LORISTA

Patient Information Leaflet

Lorista, 25 mg, film-coated tablets
Lorista, 50 mg, film-coated tablets
Lorista, 100 mg, film-coated tablets
Losartanum kalicum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• 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. This medicine may harm other people, even if their symptoms are similar.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

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

1. What Lorista is and what it is used for

Lorista 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 blood vessel walls, causing them to constrict. This leads to increased blood pressure.
Losartan, the active substance in Lorista, prevents angiotensin II from binding to these receptors, resulting in blood vessel dilation and consequently lowering blood pressure.
Losartan slows down the deterioration of kidney function in patients with high blood pressure and type 2 diabetes.
Lorista 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, with 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 (ACE) inhibitors is not considered appropriate by the doctor. If heart failure has been stabilized using an ACE inhibitor, the medication should not be switched to losartan;
• in patients with high blood pressure and left ventricular hypertrophy, because it has been shown that Lorista reduces the risk of stroke ("LIFE indication").

2. Important information before using Lorista

When not to use Lorista
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• if the patient is allergic to losartan or any of the other ingredients of this medicine (listed in section 6),
• during the third month of pregnancy (use of Lorista should also be avoided in early pregnancy – see section "Pregnancy and breastfeeding"),
• if the patient has 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 treatment with Lorista, discuss this with your doctor or pharmacist. Inform your doctor if you suspect (or are planning) pregnancy. Use of Lorista is not recommended during early pregnancy and must be avoided after the third month of pregnancy, as it may seriously harm the unborn child (see section "Pregnancy and breastfeeding"). It is important to inform your doctor before using Lorista:

• 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 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, which may lead 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 a kidney transplant,
• if the patient has liver function disorders (see sections 2 "When not to use Lorista" and 3 "Dosage in special patient groups"),
• if the patient has heart failure, with or without kidney problems, or severe, life-threatening cardiac arrhythmia. Particular caution is required when treating concomitantly with β-blockers,
• if the patient has heart valve or myocardial disorders,
• if the patient has ischemic heart disease (caused by reduced blood flow in the coronary blood vessels) or cerebrovascular disorders (caused by reduced blood circulation in the brain),
• if the patient has primary hyperaldosteronism (a syndrome caused by excessive aldosterone secretion from the adrenal glands due to adrenal abnormalities),
• if the patient is taking other medicines that may increase serum potassium levels (see section 2 "Lorista with other medicines"),
• if the patient is taking any of the following medicines used to treat high blood pressure:
• angiotensin-converting enzyme (ACE) inhibitors (e.g. enalapril, lisinopril, ramipril), particularly if the patient has kidney problems related to diabetes,
• aliskiren.

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

Children and adolescents
Studies on the use of losartan in children have been conducted. For additional information, please consult your doctor.
Losartan is not recommended for use in children and adolescents with kidney or liver function disorders due to limited data available for these patient groups. Losartan is not recommended for use in children under 6 years of age, as efficacy has not been demonstrated in this age group.
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Lorista with other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Inform your doctor if the patient is taking potassium supplements, salt substitutes containing potassium, 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 Lorista is not recommended.
Exercise particular caution when using the following medicines during treatment with Lorista:

• other medicines that lower blood pressure, as they may additionally reduce blood pressure. The following medicines/groups of medicines may also reduce blood pressure: tricyclic antidepressants, antipsychotics, baclofen, amifostine,
• 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.

Concomitant use of lithium-containing medicines with losartan should not be undertaken without strict medical supervision. Special precautions (e.g. periodic blood tests) may be necessary. Your doctor may need to adjust the dose and/or take other precautionary measures:

• if the patient is taking an ACE inhibitor or aliskiren (see also information under the headings "When not to use Lorista" and "Warnings and precautions").

Taking Lorista with food and drink
Lorista may be taken independently of meals. Grapefruit juice should be avoided during treatment with Lorista.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Inform your doctor if you suspect (or are planning) pregnancy. Your doctor will usually recommend discontinuing Lorista before planned pregnancy or immediately after pregnancy is confirmed and will recommend an alternative medicine. Use of Lorista is not recommended during early pregnancy and must be avoided after the third 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 Lorista is not recommended during breastfeeding, especially when breastfeeding a newborn or premature infant. Your doctor may recommend an alternative medicine.

Driving and operating machinery
No studies on the effect on the ability to drive and operate machinery have been performed. It is unlikely that Lorista affects the ability to drive and operate machinery. However, as with many medicines used to treat high blood pressure, losartan may cause dizziness or
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drowsiness in some individuals. If dizziness or drowsiness occurs, consult your doctor before engaging in such activities.

Lorista contains lactose monohydrate
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

3. How to use Lorista

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

Adult patients with high blood pressure
Treatment usually starts with a dose of 50 mg losartan (one tablet of Lorista 50 mg) once
daily. The maximum blood pressure-lowering effect should occur within 3 to 6 weeks after
starting treatment. In some patients, the dose may then be increased to 100 mg
losartan (two tablets of Lorista 50 mg) 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
Children under 6 years of age
Lorista is not recommended for use in children under 6 years of age, as its efficacy has not been demonstrated in this age group.

