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 pass it on to others. It may harm them, even if their symptoms are similar.
• If you experience any side 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 the walls of blood vessels, causing them to narrow. This leads to increased blood pressure.
Losartan, the active substance in Lorista, prevents angiotensin II from binding to these receptors, resulting in the dilation of blood vessels and consequently lowering blood pressure.
Losartan slows the progression of kidney damage in patients with high blood pressure and type 2 diabetes.
Lorista is used:

• for the treatment of high blood pressure (hypertension) in adults, as well as 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);
• in the treatment of patients with chronic heart failure when treatment with certain medicines known as angiotensin-converting enzyme inhibitors (ACE inhibitors, drugs used to reduce high blood pressure) is not considered appropriate by the physician. If heart failure has been stabilized with an ACE inhibitor, the treatment should not be switched to losartan;
• in patients with high blood pressure and left ventricular hypertrophy (thickening of the wall of the left ventricle of the heart), 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 (Lorista should also be avoided in early pregnancy – see section "Pregnancy and breastfeeding"),
• if the patient has severe liver dysfunction,
• 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 are pregnant or suspect you may be pregnant, or if you 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:

• 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 fluid and/or salt loss 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 fluid and salt loss (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 dysfunction (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 disorders or myocardial disease,
• if the patient has ischaemic heart disease (caused by reduced blood flow in the coronary vessels) or cerebrovascular disorders (caused by reduced blood flow to 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 blood 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 dysfunction due to limited data available in 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 and other medicines
Tell 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 about 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 cause an additional decrease in 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 reduce 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 lithium-containing medicines concomitantly with losartan without strict medical supervision. Special precautions may be necessary (e.g. periodic blood tests). 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 is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Inform your doctor if you are pregnant, suspect pregnancy, or are planning pregnancy. Your doctor will usually recommend discontinuing treatment with 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 newborns or premature infants. Your doctor may recommend an alternative medicine.

Driving and operating machinery
No studies on the effects on the ability to drive and operate machinery have been conducted. 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 drowsiness in some individuals. If dizziness or drowsiness occurs, consult your doctor before engaging in such activities.

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

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Your doctor will determine the appropriate dose of Lorista depending on your condition and other
medicines you are taking. It is important to take Lorista for as long as your doctor recommends, 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 starting 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.

Losartan may be used together 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 the heart, increase the force of cardiac 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, those with impaired liver function, or those aged over 75
years. Losartan should not be used in patients with severe liver impairment (see section "When not
to take 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.

If you miss a 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
the 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 use 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 intervention 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 a lying or sitting position,
• weakness,
• fatigue,
• low blood glucose levels (hypoglycaemia),
• high potassium levels in 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 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,
• rash,
• localised swelling,
• cough. Rare (may occur in up to 1 in 1,000 patients):
• hypersensitivity reactions,
• angioedema,
• vasculitis (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. Frequency not known (frequency cannot be estimated from available data):
• reduced platelet count (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 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 the medicine Lorista

Keep this medicine out of the 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 in use. This will help protect the environment.

6. Package Contents and Other Information

What Lorista contains

• The active substance is losartan potassium. Each coated tablet contains 25 mg, 50 mg, or 100 mg of losartan potassium.
• The other ingredients are:
  Lorista 25 mg, 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, 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, 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 convex coated tablets with a division groove on one side. The tablet can be divided into equal doses.
Lorista 50 mg: White, round, biconvex coated tablets with bevelled edges and a division groove on one side. The division line on the tablet is not intended for breaking the tablet.
Lorista 100 mg: White, oval, slightly convex coated tablets.

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