LOSARTAN HYDROCHLOROTHIAZIDE VIR 50 mg/12.5 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

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

Losartan/Hydrochlorothiazide

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Leaflet

1. What Losartan/Hydrochlorothiazide VIR is and what it is used for
2. Before taking Losartan/Hydrochlorothiazide VIR
3. How to take Losartan/Hydrochlorothiazide VIR
4. Possible side effects
5. Storage of Losartan/Hydrochlorothiazide VIR
6. Package contents and additional information

1. What Losartan/Hydrochlorothiazide VIR is and what it is used for

Losartan/Hydrochlorothiazide is a combination of an angiotensin II receptor antagonist (losartan) and a diuretic (hydrochlorothiazide). Angiotensin II is a substance produced in the body that binds to receptors in blood vessels, causing them to constrict. This leads to an increase in blood pressure. Losartan prevents angiotensin II from binding to these receptors, resulting in the relaxation of blood vessels, which in turn lowers blood pressure. Hydrochlorothiazide causes the kidneys to eliminate more water and salts. This also helps to reduce blood pressure.

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

2. What you need to know before taking Losartan/Hydrochlorothiazide VIR

Do not take Losartan/Hydrochlorothiazide VIR

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

• if you are allergic (hypersensitive) to other sulfonamide-derived substances (e.g., other thiazides, some antibiotics such as cotrimoxazole; ask your doctor if you are unsure).
• if you are pregnant for more than 3 months. (It is also recommended to avoid Losartan/Hydrochlorothiazide VIR during the first months of pregnancy – see section Pregnancy)
• if you have severe hepatic impairment.
• if you have severe renal impairment or your kidneys do not produce urine.
• if you have low potassium or sodium levels, 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 medication containing aliskiren

Warnings and precautions

Consult your doctor or pharmacist before starting to take Losartan/Hydrochlorothiazide VIR.

Inform your doctor if you are pregnant (or think you may be). Losartan/Hydrochlorothiazide VIR is not recommended during the first trimester of pregnancy, and it must not be taken if you are pregnant for more than 3 months, as it may cause serious harm to your baby when administered from that time on (see section Pregnancy).

It is essential that you inform your doctor before taking Losartan/Hydrochlorothiazide VIR:

• if you have previously experienced swelling of the face, lips, tongue, or throat
• if you are taking diuretics (medications to urinate)
• if you are on a low-salt diet
• if you have had excessive vomiting and/or diarrhea
• if you have heart failure
• if you have narrow arteries that supply 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 disease that causes thickening of the heart valves)
• if you are diabetic
• if you have had gout
• if you have had an allergic disorder, asthma, or a condition that causes joint pain, skin rash, and fever (systemic lupus erythematosus)
• if you have high calcium levels or low potassium levels or are on a low-potassium diet
• if you need to undergo anesthesia (even at the dentist) or surgery, or if you are to undergo tests to determine your parathyroid function, you must inform your doctor or healthcare professional that you are taking losartan potassium and hydrochlorothiazide tablets
• 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), particularly if you have diabetes-related kidney problems.
• 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 Losartan/Hydrochlorothiazide VIR”.

• if you have had skin cancer or if you 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 skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun and UV exposure while taking Losartan/Hydrochlorothiazide VIR
• if you experience vision loss or eye pain, which could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye, and can occur within hours to a week after taking Losartan/Hydrochlorothiazide 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 severe shortness of breath or difficulty breathing after taking Losartan-Hydrochlorothiazide 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 Losartan/Hydrochlorothiazide VIR with other medications

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

Diuretics like hydrochlorothiazide in Losartan/Hydrochlorothiazide VIR may interact with other medications. Preparations containing lithium should not be taken with Losartan/Hydrochlorothiazide VIR without careful monitoring by your doctor. Special precautions (e.g., blood tests) may be necessary if you take potassium supplements, salt substitutes containing potassium, or potassium-sparing medications, diuretics (water pills), certain laxatives, medications for gout, medications to control heart rhythm or diabetes (oral or insulin), or other blood pressure medications.

It is also important that your doctor knows if you are taking steroids, cancer medications, pain medications, antifungal medications, or arthritis medications, cholesterol-lowering resins such as cholestyramine, muscle relaxants, sleep aids, opioid medications like morphine, or "pressor amines" like adrenaline or other medications in the same class.

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

Please, when taking Losartan/Hydrochlorothiazide VIR, inform your doctor when you are scheduled to undergo an iodine-based contrast medium.

Losartan/Hydrochlorothiazide VIR with food, drinks, and alcohol

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

Excessive salt in the diet may counteract the effect of Losartan/Hydrochlorothiazide VIR tablets.

