Xartan

Package leaflet: Information for the user

XARTAN, 50 mg, coated tablets
Losartanum kalicum
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Xartan is and what it is used for
2. What you need to know 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 Xartan is and what it is used for

Xartan belongs to a group of medicines known as 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 leads to an increase in blood pressure. Losartan prevents angiotensin II from binding to these receptors,
resulting in the widening of blood vessels and consequently lowering blood pressure. Losartan slows down
the worsening of kidney function in patients with high blood pressure and type 2 diabetes.
Xartan 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, who have laboratory-confirmed kidney dysfunction and proteinuria ≥ 0.5 g per day (a condition in which the urine contains an abnormal amount of protein).
• for the treatment of patients with chronic heart failure when treatment with certain medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors, medicines used to reduce 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 ("LIFE indication").

2. Important information before using Xartan

When not to use Xartan:

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

Warnings and precautions
Before starting treatment with Xartan, discuss this with your doctor or pharmacist.
If the patient experiences abdominal pain, nausea, vomiting, or diarrhoea after taking Xartan, this should be discussed with the doctor. The doctor will decide whether treatment should continue. Do not make your own decision to stop taking Xartan.
Inform your doctor if you suspect (or are planning) pregnancy. Use of Xartan is not recommended during early pregnancy and must not be used after the 3rd month of pregnancy, as it may harm the unborn child (see section "Pregnancy").
It is important to inform your doctor before using Xartan:

• 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 diarrhoea leading to excessive loss of fluids and/or salts from the body,
• if the patient is 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 salts from the body (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 kidney transplantation,
• if the patient has liver function impairment (see sections 2 "When not to use Xartan" and 3 "Dosage in special patient groups"),
• if the patient has heart failure with or without kidney function impairment, or has severe, life-threatening cardiac arrhythmias. Particular caution is required when treating concomitantly with β-blockers,
• if the patient has heart valve or heart muscle disorders,
• if the patient has ischaemic heart disease (caused by reduced blood flow in the blood vessels of the heart) or cerebrovascular disorders (caused by reduced blood circulation in the brain),
• if the patient has primary hyperaldosteronism (a syndrome caused by increased secretion of the hormone aldosterone by the adrenal glands due to adrenal gland abnormalities),
• if the patient is taking any of the following medicines used to treat high blood pressure:
• an angiotensin-converting enzyme (ACE) inhibitor (e.g. enalapril, lisinopril, ramipril), particularly if the patient has kidney function impairment 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 Xartan".
Children and adolescents
Studies on the use of losartan in children have been conducted. For additional information, please consult your doctor. Xartan is not recommended for use in children and adolescents with kidney or liver function impairment, or in children under 6 years of age due to limited data available for these patient groups.
Xartan with other medicines
Tell your doctor or pharmacist about any other medicines the patient is currently taking, has recently taken, or might take in the future.
The treating doctor may need to adjust the dose and/or take other precautions:
If the patient is taking an ACE inhibitor or aliskiren (see also information under the headings "When not to use Xartan" and "Warnings and precautions").
Exercise particular caution when using the following medicines during treatment with Xartan:

• other medicines that lower blood pressure, as this may lead to additional reduction in blood pressure. The following medicines/groups of medicines may also reduce blood pressure: tricyclic antidepressants, antipsychotics, baclofen, amifostine,
• potassium-sparing medicines or medicines that may increase blood potassium levels (e.g. potassium supplements, potassium-containing salt substitutes, or potassium-sparing diuretics such as certain diuretics [amiloride, triamterene, spironolactone] or heparin),
• non-steroidal anti-inflammatory drugs (NSAIDs), 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 patients with impaired kidney function, concomitant use of these medicines may lead to worsening of kidney function.
Do not use medicines containing lithium in combination with losartan without strict medical supervision. Special precautions (e.g. blood tests) may be necessary.
Taking Xartan with food and drink
Xartan may be taken regardless of meals.
Pregnancy and breastfeeding
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 suspect (or are planning) pregnancy. The doctor will usually recommend discontinuing Xartan before planned pregnancy or immediately after pregnancy is confirmed, and will recommend an alternative medicine instead of Xartan. Use of Xartan is not recommended during early weeks of pregnancy and must not be used after the 3rd month of pregnancy, as it may seriously harm the unborn child.
Breastfeeding
Inform your doctor if you are breastfeeding or intend to breastfeed. Use of Xartan is not recommended during breastfeeding, especially when breastfeeding a newborn or preterm infant. The doctor may recommend using another medicine.
Consult your doctor or pharmacist before using this medicine.
Driving and operating machinery
No studies on the effect on the ability to drive and operate machinery have been conducted. It is unlikely that Xartan affects this ability. However, as with many medicines used to treat high blood pressure, losartan may cause dizziness or drowsiness in some people. If dizziness or drowsiness occurs, consult your doctor before engaging in such activities.
Xartan contains lactose
Xartan contains lactose monohydrate. If the patient has been previously diagnosed with an intolerance to certain sugars, the patient should consult their doctor before taking this medicine.
Xartan contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Xartan

