Losartan/hydrochlorothiazide Krka 100 mg/25 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Losartán/Hidroclorotiazida Krka 100 mg/25 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 or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these effects are not listed in this leaflet. See section 4.

Leaflet Contents

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

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

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 in the blood vessels, causing them to narrow. This leads to an increase in blood pressure. Losartán prevents 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 Krka is indicated for the treatment of essential hypertension (high blood pressure).

2. What you need to know before taking Losartan/Hydrochlorothiazide Krka

Do not take Losartan/Hydrochlorothiazide Krka

• if you are allergic to losartan and/or hydrochlorothiazide or to 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 antibiotics such as cotrimoxazole; ask your doctor if you are unsure),
• if you are more than three months pregnant (this medicine should also be avoided during the first trimester of pregnancy; see section "Pregnancy and breastfeeding"),
• if you have severe liver impairment, cholestasis, or biliary obstructive disorders,
• if you have severe renal impairment (e.g. creatinine clearance <30 ml/min),
• if 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 renal impairment and are being treated with an antihypertensive medicine containing aliskiren.

Warnings and precautions

Talk to your doctor or pharmacist before taking Losartan/Hydrochlorothiazide Krka.

• if you have previously experienced swelling of the face, lips, tongue, or throat,
• if you are taking diuretics (medicines to increase urine production),
• if you are on a low-salt diet,
• if you have had or currently have excessive vomiting and/or diarrhoea,
• if you have heart failure,
• if your liver function is impaired (see section 2 “Do not take Losartan/Hydrochlorothiazide Krka”),
• if you have narrowing of the arteries leading to the kidneys (renal artery stenosis), only one functioning kidney, or have recently undergone a kidney transplant,
• if you have arterial narrowing (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 have diabetes,
• if you have had gout,
• if you have or have had allergic disorders, 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 dental anesthesia) or surgery, or if you are undergoing tests to assess parathyroid function, inform your doctor or healthcare provider that you are taking losartan potassium and hydrochlorothiazide tablets,
• if you have primary hyperaldosteronism (a syndrome associated with excessive aldosterone hormone secretion from the adrenal gland due to gland dysfunction),
• if you are taking other medicines that may increase serum potassium (see section 2 “Other medicines and Losartan/Hydrochlorothiazide Krka”),
• if you have had skin cancer or 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 non-melanoma skin cancer and lip cancer. Protect your skin from sun exposure and UV radiation while taking Losartan/Hydrochlorothiazide Krka,
• if you have had respiratory or pulmonary problems (such as lung inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you develop dyspnoea or severe breathing difficulty after taking Losartan/Hydrochlorothiazide Krka, seek medical attention immediately,
• 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 weeks of taking this medicine. This may lead to permanent vision loss if not treated. If you previously had an allergy to penicillin or sulfonamides, you may be at higher risk,
• 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 related to diabetes,
  • aliskiren.

Your doctor may monitor 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 Krka”.

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

If you are pregnant, suspect you may be pregnant, or plan to become pregnant, inform your doctor. Use of Losartan/Hydrochlorothiazide Krka is not recommended during early pregnancy (first three months) and must not be used from the third month of pregnancy onward, as it may cause serious harm to your baby (see section "Pregnancy").

Other medicines and Losartan/Hydrochlorothiazide Krka

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, salt substitutes containing potassium, potassium-sparing medicines, or other medicines that may increase serum potassium (e.g. medicines containing trimethoprim), as combination with Losartan/Hydrochlorothiazide Krka is not recommended.

Diuretics such as hydrochlorothiazide contained in losartan/hydrochlorothiazide can interact with other medicines. Lithium-containing preparations should not be taken with losartan/hydrochlorothiazide unless your doctor closely monitors you. Special precautionary measures (e.g. blood tests) may be necessary if you are taking other diuretics (water tablets), certain laxatives, gout treatments, medicines to control heart rhythm, or diabetes medicines (oral agents or insulin). It is also important that your doctor knows if you are taking other blood pressure-lowering medicines, steroids, cancer treatments, painkillers, antifungal medicines, arthritis medicines, cholesterol-lowering resins such as cholestyramine, muscle relaxants, sleeping tablets, opioid medicines such as morphine, pressor amines such as adrenaline, or other medicines in the same class; or oral diabetes medicines or insulin.

