Xartan

Leaflet accompanying the packaging: information for the user

XARTAN, 50 mg, film-coated tablets

Losartan potassium

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects not mentioned in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Xartan and what is it used for

Xartan 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 blood vessel walls, causing them to narrow. This results in an increase in blood pressure. Losartan prevents angiotensin II from binding to these receptors, causing the blood vessels to widen and, as a result, lowering blood pressure. Losartan slows the progression of kidney disease in patients with high blood pressure and type 2 diabetes.

Xartan is used

• to treat high blood pressure (hypertension) in adults and 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 kidney function disorders and proteinuria ≥ 0.5 g per day (a condition in which the urine contains an abnormal amount of protein).
• to treat patients with chronic heart failure, when treatment with certain medicines 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 switched to losartan.
• in patients with high blood pressure and left ventricular hypertrophy, Xartan has been shown to reduce the risk of stroke (the "LIFE indication").

2. Important information before taking Xartan

When not to take Xartan:

• if you are allergic to losartan or any of the other ingredients of this medicine (listed in section 6),
• if you have severe liver function disorders,
• after the third month of pregnancy (you should also avoid taking Xartan during early pregnancy; see the section "Pregnancy and breastfeeding"),
• if you have diabetes or kidney function disorders and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Before taking Xartan, discuss it with your doctor or pharmacist. If you experience abdominal pain, nausea, vomiting, or diarrhea after taking Xartan, discuss it with your doctor. The doctor will decide on further treatment. Do not stop taking Xartan on your own. Inform your doctor if you suspect (or plan) pregnancy. It is not recommended to take Xartan during early pregnancy and it should not be taken after the third month of pregnancy, as it may harm the baby (see the section "Pregnancy"). It is important to inform your doctor before taking Xartan:

• if you have ever had angioedema (swelling of the face, lips, throat, and/or tongue) (see also section 4 "Possible side effects"),
• if you have severe vomiting or diarrhea leading to excessive loss of fluids and/or electrolytes from the body,
• if you are taking diuretics (medicines that increase the amount of water excreted by the kidneys) or a low-salt diet leading to excessive loss of fluids and electrolytes from the body (see section 3 "Dosage in special patient groups"),
• if you have narrowing or blockage of the blood vessels leading to the kidneys or if you have recently had a kidney transplant,
• if you have liver function disorders (see sections 2 "When not to take Xartan" and 3 "Dosage in special patient groups"),
• if you have heart failure with kidney function disorders or without kidney function disorders or co-existing, severe, life-threatening heart rhythm disorders. Particular caution is required when treating with beta-blockers,
• if you have heart valve or heart muscle disorders,
• if you have coronary heart disease (caused by reduced blood flow in the heart's blood vessels) or cerebrovascular disorders (caused by reduced blood flow in the brain's blood vessels),
• if you have primary hyperaldosteronism (a condition caused by excessive secretion of aldosterone hormone by the adrenal glands, caused by adrenal gland disorders),
• if you are taking any of the following blood pressure-lowering medicines:
• angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), especially if you have kidney function disorders associated with diabetes.
• aliskiren.

Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (e.g., potassium) in your blood at regular intervals. See also the information under the heading "When not to take Xartan".

Children and adolescents

Studies have been conducted on the use of losartan in children. For more information, you should consult your doctor. Xartan is not recommended for use in children and adolescents with kidney or liver function disorders, as well as in children under 6 years of age due to limited data available for these patient groups.

Xartan and other medicines

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take. Your doctor may need to change the dose and/or take other precautions: If you are taking an ACE inhibitor or aliskiren (see also the information under the headings "When not to take Xartan" and "Warnings and precautions"). Particular caution should be exercised when taking the following medicines during treatment with Xartan:

• other blood pressure-lowering medicines, as they may lead to additional lowering of blood pressure. Blood pressure may also be lowered by the following medicines/groups of medicines: tricyclic antidepressants, antipsychotics, baclofen, amifostine,
• potassium-sparing medicines or medicines that may increase potassium levels in the blood (e.g., potassium supplements, salt substitutes containing potassium, or certain diuretics [amiloride, triamterene, spironolactone] or heparin),
• non-steroidal anti-inflammatory drugs, such as indomethacin, including COX-2 inhibitors (medicines that reduce inflammation and are used to relieve pain), as they may weaken the blood pressure-lowering effect of losartan.

In the case of kidney function disorders, concurrent use of these medicines may lead to worsening of kidney function. Without close medical supervision, you should not take medicines containing lithium in combination with losartan. Special precautions may be necessary (e.g., blood tests).

Taking Xartan with food and drink

Xartan can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Pregnancy You should inform your doctor if you suspect (or plan) pregnancy. Your doctor will usually advise you to stop taking Xartan before planned pregnancy or as soon as possible after confirmation of pregnancy and will advise you to take another medicine instead of Xartan. It is not recommended to take Xartan during early pregnancy and it should not be taken after the third month of pregnancy, as it may seriously harm the baby. Breastfeeding You should inform your doctor if you are breastfeeding or planning to breastfeed. It is not recommended to take Xartan during breastfeeding, especially during breastfeeding of a newborn or premature baby. Your doctor may advise you to take another medicine. Before taking this medicine, you should consult your doctor or pharmacist.

