Package Leaflet: Information for the Patient

Losartán/Hidroclorotiazida Krka 100 mg/25 mg Film-Coated Tablets

losartán potassium/hydrochlorothiazide

Read this leaflet carefully before you start to take 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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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

Do not takeLosartán/Hidroclorotiazida Krka

• if you are allergic to losartan and/or hidroclorotiazida or to any of the other components of this medication (listed in section 6),
• if you are allergic to other sulfonamide-derived substances (e.g. other thiazides, some antibacterials such as cotrimoxazol, ask your doctor if you are unsure),
• if you are more than three months pregnant (it is also recommended to avoid this medication in the first trimester of pregnancy, see also section "Pregnancy and breastfeeding"),
• if you have severe liver failure,cholestasis and biliary tract disorders,
• if you have severe kidney failure (e.g. creatinine clearance <30
• if 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 aliskireno.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Losartán/Hidroclorotiazida Krka.

• 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 had excessive vomiting and/or diarrhea,
• if you have heart failure,
• if your liver function is altered (see section 2 “Do not take Losartán/Hidroclorotiazida Krka”),
• if you have narrowed arteries (renal artery stenosis), if you only have one functioning kidney or if you have recently had 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 professional 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 other medications that may increase serum potassium levels (see section 2 “Other medications and Losartán/Hidroclorotiazida Krka”),
• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hydrochlorothiazide, particularly its 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 Losartán/Hidroclorotiazida Krka,
• 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 Losartán/Hidroclorotiazida Krka, seek medical attention immediately,
• 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 hemorrhage) or increased intraocular pressure, which can occur within a few hours to several weeks after taking this medication. This can lead to permanent visual impairment if not treated. If you have previously had an allergy to penicillin or sulfonamide, you may be at higher risk of developing it,
• if you are taking any of the following medications used to treat high blood pressure (hypertension):
• • a renin-angiotensin-aldosterone system (RAAS) inhibitor (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
  • aliskireno.

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

See also the information under the heading “Do not take Losartán/Hidroclorotiazida Krka”.

If you are pregnant, think you may be pregnant, or plan to become pregnant, inform your doctor. Losartán/Hidroclorotiazida Krka is not recommended for use in the first trimester of pregnancy (first three months) and should not be taken after the third month of pregnancy, as it may cause serious harm to your baby (see section Pregnancy).

Other medications and Losartán/Hidroclorotiazida Krka

Inform your doctor or pharmacist if you aretaking, havetakenrecentlyor 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. trimetoprim-containing medications), as it is not recommended to combine them with Losartán/Hidroclorotiazida Krka.

Diuretics such as hydrochlorothiazide in losartan/hydrochlorothiazide may interact with other medications.

Preparations containing lithium should not be taken with losartan/hydrochlorothiazide without your doctor's careful monitoring.

Special precautions may be necessary (e.g. blood tests) if you are taking other diuretics (urine tablets), some laxatives, medications for gout treatment, medications for heart rhythm control 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 or arthritis medications, cholesterol-lowering resins such as cholestyramine, muscle relaxants, sleeping pills; opioid medications such as morphine, "pressor amines" such as adrenaline or other medications in the same group; (oral diabetes medications or insulin).

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

• If you are taking an angiotensin-converting enzyme (ACE) inhibitor or aliskireno (see also the information under the headings “Do not take Losartán/Hidroclorotiazida Krka” and “Warnings and precautions”).

Please inform your doctor when you plan to undergo a contrast agent with iodine.

Use of Losartán/Hidroclorotiazida Krka with food, drinks and alcohol

This medication can be taken with or without food.

It is recommended not to drink alcohol while taking these tablets: alcohol and Losartán/Hidroclorotiazida Krka tablets may increase the effects of each other.

Excessive sodium in the diet may counteract the effect of losartan and hydrochlorothiazide tablets.

The juice of a grapefruit should be avoided while taking losartan/hydrochlorothiazide tablets.

Pregnancyandbreastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

You should inform your doctor if you think you may be pregnant (or may be). Your doctor will usually advise you to 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 is not recommended during pregnancy, and it should not be taken if you are more than three months pregnant, as it may cause serious harm to your baby (see section Pregnancy).

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start breastfeeding. Losartan/hydrochlorothiazide is not recommended for breastfeeding mothers, and your doctor may choose another treatment for you if you wish to breastfeed, especially if your baby is newborn or premature.

Use in children and adolescents

There is no experience with the use of losartan/hydrochlorothiazide in children. Therefore, Losartán/Hidroclorotiazida Krka should not be administered to children.

Use in elderly patients

Losartan/hydrochlorothiazide acts with equal efficacy and is equally well tolerated by most elderly and young patients. Most elderly patients require the same dose as younger patients.

