Lorista Hd

Package Leaflet: Information for the User

Lorista HD, 100 mg + 25 mg, film-coated tablets

losartan potassium + hydrochlorothiazide

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

• Keep this package leaflet, you may need to read it again.
• 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.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the Package Leaflet

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

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

Lorista HD 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 increased 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 HD is indicated for the treatment of primary hypertension (high blood pressure).

2. Important information before taking Lorista HD

When not to take Lorista HD

• 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, certain antibacterial drugs such as co-trimoxazole; in case of doubt, consult your doctor),
• if you are pregnant more than three months (you should also avoid taking Lorista HD in early pregnancy - see "Pregnancy and breastfeeding"),
• if you have severe liver function disorders, cholestasis, and disorders causing 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 HD, discuss it with your doctor or pharmacist:

• if you have 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 2 "When not to take Lorista HD"),
• 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 heart function),
• 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 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 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 HD,
• if you have primary hyperaldosteronism (a condition related to increased secretion of aldosterone hormone by the adrenal glands, caused by adrenal gland disorders),
• if you are taking other medicines that may increase potassium levels in your blood (see section 2 "Lorista HD 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 malignant skin tumors and lip tumors (non-melanoma skin cancer). During treatment with Lorista HD, 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 HD, 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 HD. 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 blood pressure-lowering medicines:
• angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), especially if you have diabetic kidney disease,
• 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 HD".
If you experience stomach pain, nausea, vomiting, or diarrhea after taking Lorista HD, discuss it with your doctor. Your doctor will decide on further treatment. Do not stop taking Lorista HD on your own.
Inform your doctor about pregnancy, suspected pregnancy, or planned pregnancy. The use of Lorista HD is not recommended in early pregnancy and should not be taken after the third month of pregnancy, as it may harm the fetus if taken during this period of pregnancy (see "Pregnancy and breastfeeding").

Lorista HD and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
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 HD is not recommended.
Diuretics, such as hydrochlorothiazide in Lorista HD, may interact with other medicines.
Do not take lithium-containing products and Lorista HD 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 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, anticancer medicines, painkillers, antifungal medicines, or medicines for arthritis, cholesterol-lowering resins such as cholestyramine, muscle relaxants, sedatives, opioid analgesics 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 HD" and "Warnings and precautions").

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

Lorista HD with food, drink, and alcohol

Lorista HD can be taken with or without food.
It is recommended that you do not drink alcohol while taking Lorista HD, as alcohol and Lorista HD tablets may enhance each other's effects.
Excessive salt intake in your diet may reduce the effect of Lorista HD.
You should avoid drinking grapefruit juice while taking Lorista HD 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
Inform your doctor about pregnancy, suspected pregnancy, or planned pregnancy. Your doctor will usually advise you to stop taking Lorista HD before planned pregnancy or as soon as possible after finding out you are pregnant, and will recommend an alternative medicine instead of Lorista HD. Lorista HD 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
Inform your doctor about breastfeeding or intention to breastfeed. Lorista HD is not recommended during breastfeeding, and your doctor may prescribe a different treatment if you want to breastfeed, especially if your baby is a newborn or premature.

Use in children and adolescents

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

Use in elderly patients

Lorista HD is as effective and well-tolerated in elderly patients as in younger patients. Most elderly patients require the same dose as younger patients.

Driving and using machines

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

Lorista HD 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 HD

Take this medicine always as directed by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist. Your doctor will decide on the appropriate dose of Lorista HD, depending on your condition and other medicines you are taking. It is important to continue taking Lorista HD for as long as your doctor has prescribed it to maintain consistent blood pressure control.
Hypertension
Usually, for most patients with high blood pressure, one tablet of Lorista H 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 tablets of Lorista H 50 mg losartan and 12.5 mg hydrochlorothiazide once daily or change to one tablet of Lorista HD 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 HD

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

Missed dose of Lorista HD

Try to take Lorista HD 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; continue taking the medicine as before.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

• common (may affect up to 1 in 10 people): cough, upper respiratory tract infection, nasal congestion, sinusitis, sinus disorders,
• diarrhea, stomach 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).

Uncommon (may affect 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 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 disturbances, 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,
• throat pain, 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 infection, sugar in the urine,
• decreased libido, impotence,
• facial swelling, localized swelling, fever.

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

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

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

• 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 tumors and lip tumors (non-melanoma skin cancer),
• unexplained muscle pain with dark (tea-colored) urine (rhabdomyolysis),
• taste disorders,
• 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 angle-closure glaucoma).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform 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 HD

Keep this medicine 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 stated.
Do not store above 30°C.
Store in the original packaging to protect from moisture.
HDPE container:
After opening the container, the medicinal product should be used within 100 days.
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 pack and other information

What Lorista HD contains

• The active substances are losartan potassium and hydrochlorothiazide. Each film-coated tablet contains 100 mg losartan potassium, equivalent to 91.52 mg losartan, and 25 mg hydrochlorothiazide.
• The other ingredients are: tablet core: maize starch, microcrystalline cellulose, lactose monohydrate, magnesium stearate; tablet coating: hypromellose 6cP, macrogol 4000, quinoline yellow (E 104), talc, titanium dioxide (E 171). See section 2 "Lorista HD contains lactose".

What Lorista HD looks like and contents of the pack

Yellow, oval, slightly biconvex film-coated tablets, 8 mm x 15 mm in size and 5.1-6.1 mm in thickness.
Tablets are available in cardboard boxes containing:

• 10, 28, 30, 60, 90, 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, 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, please contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5
02-235 Warsaw
Phone: 22 57 37 500
Date of last revision of the leaflet:27.06.2025