Losartan/Hydrochlorothiazide VIR can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy:

You must inform your doctor if you are pregnant (or think you may be). Your doctor will generally advise you to stop taking Losartan/Hydrochlorothiazide VIR before becoming pregnant or as soon as you know you are pregnant and will recommend that you take another medication instead of Losartan/Hydrochlorothiazide VIR. Losartan/Hydrochlorothiazide VIR is not recommended during the first trimester of pregnancy, and it must not be taken if you are pregnant for more than 3 months, as it may cause serious harm to your baby when administered from that time on.

Breastfeeding:

Inform your doctor if you are breastfeeding or plan to start breastfeeding. Losartan/Hydrochlorothiazide VIR is not recommended during breastfeeding, and your doctor will choose another treatment for you if you wish to breastfeed.

Consult your doctor or pharmacist before using any medication.

Use in children and adolescents

There is no experience with the use of Losartan/Hydrochlorothiazide in children. Therefore, Losartan/Hydrochlorothiazide VIR should not be administered to children.

Use in elderly patients

Losartan/Hydrochlorothiazide VIR is equally effective and well-tolerated in most elderly patients and young patients. Most elderly patients require the same dose as younger patients.

Driving and using machines

When starting treatment with this medication, you should not perform tasks that require special attention (e.g., driving a car or using hazardous machinery) until you know how your medication is tolerated.

Important information about some of the ingredients of Losartan/Hydrochlorothiazide VIR

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

Use in athletes:

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

3. How to take Losartan/Hydrochlorothiazide VIR

Follow your doctor's instructions for taking Losartan/Hydrochlorothiazide VIR exactly. Your doctor will decide the appropriate dose of Losartan/Hydrochlorothiazide VIR, depending on your condition and whether you are taking other medications. It is essential to continue taking Losartan/Hydrochlorothiazide VIR as prescribed by your doctor to maintain constant control of your blood pressure.

High blood pressure

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 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 of losartan/12.5 mg of hydrochlorothiazide per day or 1 tablet of 100 mg of losartan/25 mg of hydrochlorothiazide per day.

If you take more Losartan/Hydrochlorothiazide VIR than you should

In case of 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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

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

If you forget to take Losartan/Hydrochlorothiazide VIR

Try to take Losartan/Hydrochlorothiazide VIR as prescribed. Do not take a double dose to make up for forgotten doses. Simply return to your regular schedule.

If you stop taking Losartan/Hydrochlorothiazide VIR

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

4. Possible side effects

Like all medications, Losartan/Hydrochlorothiazide VIR can cause side effects, although not everyone gets them.

If you experience the following, stop taking Losartan/Hydrochlorothiazide VIR 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, affecting more than 1 patient in 10,000 but less than 1 patient in 1,000. You may need urgent medical attention or hospitalization.

The following side effects have been reported:

Frequent (may affect 1 to 10 in 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,
• High potassium levels (which can cause an abnormal heart rhythm), decreased hemoglobin levels.

Uncommon (may affect 1 to 10 in 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), bruising, reduced white blood cell count, coagulation problems, and bruising,
• Loss of appetite, high uric acid levels or gout, high blood sugar levels, abnormal blood electrolyte levels,
• Anxiety, nervousness, panic disorders (recurrent panic attacks), confusion, depression, abnormal dreams, sleep disorders, somnolence, memory impairment,
• Numbness or similar sensations, pain in the limbs, tremor, migraine, fainting,
• Blurred vision, eye irritation or itching, conjunctivitis, worsening 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 glaucoma].
• Ringing, buzzing, noise, or clicking in the ears,
• Low blood pressure that may be associated with postural changes (feeling dizzy or weak when standing up), angina (chest pain), abnormal heartbeats, stroke (transient stroke, "mini-stroke"), heart attack, palpitations,
• Inflammation of blood vessels that is often associated with a skin rash or bruising,
• Sore throat, shortness of breath, bronchitis, pneumonia, fluid in the lungs (which can 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), pancreatitis,
• Hives, itching, skin inflammation, skin rash, redness of the skin, sensitivity to light, 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 desire, impotence,
• Swelling of the face, fever.

Rare (may affect 1 to 10 in 10,000 patients):

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

Very rare:

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

Frequency not known:

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

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

Reporting side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are 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 contribute to providing more information on the safety of this medication.

5. Storage of Losartan/Hydrochlorothiazide VIR

Keep out of sight and reach of children.

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

Store Losartan/Hydrochlorothiazide Vir in its original packaging.

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

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

6. Package Contents and Additional Information

Composition of Losartan/Hydrochlorothiazide Vir

The active ingredients are losartan potassium and hydrochlorothiazide.

Each Losartan/Hydrochlorothiazide Vir tablet contains, as active ingredients, 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide.

The other ingredients 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 Package Contents

Losartan/Hydrochlorothiazide Vir 50 mg/12.5 mg tablets are film-coated, yellow tablets.

Losartan/Hydrochlorothiazide 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 certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

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 leaflet was approved in: February 2025

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