Lozap hct

Package leaflet: Information for the patient

LOZAP HCT, 50 mg + 12.5 mg, coated tablets
(Losartanum kalicum + Hydrochlorothiazidum)
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Lozap HCT is and what it is 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. Contents of the pack and other information

1. What Lozap HCT is and what it is 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 constrict. This leads to increased blood pressure. Losartan prevents angiotensin II from binding to these receptors, resulting in blood vessel dilation and consequently lowering blood pressure. Hydrochlorothiazide increases the excretion of water and salts through the kidneys. This also contributes to lowering blood pressure.
Lozap HCT is indicated for the treatment of essential hypertension (high blood pressure).

2. Important information before using Lozap HCT

When not to use 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 agents such as co-trimoxazole – consult a physician in case
of doubt);
if the patient has severe liver dysfunction;
if the patient has low blood potassium or sodium levels, or high blood calcium levels that cannot be corrected by treatment;
if the patient has gout;
if the patient is more than 3 months pregnant. (It is also preferable to avoid using Lozap
HCT during early pregnancy; see section “Pregnancy”);
if the patient has severe kidney dysfunction or anuria (absence of urine production);
if the patient has diabetes or kidney impairment and is being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions
Before starting treatment with Lozap HCT, discuss this with your doctor or pharmacist.
Inform your doctor if you are pregnant, suspect you may be pregnant, or are planning pregnancy. Use of Lozap HCT is not recommended during early pregnancy and must be avoided after the 3rd month of pregnancy, as it may seriously harm the unborn child (see section “Pregnancy”).
If the patient develops abdominal pain, nausea, vomiting or diarrhoea after taking Lozap HCT, discuss this with the doctor. The doctor will decide whether treatment should continue. Do not discontinue Lozap HCT on your own initiative.

It is important to inform your doctor before starting Lozap HCT:

• if the patient has previously experienced swelling of the face, lips, throat or tongue;
• if the patient is taking diuretic medicines;
• if the patient is on a low-salt diet;
• if the patient has had or currently has severe vomiting and/or diarrhoea;
• if the patient has heart failure;
• if the patient has liver dysfunction (see section 2 “When not to use 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 received a kidney transplant;
• if the patient has arterial stenosis (arteriosclerosis), angina pectoris (chest pain due to reduced blood flow to the heart muscle);
• if the patient has aortic or mitral valve stenosis (narrowing of heart valves) or hypertrophic cardiomyopathy (a disease causing thickening of the heart muscle);
• if the patient has diabetes;
• if the patient has had gout;
• if the patient has previously had skin cancer or if unexpected skin changes occur during treatment. Treatment with hydrochlorothiazide, especially in high doses over a prolonged period, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. While taking Lozap HCT, protect the skin from sunlight and UV radiation;
• if the patient experiences visual disturbances or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive accumulation of fluid between choroid and sclera) or increased intraocular pressure – these may occur from several hours to weeks after taking Lozap HCT. This may lead to permanent vision loss if untreated. Patients who previously had an allergic reaction to penicillin or sulfonamides may be at higher risk of developing this condition;
• if the patient has had or currently has allergies, asthma, or an autoimmune disorder causing joint pain, skin rash and fever (systemic lupus erythematosus);
• if the patient has high blood calcium levels or low blood potassium levels, or if the patient is on a low-potassium diet;
• if the patient requires anaesthesia (even at the dentist) before a surgical procedure, or if the patient is scheduled for parathyroid function testing, the patient must inform the doctor or medical staff about taking Lozap HCT;
• if the patient has primary hyperaldosteronism (a condition associated with excessive aldosterone hormone secretion by the adrenal glands due to adrenal abnormalities);
• if the patient previously experienced breathing or lung problems (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If the patient develops severe shortness of breath or breathing difficulties after taking Lozap HCT, seek immediate medical help;
• if the patient is taking any of the following medicines for high blood pressure:
  • angiotensin-converting enzyme (ACE) inhibitors, such as enalapril, lisinopril, ramipril, particularly if the patient has kidney impairment related to diabetes,
  • aliskiren. The doctor may recommend regular monitoring of kidney function, blood pressure, and blood electrolyte levels (e.g. potassium). See also section “When not to use Lozap HCT”. if the patient is taking other medicines that may increase serum potassium levels (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 of age). Therefore,
Lozap HCT should not be used in children and adolescents.

Lozap HCT and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Inform your doctor about potassium supplements, potassium-containing salt substitutes, potassium-sparing medicines, or other medicines that may increase serum potassium levels (e.g. medicines containing trimethoprim), as concomitant use with Lozap HCT is not recommended.
Diuretics such as hydrochlorothiazide contained in Lozap HCT may interact with other medicines.
Do not take lithium-containing preparations together with Lozap HCT without strict medical supervision.
Special precautions (e.g. blood tests) may be necessary if the patient is taking other diuretics, certain laxatives, medicines used to treat gout, medicines to control heart rhythm, or antidiabetic medicines (oral agents or insulin).
It is also important for the doctor to know if the patient is taking:

• other blood pressure-lowering medicines;
• corticosteroids;
• medicines used in cancer treatment;
• painkillers;
• medicines used to treat fungal infections;
• medicines used to treat arthritis;
• resins used to treat high cholesterol levels, such as cholestyramine;
• muscle relaxants;
• antidepressants;
• sleeping tablets;
• opioid medicines such as morphine;
• vasoconstrictive amines such as adrenaline or other medicines of the same class;
• carbamazepine used in the treatment of epilepsy;
• oral antidiabetic medicines or insulin.

The doctor may recommend dose adjustments and/or additional precautions:
if the patient is taking an ACE inhibitor or aliskiren (see also sections “When not to use Lozap HCT” and “Warnings and precautions”).
Inform the doctor if undergoing an X-ray examination with iodine-containing contrast agents.

Lozap HCT, food, drink and alcohol
It is recommended that the patient does not drink alcohol while taking these tablets: alcohol and Lozap HCT may mutually enhance each other's effects. Do not take Lozap HCT with liquorice, as this may lead to low blood potassium levels.
Excessive dietary salt intake may reduce the effectiveness of Lozap HCT.
Lozap HCT may 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, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Inform your doctor if you are pregnant, suspect pregnancy, or are planning pregnancy. The doctor will usually advise discontinuing Lozap HCT before planned pregnancy or immediately after confirming pregnancy and will recommend an alternative medicine instead of Lozap HCT. Use of Lozap HCT is not recommended during pregnancy and must be avoided in patients beyond the 3rd month of pregnancy, as it may seriously harm the unborn child if used after the third month of pregnancy.

Breastfeeding
Inform your doctor if the patient is breastfeeding or plans to breastfeed. Use of Lozap HCT is not recommended in breastfeeding mothers. The doctor may recommend alternative treatment if the patient wishes to breastfeed.

Driving and using machines
When starting treatment with this medicine, the patient should not perform tasks requiring special attention (e.g. driving a car or operating dangerous machinery) until it is known how the patient tolerates this medicine.

Lozap HCT contains carmine and sodium
This medicine contains the colouring agent carmine, which may cause allergic reactions.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to use Lozap HCT

This medicine should always be used as directed by the physician or pharmacist. If in doubt,
consult your physician or pharmacist.
Your physician will decide the appropriate dose of Lozap HCT based on your condition and
other medications you are taking.
High blood pressure
The usual dose of Lozap HCT for controlling blood pressure over a 24-hour period is 1 tablet per day for most patients. Your physician may increase the dose to up to 2 tablets of Lozap HCT once daily. The maximum daily dose is 2 tablets of Lozap HCT.
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 well 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 may be taken with food or independently of meals. Lozap HCT tablets should be swallowed whole with a glass of water. The division line is not intended for breaking the tablet.
Taking more Lozap HCT than recommended
In case of overdose, contact your physician immediately to obtain urgent medical assistance. Overdose may cause low blood pressure, palpitations, slow heartbeat, changes in blood composition, and dehydration.
If you miss a dose of Lozap HCT
Lozap HCT should be used exactly as prescribed by your physician. Do not take a double dose to make up for a missed tablet. Simply resume the prescribed dosing schedule.
Stopping Lozap HCT
It is important to continue taking Lozap HCT for as long as your physician has instructed, to ensure blood pressure control.
If you have any further questions about the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If any of the following symptoms occur, stop taking Lozap HCT immediately and consult a 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 in swallowing or breathing).
This is a serious, but rare adverse reaction occurring in more than 1 in 10,000 but less than 1 in 1,000 patients. Urgent medical attention or hospitalization may be required.

Other reported adverse reactions:
Common (may occur in less than 1 in 10 people):

• 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;
• Increased potassium levels in the blood (which may cause heart rhythm disturbances), decreased hemoglobin levels and decreased hematocrit;
• Changes in kidney function, including kidney failure;
• Low blood sugar (hypoglycemia).

Uncommon (may occur in less than 1 in 100 people):

• Decreased number of red blood cells (anemia), red or brown spots on the skin (sometimes mainly on feet, legs, arms and buttocks, with joint pain, swelling of hands and feet, and stomach pain);
• Easy bruising, decreased number of white blood cells, coagulation disorders, decreased number of platelets, breakdown of red blood cells;
• Loss of appetite, increased uric acid levels or overt gout, increased blood sugar levels, disturbances in blood electrolyte levels;
• Anxiety, nervousness, anxiety disorder with panic attacks (recurrent panic attacks), disorientation, depression, unusual dreams, sleep disturbances, drowsiness, memory disturbances;
• Tingling or numbness sensations or similar feelings, limb pain, tremor, migraine, fainting;
• Blurred vision, burning or pricking sensation in the eye, conjunctivitis, decreased visual acuity, yellow vision;
• Ringing, buzzing, noise or crackling in the ears, vertigo of labyrinthine origin;
• Low blood pressure, which may be related to changes in body position (feeling of "emptiness" in the head or weakness upon standing), angina (chest pain), heart rhythm disturbances, cerebrovascular incident (mini-stroke), heart attack, palpitations;
• Vasculitis (inflammation of blood vessels), often associated with skin rash or purpura;
• Sore throat, shortness of breath, bronchitis, pneumonia, presence of fluid in the lungs (causing breathing difficulties), nosebleed, runny nose, congestion;
• Constipation, flatulence, upset stomach, stomach cramps, vomiting, dryness of the oral mucosa, sialadenitis, toothache;
• Jaundice (yellowing of eyes and skin), pancreatitis;
• Severe skin reactions, with rash over the entire body, peeling of the outer layer of skin and formation of blisters on the skin (toxic epidermal necrolysis);
• Urticaria, itching, dermatitis, rash, skin redness, photosensitivity, dry skin, sudden flushing (especially of the face), excessive sweating, alopecia;
• Pain in arms, shoulders, hips, knees or other joints, joint swelling, stiffness, muscle weakness;
• Frequent urination, including at night, disturbances in kidney function, including nephritis, urinary tract infection, presence of glucose in urine;
• Slight increase in blood urea and creatinine levels in serum;
• Low sodium levels in the blood (hyponatremia), low potassium levels in the blood (hypokalemia);
• Decreased libido, impotence;
• Facial swelling, localized swelling, fever.

Rare (may occur in less than 1 in 1,000 people):

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

Very rare (may occur in less than 1 in 10,000 people):

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

Unknown (frequency cannot be estimated from available data):

• Unexplained muscle pain accompanied by dark (tea-colored) urine (rhabdomyolysis);
• Autoimmune disease with skin symptoms such as red scaly patches or ring-shaped lesions on the skin, which may be itchy and usually appear on sun-exposed areas of the body (cutaneous lupus erythematosus);
• Influenza-like symptoms;
• General malaise;
• Taste disturbances;
• Malignant skin and lip tumors (non-melanoma skin cancers);
• Impaired vision or eye pain due to elevated pressure (possible symptoms of fluid accumulation in the vascular membrane surrounding the eye (excessive fluid accumulation between choroid and sclera), acute myopia or acute closed-angle glaucoma).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration 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
Adverse reactions can also be reported to the marketing authorization holder or its representative in Poland.
Reporting adverse reactions helps to provide more information on the safety of the 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 stated month.
Store below 30°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package 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.
• Other components: mannitol, microcrystalline cellulose, sodium croscarmellose, povidone 30, magnesium stearate; coating components: hypromellose 2910/5, macrogol 6000, talc; simethicone, SE 4 emulsion, titanium dioxide (E171), quinoline yellow, lac (E104), carmine red, lac (E124).

What Lozap HCT looks like and contents of the pack
Lozap HCT is yellow, film-coated, elongated tablets with a break line on both sides;
tablets measuring approximately 14 x 7 mm.
Pack contents: 30, 60 or 90 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Zentiva k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic.

For further information about this medicinal product and its names in the countries of the European Economic Area, please contact the representative of the Marketing Authorisation Holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00