Lorista Hl

Leaflet accompanying the packaging: information for the user

Lorista HL, 100 mg + 12.5 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 any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

Lorista HL 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 dilate and, as a result, reducing blood pressure. Hydrochlorothiazide works by increasing water and salt flow through the kidneys. This also helps to reduce blood pressure.
Lorista HL is indicated for the treatment of primary hypertension (high blood pressure).

2. Important information before taking Lorista HL

When not to take Lorista HL

• if the patient is allergic to losartan, hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6),
• if the patient is allergic to sulfonamide derivatives (e.g., other thiazide diuretics, some antibacterial drugs such as cotrimoxazole; in case of doubt, consult your doctor),
• if the patient has severe liver function impairment,
• if the patient has low potassium, low sodium, or high calcium levels in the blood that cannot be corrected by treatment,
• if the patient has gout,
• if the patient is pregnant after the third month (it is also recommended to avoid taking Lorista HL in early pregnancy - see section "Pregnancy and breastfeeding"),
• if the patient has severe kidney function impairment or if the kidneys do not produce urine,
• if the patient has diabetes or kidney function impairment and is being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Before starting to take Lorista HL, discuss it with your doctor or pharmacist.
Inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will normally advise you to stop taking Lorista HL 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 HL. Lorista HL is not recommended during pregnancy and should not be taken after the third month of pregnancy, as it may seriously harm the baby if taken during this period of pregnancy.
Before starting to take Lorista HL, inform your doctor:

• 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 or diarrhea,
• if you have heart failure,
• if you have liver function impairment (see section 2 "When not to take Lorista HL"),
• if you have narrowing of the blood vessels leading to the kidneys (renal artery stenosis), 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 the blood or if you are on a low-potassium diet,
• if you are going to have anesthesia (even at the dentist), are going to have surgery, or if a parathyroid function test is planned, you must inform your doctor or medical staff that you are taking Lorista HL,
• if you have primary hyperaldosteronism (a condition related to 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 the blood (see section 2 "Lorista HL 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 HL, 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 HL, 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 HL. 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 (ACE) inhibitor, such as enalapril, lisinopril, ramipril, especially if you have diabetic kidney disease,
• aliskiren.

Your doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood.
See also section "When not to take Lorista HL".
If you experience stomach pain, nausea, vomiting, or diarrhea after taking Lorista HL, discuss it with your doctor. Your doctor will decide on further treatment. Do not stop taking Lorista HL on your own.

Children and adolescents

There is no experience with the use of Lorista HL in children. Therefore, Lorista HL should not be used in children.

Lorista HL and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Tell your doctor about any potassium supplements, salt substitutes containing potassium, potassium-sparing medicines, or other medicines that may increase potassium levels in the blood (e.g., trimethoprim-containing medicines), as their concurrent use with Lorista HL is not recommended.
Diuretics, such as hydrochlorothiazide in Lorista HL, may interact with other medicines. Without close medical supervision, do not take lithium-containing products and Lorista HL 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;
• corticosteroids;
• anticancer medicines;
• analgesics;
• antifungal medicines;
• medicines for arthritis;
• cholestyramine or other cholesterol-lowering resins;
• muscle relaxants;
• sleeping pills;
• opioid analgesics such as morphine;
• amines that increase blood pressure, such as adrenaline or other medicines from the same group;
• oral antidiabetics or insulins.

Your doctor may decide to adjust the dose and/or take other precautions:

• if you are taking an ACE inhibitor or aliskiren (see also sections "When not to take Lorista HL" and "Warnings and precautions").

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

Lorista HL with food, drink, and alcohol

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

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will normally advise you to stop taking Lorista HL 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 HL. Lorista HL is not recommended during pregnancy and 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
Inform your doctor if you are breastfeeding or plan to breastfeed. Lorista HL is not recommended during breastfeeding, and your doctor may prescribe a different treatment if you plan to breastfeed.

Use in elderly patients

Lorista HL works as well and is as well tolerated in most elderly patients as in younger patients. Most elderly patients require the same dose as younger patients.

Driving and operating machinery

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

Lorista HL 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 HL

Take this medicine always as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist. Your doctor will decide on the appropriate dose of Lorista HL, depending on your condition and other medicines you are taking. To achieve proper blood pressure control, you should continue taking Lorista HL for as long as your doctor recommends.
The combination of losartan and hydrochlorothiazide is available in three strengths: Lorista H, 50 mg + 12.5 mg, Lorista HL, 100 mg + 12.5 mg, and Lorista HD, 100 mg + 25 mg.
Hypertension
Usually, for most patients with high blood pressure, 1 tablet of Lorista H, 50 mg + 12.5 mg per day is sufficient to control blood pressure for a 24-hour period. Your doctor may increase the dose to 2 tablets of Lorista H, 50 mg + 12.5 mg once a day or change to 1 tablet of Lorista HD, 100 mg + 25 mg (stronger dose) once a day.
The maximum daily dose is 2 tablets per day of Lorista H, 50 mg + 12.5 mg or 1 tablet of Lorista HD, 100 mg + 25 mg.
Lorista HL, 100 mg + 12.5 mg (100 mg losartan potassium and 12.5 mg hydrochlorothiazide), is intended for patients who have been titrated to 100 mg losartan and require additional blood pressure control.

Administration

Swallow the tablets whole with a glass of water.

Overdose of Lorista HL

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

Missed dose of Lorista HL

Try to take Lorista HL 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 according to the established schedule.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Lorista HL can cause side effects, although not everybody gets them.
In case of the following side effect, stop taking Lorista HL and consult your doctor or go to the emergency department of the 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 serious but rare side effect that may occur in up to 1 in 1,000 patients. Emergency medical intervention or hospitalization may be necessary.
Acute respiratory failure (symptoms include severe shortness of breath, fever, weakness, and confusion).
This is a serious but very rare side effect that may occur in up to 1 in 10,000 patients. Emergency medical intervention or hospitalization may be necessary.
The following side effects have been reported:

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

Less frequently (may occur in less than 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, bleeding disorders, decreased platelet count,
• loss of appetite, increased uric acid or gout, increased 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 in the eye, conjunctivitis, decreased vision, 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 disturbances, 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, upset stomach, 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, especially 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 impairment, including kidney inflammation, urinary tract infection, sugar in the urine,
• decreased libido, impotence,
• facial swelling, localized swelling, fever.

Rarely (may occur in less than 1 in 1,000 patients):

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

Unknown frequency (cannot be estimated from available data):

• malignant skin tumors 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 malaise,
• 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 angle-closure glaucoma).

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 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 HL

Keep the 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.
Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. 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 HL contains

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

What Lorista HL looks like and contents of the pack

White, oval, biconvex film-coated tablets. Tablet dimensions: 13 mm x 8 mm.
Tablets are available in packs containing 28 or 56 film-coated tablets in blisters, in a cardboard box.

Marketing authorization holder

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

Manufacturer

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 for use 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, 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