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

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

Please inform your doctor if you are scheduled to receive iodinated contrast media while taking Losartan/Hydrochlorothiazide Krka.

Use of Losartan/Hydrochlorothiazide Krka with food, drinks, and alcohol

This medicine can be taken with or without food.

You are advised not to drink alcohol while taking these tablets: alcohol and Losartan/Hydrochlorothiazide Krka tablets may increase each other's effects.

Excessive dietary salt intake may counteract the effect of losartan/hydrochlorothiazide tablets.

Grapefruit juice should be avoided while taking losartan/hydrochlorothiazide tablets.

Pregnancy and breastfeeding

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

Pregnancy

Inform your doctor if you think you are pregnant (or might be). Your doctor will usually advise stopping treatment with losartan/hydrochlorothiazide before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Losartan/hydrochlorothiazide is not recommended during pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to your baby if used beyond the third month.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to breastfeed. Use of losartan/hydrochlorothiazide is not recommended in breastfeeding mothers, and your doctor may choose another treatment for you if you wish to breastfeed, especially if your baby is a newborn or was born prematurely.

Use in children and adolescents

There is no experience with the use of losartan/hydrochlorothiazide in children. Therefore, Losartan/Hydrochlorothiazide Krka must not be administered to children.

Use in elderly patients

Losartan/hydrochlorothiazide works equally effectively and is similarly well tolerated by 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 Krka contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Losartán/Hidroclorotiazida Krka

Follow exactly the instructions for use of this medicine as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will decide the appropriate dose of losartán/hidroclorotiazida based on your condition and whether you are taking other medicines. It is important to keep taking losartán/hidroclorotiazida 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 losartán/hidroclorotiazida 50 mg/12.5 mg once daily to control blood pressure over 24 hours. This dose may be increased to 2 film-coated tablets of losartán/hidroclorotiazida 50 mg/12.5 mg once daily or switched to 1 film-coated tablet of Losartán/Hidroclorotiazida Krka 100 mg/25 mg (a stronger dose) once daily. The maximum daily dose is 2 film-coated tablets of losartán/hidroclorotiazida 50 mg/12.5 mg per day or 1 film-coated tablet of Losartán/Hidroclorotiazida Krka 100 mg/25 mg per day.

If you take more Losartán/Hidroclorotiazida Krka than you should

In case of overdose, contact your doctor immediately or go directly to the hospital to receive immediate medical attention. Overdose may cause low blood pressure, palpitations, slow pulse, changes in blood composition, and dehydration.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Losartán/Hidroclorotiazida Krka

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

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

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 and contact your doctor immediately 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 rare but serious adverse effect, affecting more than 1 in 10,000 patients but less than 1 in 1,000. 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, upper respiratory tract 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 abnormal heart rhythm), decreased hemoglobin levels.
• Changes in kidney 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), reduced white blood cell count, blood clotting problems, and reduced 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, limb pain, tremor, migraine, fainting.
• Blurred vision, eye irritation or itching, conjunctivitis, worsening of vision, seeing things in yellow.
• Ringing, buzzing, noise, or crackling in the ears, dizziness.
• Low blood pressure which may be associated with postural changes (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), nosebleeds, runny nose, congestion.
• Constipation, chronic 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, photosensitivity, 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 causing symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

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

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

Frequency not known (cannot be estimated from available data)

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, 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: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Losartan/Hydrochlorothiazide Krka

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

Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Keep in the original packaging to protect from moisture.

HDPE bottle:

After first opening the container, the medicine should be used within the next 100 days.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Losartan/Hydrochlorothiazide Krka

• The active substances are losartan potassium and hydrochlorothiazide. Each Losartan/Hydrochlorothiazide 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 “Losartan/Hydrochlorothiazide Krka contains lactose”.

Appearance of the product and contents of the pack

Losartan/Hydrochlorothiazide Krka 100 mg/25 mg: yellow, oval, slightly biconvex film-coated tablets with dimensions of 8 mm x 15 mm and a thickness of 5.1 – 6.1 mm.

The tablets are contained in boxes with:

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

Only certain pack 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) under the following names:

This leaflet was approved in: June 2025

Detailed 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/).