LOSARTAN HYDROCHLOROTHIAZIDE VIR 100 mg/25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Losartan/Hydrochlorothiazide VIR 100 mg/25 mg Film-Coated Tablets EFG

Losartan/Hydrochlorothiazide

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Losartan/Hydrochlorothiazide VIR and what is it used for
2. Before you take Losartan/Hydrochlorothiazide VIR
3. How to take Losartan/Hydrochlorothiazide VIR
4. Possible side effects
5. Storing Losartan/Hydrochlorothiazide VIR
6. Contents of the pack and other information

1. What is Losartan/Hydrochlorothiazide VIR and what is it 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 which binds to receptors in blood vessels, causing them to narrow. This leads to an increase in blood pressure. Losartan prevents the binding of angiotensin II 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 lower blood pressure.

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

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

Do not take Losartan/Hydrochlorothiazide 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 antibacterial drugs such as cotrimoxazole; ask your doctor if you are not sure).
• if you are more than 3 months pregnant. (It is also better 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 are not producing urine.
• if you have low levels of potassium or sodium, high levels of calcium that cannot be corrected by 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

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

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

It is important that you tell your doctor before taking Losartan/Hydrochlorothiazide VIR:

• if you have previously suffered from swelling of the face, lips, tongue or throat
• if you are taking diuretics (water tablets)
• if you are on a low-salt diet
• if you have had excessive vomiting and/or diarrhoea
• if you have heart failure
• if you have narrowing of the arteries that supply blood to the kidneys (renal artery stenosis)
• if you only have one functioning kidney or have recently had a kidney transplant
• if you have narrowing of the arteries (atherosclerosis), angina pectoris (chest pain due to poor heart function)
• if you have narrowing of the heart valves (aortic or mitral stenosis) 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 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 need to have anaesthesia (even at the dentist) or before surgery, or if you are going to have tests to check your parathyroid function, you must inform your doctor or healthcare staff 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 an alteration 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 associated with diabetes.
• aliskiren

Your doctor may check 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 some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Losartan/Hydrochlorothiazide VIR
• if you experience a decrease in vision or eye pain, these 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 a few hours to a week after taking Losartan/Hydrochlorothiazide 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 experience shortness of breath or severe difficulty breathing after taking Losartan-Hydrochlorothiazide Vir, go to 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 Losartan/Hydrochlorothiazide VIR with other medicines

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

Diuretics like hydrochlorothiazide contained in Losartan/Hydrochlorothiazide VIR may interact with other medicines. Preparations containing lithium should not be taken with Losartan/Hydrochlorothiazide VIR without your doctor carrying out close monitoring. Special precautions may be necessary (e.g. blood tests) if you take potassium supplements, salt substitutes that contain potassium or potassium-sparing medicines, diuretics (water tablets), some laxatives, medicines for treating gout, medicines for controlling heart rhythm or for diabetes (oral medicines or insulins). It is also important that your doctor knows if you are taking other medicines to lower your blood pressure, steroids, medicines for treating cancer, painkillers, medicines for treating fungal infections or medicines for arthritis, cholesterol-lowering resins such as colestyramine, muscle relaxants, sleeping tablets; opioid medicines such as morphine, "pressor amines" such as adrenaline or other medicines in the same class; (oral medicines for diabetes or insulins).

Your doctor may need to change 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 have a contrast medium with iodine.

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

Breastfeeding:

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

Ask your doctor or pharmacist for advice before taking any medicine.

Use in children and adolescents

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

Use in elderly patients

Losartan/Hydrochlorothiazide VIR works as well and is as well tolerated by most elderly patients as it is by younger patients. Most elderly patients require the same dose as younger patients.

Driving and using machines

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

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

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

Use in athletes:

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

3. How to take Losartan/Hydrochlorothiazide VIR

Follow exactly the instructions of administration of Losartan/Hydrochlorothiazide VIR given by your doctor. Your doctor will decide the appropriate dose of Losartan/Hydrochlorothiazide VIR, depending on your condition and whether you are taking other medicines. It is important to keep taking Losartan/Hydrochlorothiazide VIR while your doctor prescribes it to you to maintain constant control of your blood pressure

High blood pressure

For most patients with high blood pressure, the usual dose is one losartan/hydrochlorothiazide 50 mg/12.5 mg tablet per day to control blood pressure over 24 hours. It can be increased to two losartan/hydrochlorothiazide 50 mg/12.5 mg film-coated tablets per day or changed to one losartan/hydrochlorothiazide 100 mg/25 mg film-coated tablet (a stronger dose) per day. The maximum daily dose is two losartan 50 mg/hydrochlorothiazide 12.5 mg tablets per day or one losartan 100 mg/hydrochlorothiazide 25 mg tablet 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, telephone 91 562 04 20, indicating the medicine 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 normal schedule.

If you stop taking Losartan/Hydrochlorothiazide VIR

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

4. Possible side effects

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

If you experience the following, stop taking Losartan/Hydrochlorothiazide VIR tablets and inform your doctor immediately or go to the casualty department of your nearest hospital:

A severe allergic reaction (skin rash, itching, swelling of the face, lips, mouth or throat that can cause difficulty in swallowing or breathing).

This is a serious but rare side effect, affecting more than 1 patient in 10,000 but fewer than 1 patient in 1,000. You may need urgent medical attention or hospitalization.

The following side effects have been reported:

Common (may affect up to 1 in 10 people):

• Cough, respiratory infection, nasal congestion, sinusitis, sinus disorder,
• Diarrhoea, abdominal pain, nausea, indigestion,
• Muscle or leg cramps, back pain,
• Insomnia, headache, dizziness,
• Weakness, fatigue, chest pain,
• High levels of potassium (which can cause an abnormal heart rhythm), decrease in haemoglobin levels.

Uncommon (may affect up to 1 in 100 people):

• Anaemia, 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, reduction in white blood cells, blood clotting problems and bruising,
• Loss of appetite, high levels of uric acid 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 problems,
• Numbness or similar sensations, pain in the limbs, tremor, migraine, fainting,
• Blurred vision, eye irritation or itching, 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 glaucoma].
• Ringing, buzzing, noises or clicking 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, 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 up to 1 in 1,000 people):

• 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 diarrhoea.

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 of side effects:

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Losartan/Hydrochlorothiazide VIR

Keep out of the sight and reach of children.

Do not use Losartan/Hydrochlorothiazide VIR after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Store in the original package.

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

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help to protect the environment.

6. Packaging Content 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, 100 mg of losartan potassium 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 Product and Packaging Content

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

Losartan/Hydrochlorothiazide VIR 100 mg/25 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 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 medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.