Losartan Hidrohlorothiazid Krka

Leaflet accompanying the packaging: information for the user

Losartan Hydrochlorothiazide Krka, 100 mg + 12.5 mg, film-coated tablets

losartan potassium + hydrochlorothiazide

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

• 1. What is Losartan Hydrochlorothiazide Krka and what is it used for
• 2. Important information before taking Losartan Hydrochlorothiazide Krka
• 3. How to take Losartan Hydrochlorothiazide Krka
• 4. Possible side effects
• 5. How to store Losartan Hydrochlorothiazide Krka
• 6. Contents of the packaging and other information

1. What is Losartan Hydrochlorothiazide Krka and what is it used for

Losartan Hydrochlorothiazide Krka is a combination of an angiotensin II receptor antagonist (losartan) and a diuretic (hydrochlorothiazide). Angiotensin II is a substance produced in the body that binds to receptors in blood vessels, causing them to narrow. This leads to an increase in blood pressure. Losartan prevents angiotensin II from binding to these receptors, causing blood vessels to widen and blood pressure to decrease. Hydrochlorothiazide works by increasing the amount of water and salt excreted in the urine. This also helps to lower blood pressure. Losartan Hydrochlorothiazide Krka is indicated for the treatment of primary hypertension (high blood pressure).

2. Important information before taking Losartan Hydrochlorothiazide Krka

When not to take Losartan Hydrochlorothiazide Krka:

• if you are allergic to losartan and/or 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 thiazide diuretics, certain antibacterial drugs such as cotrimoxazole - if in doubt, consult your doctor),
• if you have severe liver function disorders,
• if you have low potassium, low sodium or high calcium levels in your blood that cannot be corrected by treatment,
• if you have gout,
• if you are pregnant more than three months (you should also avoid taking Losartan Hydrochlorothiazide Krka in early pregnancy - see section "Pregnancy and breastfeeding"),
• if you have severe kidney function disorders or if your kidneys do not produce urine,
• if you have diabetes or kidney function disorders and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Before starting treatment with Losartan Hydrochlorothiazide Krka, you should discuss it with your doctor or pharmacist. You should inform your doctor about pregnancy, suspected pregnancy or planned pregnancy. It is not recommended to take Losartan Hydrochlorothiazide Krka in early pregnancy and it should not be taken after the third month of pregnancy, as it may have a very harmful effect on the baby if taken during this period of pregnancy (see "Pregnancy and breastfeeding"). It is important to inform your doctor before taking Losartan Hydrochlorothiazide Krka:

• if you have ever had swelling of the face, lips, throat or tongue,
• if you are taking diuretics,
• if you are on a low-salt diet,
• if you have had severe vomiting and/or diarrhea,
• if you have heart failure,
• if you have liver function disorders (see section "When not to take Losartan Hydrochlorothiazide Krka"),
• if you have narrowing of the blood vessels leading to the kidneys (renal artery stenosis) or if you have only one functioning kidney or if you have recently had a kidney transplant,
• if you have narrowing of the arteries (arteriosclerosis), angina pectoris (chest pain due to reduced blood flow to the heart),
• if you have narrowing of the aortic or mitral valve (narrowing of the heart valves) or hypertrophic cardiomyopathy (a disease that causes thickening of the heart muscle),
• if you have diabetes,
• if you have had gout,
• if you have or have had an allergy, asthma or a disease that causes joint pain, skin rash and fever (systemic lupus erythematosus),
• if you have high calcium or low potassium levels in your blood or if you are on a low-potassium diet,
• if you are going to have anesthesia (even at the dentist) or surgery, or if you are going to have a parathyroid function test, you must inform your doctor or medical staff that you are taking Losartan Hydrochlorothiazide Krka,
• if you have primary hyperaldosteronism (a condition associated with increased secretion of aldosterone hormone by the adrenal glands, caused by adrenal gland disease),
• if you are taking other medicines that may increase potassium levels in your blood (see section 2 "Losartan Hydrochlorothiazide Krka and other medicines"),
• if you have had a malignant skin tumor or if an unexpected skin change occurs during treatment. Treatment with hydrochlorothiazide, especially in high doses and for a long time, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). During treatment with Losartan Hydrochlorothiazide Krka, you should protect your skin from sunlight and UV radiation,
• if you have had breathing or lung problems after taking hydrochlorothiazide (including pneumonia or fluid accumulation in the lungs). If you experience severe shortness of breath or difficulty breathing after taking Losartan Hydrochlorothiazide Krka, seek medical attention immediately,
• if you experience vision disturbances or pain in one or both eyes during treatment with Losartan Hydrochlorothiazide Krka. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between the choroid and sclera) or glaucoma, increased pressure in one or both eyes - they may occur within a few hours to weeks after taking Losartan Hydrochlorothiazide Krka. You should stop taking Losartan Hydrochlorothiazide Krka and consult your doctor.

