Lozap 50

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Lozap 50, 50 mg, film-coated tablets
Losartanum kalicum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, 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 50 is and what it is 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 LOZAP 50 IS AND WHAT IT IS 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 blood vessel walls, causing them to narrow. 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. Losartan slows down the worsening of kidney function in patients with high blood pressure and type 2 diabetes.
Lozap 50 is used:

• for the treatment of high blood pressure (hypertension) in adults and in children and adolescents aged 6 to 18 years,
• to protect the kidneys in patients with high blood pressure and type 2 diabetes, confirmed laboratory evidence of impaired kidney function, and proteinuria ≥ 0.5 g per day (a condition in which the urine contains excessive amounts of protein),
• in the treatment of patients with chronic heart failure when medicines known as angiotensin-converting enzyme inhibitors (ACE inhibitors, drugs used to lower high blood pressure) are not considered appropriate by the doctor. If heart failure has been stabilized with an ACE inhibitor, the medicine should not be switched to losartan,
• in patients with high blood pressure and left ventricular hypertrophy; it has been shown that Lozap 50 reduces the risk of stroke ("LIFE indication").

2. IMPORTANT INFORMATION BEFORE USING LOZAP 50

When not to use Lozap 50

• if the patient is allergic to losartan or any of the other ingredients of this medicine (listed in section 6),
• after the 3rd month of pregnancy (Lozap 50 should also be avoided during early pregnancy – see section “Pregnancy”),
• in case of severe liver function impairment,
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions
Before starting Lozap 50, discuss this with your doctor or pharmacist.
Inform your doctor if you think you may be pregnant (or could become pregnant). Lozap 50 is not recommended during early pregnancy and must not be used after the 3rd month of pregnancy, as it may seriously harm the unborn child if used at this stage of pregnancy (see section “Pregnancy”).
It is important to inform your doctor before taking Lozap 50:

• if the patient has ever experienced angioedema (swelling of the face, lips, throat, and/or tongue) (see also section 4 “Possible side effects”),
• if the patient is experiencing severe vomiting or diarrhoea, leading to excessive loss of body fluids and/or salts,
• if the patient is taking diuretics (medicines that increase the amount of water excreted by the kidneys) or a low-salt diet, which may cause excessive loss of body fluids and salts (see section 3 “Dosage in special patient groups”),
• if the patient has narrowing or blockage of the blood vessels leading to the kidneys or has recently undergone a kidney transplant,
• if the patient has liver function impairment (see sections 2 “When not to use Lozap 50” and 3 “Dosage in special patient groups”),
• if the patient has heart failure with or without kidney problems, or has severe, life-threatening heart rhythm disorders. Particular caution is required when Lozap 50 is used together with beta-blockers,
• if the patient has heart valve disorders or heart muscle disease,
• if the patient has ischaemic heart disease (caused by reduced blood flow in the heart's blood vessels) or cerebrovascular disease (caused by reduced blood flow to the brain),
• if the patient has primary hyperaldosteronism (a condition associated with increased secretion of the hormone aldosterone by the adrenal glands due to adrenal abnormalities),
• if the patient is taking any of the following medicines for high blood pressure:
  • an angiotensin-converting enzyme (ACE) inhibitor (e.g. enalapril, lisinopril, ramipril), particularly if the patient has kidney problems related to diabetes,
  • aliskiren. The treating doctor may monitor kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals. See also information under the heading “When not to use Lozap 50”.
• if the patient is taking other medicines that may increase serum potassium levels (see section 2 “Lozap 50 and other medicines”).

Children and adolescents
Studies on the use of losartan in children have been conducted. For additional information, consult your doctor.
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 efficacy has not been demonstrated in this age group.

