LOREBLOK 50 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Loreblok, 50 mg, Film-Coated Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for you.
   2. Table of Contents of the Package Leaflet
3. What is Loreblok and what is it used for
4. Important information before taking Loreblok
   1. When not to take Loreblok:
   2. Warnings and precautions
   3. Children and adolescents
   4. Loreblok with other medicines
   5. Loreblok with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Loreblok contains lactose
5. How to take Loreblok
   1. Dosage in special patient groups
   2. Administration
   3. Overdose of Loreblok
   4. Missed dose of Loreblok
6. Possible side effects
   1. Reporting side effects
7. How to store Loreblok
8. Contents of the pack and other information
   1. What Loreblok contains
   2. What Loreblok looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. This medicinal product is authorized in the Member States of the EEA under the following names:

Package Leaflet: Information for the User

Loreblok, 50 mg, Film-Coated Tablets

Losartan Potassium

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

• 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, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Loreblok and what is it used for

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 results in an increase in blood pressure. Losartan prevents angiotensin II from binding to these receptors, causing blood vessels to widen, which in turn lowers blood pressure. Losartan also slows the progression of kidney disease in patients with high blood pressure and type 2 diabetes.

Loreblok is used:

• to treat high blood pressure (hypertension),
• to protect the kidneys in patients with high blood pressure and type 2 diabetes, with laboratory-confirmed kidney dysfunction and proteinuria ≥ 0.5 g/day (a condition where the urine contains an excessive amount of protein),
• to treat patients with chronic heart failure, if treatment with medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors, medicines used to lower high blood pressure) is not considered suitable 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 thickening of the left ventricular wall, losartan has been shown to reduce the risk of stroke (the "LIFE indication").

2. Important information before taking Loreblok

When not to take Loreblok:

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

Warnings and precautions

Before taking Loreblok, discuss with your doctor or pharmacist:

• if you have ever had angioedema (sudden swelling of the face, lips, throat, and/or tongue) (see also section 4),
• if you have severe vomiting or diarrhea leading to excessive loss of fluids and/or electrolytes,
• if you are taking diuretics (medicines that increase the amount of water excreted by the kidneys) or are on a low-salt diet, which can lead to excessive loss of fluids and/or electrolytes (see section 3 "Dosage in special patient groups"),
• if you have narrowing or blockage of the blood vessels supplying the kidneys or have recently had a kidney transplant,
• if you have liver dysfunction (see sections 2 "Do not take Loreblok" and 3 "Dosage in special patient groups"),
• if you have heart failure with kidney dysfunction or without kidney dysfunction, or if you have severe, life-threatening heart rhythm disorders. Special caution is required when taking beta-blockers concomitantly,
• if you have valve problems or heart muscle problems,
• if you have coronary heart disease (caused by reduced blood flow in the coronary arteries) or cerebrovascular disorders (caused by reduced blood flow in the brain),
• if you have primary hyperaldosteronism (a condition caused by excessive production of aldosterone hormone by the adrenal glands, due to abnormalities in the adrenal glands),
• if you are taking any of the following medicines used to treat high blood pressure:
• an ACE inhibitor (e.g., enalapril, lisinopril, ramipril), especially if you have kidney dysfunction associated with diabetes,
• aliskiren.

Your doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood.

See also the subsection "Do not take Loreblok".

You should inform your doctor if you suspect or plan to become pregnant. It is not recommended to take Loreblok during the early stages of pregnancy and it should not be taken after the third month of pregnancy, as it may cause serious harm to the baby (see section "Pregnancy and breastfeeding").

Children and adolescents

Studies have been conducted on the use of losartan in children. For more information, please consult your doctor. Losartan is not recommended for children with kidney or liver dysfunction, as data on its use in these patient groups are limited. Losartan is not recommended for children under 6 years of age, as its efficacy has not been demonstrated in this age group.

Loreblok with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take.

• if you are taking an ACE inhibitor or aliskiren (see also subsections "Do not take Loreblok" and "Warnings and precautions").

Special caution is required when taking the following medicines during treatment with Loreblok:

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

In the case of kidney dysfunction, concomitant 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).

Loreblok with food and drink

Loreblok 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.

Your doctor will usually recommend stopping Loreblok before planned pregnancy and will advise you to take a different medicine instead of Loreblok. It is not recommended to take Loreblok during the early stages of pregnancy and it should not be taken after the third month of pregnancy, as it may cause serious harm to the baby.

You should inform your doctor if you are breastfeeding or plan to breastfeed. It is not recommended to take Loreblok during breastfeeding, especially during breastfeeding of a newborn or premature baby. Your doctor may recommend a different medicine.

Driving and using machines

No studies have been conducted on the effects of Loreblok on the ability to drive or operate machinery.

It is unlikely that Loreblok will affect your ability to drive or operate machinery. However, as with many other blood pressure-lowering medicines, losartan may cause dizziness or drowsiness in some people.

If you experience dizziness or drowsiness, consult your doctor before performing such activities.

Loreblok contains lactose

Loreblok contains 102 mg of lactose in 50 mg tablets. If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Loreblok

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Your doctor will determine the appropriate dose of Loreblok, depending on your condition and the other medicines you are taking. It is important to continue taking Loreblok for as long as your doctor has prescribed it in order to maintain consistent blood pressure control.

The recommended dose is:

Patients with high blood pressure

Treatment usually starts with a dose of 50 mg of losartan (one 50 mg tablet) once daily. The maximum blood pressure-lowering effect should occur within 3 to 6 weeks after starting treatment. In some patients, the doctor may then increase the dose to 100 mg of losartan once daily.

If you feel that the effect of losartan is too strong or too weak, consult your doctor or pharmacist.

Patients with high blood pressure and type 2 diabetes

Treatment usually starts with a dose of 50 mg of losartan (one 50 mg tablet) once daily. The doctor may then increase the dose to 100 mg of losartan once daily, depending on the patient's blood pressure changes.

Loreblok 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 glucose levels (e.g., sulfonylurea derivatives, glitazones, and glucose inhibitors).

Patients with heart failure

Treatment usually starts with a dose of 12.5 mg of losartan once daily.

Usually, the doctor will 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) until the usual maintenance dose of 50 mg of losartan (one 50 mg tablet) once daily is reached, depending on the patient's condition.

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 and increase its efficiency) and/or beta-blockers.

Dosage in special patient groups

The doctor may recommend a lower dose, especially during the initial treatment phase, in certain patients, such as those taking high doses of diuretics, patients with liver dysfunction, or patients over 75 years of age. Losartan should not be taken by patients with severe liver dysfunction (see section "Do not take Loreblok").

Administration

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

Overdose of Loreblok

If you have taken more than the prescribed dose of Loreblok or if a child has accidentally taken the medicine, contact your doctor or go to the emergency department of the nearest hospital immediately. Symptoms of overdose are low blood pressure, rapid heartbeat, and possibly slow heartbeat.

Missed dose of Loreblok

If you miss a dose, take the next dose at the usual time. Do not take a double dose to make up for a forgotten tablet.

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

4. Possible side effects

Like all medicines, Loreblok can cause side effects, although not everybody gets them.

If you experience any of the following side effects, stop taking Loreblok and consult your doctor or go to the emergency department of the nearest hospital immediately:

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 but rare side effect, occurring in more than 1 in 10,000 patients but less than 1 in 1,000 patients. Emergency medical attention or hospitalization may be necessary.

The following side effects have been reported for losartan:

Common (occurring in less than 1 in 10 people):

• central nervous system dizziness, vertigo,
• low blood pressure, which may cause dizziness when standing up,
• weakness,
• fatigue,
• low blood sugar (hypoglycemia),
• high potassium levels in the blood (hyperkalemia),
• increased levels of urea, creatinine, and potassium in the blood in patients with heart failure,
• reduced red blood cell count (anemia),
• kidney dysfunction, kidney failure.

Uncommon (occurring in less than 1 in 100 people):

• drowsiness,
• headache,
• sleep disturbances,
• palpitations (feeling of rapid or irregular heartbeat),
• severe chest pain (angina pectoris),
• shortness of breath,
• cough,
• abdominal pain,
• constipation,
• diarrhea,
• nausea,
• vomiting,
• localized swelling,
• hives (elevated, red, itchy patches on the skin),
• itching of the skin,
• rash.

Rare (occurring in less than 1 in 1,000 people):

• vasculitis (including Henoch-Schönlein purpura),
• numbness or tingling (paresthesia),
• irregular heartbeat (atrial fibrillation), stroke,
• hepatitis,
• increased alanine aminotransferase (ALT) activity in the blood (a liver function test), usually resolving after discontinuation of treatment,
• hypersensitivity,
• fainting (loss of consciousness),
• angioedema,
• allergic reactions (anaphylactic reactions).

Unknown (frequency cannot be estimated from the available data):

• ringing, buzzing, or other persistent noises in the ears (tinnitus),
• pancreatitis,
• general feeling of being unwell,
• urinary tract infections,
• rash,
• photosensitivity reactions,
• erectile dysfunction/impotence,
• depression,
• reduced platelet count,
• migraine,
• liver dysfunction,
• muscle or joint pain,
• serious muscle damage, which can cause muscle pain and dark-colored urine, leading to kidney failure (rhabdomyolysis),
• flu-like symptoms,
• low sodium levels in the blood (hyponatremia),
• back pain,
• taste disturbances.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. 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 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301,

Fax: +48 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 Loreblok

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the outer packaging and blister.

The expiry date refers to the last day of the month.

There are no special storage precautions for this medicine.

Medicines should 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. Contents of the pack and other information

What Loreblok contains

• The active substance is losartan potassium. Each film-coated tablet contains 50 mg of losartan potassium.
• The other ingredients are: core - microcrystalline cellulose, lactose anhydrous, maize starch, magnesium stearate, talc, colloidal anhydrous silica, coating - hypromellose (6 cPs), hydroxypropylcellulose, and titanium dioxide (E171).

What Loreblok looks like and contents of the pack

White, oval, biconvex film-coated tablets with a score line on both sides.

Dimensions: approximately 5.5 x 10.5 mm. The tablet can be divided into equal doses.

Package sizes: 28 or 98 film-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Manufacturer

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Orion Corporation Orion Pharma

Joensuunkatu 7

FI-24100 Salo

Finland