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

Patient Information Leaflet

Introduction

Patient Information Leaflet

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

losartan potassium/hydrochlorothiazide

Read the entire leaflet carefully before you start taking this medicine, as 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, pharmacist, or nurse.
• 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, as it could harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Losartán/Hidroclorotiazida Viatis is and what it is used for

Losartán/Hidroclorotiazida Viatris is a combination of an angiotensin II receptor antagonist (losartán) and a diuretic (hidroclorotiazida).

Angiotensin II is a substance produced by the body that binds to receptors in the blood vessels, causing them to narrow. This leads to an increase in blood pressure.

Losartán blocks 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 is indicated for the treatment of essential hypertension (high blood pressure).

2. What you need to know before taking 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 antibacterial agents such as cotrimoxazole; ask your doctor if you are unsure).
• If you are more than 3 months pregnant (losartan/hydrochlorothiazide should also be avoided 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 kidney impairment and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

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

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

• If you have previously experienced swelling of the face, lips, tongue, or throat.
• If you are taking diuretics (medicines for increasing urine production).
• 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 narrowed arteries supplying the kidneys (renal artery stenosis), if you only have one functioning kidney, or if you 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 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 (including at the dentist) or before surgery, or if you are undergoing tests to assess parathyroid function, you must inform the doctor or healthcare professional 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 adrenal dysfunction).
• If you are taking any of the following medicines used to treat high blood pressure (hypertension):
• An angiotensin-converting enzyme (ACE) inhibitor (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• 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 develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially 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 sun exposure and UV radiation while taking losartan/hydrochlorothiazide.
• If you are taking other medicines that may increase serum potassium (see section 2 “Other medicines and Losartan/Hydrochlorothiazide Viatris”);
• If you experience vision changes or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur within hours to a week after taking losartan/hydrochlorothiazide. This may lead to permanent vision loss if not treated.
• If you have previously experienced breathing or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop severe shortness of breath or 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

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

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

Diuretics such as hydrochlorothiazide contained in Losartan/Hydrochlorothiazide Viatris can interact with other medicines.

Lithium-containing preparations should not be taken with losartan/hydrochlorothiazide unless your doctor performs careful monitoring.

Special precautionary measures (e.g., blood tests) may be appropriate if you are taking potassium supplements, potassium-containing salt substitutes, potassium-sparing medicines, diuretics (water tablets), certain laxatives, medicines for treating gout, medicines to control heart rhythm, or medicines for diabetes (oral agents or insulin).

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.
• Medicines for arthritis.
• Resins used for high cholesterol, such as cholestyramine.
• Medicines that relax muscles.
• Sleeping tablets.
• Opioid medicines such as morphine.
• "Pressor amines" such as adrenaline or other medicines in the same group.
• Oral medicines for diabetes or insulin.

Please inform your doctor when you plan to undergo iodine-containing contrast media procedures while taking losartan/hydrochlorothiazide.

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

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

Taking Losartan/Hydrochlorothiazide Viatris with food and drink

You are advised not to drink alcohol while taking this medicine: alcohol and losartan/hydrochlorothiazide may increase each other's effects.

Excessive dietary salt intake 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 plan to become pregnant, consult your doctor or pharmacist before taking this medicine. Your doctor will usually advise you to stop taking losartan/hydrochlorothiazide before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. The use of losartan/hydrochlorothiazide 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 your baby when used from that stage.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to breastfeed. The use of losartan/hydrochlorothiazide is not recommended during breastfeeding, 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 losartan/hydrochlorothiazide in children. Therefore, losartan/hydrochlorothiazide should not be given to children.

Use in elderly patients

Losartan/hydrochlorothiazide is equally effective and well tolerated in 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.

Losartan/Hydrochlorothiazide Viatris contains lactose

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

Use in athletes

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

3. How to take Losartan/Hydrochlorothiazide Viatris

Follow exactly the dosing instructions for losartan/hydrochlorothiazide given by your doctor. If in doubt, consult your doctor or pharmacist again. Your doctor will determine the appropriate dose of losartan/hydrochlorothiazide based on your condition and whether you are taking other medications. It is important to keep taking losartan/hydrochlorothiazide as prescribed by your doctor 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. This dose may be increased to 2 tablets of losartan/hydrochlorothiazide 50 mg/12.5 mg daily or switched to 1 tablet of losartan/hydrochlorothiazide 100 mg/25 mg (a stronger dose) daily.

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.

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 to receive immediate medical attention, indicating the medicine and the amount ingested.

You may also call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

Overdose may cause low 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 resume your regular dosing schedule.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If you experience the following, stop taking losartan/hydrochlorothiazide tablets immediately and contact your doctor right away 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 serious but rare adverse effect, which may affect up to 1 in 1,000 people. It may require urgent medical attention or hospitalization.

The following adverse effects have been reported:

Common (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.
• Elevated potassium levels (which may cause an abnormal heart rhythm), decreased hemoglobin levels.
• Changes in kidney function including kidney failure;
• Blood sugar too low (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 hands and feet and abdominal pain), bruising, reduced white blood cells, blood clotting problems and low platelet count.
• 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, drowsiness, memory impairment.
• Tingling or similar sensations, pain in the limbs, tremor, migraine, fainting.
• Blurred vision, burning or itching in the eyes, conjunctivitis, worsening of vision, seeing things in yellow.
• Ringing, buzzing, noise or crackling in the ears.
• Low blood pressure which may be associated with changes in posture (feeling dizzy or weak when standing up), angina (chest pain), abnormal heartbeats, stroke (transient ischemic 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), nosebleed, 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, rash, skin redness, light sensitivity, dry skin, flushing, sweating, hair loss.
• Pain in 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, localized swelling (edema), 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 presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhea.

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

• Acute breathing difficulty (signs include severe shortness of breath, fever, weakness and confusion).

Frequency not known (cannot be estimated from available data)

• Flu-like symptoms.
• Muscle pain of unknown origin with dark-colored urine (tea-colored) (rhabdomyolysis).
• Low levels of sodium in the blood (hyponatremia);
• Generally feeling unwell (malaise).
• Taste disturbance (dysgeusia).
• Vision loss 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, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You may 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 Viatris

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

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

Do not store above 30°C.

Store this medicine in the original container.

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

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

6. Package contents and additional information

Composition of Losartan/Hydrochlorothiazide Viatris

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

Contains 4.24 mg (0.108 mEq) of potassium.

The other components 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 contents of the pack

Losartan/Hydrochlorothiazide Viatris is presented as film-coated tablets, unmarked and yellow in colour.

It is available in blisters of 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Manufacturer:

Laboratorios Liconsa, S.A.

Avda. Miralcampo, nº7, Polígono Industrial Miralcampo

19200 – Azuqueca de Henares (Guadalajara)

Spain

Or

Mylan Hungary Kft.

H-2900 Komárom

Mylan utca 1.

Hungary

Date of the most recent review of this leaflet: September 2025

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