Lozap Hct

Leaflet attached to the packaging: patient information

LOZAP HCT, 50 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 Lozap HCT and what is it used for
• 2. Important information before taking Lozap HCT
• 3. How to take Lozap HCT
• 4. Possible side effects
• 5. How to store Lozap HCT
• 6. Package contents and other information

1. What is Lozap HCT and what is it used for

Lozap HCT is a combination medicine containing an angiotensin II receptor antagonist (losartan) and a diuretic (hydrochlorothiazide). Angiotensin II is a substance produced by the body that binds to receptors in blood vessels, causing them to narrow. This results in increased blood pressure. Losartan prevents angiotensin II from binding to these receptors, causing blood vessels to widen, and consequently, lowering blood pressure. Hydrochlorothiazide increases the excretion of water and salt by the kidneys. This also helps to lower blood pressure.
Lozap HCT is indicated for the treatment of primary hypertension (high blood pressure).

2. Important information before taking Lozap HCT

When not to take Lozap HCT

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 other sulfonamide-derived substances (e.g., other thiazide diuretics, certain antibacterial drugs, such as cotrimoxazole - in case of doubt, consult a doctor);
if the patient has severe liver dysfunction;
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 for more than 3 months. (It is also recommended to avoid taking Lozap HCT in early pregnancy, see "Pregnancy");
if the patient has severe kidney dysfunction or if the kidneys do not produce urine;
if the patient has diabetes or kidney dysfunction and is being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Before starting to take Lozap HCT, discuss it with your doctor or pharmacist.
Inform your doctor about pregnancy, suspected pregnancy, or planned pregnancy. It is not recommended to take Lozap HCT in early pregnancy and it should not be taken after the 3rd month of pregnancy, as it may seriously harm the fetus (see "Pregnancy").
If the patient experiences abdominal pain, nausea, vomiting, or diarrhea after taking Lozap HCT, they should discuss it with their doctor. The doctor will decide on further treatment. Do not stop taking Lozap HCT on your own.
It is essential to inform your doctor before starting to take Lozap HCT:

• if the patient has had facial, lip, throat, or tongue swelling;
• if the patient is taking diuretics;
• if the patient is on a low-salt diet;
• if the patient has had severe vomiting and/or diarrhea;
• if the patient has heart failure;
• if the patient has liver dysfunction (see section 2 "When not to take Lozap HCT");
• if the patient has narrowing of the blood vessels leading to the kidneys (renal artery stenosis) or if the patient has only one functioning kidney or if the patient has recently had a kidney transplant;
• if the patient has narrowing of the arteries (arteriosclerosis), angina pectoris (chest pain due to reduced blood flow to the heart muscle);
• if the patient has narrowing of the aortic or mitral valve or hypertrophic cardiomyopathy (a disease that causes thickening of the heart muscle);
• if the patient has diabetes;
• if the patient has had gout;
• if the patient has 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 Lozap HCT treatment, protect your skin from sunlight and UV radiation;
• if the patient experiences vision loss 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 within the eye - these can occur within a few hours to weeks after taking Lozap HCT. This can lead to permanent vision loss if left untreated. If the patient has previously been allergic to penicillin or sulfonamides, they may be more prone to developing this disease;
• if the patient has allergies, asthma, or a condition that causes joint pain, skin rash, and fever (systemic lupus erythematosus);
• if the patient has high calcium or low potassium levels in the blood or if the patient is on a low-potassium diet;
• if the patient needs to be anesthetized (even by a dentist) before surgery or if the patient is scheduled for a parathyroid function test, they must inform their doctor or medical staff about taking Lozap HCT;
• if the patient has primary hyperaldosteronism (a condition associated with increased secretion of aldosterone hormone by the adrenal glands, caused by adrenal gland disorders);
• if the patient has had breathing or lung problems (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide in the past. If the patient experiences severe shortness of breath or difficulty breathing after taking Lozap HCT, they should seek medical help immediately;
• if the patient is taking any of the following medicines for high blood pressure:
• angiotensin-converting enzyme (ACE) inhibitor, such as enalapril, lisinopril, ramipril, especially if the patient has diabetic kidney disease,
• aliskiren; The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood. See also the subsection "When not to take Lozap HCT". if the patient is taking other medicines that may increase potassium levels in the blood (see section 2 "Lozap HCT and other medicines").