Driving and operating machinery

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

Losartán/Hidroclorotiazida Krka contains lactose

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

Follow exactly the administration instructions for this medication described in this leaflet or those indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will decide the appropriate dose of losartan/hidroclorotiazida, depending on your condition and if you are taking other medications. It is essential to continue taking losartan/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 tablet oflosartan/hidroclorotiazida50 mg/12.5 mg per day to control blood pressure for 24 hours. It can be increased to 2 tablets oflosartan/hidroclorotiazida50 mg/12.5 mg once a day or changed to 1 tablet ofLosartán/Hidroclorotiazida Krka100 mg/25 mg (a higher dose) per day. The maximum daily dose is 2 tablets oflosartan/hidroclorotiazida50 mg/12.5 mg per day or 1 tablet ofLosartán/Hidroclorotiazida Krka100 mg/25 mg per day.

If you take more Losartán/Hidroclorotiazida Krka than you should

In case of an overdose, contact your doctor immediately or go directly to the hospital for immediate medical attention. An overdose can cause a drop in blood pressure, palpitations, slow pulse, changes in blood composition, and dehydration.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount ingested.

If you forgot to take Losartán/Hidroclorotiazida Krka

Try to take losartan/hidroclorotiazida at the same time each day as prescribed. However, if you miss a dose, do not take an extra dose. Simply return to your regular schedule.

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

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

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 affects more than 1 in 10,000 patients but fewer than 1 in 1,000. You may need urgent medical attention or hospitalization.

The following side effects have been reported:

Frequent (may affect up to 1 in 10 people)

• Cough, respiratory tract infections, congestion, sinusitis, breast tenderness.
• Diarrhea, abdominal pain, nausea, indigestion.
• Muscle pain, leg pain, back pain.
• Insomnia, headache, dizziness.
• Weakness, fatigue, chest pain.
• Elevated potassium levels (which may cause abnormal heart rhythm), decreased hemoglobin levels.
• Changes in renal function, including renal insufficiency.
• Low blood sugar (hypoglycemia).

Infrequent (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), reduced white blood cell count, coagulation problems, and reduced platelet count.
• Loss of appetite, elevated uric acid levels or manifest gout, elevated blood glucose levels, abnormal electrolyte levels in the blood.
• Anxiety, nervousness, panic attacks (recurrent panic attacks), confusion, depression, abnormal dreams, sleep disorders, somnolence, memory alteration.
• Tingling or similar sensations, limb pain, tremor, migraine, fainting.
• Blurred vision, eye itching or prickling, conjunctivitis, worsening vision, seeing things in yellow.
• Ringing, buzzing, or clicking sounds in the ears, vertigo.
• 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.
• Sore throat, shortness of breath, bronchitis, pneumonia, fluid in the lungs (which may cause difficulty breathing), nasal bleeding, runny nose, congestion.
• Constipation, chronic 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, 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 libido, 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.

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

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

Frequency unknown (cannot be estimated from available data)

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

Reporting of side effects

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

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

Do not use this medication after the expiration date that appears on the box and on the blister pack after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Store in the original packaging to protect it from moisture.

HDPE Bottle:

After the first opening of the packaging, the medication must be used within the next 100 days.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and unused medications at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the containers and unused medications. In this way, you will help protect the environment.

Composition of Losartán/Hidroclorotiazida Krka

• The active principles are losartan potassium and hydrochlorothiazide. Each Losartán/Hidroclorotiazida Krka tablet contains 100 mg of losartan potassium equivalent to 91.52 mg of losartan, and 25 mg of hydrochlorothiazide.
• The other components are:

Core:pregelatinized maize starch, microcrystalline cellulose, lactose monohydrate, and magnesium stearate.

Coating:hypromellose, macrogol 4000, quinoline yellow (E104), talc, and titanium dioxide (E171). See section 2 “Losartán/Hidroclorotiazida Krka contains lactose”.

Appearance of the product and contents of the package

Losartán/Hidroclorotiazida Krka100 mg/25 mg: film-coated tablets, yellow, oval, and slightly biconvex with dimensions of 8 mm x 15 mm and 5.1 – 6.1 mm thickness.

The tablets are found in boxes containing:

• 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, and 112 film-coated tablets in a transparent Al/PVC/PVDC blister.
• 100 film-coated tablets in a plastic bottle with a child-resistant closure, in a box.

Only some package sizes may be marketed.

Marketing Authorization Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturers

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

KRKA Farmacéutica S.L., C/Anabel Segura 10, Pta. Baja, Oficina 1, 28108, Alcobendas, Madrid, Spain

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

This leaflet was last approved in:September 2023

Further information about this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).