Product Information for the User

Losartán/Hidroclorotiazida Viatris 100 mg/25 mg Film-Coated Tablets EFG

losartán potassium/hydrochlorothiazide

Read this leaflet carefully before you start taking this medicine because 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. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before you start taking Losartán/Hidroclorotiazida Viatris

3.How to take Losartán/Hidroclorotiazida Viatris

4.Possible side effects

5.Storage of Losartán/Hidroclorotiazida Viatris

6.Contents of the pack and additional information

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

Do not take Losartán/Hidroclorotiazida Viatris

• If you are allergic to losartan, hydrochlorothiazide, or any of the other ingredients in this medication (listed in section 6).
• If you are allergic to other sulfonamide-derived substances (e.g. other thiazides, some antibiotics such as cotrimoxazole, ask your doctor if you are unsure).
• If you are more than 3 months pregnant (it is best to avoid losartan/hydrochlorothiazide 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 medication to lower blood pressure that contains aliskiren.

Warnings and Precautions

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

It is important to 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 (urine medications).
• If you are following a low-sodium diet.
• If you have excessive vomiting and/or diarrhea.
• If you have heart failure.
• If you have narrowed arteries (arterial stenosis), a single functioning kidney, or have recently undergone a kidney transplant.
• If you have atherosclerosis, angina pectoris (chest pain due to heart dysfunction).
• 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 eruptions, 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 (including dental anesthesia) or before surgery, or if you are undergoing tests to determine your parathyroid function, inform your doctor or healthcare provider 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 medications 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 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 renal function, blood pressure, and electrolyte levels (e.g. potassium) at regular intervals.

• If you have had skin cancer or if a skin lesion appears unexpectedly during treatment. The treatment with hydrochlorothiazide, particularly 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 sun exposure and UV rays while taking losartan/hydrochlorothiazide.
• If you experience a decrease in vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which can occur within a few hours to a week after taking losartan/hydrochlorothiazide. This can lead to permanent vision loss if not treated.
• 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, seek medical attention immediately.

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

Other Medications and Losartan/Hidroclorotiazida Viatris

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

Inform your doctor if you are taking potassium supplements, salt substitutes containing potassium, potassium-sparing medications, or other medications that may increase serum potassium levels (e.g. trimethoprim-containing medications), as it is not recommended to combine them with losartan/hydrochlorothiazide.

Diuretics like hydrochlorothiazide in Losartan/Hidroclorotiazida Viatris may interact with other medications.

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

Special precautions may be necessary (e.g. blood tests) if you take potassium supplements, salt substitutes containing potassium, potassium-sparing medications, diuretics (urine tablets), some laxatives, medications for gout treatment, medications to control heart rhythm or diabetes (oral medications or insulin).

It is also important for your doctor to know if you are taking:

• Other medications to lower your blood pressure.
• Steroids.
• Cancer medications.
• Pain medications.
• Antifungal medications.
• Arthritis medications.
• Resins used for high cholesterol, such as cholestyramine.
• Muscle relaxants.
• Sleeping pills.
• Opioid medications like morphine.
• "Pressor amines" like adrenaline or other medications in the same group.
• Oral diabetes medications or insulin.

Please inform your doctor when you plan to have a contrast agent 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/Hidroclorotiazida Viatris” and “Warnings and Precautions”.

Taking Losartan/Hidroclorotiazida Viatris with Food and Beverages

It is recommended not to drink alcohol while taking this medication: alcohol and losartan/hydrochlorothiazide may increase the effects of each other.

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

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

Pregnancy and Breastfeeding

Pregnancy

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before taking this medication.. Your doctor will usually recommend that you stop taking losartan/hydrochlorothiazide before becoming pregnant or as soon as you know you are pregnant and recommend that you take another medication instead of losartan/hydrochlorothiazide. Losartan/hydrochlorothiazide should not be used 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 time.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start breastfeeding. Losartan/hydrochlorothiazide is not recommended during breastfeeding, and your doctor will choose another treatment for you if you want 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 should not be administered to children.