Children and adolescents

There is no experience with the use of Lozap HCT in children and adolescents (<18 years). therefore, lozap hct should not be used in children and adolescents.< p>

Lozap HCT and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you 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., trimetoprim-containing medicines), as it is not recommended to take them with Lozap HCT.
Diuretics, such as hydrochlorothiazide in Lozap HCT, may interact with other medicines.
Without close medical supervision, do not take Lozap HCT with lithium-containing preparations.
Special precautions (e.g., blood tests) may be necessary if you are taking other diuretics, certain laxatives, gout medicines, heart rate control medicines, or oral antidiabetic medicines (or insulin).
It is also important for your doctor to know if you are taking:

• other blood pressure-lowering medicines;
• corticosteroids;
• cancer medicines;
• painkillers;
• antifungal medicines;
• medicines for arthritis;
• cholesterol-lowering resins, such as cholestyramine;
• muscle relaxants;
• antidepressants;
• sleeping pills;
• opioid medicines, such as morphine;
• amines that increase blood pressure, such as adrenaline or other medicines from the same group;
• carbamazepine used to treat epilepsy;
• oral antidiabetic medicines or insulins.

Your doctor may recommend a dose change and/or take other precautions:
if you are taking an ACE inhibitor or aliskiren (see also subsections "When not to take Lozap HCT" and "Warnings and precautions").
Inform your doctor about taking Lozap HCT when undergoing radiographic examination and administration of iodine-containing contrast agents.

Lozap HCT with food, drink, and alcohol

It is recommended that the patient does not drink alcohol while taking these tablets: alcohol and Lozap HCT may enhance each other's effects. Do not take Lozap HCT with licorice, as it may result in low potassium levels in the blood.
Excessive salt in the diet may reduce the effect of Lozap HCT.
Lozap HCT can be taken with or without food.
Avoid drinking grapefruit juice while taking Lozap HCT tablets.

Pregnancy, breastfeeding, and fertility

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
Inform your doctor about pregnancy, suspected pregnancy, or planned pregnancy). The doctor will usually recommend stopping Lozap HCT before planned pregnancy or immediately after confirming pregnancy and recommend an alternative to Lozap HCT. It is not recommended to take Lozap HCT during pregnancy and it should not be taken in pregnant women after the 3rd month, as it may seriously harm the fetus if taken after the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or plan to breastfeed.
It is not recommended to take Lozap HCT in breastfeeding mothers. The doctor may recommend alternative treatment if the patient wants to breastfeed.

Driving and using machines

When starting treatment with this medicine, the patient should not perform activities that require special attention (e.g., driving a car or operating hazardous machines) until it is known how the patient tolerates the medicine.

Lozap HCT contains sunset yellow FCF and sodium

This medicine contains a coloring agent - sunset yellow FCF, which may cause allergic reactions.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Lozap HCT

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
The doctor will decide what dose of Lozap HCT is suitable for you, depending on your condition and other medicines you are taking.

Hypertension

The usual dose of Lozap HCT for 24-hour blood pressure control is 1 tablet per day for most patients. The doctor may increase the dose to 2 Lozap HCT tablets once a day. The maximum daily dose is 2 Lozap HCT tablets.

Use in children and adolescents

There is no experience with the use of Lozap HCT in children and adolescents under 18 years of age. Therefore, Lozap HCT should not be used in children and adolescents.

Elderly patients

Lozap HCT is similarly effective and tolerated in most adult patients, both elderly and younger. Most elderly patients require the same dose as younger patients.

Method of administration

Lozap HCT tablets can be taken with or without food. Lozap HCT tablets should be swallowed whole with a glass of water. The score line is not intended for breaking the tablet.

Overdose of Lozap HCT

In case of overdose, contact your doctor immediately to get medical help as soon as possible. Overdose may cause low blood pressure, rapid heartbeat, slow heartbeat, changes in blood composition, and dehydration.

Missing a dose of Lozap HCT

Lozap HCT should be taken as prescribed by your doctor. Do not take a double dose to make up for a missed tablet. Simply return to the prescribed dosage schedule.