Driving and using machines

No studies have been conducted on the effect on the ability to drive and use machines. It is unlikely that Xartan will affect this ability. However, as with many medicines used to treat high blood pressure, losartan may cause dizziness or drowsiness. If you experience dizziness or drowsiness, you should consult your doctor before performing such activities.

Xartan contains lactose

Xartan contains lactose monohydrate. If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking this medicine.

Xartan contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Xartan

Take this medicine always as directed by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist. Your doctor will determine the appropriate dose of Xartan, depending on your condition and the medicines you are taking. It is important to take Xartan for as long as your doctor has prescribed it to maintain constant blood pressure control. Adult patients with high blood pressure Treatment usually starts with a dose of 50 mg of losartan (one Xartan 50 mg tablet) once a day. The maximum blood pressure-lowering effect should occur 3 to 6 weeks after starting treatment. In some patients, the dose may then be increased to 100 mg of losartan (two Xartan 50 mg tablets) once a day. If you feel that the effect of losartan is too strong or too weak, you should consult your doctor or pharmacist. Use in children and adolescents (6 to 18 years) In patients with a body weight >20 kg to <50 kg who can swallow tablets, the recommended dose is 25 mg. (in exceptional cases, be increased to a maximum of 50 mg once day.) should adjusted according change in blood pressure values. patients with body weight>50 kg, the usual dose is 50 mg once a day. In exceptional cases, the dose can be increased to a maximum of 100 mg once a day. For children, another form of this medicine may be more suitable. You should consult your doctor or pharmacist. Adult patients with high blood pressure and type 2 diabetes Treatment usually starts with a dose of 50 mg of losartan (one Xartan 50 mg tablet) once a day. The dose may then be increased to 100 mg of losartan (two Xartan 50 mg tablets) once a day, depending on the change in blood pressure values. Losartan 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 that 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. This dose is usually increased gradually 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 is reached, as advised by your doctor. The maximum permissible dose is 150 mg of losartan (three Xartan 50 mg tablets) once a day, if it is well tolerated by the patient. In the treatment of heart failure, losartan is usually taken with diuretics (medicines that increase the amount of water excreted by the kidneys) and/or digitalis glycosides (medicines that strengthen and increase the efficiency of the heart) and/or beta-blockers. Reduction of the risk of stroke in patients with high blood pressure and left ventricular hypertrophy confirmed by ECG. The usual starting dose of losartan is 50 mg once a day. Depending on the change in blood pressure values, hydrochlorothiazide may be added in a low dose and/or the dose of losartan may be increased to 100 mg once a day.

Dosage in special patient groups

Your doctor may advise 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 should not be taken by patients with severe liver function disorders (see the section "When not to take Xartan").

Administration

Swallow the tablets with a glass of water. Try to take your daily dose of Xartan at the same time each day. It is important to continue taking Xartan unless your doctor advises you to stop.

Taking a higher dose of Xartan than recommended

If you have accidentally taken too many tablets, you should contact your doctor immediately. Symptoms of overdose are low blood pressure, rapid heartbeat, and possibly slow heartbeat.

Missing a dose of Xartan

If you miss a dose, take the next dose at the usual time. Do not take a double dose to make up for the missed dose. If you have any doubts about taking this medicine, you should consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Xartan can cause side effects, although not everybody gets them. If you experience any of the following side effects, stop taking losartan and consult your doctor or go to the emergency department of your nearest hospital immediately: Severe allergic reactions (rash, itching, swelling of the face, lips, tongue, or throat, which may cause difficulty in swallowing or breathing). This is a serious but rare side effect, occurring in more than 1 in 10,000 patients but less than 1 in 1,000 patients. Immediate medical attention or hospitalization may be necessary. The following side effects have been reported for Xartan:

• Frequent (may occur in up to 1 in 10 people):
• dizziness,
• low blood pressure (especially after excessive loss of water from the body, e.g., in patients with severe heart failure or those treated with high doses of diuretics),
• dose-dependent orthostatic symptoms, such as decreased blood pressure 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 levels of urea, creatinine, and potassium in the blood in patients with heart failure.

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

• drowsiness,
• headache,
• sleep disorders,
• palpitations (rapid or irregular heartbeat),
• 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 people):

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

Unknown frequency (cannot be estimated from the 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, hissing, or clicking in the ears (tinnitus),
• taste disorders.

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl. You can also report side effects 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 Xartan

Keep the medicine out of the sight and reach of children. Store the medicine in its original packaging. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month. 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 Xartan contains

• The active substance of Xartan is losartan potassium. Each tablet contains 50 mg of losartan potassium.
• The other ingredients are:

Core:
Lactose monohydrate
Microcrystalline cellulose
Croscarmellose sodium
Magnesium stearate
Coating:
Hypromellose
Lactose monohydrate
Titanium dioxide
Polyethylene glycol 3000
Triacetin
Iron oxide red (E 172)
Iron oxide yellow (E 172)

What Xartan looks like and contents of the pack

Xartan tablets are round, biconvex, with a score line on one side. Pack sizes: 10 film-coated tablets in a cardboard box, 30 film-coated tablets in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
tel.: +48 22 732 77 00

Manufacturer

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Date of last revision of the leaflet: