Lorista H

Leaflet accompanying the packaging: information for the user

Lorista H, 50 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, you should 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.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What is Lorista H and what is it used for

Lorista H is a combination of an angiotensin II receptor antagonist (losartan) and a diuretic (hydrochlorothiazide). Angiotensin II is a substance produced in the body that, by binding to receptors in blood vessel walls, causes them to narrow. This results in an increase in blood pressure. Losartan prevents angiotensin II from binding to these receptors, causing blood vessels to widen and, as a result, lowering blood pressure. Hydrochlorothiazide works by increasing the flow of water and salt through the kidneys. This also helps to lower blood pressure.
Lorista H is indicated for the treatment of primary hypertension (high blood pressure).

2. Important information before taking Lorista H

When not to take Lorista H

• 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 sulfonamide derivatives (e.g. other thiazide diuretics, some antibacterial drugs such as cotrimoxazole; in case of doubt, consult your doctor),
• if you are pregnant over three months (you should also avoid taking Lorista H in early pregnancy - see "Pregnancy and breastfeeding"),
• if you have severe liver function disorders, cholestasis, and disorders leading to bile duct obstruction,
• if you have severe kidney function disorders (creatinine clearance <30 ml min),< li>
• if your kidneys do not produce urine,
• 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 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 Lorista H, you should discuss it with your doctor or pharmacist:

• if you have ever had swelling of the face, lips, tongue, or throat,
• 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 2 "When not to take Lorista H"),
• 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 poor heart function),
• if you have "aortic or mitral stenosis" (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 had an allergy, asthma, or a disease that causes joint pain, 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 need to be anesthetized (even by a dentist) or if you are about to undergo surgery, or if a parathyroid function test is planned, you must inform your doctor or medical staff that you are taking Lorista H,
• if you have primary hyperaldosteronism (a condition associated with increased secretion of aldosterone hormone by the adrenal glands, caused by adrenal gland abnormalities),
• if you are taking other medicines that may increase potassium levels in your blood (see section 2 "Lorista H 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 Lorista H, 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 Lorista H, you should seek medical attention immediately,
• if you have blurred vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between the choroid and sclera) or increased pressure inside the eye - they can occur within a few hours to weeks after taking Lorista H. If left untreated, they can lead to permanent vision loss. If you have previously been allergic to penicillin or sulfonamides, you may be more prone to developing this disease.
• if you are taking any of the following medicines for high blood pressure:
• angiotensin-converting enzyme (ACE) inhibitor (e.g. enalapril, lisinopril, ramipril), especially if you have kidney function disorders associated with 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 Lorista H".
If you experience stomach pain, nausea, vomiting, or diarrhea after taking Lorista H, you should discuss it with your doctor. Your doctor will decide on further treatment. Do not stop taking Lorista H on your own.
You should inform your doctor about pregnancy, suspected pregnancy, or planned pregnancy. The use of Lorista H is not recommended in early pregnancy and 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").

Lorista H and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or plan to take.
You should 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 their concurrent use with Lorista H is not recommended.
Diuretics, such as hydrochlorothiazide in Lorista H, may interact with other medicines. Without close medical supervision, you should not take lithium-containing preparations and Lorista H at the same time. Special precautions (e.g. blood tests) may be necessary if you are taking other diuretics, certain laxatives, gout treatments, or medicines for heart rhythm or diabetes control (oral antidiabetics or insulin). It is also important for your doctor to know if you are taking other blood pressure-lowering medicines, steroids, cancer treatments, painkillers, antifungal infection treatments, or arthritis treatments, cholesterol-lowering resins such as cholestyramine, muscle relaxants, sedatives, opioid painkillers such as morphine, "pressor amines" such as adrenaline, or other medicines from the same group, as well as oral antidiabetics 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 Lorista H" and "Warnings and precautions").

You should also inform your doctor about taking Lorista H before planned administration of iodine-containing contrast agents.

Lorista H with food, drink, and alcohol

Lorista H can be taken with or without food.
You are advised not to drink alcohol while taking Lorista H, as alcohol and Lorista H tablets may enhance each other's effects.
Excessive salt intake in your diet may counteract the effect of Lorista H.
You should avoid drinking grapefruit juice while taking Lorista H tablets.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should 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 Lorista H 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 Lorista H. Lorista H 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
You should inform your doctor about breastfeeding or intending to breastfeed. Lorista H is not recommended during breastfeeding, and your doctor may prescribe a different treatment if you want to breastfeed, especially if your baby is newborn or premature.

Use in children and adolescents

There is no experience with the use of Lorista H in children and adolescents, so it should not be used in this patient group.

Use in elderly patients

Lorista H is equally effective and well-tolerated in most patients, both in the elderly and in younger patients. Most elderly patients require the same dose as younger patients.

Driving and using machines

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

Lorista H contains lactose

If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking this medicine.

3. How to take Lorista H

This medicine should always be taken exactly as your doctor or pharmacist has told you. If you are not sure, you should ask your doctor or pharmacist. Your doctor will decide on the appropriate dose of Lorista H, depending on your condition and other medicines you are taking. It is important to continue taking Lorista H for as long as your doctor has prescribed it in order to maintain consistent blood pressure control.
Hypertension
Usually, for most patients with high blood pressure, one Lorista H tablet of 50 mg losartan and 12.5 mg hydrochlorothiazide per day is sufficient to control blood pressure for 24 hours. Your doctor may increase the dose to two Lorista H tablets of 50 mg losartan and 12.5 mg hydrochlorothiazide once daily or change to one Lorista HD tablet of 100 mg losartan and 25 mg hydrochlorothiazide (higher dose) once daily. The maximum daily dose is two tablets of Lorista H 50 mg losartan and 12.5 mg hydrochlorothiazide or one tablet of Lorista HD 100 mg losartan and 25 mg hydrochlorothiazide.

Overdose of Lorista H

In case of overdose, you should immediately contact your doctor to take immediate action. Overdose may cause a drop in blood pressure, rapid heartbeat, slow heart rate, changes in blood composition, and dehydration.

Missed dose of Lorista H

You should try to take Lorista H every day as prescribed by your doctor. If you miss a dose, do not take a double dose to make up for the missed dose; instead, continue taking the medicine as before.
If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Lorista H can cause side effects, although not everybody gets them.
In case of the following side effect, you should stop taking Lorista H and immediately consult your doctor or go to the emergency department of the nearest hospital:
Severe allergic reaction (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 intervention or hospitalization may be necessary.
The following side effects have been reported:

• Frequently (may affect 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 may cause heart rhythm disorders), low hemoglobin levels,
• kidney function disorders, including kidney failure,
• low blood sugar levels (hypoglycemia).

Less frequently (may affect 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, low white blood cell count, blood clotting disorders, and low platelet count,
• loss of appetite, increased uric acid levels or overt gout, high blood sugar levels, electrolyte disturbances in the blood,
• anxiety, nervousness, panic disorder (recurring panic attacks), disorientation, depression, unusual dreams, sleep disturbances, drowsiness, memory disorders,
• tingling or numbness, limb pain, tremors, migraine, fainting,
• blurred vision, burning or stinging sensation in the eye, conjunctivitis, vision impairment, yellow vision,
• ringing, buzzing, humming, or tapping in the ears, dizziness of labyrinthine origin,
• low blood pressure, which may be associated with postural changes (feeling dizzy or weak when standing up), angina pectoris (chest pain), heart rhythm disorders, stroke (transient ischemic attack, "mini-stroke"), heart attack, rapid heartbeat,
• vasculitis, often with accompanying skin rash or bruising,
• sore throat, shortness of breath, bronchitis, pneumonia, fluid accumulation in the lungs (which can cause difficulty breathing), nosebleeds, runny nose, nasal congestion,
• constipation, inability to pass stools, 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, hot flashes with redness of the face, excessive sweating, hair loss,
• 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, fever.

Rarely (may affect up to 1 in 1,000 patients):

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

Very rarely (may affect up to 1 in 10,000 patients):

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

Frequency not known (cannot be estimated from the available data):

• flu-like symptoms,
• low sodium levels in the blood (hyponatremia),
• general malaise,
• malignant skin and lip tumors (non-melanoma skin cancer),
• unexplained muscle pain with accompanying dark (tea-colored) urine (rhabdomyolysis),
• taste disorders,
• vision impairment 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 angle-closure glaucoma).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lorista H

The medicine should be stored out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Do not store above 30°C.
Store in the original packaging to protect from moisture.
HDPE container:
After first opening the container, the medicinal product should be used within 100 days.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Lorista H contains

• The active substances of Lorista H 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 ingredients are maize starch, 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 "Lorista H contains lactose".

What Lorista H looks like and contents of the pack

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 the tablet to make it easier to swallow, and not to divide it into equal doses.
Tablets are available in cardboard boxes containing:

• 10, 14, 28, 30, 56, 60, 84, 90, 98, or 112 film-coated tablets in blisters,
• 100 film-coated tablets in a white, plastic container with a white closure, allowing the detection of attempted opening.

Not all pack sizes may be marketed.

Marketing authorization holder:

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

Manufacturer/Importer:

KRKA Polska Sp. z o.o., ul. Równoległa 5, 02-235 Warsaw, Poland
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

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

For more detailed information on this medicine, you should contact your local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Phone: 22 57 37 500
Date of last revision of the leaflet:27.06.2025