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

Introduction

Package Leaflet: Information for the User

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

losartan potassium/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, pharmacist, or nurse.
• 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Losartan/Hydrochlorothiazide Viatris 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 present in blood vessels, causing them to narrow. This leads to an increase in blood pressure.

Losartan prevents angiotensin II from binding to these receptors, which causes the blood vessels to relax, thereby decreasing blood pressure.

Hydrochlorothiazide causes the kidneys to eliminate more water and salts. This also helps to reduce blood pressure.

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

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

Do not take Losartan/Hydrochlorothiazide Viatris

• If you are allergic to losartan, hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other sulfonamide-derived substances (e.g., other thiazides, certain antibacterials 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 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 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-lowering medicine that contains aliskiren.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Losartan/Hydrochlorothiazide Viatris.

It is important that you inform your doctor before taking losartan/hydrochlorothiazide:

• 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 diarrhea.
• If you have heart failure.
• If you have narrowings of the arteries that supply the kidneys (renal artery stenosis), if you only have one functioning kidney, or if you have recently had a kidney transplant.
• If you have narrowing of the arteries (arteriosclerosis), angina pectoris (chest pain due to poor heart function).
• If you have narrowing of the aortic or mitral valve (valvular 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 calcium levels or low potassium levels or if you are on a low-potassium diet.
• If you need to have anesthesia (even at the dentist) or before surgery, or if you are to have tests to determine your parathyroid function, you should 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 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 diabetes-related kidney problems.
• Aliskiren.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking losartan/hydrochlorothiazide. Your doctor will decide whether to continue treatment. Do not stop taking losartan/hydrochlorothiazide on your own.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.

• 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.
• 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 an increase in eye pressure and can occur within hours to a week after taking losartan/hydrochlorothiazide. This can lead to permanent vision impairment if left untreated.
• 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, seek medical attention immediately.

See also the information under the heading “Do not take Losartan/Hydrochlorothiazide Viatris”.

Other medicines and Losartan/Hydrochlorothiazide Viatris

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

Tell your doctor if you are taking potassium supplements, salt substitutes that contain potassium, potassium-sparing medicines, or other medicines that may increase serum potassium levels (e.g., trimethoprim-containing medicines), as combination with losartan/hydrochlorothiazide is not recommended.

Diuretics like hydrochlorothiazide in Losartan/Hydrochlorothiazide Viatris may interact with other medicines.

Lithium-containing preparations should not be taken with losartan/hydrochlorothiazide without careful monitoring by your doctor.

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), certain laxatives, gout treatments, heart rhythm or diabetes medicines (oral or insulin).

It is also important that your doctor knows if you are taking:

• Other medicines to reduce your blood pressure.
• Steroids.
• Cancer treatments.
• Painkillers.
• Antifungal medicines.
• Arthritis medicines.
• Cholesterol-lowering resins such as cholestyramine.
• Muscle relaxants.
• Sleeping tablets.
• Opioid medicines like morphine.
• "Pressor amines" like adrenaline or other medicines of the same group.
• Oral diabetes medicines or insulins.

Please inform your doctor when you are scheduled to have a contrast medium with iodine.

Your doctor may need to adjust your dose and/or take other precautions:

If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Losartan/Hydrochlorothiazide Viatris” and “Warnings and precautions”.

Taking Losartan/Hydrochlorothiazide Viatris with food and drinks

It is recommended that you do not drink alcohol while taking this medicine: alcohol and losartan/hydrochlorothiazide may increase the effects of each other.

Excessive salt in the diet may counteract the effect of losartan/hydrochlorothiazide.

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

Grapefruit juice should be avoided while taking this medicine.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will normally advise you to stop taking losartan/hydrochlorothiazide 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. Losartan/hydrochlorothiazide is not recommended during the first trimester of pregnancy and must not be taken after the first trimester, as it may cause serious harm to your baby.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. Losartan/hydrochlorothiazide 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 should not be given to children.

Use in elderly patients

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

Driving and using machines

When starting 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.

Losartan/Hydrochlorothiazide Viatris contains lactose

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 Viatris

Follow exactly the administration instructions of losartan/hydrochlorothiazide given by your doctor. In case of doubt, consult your doctor or pharmacist again. Your doctor will decide the appropriate dose of losartan/hydrochlorothiazide, depending on your condition and whether you are taking other medicines. It is important to continue taking losartan/hydrochlorothiazide as long as your doctor prescribes it 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 over 24 hours. The dose 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 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.

Administration

The tablets should be swallowed whole with a glass of water.

If you take more Losartan/Hydrochlorothiazide Viatris than you should

In case of overdose or accidental ingestion, contact your doctor immediately or go directly to the hospital for immediate medical attention, stating the medicine and the amount taken.

You can also call the Toxicology Information Service, telephone 91 562 04 20, stating the medicine and the amount taken. It is recommended to take the package and the leaflet of the medicine to the healthcare professional.

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

If you forget to take Losartan/Hydrochlorothiazide Viatris

Try to take losartan/hydrochlorothiazide every day as prescribed. However, if you miss a dose, do not take an extra dose. Simply return to your regular schedule.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

If you experience the following, stop taking the losartan/hydrochlorothiazide 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 adverse effect that can affect up to 1 in 1,000 people. You may need urgent medical attention or hospitalization.

The following adverse effects have been reported:

Frequent(may affect up to 1 in 10 people)

• 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 levels of potassium (which can cause an abnormal heart rhythm), decreased hemoglobin levels.
• Changes in renal function, including renal failure;
• Low blood sugar (hypoglycemia).

Uncommon(may affect up to 1 in 100 people)

• 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 cell count, coagulation problems, and reduced platelet count.
• Loss of appetite, high levels of uric acid or gout, high blood glucose 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, tremors, migraine, fainting.
• Blurred vision, itching or burning in the eyes, conjunctivitis, worsening vision, seeing things in yellow.
• Ringing, buzzing, noises, 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 cerebral stroke, "mini-stroke"), heart attack, palpitations.
• Inflammation of blood vessels, often associated with a skin rash or hematoma.
• Sore throat, shortness of breath, bronchitis, pneumonia, fluid in the lungs (which can cause difficulty breathing), nasal bleeding, 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 renal function, including kidney inflammation, urinary tract infection, sugar in the urine.
• Decreased sexual appetite, impotence.
• Swelling of the face, localized swelling (edema), fever.

Rare(may affect up to 1 in 1,000 people)

• 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(may affect up to 1 in 10,000 people)

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

Frequency Not Known(cannot be estimated from the available data)

• Flu-like symptoms.
• Muscle pain of unknown origin with dark-colored urine (tea-colored) (rhabdomyolysis).
• Low sodium levels in the blood (hyponatremia);
• Generally feeling unwell (malaise).
• Taste disturbance (dysgeusia).
• Decreased vision or eye pain (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).
• Skin and lip cancer (non-melanoma skin cancer).

Reporting of Adverse Effects

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

5. Storage of Losartan/Hydrochlorothiazide Viatris

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the packaging after CAD or EXP. The expiration date is the last day of the month indicated.

Do not store above 30°C.

Store this medicine in its original packaging.

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. Deposit the packaging and any unused medicines in the SIGRE collection point at 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 Viatris

The active ingredients are losartan potassium and hydrochlorothiazide. Each tablet contains, as active ingredients, 50 mg of losartan (potassium) and 12.5 mg of hydrochlorothiazide.

It contains 4.24 mg (0.108 mEq) of potassium.

The other ingredients are microcrystalline cellulose (E-460), lactose monohydrate, pregelatinized corn starch, magnesium stearate (E-470B), hydroxypropylcellulose (E-463), hypromellose (E-464), titanium dioxide (E-171), and yellow iron oxide (E-172).

Appearance of the Product and Package Contents

Losartan/Hydrochlorothiazide Viatris is presented in the form of film-coated tablets, without scoring, and yellow in color.

It is available in blisters of 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Manufacturer:

Laboratorios Liconsa, S.A.

Avda. Miralcampo, nº7, Polígono Industrial Miralcampo

19200 – Azuqueca de Henares (Guadalajara)

Spain

O

Mylan Hungary Kft.

H-2900 Komárom

Mylan utca 1.

Hungary

Date of the Last Revision of this Leaflet:September 2025

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