or if you are taking any of the following medicines used to treat high blood pressure:

• angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), especially if you have kidney function disorders related to diabetes,
• aliskiren.

Your doctor may monitor your kidney function, blood pressure and electrolyte levels (e.g. potassium) in your blood at regular intervals. See also the information under the heading "When not to take Losartan Hydrochlorothiazide Krka". If you experience abdominal pain, nausea, vomiting or diarrhea after taking Losartan Hydrochlorothiazide Krka, you should discuss it with your doctor. Your doctor will decide on further treatment. Do not stop taking Losartan Hydrochlorothiazide Krka on your own.

Children and adolescents

There is no experience with the use of the medicine in children and adolescents. Therefore, Losartan Hydrochlorothiazide Krka should not be given to these patient groups.

Losartan Hydrochlorothiazide Krka and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken or might take, as well as any supplements you are taking. Tell your doctor about any potassium supplements, salt substitutes containing potassium, potassium-sparing medicines, or other medicines that may increase potassium levels in your blood (e.g. trimethoprim-containing medicines), as concomitant use with Losartan Hydrochlorothiazide Krka is not recommended. Diuretics, such as hydrochlorothiazide contained in Losartan Hydrochlorothiazide Krka, may interact with other medicines. Do not take lithium-containing products and Losartan Hydrochlorothiazide Krka at the same time without close medical supervision. Special precautions (e.g. blood tests) may be necessary if you are taking other diuretics, certain laxatives, gout medicines, or medicines used to control heart rhythm or diabetes medicines (oral or insulin). Your doctor may need to adjust the dose and/or take other precautions:

• if you are taking an ACE inhibitor or aliskiren (see also the information under the heading "When not to take Losartan Hydrochlorothiazide Krka" and "Warnings and precautions").

You should also inform your doctor about taking any of the following medicines:

• other blood pressure-lowering medicines,
• corticosteroids,
• anticancer medicines,
• analgesics,
• antifungal medicines,
• medicines used to treat arthritis,
• cholestyramine (a medicine used to lower cholesterol levels),
• muscle relaxants,
• sleeping pills,
• opioid medicines, such as morphine,
• "pressor amines", such as adrenaline or other medicines in this group,
• oral diabetes medicines or insulin.

You should also inform your doctor about taking Losartan Hydrochlorothiazide Krka if you are scheduled for radiological examinations with contrast agents containing iodine.

Losartan Hydrochlorothiazide Krka with food, drink and alcohol

It is recommended that you do not drink alcohol while taking Losartan Hydrochlorothiazide Krka, as alcohol and Losartan Hydrochlorothiazide Krka may enhance each other's effects. Excessive salt intake may counteract the effect of Losartan Hydrochlorothiazide Krka. Losartan Hydrochlorothiazide Krka can be taken with or without food. You should avoid drinking grapefruit juice while taking Losartan Hydrochlorothiazide Krka tablets.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Pregnancy You should inform your doctor about pregnancy, suspected pregnancy or planned pregnancy. Your doctor will usually advise you to stop taking Losartan Hydrochlorothiazide Krka before planned pregnancy or as soon as possible after finding out you are pregnant, and will advise you to take a different medicine instead of Losartan Hydrochlorothiazide Krka. It is not recommended to take Losartan Hydrochlorothiazide Krka in early pregnancy and it should not be taken after the third month of pregnancy, as it may seriously harm the baby if taken during this period of pregnancy. Breastfeeding You should inform your doctor about breastfeeding or intending to breastfeed. It is not recommended to take Losartan Hydrochlorothiazide Krka during breastfeeding - your doctor may use a different treatment if you intend to breastfeed.

Use in the elderly

Losartan Hydrochlorothiazide Krka has been shown to be as effective and well-tolerated in most elderly patients as in younger patients. Most elderly patients require the same doses as younger patients.

Driving and using machines

When starting treatment with Losartan Hydrochlorothiazide Krka, you should not perform activities that require special attention (e.g. driving a car or operating hazardous machines) until you know how you tolerate this medicine.

Losartan Hydrochlorothiazide Krka contains lactose

If you have been told that you have an intolerance to some sugars, you should consult your doctor before taking this medicine.

3. How to take Losartan Hydrochlorothiazide Krka

This medicine should always be taken exactly as directed by your doctor. If you are unsure, consult your doctor or pharmacist. Your doctor will decide on the appropriate dose of Losartan Hydrochlorothiazide Krka, depending on your condition and other medicines you are taking. To achieve proper blood pressure control, you should continue taking Losartan Hydrochlorothiazide Krka for as long as your doctor recommends. Hypertension The recommended dose for most patients with high blood pressure is 1 tablet containing 50 mg of losartan and 12.5 mg of hydrochlorothiazide per day, which is sufficient to control blood pressure for 24 hours. Your doctor may increase the dose to 2 tablets of the medicine containing 50 mg of losartan and 12.5 mg of hydrochlorothiazide once a day or change to 1 tablet of the medicine containing 100 mg of losartan and 25 mg of hydrochlorothiazide (a stronger dose) once a day. The maximum daily dose is 2 tablets per day of the medicine containing 50 mg of losartan and 12.5 mg of hydrochlorothiazide or 1 tablet of the medicine containing 100 mg of losartan and 25 mg of hydrochlorothiazide. Losartan Hydrochlorothiazide Krka 100 mg + 12.5 mg (100 mg of losartan and 12.5 mg of hydrochlorothiazide) is intended for patients who are taking a dose of 100 mg of losartan and require additional blood pressure control.

Taking a higher dose of Losartan Hydrochlorothiazide Krka than recommended

In case of overdose, you should immediately contact your doctor or seek emergency medical attention. Overdose may cause a decrease in blood pressure, rapid heartbeat, slow heart rate, changes in blood composition, and dehydration.

Missing a dose of Losartan Hydrochlorothiazide Krka

You should try to take Losartan Hydrochlorothiazide Krka every day, as directed by your doctor. If you miss a dose, do not take a double dose to make up for the missed dose. You should continue taking the medicine according to the established schedule. If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Losartan Hydrochlorothiazide Krka can cause side effects, although not everybody gets them. If you experience any of the following side effects, stop taking Losartan Hydrochlorothiazide Krka and consult your doctor or go to the emergency department of your nearest hospital immediately: Severe allergic reactions (rash, itching, swelling of the face, lips, mouth or throat, which may cause difficulty swallowing or breathing). This is a serious but rare side effect, occurring in more than 1 in 10,000 patients but less than 1 in 1,000 patients. Emergency medical attention or hospitalization may be necessary. The following side effects have been reported:

• Frequent (may occur in up to 1 in 10 people):
• cough, upper respiratory tract infection, nasal congestion, sinusitis, sinus disorders,
• diarrhea, abdominal pain, nausea, indigestion,
• muscle pain or cramps, leg pain, back pain,
• insomnia, headache, dizziness,
• weakness, fatigue, chest pain,
• increased potassium levels in the blood (which may cause heart rhythm disturbances), decreased hemoglobin levels,
• kidney function disorders, including kidney failure,
• low blood sugar levels (hypoglycemia).

Uncommon (may occur in up to 1 in 100 people):

• anemia, red or brown spots on the skin (usually mainly on the feet, legs, arms and buttocks, with joint pain, swelling of the hands and feet, and abdominal pain), easy bruising, decreased white blood cell count, bleeding disorders, decreased platelet count,
• loss of appetite, increased uric acid or overt gout, increased blood sugar levels, electrolyte disturbances in the blood,
• anxiety, nervousness, anxiety disorder with panic attacks, disorientation, depression, unusual dreams, sleep disturbances, drowsiness, memory disorders,
• tingling and numbness, limb pain, tremors, migraine, fainting,
• blurred vision, burning or stinging eyes, conjunctivitis, impaired vision, yellow vision,
• ringing, buzzing, humming or tapping in the ears, dizziness of labyrinthine origin,
• low blood pressure, which may be associated with changes in body position (feeling dizzy or weak when standing up), angina pectoris (chest pain), heart rhythm disturbances, transient ischemic attack (temporary lack of blood flow to the brain, "mini-stroke"), heart attack, rapid heartbeat,
• vasculitis, often with accompanying skin rash or bruising,
• sore throat, shortness of breath, bronchitis, pneumonia, pulmonary edema (which causes difficulty breathing), nosebleeds, runny nose, nasal congestion,
• constipation, gas, stomach upset, stomach cramps, vomiting, dry mouth, salivary gland inflammation, toothache,
• jaundice (yellowing of the eyes and skin), pancreatitis,
• hives, itching, skin inflammation, rash, redness of the skin, increased sensitivity to light, dry skin, sudden flushing (especially of the face), sweating,
• shoulder, arm, hip, knee or other joint pain, joint swelling, stiffness, muscle weakness,
• frequent urination, also at night, kidney function disorders, including kidney inflammation, urinary tract infections, sugar in the urine,
• decreased libido, impotence,
• facial swelling, localized swelling (edema), fever.

Rare (may occur in up to 1 in 1,000 people):

• hepatitis, abnormal liver function test results,
• intestinal angioedema: swelling in the intestine with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

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

• acute respiratory failure (symptoms include severe shortness of breath, fever, weakness, and confusion).

Frequency not known(frequency cannot be estimated from available data)

• malignant skin and lip tumors (non-melanoma skin cancer),
• flu-like symptoms
• unexplained muscle pain with dark (tea-colored) urine (rhabdomyolysis),
• low sodium levels in the blood (hyponatremia),
• general feeling of being unwell,
• taste disturbances,
• vision loss or eye pain due to increased pressure (possible symptoms of fluid accumulation in the vascular layer surrounding the eye - excessive fluid accumulation between the choroid and sclera - or acute glaucoma).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 stated. Do not store above 30°C. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Losartan Hydrochlorothiazide Krka contains

• The active substances are losartan potassium and hydrochlorothiazide. Each film-coated tablet contains 100 mg of losartan potassium, equivalent to 91.52 mg of losartan, and 12.5 mg of hydrochlorothiazide.
• The other ingredients are maize starch, cornstarch, microcrystalline cellulose, lactose monohydrate, and magnesium stearate in the tablet core, and hypromellose, macrogol 4000, talc, and titanium dioxide (E 171) in the tablet coating. See section 2: "Losartan Hydrochlorothiazide Krka contains lactose".

What Losartan Hydrochlorothiazide Krka looks like and contents of the pack

White, oval, biconvex film-coated tablets, 8 mm x 13 mm in size and 4.4-5.1 mm in thickness. Packaging: 28, 30, 56 or 60 film-coated tablets in blisters, in a cardboard box.

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8000 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia, Genenpharm S.A., 18 km Marathon Avenue, 15351 Pallini, Greece

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet:27.06.2025