Lozap 50 and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Inform your doctor if you are taking potassium supplements, potassium-containing salt substitutes, potassium-sparing agents such as certain diuretics (amiloride, triamterene, spironolactone), or other medicines that may increase serum potassium levels (e.g. heparin, trimethoprim-containing medicines), as concomitant use with Lozap 50 is not recommended.
Exercise particular caution when using the following medicines during treatment with Lozap 50:

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

Your doctor may recommend adjusting the dose and/or taking additional precautions:

• if the patient is taking an ACE inhibitor or aliskiren (see also subsections “When not to use Lozap 50” and “Warnings and precautions”). In patients with impaired kidney function, concomitant use of these medicines may lead to worsening of kidney function.

Do not use lithium-containing medicines in combination with losartan without strict medical supervision.
Special precautions (e.g. blood tests) may be necessary.
If the patient experiences abdominal pain, nausea, vomiting, or diarrhoea after taking Lozap 50, discuss this with your doctor. Your doctor will decide on further treatment. Do not discontinue Lozap 50 on your own initiative.

Lozap 50 with food and drink
Lozap 50 can be taken independently of meals.
Avoid drinking grapefruit juice while taking Lozap 50.

Pregnancy, breastfeeding, and fertility
If you are pregnant, breastfeeding, think you may be pregnant, or are planning a pregnancy, consult your doctor or pharmacist before using this medicine.
Pregnancy
Inform your doctor if you suspect or are planning pregnancy. Your doctor will usually recommend discontinuing Lozap 50 before planned pregnancy or immediately after pregnancy is confirmed and will advise taking an alternative medicine instead of Lozap 50. Lozap 50 is not recommended during early pregnancy and must not be used after the 3rd month of pregnancy, as it may seriously harm the unborn child if used beyond the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or intend to breastfeed. Lozap 50 is not recommended during breastfeeding, especially when breastfeeding a newborn or preterm infant. Your doctor may recommend an alternative medicine.

Driving and operating machinery
Studies on the effect of Lozap 50 on the ability to drive and operate machinery have not been conducted. However, like many other medicines used to treat high blood pressure, Lozap 50 may cause dizziness or drowsiness in some individuals. If dizziness or drowsiness occurs, consult your doctor before performing such activities.

3. HOW TO USE LOZAP 50

This medicine should always be taken as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Your doctor will determine the appropriate dose of Lozap 50 based on your condition and any other medications you are taking. It is important to continue taking Lozap 50 for as long as your doctor has instructed, in order to maintain consistent blood pressure control.

Adult patients with high blood pressure
Treatment usually starts with a dose of 50 mg losartan (one Lozap 50 tablet) once daily. The full blood pressure-lowering effect should be achieved within 3 to 6 weeks after starting treatment. Your doctor may then increase the dose to 100 mg losartan (two Lozap 50 tablets) once daily in some patients.
If you feel that the effect of losartan is too strong or too weak, consult your 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 efficacy has not been demonstrated in this age group.

Children aged 6 to 18 years
The recommended initial dose for patients weighing between 20 and 50 kg is 0.7 mg losartan per kg of body weight once daily (up to 25 mg of Lozap 50). Your doctor may increase the dose if blood pressure is not adequately controlled.

Adult patients with high blood pressure and type 2 diabetes
Treatment usually starts with a dose of 50 mg losartan (one Lozap 50 tablet) once daily. Your doctor may then increase the dose to 100 mg losartan (two Lozap 50 tablets) once daily, depending on blood pressure changes.

Lozap 50 tablets may be used together with other antihypertensive medicines (e.g. diuretics, calcium antagonists, alpha- or beta-blockers, and centrally acting agents), as well as with insulin and other commonly used glucose-lowering medicines (e.g. sulfonylurea derivatives, glitazones, and glucosidase inhibitors).

Adult patients with heart failure
Treatment usually starts with a dose of 12.5 mg losartan once daily.
Your doctor will usually gradually increase the dose at weekly intervals (i.e. 12.5 mg daily during the first week, 25 mg daily during the second week, 50 mg daily during the third week, 100 mg daily during the fourth week, and 150 mg daily during the fifth week), until reaching the maintenance dose determined by your doctor. The maximum dose of losartan is 150 mg (e.g. three Lozap 50 tablets) once daily. In the treatment of heart failure, losartan is usually used in combination with diuretics (medicines that increase the amount of water excreted by the kidneys) and/or cardiac glycosides (medicines that strengthen the heart and improve its function) and/or beta-blockers.

Dosing in special patient groups
Your doctor may recommend a lower dose, especially at the beginning of treatment, in certain patients such as those taking high doses of diuretics, patients with impaired liver function, or patients over 75 years of age. Losartan is not recommended in patients with severe impairment of liver function (see section "When not to use Lozap 50").

Administration
Tablets should be swallowed with a glass of water. Try to take the medicine at the same time each day. It is important to continue taking Lozap 50 for as long as your doctor has instructed.
Lozap 50 tablets may be divided into equal doses.

Taking more Lozap 50 than prescribed
If you accidentally take too many tablets, contact your doctor immediately. Symptoms of overdose may include low blood pressure, rapid heartbeat, and possibly slow heartbeat.

Missed dose of Lozap 50
If you accidentally miss a daily dose, take the next dose at your usual time. Do not take a double dose to make up for the missed tablet.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following symptoms occur, stop taking Lozap 50 immediately and
consult a doctor or go to the nearest hospital emergency department without delay:
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, although rare, adverse reaction, occurring in up to 1 in 1,000 patients. Urgent medical
treatment or hospitalization may be required.

The following adverse reactions have been reported with 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 treated with high doses of diuretics), dose-dependent orthostatic symptoms such as reduced blood pressure occurring when standing up from lying or sitting position,
• weakness,
• fatigue,
• low blood sugar (hypoglycaemia),
• high potassium levels in the blood (hyperkalaemia),
• changes in kidney function including kidney failure,
• reduced number of red blood cells (anaemia),
• increased blood urea levels, increased serum creatinine and potassium levels in patients with heart failure.

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

• drowsiness,
• headache,
• sleep disturbances,
• sensation of rapid heartbeat (palpitations),
• severe chest pain (angina pectoris),
• shortness of breath (dyspnoea),
• abdominal pain,
• constipation,
• diarrhoea,
• nausea,
• vomiting,
• urticaria,
• itching (pruritus),
• rash,
• localized swelling,
• cough.

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

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

Unknown frequency (cannot be estimated from available data):

• reduced platelet count,
• migraine,
• liver function disorders,
• muscle and joint pain,
• influenza-like symptoms,
• back pain and urinary tract infections,
• increased sensitivity to sunlight (light),
• unexplained muscle pain with dark (tea-coloured) urine (rhabdomyolysis),
• impotence,
• pancreatitis,
• low sodium levels in blood (hyponatraemia),
• depression,
• general malaise,
• ringing, buzzing, noise or clicking in the ears (tinnitus),
• altered taste sensation (taste disturbances).

Adverse reactions in children are similar to those observed in adults.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can also 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 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. HOW TO STORE LOZAP 50

Keep the medicine out of the 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 below 30°C. Keep in the original packaging to protect from light.
Medicines must not be disposed of via sewage 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 50 contains
The active substance is losartan potassium.
Each tablet contains 50 mg of losartan potassium.
Other ingredients are: Tablet core: microcrystalline cellulose, mannitol, crospovidone, anhydrous colloidal silicon dioxide, talc, magnesium stearate; Tablet coating: Album Sepifilm 752 [hypromellose, microcrystalline cellulose, stearic acid macrogol 2000, titanium dioxide], macrogol 6000.

What Lozap 50 looks like and contents of the pack
White or almost white, oval, biconvex coated tablets with a breakline on both sides (approximately 11.0 x 5.5 mm). The tablet can be divided into equal doses.
Pack sizes contain 30, 60 or 90 coated tablets.

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