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

Adult patients with high blood pressure and type 2 diabetes
Treatment usually starts with a dose of 50 mg losartan (one tablet of Lorista 50 mg) once
daily. The dose may then be increased to 100 mg losartan (two tablets of Lorista 50
mg) once daily, depending on the blood pressure response achieved.
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. sulfonylureas, glitazones, and alpha-glucosidase inhibitors).

Adult patients with heart failure
Treatment usually starts with a dose of 12.5 mg losartan (half a tablet of Lorista 25 mg) once
daily. This dose should usually 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 dose of 150 mg losartan (e.g. three tablets of Lorista 50 mg or one tablet of Lorista 100 mg and one tablet of Lorista 50 mg) once daily may be used.

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.

Dosage in special patient groups
Your doctor may recommend a lower dose, especially when starting 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 Lorista").

Method of administration
Tablets should be swallowed with a glass of water. Try to take your daily dose at the same time each day. It is important to continue taking Lorista for as long as your doctor has instructed.

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

Missed dose of Lorista
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 further questions about the use of this medicine, consult your doctor or pharmacist.
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4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur, discontinue losartan immediately and consult a doctor or go to the emergency department of the nearest hospital:
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, but rare adverse reaction, occurring in more than 1 in 10,000 patients, but less than 1 in 1,000 patients. Immediate medical treatment or hospitalization may be required.
The following adverse reactions have been reported with losartan:
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 glucose levels (hypoglycaemia),
• high potassium levels in the blood (hyperkalaemia),
• changes in kidney function, including kidney failure,
• reduced number of red blood cells (anaemia),

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• increased levels of blood urea, creatinine and serum potassium in patients with heart failure. Uncommon (may affect up to 1 in 100 people):
• drowsiness,
• headache,
• sleep disorders,
• sensation of rapid heartbeat (palpitations),
• severe chest pain (angina),
• shortness of breath (dyspnoea),
• abdominal pain,
• constipation,
• diarrhoea,
• nausea,
• vomiting,
• urticaria,
• itching,
• rash,
• localised swelling,
• cough. Rare (may affect up to 1 in 1,000 people):
• hypersensitivity reactions,
• angioedema,
• vasculitis (including Henoch-Schönlein purpura),
• sensation of numbness or tingling (paraesthesiae),
• fainting,
• very fast and irregular heartbeat (atrial fibrillation),
• stroke,
• hepatitis,
• increased alanine aminotransferase (AlAT) activity in blood, usually resolving after discontinuation of treatment. Frequency not known (frequency cannot be estimated from available data):
• reduced number of platelets (thrombocytopenia),
• migraine,
• liver function disorders,
• joint and muscle pain,
• influenza-like symptoms,
• back pain and urinary tract infections,
• increased sensitivity to sunlight,
• unexplained muscle pain and dark (tea-coloured) urine (rhabdomyolysis),
• impotence,
• pancreatitis,
• low sodium levels in blood (hyponatraemia),
• depression,
• general malaise,
• ringing, buzzing, humming or pulsating sounds in the ears (tinnitus),
• taste disturbances. Adverse reactions occurring in children are similar to those observed 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 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:

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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.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Lorista

Keep this medicine out of sight and reach of children.
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.
Store below 30°C, in the original packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Lorista contains

• The active substance is losartan potassium. Each film-coated tablet contains 25 mg, 50 mg, or 100 mg of losartan potassium.
• Other components are:
  Lorista 25 mg, film-coated tablets: corn starch, pregelatinized corn starch, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, cellactose (monohydrate lactose and cellulose);
  coating: hypromellose, talc, propylene glycol, titanium dioxide (E 171), quinoline yellow (E 104).
  Lorista 50 mg, film-coated tablets: corn starch, pregelatinized starch, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, cellactose (monohydrate lactose and cellulose);
  coating: hypromellose, talc, propylene glycol, titanium dioxide (E 171).
  Lorista 100 mg, film-coated tablets: corn starch, pregelatinized corn starch, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, cellactose (monohydrate lactose and cellulose);
  coating: hypromellose, talc, propylene glycol, titanium dioxide (E 171).
  See section 2 "Lorista contains monohydrate lactose".

What Lorista looks like and contents of the pack

Lorista 25 mg: Yellow, oval, slightly biconvex film-coated tablets with a dividing groove on one side. The tablet can be divided into equal doses.

Lorista 50 mg: White, round, slightly biconvex film-coated tablets with bevelled edges and a dividing groove on one side. The dividing line is not intended for breaking the tablet.

Lorista 100 mg: White, oval, slightly biconvex film-coated tablets.

Pack sizes

Lorista 25 mg: 28 or 56 film-coated tablets in blisters, packed in a cardboard box.
Lorista 50 mg, 100 mg: 28, 56, or 84 film-coated tablets in blisters, packed in a cardboard box.

Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

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Manufacturer/Importer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany (only for Lorista 50 mg)
KRKA-POLSKA Sp. z o.o., ul. Równoległa 5, 02-235 Warsaw, Poland (only for Lorista 50 mg and 100 mg)

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Tel. 22 57 37 500
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