlorothiazide.

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

The other components are:

Core: lactose monohydrate, pregelatinized cornstarch, 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 content of the packaging

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

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

Only some pack sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing Authorization Holder:

INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A.

C/Laguna, 66-68-70. Poligono Industrial Urtinsa II

28923- Alcorcón (Madrid).

Spain

Responsible Manufacturer:

SOFARIMEX Avda. Das Industrias - Alto do Colaride

P-2735 (Agualva- Cacem)

Portugal

Ó

INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A.

C/Laguna, 66-68-70. Poligono Industrial Urtinsa II

28923- Alcorcón (Madrid).

Spain

This leaflet has been approved in: February 2025

The detailed and updated information about this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.