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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Losartán/Hidroclorotiazida Krka 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, 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 they are adverse effects 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 works by making the kidneys eliminate more 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 Losartán/Hidroclorotiazida Krka

Do not take Losartán/Hidroclorotiazida 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 antibacterial medicines such as cotrimoxazole; ask your doctor if you are unsure);
• if you have severe liver impairment;
• if you have low levels of potassium or sodium, or high levels of calcium that cannot be corrected with treatment;
• if you have gout;
• if you are more than three months pregnant. (It is also advisable to avoid this medicine during the first trimester of pregnancy; see also pregnancy section);
• if you have severe renal impairment or your kidneys are not producing urine;
• if you have diabetes or renal impairment and are being treated with an antihypertensive medicine containing aliskiren.

Warnings and precautions

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

It is important that you inform your doctor before taking Losartán/Hidroclorotiazida 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 diarrhea;
• if you have heart failure;
• if your liver function is impaired (see section 2 “Do not take Losartán/Hidroclorotiazida Krka”);
• if you have narrowing of the 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 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 allergic disorders, asthma, or a disease 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 your doctor or healthcare provider 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 other medicines that may increase serum potassium (see section 2 “Other medicines and Losartán/Hidroclorotiazida 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 and lip cancer. Protect your skin from exposure to sunlight 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 dyspnea or severe difficulty breathing after taking Losartán/Hidroclorotiazida Krka, seek medical attention immediately;
• if you experience a decrease in vision or eye pain, which could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, occurring within hours to weeks after taking losartan/hydrochlorothiazide. If untreated, this may lead to permanent vision loss. Your risk may be higher if you previously had an allergy to penicillin or sulfonamides.

• if you are taking any of the following medicines used to treat high blood pressure:
• ACE inhibitors (e.g. enalapril, lisinopril, ramipril), especially if you have diabetes-related kidney problems,
• 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 Losartán/Hidroclorotiazida Krka”.

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

You should inform your doctor if you think you are pregnant (or might be). Use of Losartán/Hidroclorotiazida Krka is not recommended at the beginning of pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to your baby if used during this period (see section on pregnancy).

Other medicines and Losartán/Hidroclorotiazida 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 Losartán/Hidroclorotiazida Krka is not recommended.

Diuretics such as hydrochlorothiazide contained in Losartán/Hidroclorotiazida Krka can interact with other medicines. Preparations containing lithium should not be taken with Losartán/Hidroclorotiazida Krka without careful monitoring by your doctor. Special precautionary measures (e.g. blood tests) may be appropriate if you are taking diuretics (water tablets), certain laxatives, medicines for 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 that lower blood pressure;
• steroids;
• cancer treatment medicines;
• painkillers;
• antifungal medicines;
• arthritis medicines;
• resins used for high cholesterol, such as cholestyramine;
• muscle relaxants;
• sleeping tablets;
• opioid medicines such as morphine;
• "pressor amines" such as adrenaline or other medicines in the same group;
• oral antidiabetic medicines or insulin.

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

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

Please inform your doctor if you are scheduled for an X-ray examination with iodinated contrast medium while taking Losartán/Hidroclorotiazida Krka.

Taking Losartán/Hidroclorotiazida Krka with food, drinks, and alcohol

You are advised not to drink alcohol while taking these tablets: alcohol and Losartán/Hidroclorotiazida Krka tablets may enhance each other's effects.

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

Losartán/Hidroclorotiazida Krka tablets can be taken with or without food.

Grapefruit juice should be avoided while taking losartan/hydrochlorothiazide.

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 you to stop treatment with Losartán/Hidroclorotiazida Krka before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of losartan/hydrochlorothiazide. Losartán/Hidroclorotiazida Krka 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 of pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding. Use of Losartán/Hidroclorotiazida Krka is not recommended for breastfeeding mothers, and your doctor may choose another treatment if you wish to continue breastfeeding.

Children and adolescents

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

Use in elderly patients

Losartán/Hidroclorotiazida Krka works in the same way and is equally well tolerated by most elderly and younger patients. Most elderly patients require the same dose as younger patients.

Driving and use of machines

When starting treatment with this medicine, do not perform tasks requiring special attention (e.g. driving a car or operating dangerous machinery) until you know how you react to the medicine.

Losartán/Hidroclorotiazida Krka contains lactose

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

Use in athletes: this medicine contains hydrochlorothiazide, which may result in a positive test in doping controls.

3. How to take Losartán/Hidroclorotiazida Krka

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Your doctor will determine the appropriate dose of losartan/hydrochlorothiazide depending on your condition and whether you are taking other medicines. It is important to continue taking this medicine 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 Krka 50 mg/12.5 mg daily to control blood pressure over 24 hours. The dose may be increased to 2 film-coated tablets of Losartán/Hidroclorotiazida Krka 50 mg/12.5 mg daily or changed to 1 film-coated tablet of Losartán/Hidroclorotiazida 100 mg/25 mg (a stronger dose) daily. The maximum daily dose is 2 film-coated tablets of Losartán/Hidroclorotiazida Krka 50 mg/12.5 mg daily or 1 film-coated tablet of Losartán/Hidroclorotiazida 100 mg/25 mg daily.

Administration

The tablets should be swallowed with a glass of water.

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, consult 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

Do not take a double dose to make up for missed doses.

Try to take this medicine every day as prescribed. However, if you miss a dose, do not take an extra dose. Simply go back to your regular 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 Losartán/Hidroclorotiazida Krka 50 mg/12.5 mg 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 serious but rare adverse effect, which may affect more than 1 in 10,000 people but less than 1 in 1,000 patients. 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 abnormal heart rhythm), decreased hemoglobin levels.
• Changes in kidney function including kidney failure.
• Low blood sugar levels (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), bruising, reduction in white blood cells, blood clotting problems, 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 disturbance.
• 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, noises 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), nosebleed, 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, hip, knee 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 appetite, impotence.
• Facial swelling, 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.
• Muscle pain of unknown origin with dark-colored urine (tea-colored) (rhabdomyolysis).
• Low sodium levels in the blood (hyponatremia).
• General feeling of being unwell (malaise).
• Altered taste (dysgeusia).
• Skin and lip cancer (non-melanoma skin cancer).
• 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].

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

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 can also report them directly through the national reporting system: 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 packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C. Store in the original packaging to protect from moisture.

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

6. Contents of the pack and other information

Composition of Losartan/Hydrochlorothiazide Krka 50 mg/12.5 mg

• The active substances are losartan potassium and hydrochlorothiazide.

Each film-coated tablet contains 50 mg of losartan potassium (equivalent to 45.76 mg of losartan) and 12.5 mg of hydrochlorothiazide.

• The other components are pregelatinized maize starch, microcrystalline cellulose, lactose monohydrate and magnesium stearate in the tablet core, and hypromellose, macrogol 4000, quinoline yellow (E104), talc and titanium dioxide (E171) in the film coating.

Appearance of the product and contents of the pack

The film-coated tablets are yellow, oval-shaped, moderately biconvex, with a score line on one side and dimensions of 6 mm x 12 mm (oval shape) and thickness of 3.8 – 4.7 mm.

The score line is intended only to facilitate breaking the tablet for ease of swallowing and not to divide it into equal doses.

Pack size: 28 film-coated tablets in PVC/PVDC//Al blister packs, in a carton.

Marketing Authorization Holder and Manufacturer

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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

KRKA Farmacéutica, S.L., Calle 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:

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

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