Use in Elderly Patients

Losartan/hydrochlorothiazide 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 medication, do not perform tasks that may require special attention (e.g. driving a car or operating hazardous machinery) until you know how you tolerate your medication.

Losartan/Hidroclorotiazida Viatris contains lactose

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

Use in Athletes

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

Follow exactly the administration instructions for losartán/hidroclorotiazida as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. Your doctor will decide the appropriate dose of losartán/hidroclorotiazida, depending on your condition and if you are taking other medications. It is essential to continue taking losartán/hidroclorotiazida as prescribed by your doctor to maintain consistent blood pressure control.

Hypertension

For most patients with high blood pressure, the usual dose is 1 losartán/hidroclorotiazida 50 mg/12.5 mg tablet per day to control blood pressure for 24 hours. The dose can be increased to 2 losartán/hidroclorotiazida 50 mg/12.5 mg tablets per day or changed to 1 losartán/hidroclorotiazida 100 mg/25 mg tablet per day.

The maximum daily dose is 2 losartán 50 mg/hidroclorotiazida 12.5 mg tablets per day or 1 losartán 100 mg/hidroclorotiazida 25 mg tablet per day.

Administration

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

If You Take More Losartán/Hidroclorotiazida 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, indicating the medication and the amount ingested.

You can also call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication 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 Losartán/Hidroclorotiazida Viatris

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

If you experience any of the following, stop taking the losartan/hydrochlorothiazide tablets and inform your doctor immediately or go to the emergency service of your nearest hospital:

• A 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 may affect up to 1 in 1,000 people. 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, breast 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 renal function that include renal insufficiency;
• 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, reduction of white blood cells, and coagulation problems.
• Loss of appetite, elevated uric acid levels or manifest gout, elevated blood glucose levels, abnormal electrolyte levels in the blood.
• Anxiety, nervousness, panic disorders (recurrent panic attacks), confusion, depression, abnormal dreams, sleep disorders, somnolence, memory alteration.
• Tickling or similar sensations, pain in the extremities, tremor, migraine, fainting.
• Blurred vision, eye itching or stinging, conjunctivitis, worsening of vision, seeing things in yellow.
• 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, water 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, redness of the skin, 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 renal function including kidney inflammation, urinary tract infection, sugar in the urine.
• Decreased libido, impotence.
• Swelling of the face, localized swelling (edema), fever.

Rare(may affect up to1in 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 (symptoms include severe difficulty breathing, fever, weakness, and confusion).

Frequency not known(cannot be estimated from available data)

• Symptoms similar to the flu.
• Muscle pain of unknown origin with dark-colored urine (rhabdomyolysis).
• Low sodium levels in the blood (hyponatremia);
• Usually feeling unwell (malaise).
• Alteration of taste (dysgeusia).
• Decreased vision or eye pain(possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma).
• Skin and lip cancer (non-melanoma skin cancer).

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse,even if it is a possible side effect that does not appear in this leaflet. 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 this medication out of the sight and reach of children.

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

Do not store at a temperature above30°C.

Store this medication in the original packaging.

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Losartán/Hidroclorotiazida Viatris

The active principles are losartan potassium and hydrochlorothiazide.Each tablet contains, as active principles, 100 mg of losartan (potassium) and 25 mg of hydrochlorothiazide.

It contains8.48 mg (0.216 mEq) of potassium.

The other components are microcrystalline cellulose (E-460), lactose monohydrate, pregelatinized cornstarch, 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 content of the packaging

Losartán/Hidroclorotiazida Viatris is presented in the form of film-coated, non-scored, and yellow-colored tablets.

It is available in blisters of 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Responsible for manufacturing:

Laboratorios LICONSA, S.A.

Avda. Miralcampo, nº7, Industrial Estate Miralcampo

19200 – Azuqueca de Henares (Guadalajara)

Spain

Or

McDermott Laboratories Ltd. t/a Gerard Laboratories

Industrial Estate, Grange Road, Dublin 13

Ireland

Or

Mylan Hungary Kft.

H-2900 Komárom

Mylan utca 1.

Hungary

Last review date of this leaflet:January 2025

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