Stopping Lozap HCT treatment

It is essential to continue taking Lozap HCT for as long as your doctor has prescribed it to control blood pressure.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Lozap HCT can cause side effects, although not everybody gets them.
If you experience the following symptoms, stop taking Lozap HCT 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 can 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. Emergency medical attention or hospitalization may be necessary.
Other reported side effects:
Common(may affect up to 1 in 10 people):

• Cough, upper respiratory tract infection, nasal congestion, sinusitis, sinus disorders;
• Diarrhea, abdominal pain, nausea, indigestion;
• Muscle or 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 and low hematocrit;
• Changes in kidney function, including kidney failure;
• Low blood sugar (hypoglycemia).

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

• Decreased red blood cell count (anemia), red or brown spots on the skin (sometimes mainly on the feet, legs, arms, and buttocks, with joint pain, swelling of the hands and feet, and stomach pain);
• Easy bruising, decreased white blood cell count, blood clotting disorders, decreased platelet count, breakdown of red blood cells;
• Loss of appetite, increased uric acid or gout, high blood sugar, electrolyte disturbances in the blood;
• Anxiety, nervousness, anxiety disorder with panic attacks, disorientation, depression, unusual dreams, sleep disturbances, drowsiness, memory disorders;
• Numbness or tingling or similar sensations, limb pain, tremors, migraine, fainting;
• Blurred vision, burning or stinging in the eye, conjunctivitis, decreased visual acuity, yellow vision;
• Ringing, buzzing, noise, or crackling in the ears, dizziness of labyrinthine origin;
• Low blood pressure, which may be associated with changes in body position (feeling of "emptiness" in the head or weakness when standing up, angina pectoris (chest pain), heart rhythm disturbances, stroke, heart attack, rapid heartbeat;
• Vasculitis, which is often associated with skin rash or purpura;
• Sore throat, shortness of breath, bronchitis, pneumonia, fluid accumulation in the lungs (which can cause difficulty breathing), nosebleeds, runny nose, congestion;
• Constipation, gas, stomach upset, stomach cramps, vomiting, dry mouth, salivary gland inflammation, toothache;
• Jaundice (yellowing of the eyes and skin), pancreatitis;
• Severe skin reactions, with rash all over the body, peeling of the skin, and blistering (toxic epidermal necrolysis);
• Hives, itching, skin inflammation, rash, redness of the skin, sensitivity to light, dry skin, sudden flushing (especially of the face), excessive sweating, hair loss;
• Pain in the shoulders, arms, hips, knees, or other joints, joint swelling, stiffness, muscle weakness;
• Frequent urination, also at night, kidney function disorders, including kidney inflammation, urinary tract infections, sugar in the urine;
• Slight increase in urea and creatinine levels in the blood;
• Low sodium levels in the blood (hyponatremia), low potassium levels in the blood (hypokalemia);
• Decreased libido, impotence;
• Facial swelling, localized swelling, fever.

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

• Hepatitis, abnormal liver function test results.
• Angioedema of the intestine: intestinal swelling with symptoms such as abdominal 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).

Not known(frequency cannot be estimated from the available data)

• Unexplained muscle pain with dark (tea-colored) urine (rhabdomyolysis);
• Autoimmune disease with skin symptoms, such as red scaly patches or ring-shaped lesions on the skin, which can be itchy and usually appear on sun-exposed parts of the body (subacute cutaneous lupus erythematosus);
• Flu-like symptoms;
• General malaise;
• Taste disorders;
• Malignant skin and lip tumors (non-melanoma skin cancer);
• 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), acute narrow-angle glaucoma, or acute glaucoma).

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse.
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, tel.: +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 or its representative in Poland.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Lozap HCT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister. The expiry date refers to the last day of the month.
Store below 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. Package contents and other information

What Lozap HCT contains

• The active substances are losartan potassium and hydrochlorothiazide. Each tablet contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide.
• The other ingredients are: mannitol, microcrystalline cellulose, sodium croscarmellose, povidone 30, magnesium stearate, coating: hypromellose 2910/5, macrogol 6000, talc; simethicone, SE 4 titanium dioxide (E171), quinoline yellow, lake (E104), sunset yellow FCF, lake (E124).

What Lozap HCT looks like and contents of the pack

Lozap HCT is yellow, oval, film-coated tablets with a score line on both sides;
tablets measuring approximately 14 x 7 mm.
The pack contains: 30, 60, or 90 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Zentiva k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic.