Lozap 50

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

Lozap 50, 50 mg, film-coated tablets

Losartan potassium

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

• This leaflet should be kept, so that it can be re-read if necessary.
• In case of any further doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed specifically for one person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If any side effects occur, including any side effects not mentioned in this leaflet, the doctor or pharmacist should be informed. See section 4.

Table of contents of the leaflet:

• 1. What is Lozap 50 and what is it used for
• 2. Important information before taking Lozap 50
• 3. How to take Lozap 50
• 4. Possible side effects
• 5. How to store Lozap 50
• 6. Contents of the pack and other information

1. WHAT IS LOZAP 50 AND WHAT IS IT USED FOR

Lozap 50 contains the active substance – losartan. Losartan belongs to a group of medicines called angiotensin II receptor antagonists. Angiotensin II is a substance produced in the body that binds to receptors in the walls of blood vessels, causing them to narrow. This results in increased blood pressure. Losartan prevents angiotensin II from binding to these receptors, causing the blood vessels to widen, which in turn reduces blood pressure. Losartan slows down the deterioration of kidney function in patients with high blood pressure and type 2 diabetes.

Lozap 50 is used:

• to treat high blood pressure (hypertension) in adults and in children and adolescents from 6 to 18 years of age,
• to protect the kidneys in patients with high blood pressure and type 2 diabetes with laboratory-confirmed impaired kidney function and proteinuria ≥ 0.5 g per day (a condition in which the urine contains an excessive amount of protein),
• to treat patients with chronic heart failure, if the use of drugs called angiotensin-converting enzyme inhibitors (ACE inhibitors, drugs used to lower high blood pressure) is not considered appropriate by the doctor. If heart failure has been stabilized with an ACE inhibitor, the medicine should not be changed to losartan,
• in patients with high blood pressure and thickening of the left ventricular wall; it has been shown that Lozap 50 reduces the risk of stroke (the "LIFE indication").

2. IMPORTANT INFORMATION BEFORE TAKING LOZAP 50

When not to take Lozap 50

• if the patient is allergic to losartan or any of the other ingredients of this medicine (listed in section 6),
• after the third month of pregnancy (it is also recommended to avoid taking Lozap 50 in early pregnancy - see section "Pregnancy"),
• in case of severe liver function disorders,
• if the patient has diabetes or kidney function disorders and is being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Before starting treatment with Lozap 50, the doctor or pharmacist should be consulted.

The doctor should be informed if the patient thinks she is pregnant (or may become pregnant). Lozap 50 is not recommended in early pregnancy and should not be taken by pregnant women after the third month of pregnancy, as it may seriously harm the baby if taken at this stage of pregnancy (see section "Pregnancy").

It is important to inform the doctor before taking Lozap 50:

• if the patient has ever had angioedema (swelling of the face, lips, throat, and/or tongue) (see also section 4 "Possible side effects"),
• if the patient has severe vomiting or diarrhea, leading to excessive loss of fluids and/or electrolytes from the body,
• if the patient is taking diuretics (medicines that increase the amount of water excreted by the kidneys) or is on a low-salt diet, which can lead to excessive loss of fluids and electrolytes from the body (see section 3 "Dosage in special patient groups"),
• if the patient has narrowing or obstruction of the blood vessels leading to the kidneys or has recently undergone kidney transplantation,
• if the patient has liver function disorders (see sections 2 "When not to take Lozap 50" and 3 "Dosage in special patient groups"),
• if the patient has heart failure with kidney function disorders or without kidney function disorders, or if there are life-threatening heart rhythm disorders. Particular caution is required when treating with beta-blockers,
• if the patient has valve or heart muscle disorders,
• if the patient has coronary heart disease (caused by reduced blood flow in the heart's blood vessels) or cerebrovascular disease (caused by reduced blood flow in the brain's blood vessels),
• if the patient has primary hyperaldosteronism (a condition related to increased production of aldosterone hormone by the adrenal glands, caused by adrenal gland disorders),
• if the patient is taking any of the following blood pressure-lowering medicines:
• angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), especially if the patient has kidney function disorders related to diabetes.
• aliskiren. The doctor may monitor kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood at regular intervals. See also the information under the heading "When not to take Lozap 50".
• if the patient is taking other medicines that may increase potassium levels in the blood (see section 2 "Lozap 50 and other medicines").

Children and adolescents

Studies have been conducted on the use of losartan in children. For more information, the doctor should be consulted.

Lozap 50 is not recommended for children with kidney or liver problems due to limited data available in this patient group. Lozap 50 is not recommended for children under 6 years of age, as its effectiveness has not been demonstrated in this age group.

Lozap 50 and other medicines

The doctor or pharmacist should be informed about all medicines currently being taken or recently taken, as well as any medicines that the patient plans to take.

The doctor should be informed about any potassium supplements, salt substitutes containing potassium, potassium-sparing diuretics (e.g., amiloride, triamterene, spironolactone), or other medicines that may increase potassium levels in the blood (e.g., heparin, trimetoprim-containing medicines), as their concurrent use with Lozap 50 is not recommended.

Particular caution should be exercised when taking the following medicines during treatment with Lozap 50:

• other blood pressure-lowering medicines, as they may further lower blood pressure. Blood pressure may also be lowered by one of the following groups of medicines: tricyclic antidepressants, antipsychotics, baclofen, amifostine,
• non-steroidal anti-inflammatory drugs, such as indomethacin, including COX-2 inhibitors (medicines that reduce inflammation and may be used to reduce pain), as they may weaken the blood pressure-lowering effect of losartan.

The doctor may recommend a dose change and/or take other precautions:

• if the patient is taking an ACE inhibitor or aliskiren (see also subsections "When not to take Lozap 50" and "Warnings and precautions"). In case of kidney function disorders, concurrent use of these medicines may lead to worsening of kidney function.

Without close medical supervision, medicines containing lithium should not be taken in combination with losartan.

Special precautions (e.g., blood tests) may be necessary.

If the patient experiences abdominal pain, nausea, vomiting, or diarrhea after taking Lozap 50, they should consult their doctor. The doctor will decide on further treatment. The patient should not stop taking Lozap 50 on their own.

Lozap 50 with food and drink

Lozap 50 can be taken with or without food.

Grapefruit juice should be avoided during treatment with Lozap 50.

Pregnancy, breastfeeding, and fertility

In pregnancy, during breastfeeding, or if pregnancy is suspected, or if the patient is planning to become pregnant, the doctor or pharmacist should be consulted before taking this medicine.

Pregnancy

The doctor should be informed if the patient suspects (or plans) to become pregnant. The doctor will usually recommend stopping Lozap 50 before planned pregnancy or immediately after confirming pregnancy and recommend taking another medicine instead of Lozap 50. Lozap 50 is not recommended in early pregnancy and should not be taken after the third month of pregnancy, as it may seriously harm the baby if taken at this stage of pregnancy.

Breastfeeding

The doctor should be informed if the patient is breastfeeding or plans to breastfeed. Lozap 50 is not recommended during breastfeeding, especially in newborns or premature babies. The doctor may recommend another medicine.

Driving and using machines

No studies have been conducted on the effect of the medicine on the ability to drive and use machines. However, like many other medicines used to treat high blood pressure, Lozap 50 may cause dizziness or drowsiness in some people. If dizziness or drowsiness occurs, the patient should consult their doctor before performing such activities.

3. HOW TO TAKE LOZAP 50

This medicine should always be taken as directed by the doctor. In case of doubts, the doctor or pharmacist should be consulted.

The doctor will determine the appropriate dose of Lozap 50, depending on the patient's condition and the use of other medicines. It is essential to continue taking Lozap 50 for as long as the doctor recommends to maintain consistent blood pressure control.

Adult patients with high blood pressure

Treatment usually starts with a dose of 50 mg of losartan (one Lozap 50 tablet) once a day.

The maximum blood pressure-lowering effect should occur within 3 to 6 weeks after starting treatment. In some patients, the doctor may then increase the dose to 100 mg of losartan (two Lozap 50 tablets) once a day.

If the patient feels that the effect of losartan is too strong or too weak, they should consult their doctor or pharmacist.

Use in children and adolescents

Children under 6 years of age

Lozap 50 is not recommended for children under 6 years of age, as its effectiveness has not been demonstrated in this age group.

Children from 6 to 18 years of age

The recommended initial dose for patients weighing between 20 and 50 kg is 0.7 mg of losartan per kg of body weight, given once daily (up to 25 mg of Lozap 50). The doctor may increase the dose if blood pressure is not controlled.

Adult patients with high blood pressure and type 2 diabetes

Treatment usually starts with a dose of 50 mg of losartan (one Lozap 50 tablet) once a day.

The doctor may then increase the dose to 100 mg of losartan (two Lozap 50 tablets) once a day, depending on changes in blood pressure.

Lozap 50 tablets can be taken with other blood pressure-lowering medicines (e.g., diuretics, calcium channel blockers, alpha- or beta-blockers) and with insulin and other commonly used medicines to lower blood sugar levels (e.g., sulfonylurea derivatives, glitazones, and glucose inhibitors).

Adult patients with heart failure

Treatment usually starts with a dose of 12.5 mg of losartan once a day.

The doctor will usually gradually increase the dose at weekly intervals (i.e., 12.5 mg per day during the first week, 25 mg per day during the second week, 50 mg per day during the third week, 100 mg per day during the fourth week, 150 mg per day during the fifth week), until the maintenance dose determined by the doctor is reached. The maximum dose of losartan 150 mg (e.g., three Lozap 50 tablets) may be taken once a day. In the treatment of heart failure, losartan is usually taken in combination with diuretics (medicines that increase the amount of water excreted by the kidneys) and/or digitalis glycosides (medicines that strengthen the heart and increase its efficiency) and/or beta-blockers.

Dosage in special patient groups

The doctor may recommend a lower dose, especially when starting treatment in certain patients, such as those taking high doses of diuretics, patients with liver function disorders, or patients over 75 years of age. Losartan is not recommended for patients with severe liver function disorders (see section "When not to take Lozap 50").

Administration

The tablets should be swallowed with a glass of water. It is essential to try to take the medicine at the same time every day. The patient should continue taking Lozap 50 for as long as the doctor recommends.

A Lozap 50 tablet can be divided into equal doses.

Taking a higher than recommended dose of Lozap 50

In case of accidental ingestion of too many tablets, the doctor should be contacted immediately. Symptoms of overdose are low blood pressure, rapid heart rate, and possible slow heart rate.

Missing a dose of Lozap 50

In case of missing a daily dose, the next dose should be taken at the usual time. A double dose should not be taken to make up for the missed tablet.

In case of any further doubts about taking this medicine, the doctor or pharmacist should be consulted.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Lozap 50 can cause side effects, although not everybody gets them.

In case of the following symptoms, the patient should stop taking Lozap 50 and consult their 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 that may occur in up to 1 in 1,000 patients. Emergency medical attention or hospitalization may be necessary.

The following side effects have been reported for losartan:

Common (may occur in up to 1 in 10 patients):

• dizziness,
• low blood pressure (especially after excessive fluid loss, e.g., in patients with severe heart failure or those treated with high doses of diuretics), dose-dependent orthostatic effects, such as decreased blood pressure, occurring when standing up from a lying or sitting position,
• weakness,
• fatigue,
• low blood sugar (hypoglycemia),
• high potassium levels in the blood (hyperkalemia),
• changes in kidney function, including kidney failure,
• decreased red blood cell count (anemia),
• increased urea and creatinine levels in the blood, increased potassium levels in the blood in patients with heart failure.

Uncommon (may occur in up to 1 in 100 patients):

• drowsiness,
• headache,
• sleep disorders,
• increased heart rate (palpitations),
• severe chest pain (angina pectoris),
• shortness of breath (dyspnea),
• abdominal pain,
• constipation,
• diarrhea,
• nausea,
• vomiting,
• hives,
• itching (pruritus),
• rash,
• localized swelling,
• cough.

Rare (may occur in up to 1 in 1,000 patients):

• hypersensitivity,
• angioedema,
• intestinal angioedema: swelling in the intestine with symptoms such as abdominal pain, nausea, vomiting, and diarrhea,
• vasculitis (inflammation of blood vessels, including Henoch-Schönlein purpura),
• numbness or tingling (paresthesia),
• fainting,
• very rapid and irregular heart rhythm (atrial fibrillation), stroke,
• hepatitis,
• increased alanine aminotransferase (ALT) activity in the blood, usually resolving after discontinuation of treatment.

Unknown (frequency cannot be estimated from available data):

• decreased platelet count,
• migraine,
• liver function disorders,
• muscle and joint pain,
• flu-like symptoms,
• back pain and urinary tract infections,
• increased sensitivity to sunlight (photosensitivity),
• unexplained muscle pain with dark (tea-colored) urine (rhabdomyolysis),
• impotence,
• pancreatitis,
• low sodium levels in the blood (hyponatremia),
• depression,
• general feeling of being unwell,
• ringing, buzzing, humming, or clicking in the ears (tinnitus),
• disturbed sense of taste (taste disorders).

Side effects in children are similar to those observed in adults.

Reporting side effects

If any side effects occur, including any side effects not mentioned in the leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.

Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl

By reporting side effects, more information can be gathered on the safety of the medicine.

5. HOW TO STORE LOZAP 50

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month.

Store in a temperature below 30°C. Store in the original packaging to protect from light.

Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked 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 Lozap 50 contains

The active substance is losartan potassium.

Each tablet contains 50 mg of losartan potassium.

In addition, the medicine contains:

Core: microcrystalline cellulose, mannitol, crospovidone, colloidal anhydrous silica, talc, magnesium stearate;

Coating: Album Sepifilm 752 [hypromellose, microcrystalline cellulose, macrogol 2000 stearate, titanium dioxide], macrogol 6000.

What Lozap 50 looks like and contents of the pack

White or almost white, oval, biconvex, film-coated tablets with a score line on both sides (approximately 11.0 x 5.5 mm). The tablet can be divided into equal doses.

Packaging contains 30, 60, or 90 film-coated tablets.

Marketing authorization holder

Zentiva, a.s., Einsteinova 24, 851 01 Bratislava, Slovak Republic

Manufacturer

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

For more information about the medicine and its names in the Member States of the European Economic Area, please contact:

Zentiva Polska Sp. z o.o.

ul. Bonifraterska 17

00-203 Warsaw

Tel: +48 22 375 92 00

Date of last revision of the leaflet:January 2025