Losartan Hidrohlorothiazid Krka

Leaflet accompanying the packaging: information for the user

Losartan Hydrochlorothiazide Krka, 50 mg + 12.5 mg, film-coated tablets
Losartan Hydrochlorothiazide Krka, 100 mg + 25 mg, film-coated tablets
losartan potassium + hydrochlorothiazide

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of 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 constrict. This leads to an increase in blood pressure. Losartan prevents angiotensin II from binding to these receptors, causing blood vessels to dilate 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

Warnings and precautions

Before starting treatment with Losartan Hydrochlorothiazide Krka, the patient should discuss it with their doctor or pharmacist.
The patient should inform their 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 fetus if taken during this period of pregnancy (see "Pregnancy and breastfeeding").

Before taking Losartan Hydrochlorothiazide Krka, the patient should inform their doctor:

• angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), especially if the patient has diabetic nephropathy,
• aliskiren.

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

Children and adolescents

There is no experience with the use of Losartan Hydrochlorothiazide Krka in children and adolescents, so it should not be used in this group of patients.

Use in elderly patients

Losartan Hydrochlorothiazide Krka works just as well and is just as well tolerated by most elderly patients as by younger patients. In most elderly patients, the same dose is used as in younger patients.

Losartan Hydrochlorothiazide Krka and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The patient should tell their doctor about any potassium supplements, salt substitutes containing potassium, potassium-sparing medicines, or other medicines that may increase potassium levels in the blood, as it is not recommended to take them with Losartan Hydrochlorothiazide Krka.
Diuretics, such as hydrochlorothiazide in Losartan Hydrochlorothiazide Krka, may interact with other medicines.
Without close medical supervision, the patient should not take lithium preparations with Losartan Hydrochlorothiazide Krka.
If the patient is taking other diuretics, certain laxatives, gout treatments, or medicines for heart rhythm or diabetes control (oral antidiabetic drugs or insulin), special precautions may be necessary (e.g. blood tests).
The doctor may need to adjust the dose and/or take other precautions:

It is also important for the doctor to know if the patient is taking:

• other medicines to lower blood pressure,
• corticosteroids,
• cancer treatments,
• painkillers,
• antifungal medicines,
• arthritis treatments,
• cholesterol-lowering resins such as cholestyramine,
• muscle relaxants,
• sleeping pills,
• opioid analgesics such as morphine,
• "pressor amines" such as adrenaline or other medicines from the same group,
• oral antidiabetic drugs or insulin.

In case of planned administration of iodine-containing contrast agents, the patient should inform their doctor about taking Losartan Hydrochlorothiazide Krka.

Losartan Hydrochlorothiazide Krka with food and drink and alcohol

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

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
The patient should inform their doctor about pregnancy, suspected pregnancy or planned pregnancy. The doctor will usually recommend stopping Losartan Hydrochlorothiazide Krka before planned pregnancy or as soon as possible after pregnancy is confirmed, and will recommend taking a different medicine instead of Losartan Hydrochlorothiazide Krka. Losartan Hydrochlorothiazide Krka is not recommended during early pregnancy and should not be taken after the third month of pregnancy, as it may seriously harm the fetus if taken during this period of pregnancy.
Breastfeeding
The patient should inform their doctor about breastfeeding or intending to breastfeed. Losartan Hydrochlorothiazide Krka is not recommended during breastfeeding, and the doctor may prescribe a different treatment if the patient wants to breastfeed.

Driving and using machines

When starting treatment with Losartan Hydrochlorothiazide Krka, the patient should not perform activities that require special attention (e.g. driving a car or operating hazardous machines) until it is known how they tolerate this medicine.
Losartan Hydrochlorothiazide Krka contains lactose.If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.

3. How to take Losartan Hydrochlorothiazide Krka

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
The doctor will decide on the appropriate dose of Losartan Hydrochlorothiazide Krka, depending on the patient's condition and other medicines they are taking. To achieve proper blood pressure control, the patient should continue taking Losartan Hydrochlorothiazide Krka for as long as the doctor recommends.
Hypertension
The recommended dose for most patients with high blood pressure is 1 tablet of Losartan Hydrochlorothiazide Krka 50 mg + 12.5 mg per day, which allows for 24-hour blood pressure control. The doctor may increase the dose to 2 tablets of losartan + hydrochlorothiazide 50 mg + 12.5 mg once a day or change to 1 tablet of losartan + hydrochlorothiazide 100 mg + 25 mg (stronger dose) once a day. The maximum daily dose is 2 tablets per day of losartan + hydrochlorothiazide 50 mg + 12.5 mg or 1 tablet of losartan + hydrochlorothiazide 100 mg + 25 mg.

Taking a higher dose of Losartan Hydrochlorothiazide Krka than recommended

In case of taking a higher dose than recommended, the patient should immediately contact their doctor to take immediate action. Overdose may cause a drop in blood pressure, rapid heartbeat, slow heart rate, changes in blood composition, and dehydration.

Missing a dose of Losartan Hydrochlorothiazide Krka

The patient should not take a double dose to make up for a missed dose.
Losartan Hydrochlorothiazide Krka should be taken every day, as prescribed by the doctor.
If a dose is missed, the patient should not take a double dose to make up for the missed dose, but should continue taking the medicine according to the established schedule.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Losartan Hydrochlorothiazide Krka can cause side effects, although not everybody gets them.
In case of the following side effects, the patient should stop taking Losartan Hydrochlorothiazide Krka and consult their doctor or go to the emergency room at the nearest hospital:
Severe allergic reactions (rash, itching, swelling of the face, lips, mouth or throat, which can cause difficulty swallowing or breathing).
This is a severe but rare side effect that may occur in no more than 1 in 1,000 patients. Immediate medical intervention or hospitalization may be necessary.
The following side effects have been reported:

• common ((may occur in up to 1 in 10 patients):
• 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,
• high potassium levels in the blood (which can cause heart rhythm disturbances), low hemoglobin levels,
• kidney dysfunction, including kidney failure,
• low blood sugar (hypoglycemia).

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

• 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 stomach pain), bruising, decreased white blood cell count, blood clotting disorders, decreased platelet count,
• loss of appetite, increased uric acid or gout, increased blood sugar, electrolyte disturbances in the blood,
• anxiety, nervousness, panic disorder (recurring panic attacks), disorientation, depression, unusual dreams, sleep disturbances, drowsiness, memory disturbances,
• tingling or numbness, limb pain, tremors, migraine, fainting,
• blurred vision, burning or stinging eyes, conjunctivitis, vision impairment, yellow vision,
• ringing, buzzing, humming or tapping in the ears, dizziness
• low blood pressure, which may be associated with postural changes (feeling dizzy or weak when standing up), angina pectoris (chest pain), heart rhythm disturbances, stroke (transient ischemic attack, "mini-stroke"), heart attack, rapid heartbeat,
• vasculitis, often with accompanying skin rash or bruising,
• throat pain, 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, skin redness, increased sensitivity to light, dry skin, hot flashes, sweating, hair loss,
• shoulder, arm, hip, knee or other joint pain, joint swelling, stiffness, muscle weakness,
• frequent urination (also at night), kidney dysfunction, including kidney inflammation, urinary tract infection, sugar in the urine,
• decreased libido, impotence,
• facial swelling, localized facial swelling, fever.

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

• hepatitis, abnormal liver function tests,
• 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 patients):

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

Unknown (frequency cannot be estimated from available data):

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

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw,
phone: +48 22 49 21 301, fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Losartan Hydrochlorothiazide Krka

The medicine should be stored out of 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. Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Losartan Hydrochlorothiazide Krka contains

• The active substances of the medicine are losartan potassium and hydrochlorothiazide. 50 mg + 12.5 mg: Each film-coated tablet contains 50 mg of losartan potassium, equivalent to 45.76 mg of losartan, and 12.5 mg of hydrochlorothiazide. 100 mg + 25 mg: Each film-coated tablet contains 100 mg of losartan potassium, equivalent to 91.52 mg of losartan, and 25 mg of hydrochlorothiazide.
• Other ingredients are: maize starch, cornstarch, microcrystalline cellulose, lactose monohydrate, magnesium stearate in the tablet core, hypromellose, macrogol 4000, quinoline yellow (E 104), talc, 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

50 mg + 12.5 mg: yellow, oval, moderately convex film-coated tablets with a dividing line on one side; tablet size 6 mm x 12 mm (oval shape) and thickness 3.8 - 4.7 mm. The dividing line on the tablet is only to facilitate breaking and does not divide the tablet into equal doses.
100 mg + 25 mg: yellow, oval, slightly convex film-coated tablets; tablet size 8 mm x 15 mm (oval shape) and thickness 5.1 – 6.1 mm.
Packaging: 28, 30, 56, 60 or 90 film-coated tablets in blisters, in a cardboard box.

Marketing authorization holder and manufacturer/importer

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

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

To obtain more detailed information on this medicine, the patient should contact the local representative of the marketing authorization holder:

KRKA-POLSKA Sp. z o.o.
Równoległa 5
02-235 Warsaw
phone: +48 22 573 75 00
Date of last revision of the leaflet:27.06.2025