This medicine should always be used as directed by your doctor or pharmacist. If you are in any doubt,
you should consult your doctor or pharmacist.
Your doctor will determine the appropriate dose of Xartan based on your condition and any other
medicines you are taking. It is important to continue using Xartan for as long as your doctor has
recommended 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 Xartan 50 mg tablet) once daily. The full
blood pressure-lowering effect should be achieved within 3 to 6 weeks after starting treatment. In some
patients, the dose may subsequently be increased to 100 mg losartan (two Xartan 50 mg tablets) once
daily. If you feel that the effect of losartan is too strong or too weak, consult your doctor or pharmacist.

Use in children and adolescents (6 to 18 years)
For patients with body weight (b.w.) >20 kg to <50 kg who are able to swallow tablets, the recommended
dose is 25 mg. (In exceptional cases, the dose may be increased up to a maximum of 50 mg once
daily.) The dose should be adjusted according to the observed change in arterial blood pressure.
For patients with body weight >50 kg, the usual dose is 50 mg once daily.
In exceptional cases, the dose may be increased up to a maximum of 100 mg once daily.
Another formulation of this medicine may be more suitable for children. Please consult your doctor or
pharmacist.

Adult patients with high blood pressure and type 2 diabetes
Treatment usually starts with a dose of 50 mg losartan (one Xartan 50 mg tablet) once daily. The dose
may then be increased to 100 mg losartan (two Xartan 50 mg tablets) once daily, depending on the
observed change in arterial blood pressure.

Tablets containing losartan may be used concomitantly with other antihypertensive medicines (e.g.
diuretics, calcium channel blockers, 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. This dose should generally be
gradually increased 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, 150 mg daily
during the fifth week), until the maintenance dose is reached, as directed by your doctor. A maximum
daily dose of 150 mg losartan (three Xartan tablets) once daily may be used if tolerated by the patient.

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) digitalis glycosides (medicines that
strengthen, increase the force of heart contractions and improve heart function) and (or) beta-blockers.

Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy confirmed by ECG
The usual initial dose of losartan is 50 mg once daily. Depending on the observed change in arterial
blood pressure, a low dose of hydrochlorothiazide should be added and (or) the losartan dose
increased to 100 mg once daily.

Dosage in specific patient groups
Your doctor may recommend a lower dose, especially at the start of treatment, in certain patients such
as those taking high-dose diuretics, patients with impaired liver function, or patients over 75 years of
age. Losartan should not be used in patients with severe liver impairment (see section “When not to
use Xartan”).

Administration
The tablets should be swallowed with a glass of water. You should try to take the daily dose at the
same time each day. It is important to continue taking Xartan unless your doctor advises otherwise.

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

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If any of the following adverse reactions occur, losartan should be discontinued immediately
and you should consult a doctor immediately or go to the nearest hospital emergency department:
Severe allergic reactions (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 more than 1 in 10,000
patients, but less than 1 in 1,000 patients. Immediate medical intervention or hospitalization may be required.

The following adverse reactions have been reported for the medicine Xartan:

Common (may affect up to 1 in 10 people):

• 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 a 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, serum creatinine and potassium levels in patients with heart failure.

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

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

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

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

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 (photosensitivity),
• unexplained muscle pain with dark (tea-coloured) urine (rhabdomyolysis),
• impotence,
• pancreatitis,
• low sodium levels in blood (hyponatraemia),
• depression,
• general malaise,
• ringing, buzzing, humming or crackling sounds in the ears (tinnitus),
• taste disturbances.

Adverse reactions occurring in children are similar to those described in adults.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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 may also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store the medicine Xartan

Keep the medicine out of 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Xartan contains

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

Core:
Monohydrate lactose
Microcrystalline cellulose
Carboxymethyl starch
Magnesium stearate
Coating:
Hypromellose
Monohydrate lactose
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 break line on one side.
Pack sizes:
Pack of 10 coated tablets in a cardboard box
Pack of 30 coated tablets in a cardboard box
Not all pack sizes may be marketed.

Marketing Authorisation 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