Loreblok

Patient Information Leaflet: Instructions for the User

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

• Keep this leaflet so that you can read it again if necessary.
• If you have any 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 other people, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

1. What Loreblok is and what it is 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 Loreblok is and what it is used for

Losartan 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 prevents angiotensin II from binding to these receptors, resulting in blood vessel dilation and consequently lowering blood pressure. Losartan slows the progression of kidney damage in patients with high blood pressure and type 2 diabetes.
Loreblok is used:

• for the treatment of high blood pressure (hypertension),
• to protect the kidneys in patients with hypertension and type 2 diabetes, with laboratory-confirmed kidney dysfunction and proteinuria ≥ 0.5 g per day (a condition in which the urine contains excessive amounts of protein),
• for the treatment of patients with chronic heart failure when treatment with medicines known as angiotensin-converting enzyme (ACE) inhibitors (medicines used to reduce high blood pressure) is not considered appropriate by the physician. 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, losartan has been shown to reduce the risk of stroke ("LIFE indication").

2. Important information before using the medicine Loreblok

When not to use Loreblok:

• 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 during early pregnancy should also be avoided – see section "Pregnancy and breastfeeding"),
• if the patient has diabetes or kidney function impairment and is being treated with an antihypertensive medicine containing aliskiren.

Warnings and precautions
Before starting treatment with Loreblok, discuss this with your doctor or pharmacist:

• if the patient has ever experienced angioedema (sudden swelling of the face, lips, throat, and/or tongue) (see also section 4),
• if the patient suffers from severe vomiting or diarrhoea leading to excessive fluid and/or salt loss from the body,
• if the patient is taking diuretics (medicines increasing the amount of water excreted by the kidneys) or a low-salt diet, resulting in excessive fluid and/or salt loss from the body (see section 3 “Dosage in special patient populations”),
• if the patient has narrowing or blockage of the blood vessels supplying the kidneys or has recently undergone kidney transplantation,
• if the patient has liver function impairment (see sections 2 "When not to use Loreblok" and 3 “Dosage in special patient populations”),
• 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 disorders or myocardial disease,
• if the patient has ischaemic heart disease (caused by reduced blood flow in the coronary blood vessels) or cerebrovascular disorders (caused by reduced blood flow to the brain),
• if the patient has primary hyperaldosteronism (a syndrome caused by increased secretion of the hormone aldosterone by the adrenal glands due to abnormalities of the adrenal glands),
• if the patient is taking any of the following medicines used to treat high blood pressure:
• an ACE inhibitor (e.g. enalapril, lisinopril, ramipril), especially if the patient has kidney problems related to diabetes,
• aliskiren.

The treating physician may recommend regular monitoring of kidney function, blood pressure, and
blood electrolyte levels (e.g. potassium).
See also the subsection “When not to use Loreblok”.
Inform your doctor if you suspect (or are planning) pregnancy. Use of Loreblok is not recommended during early pregnancy and must be avoided after the 3rd month of pregnancy, as it may cause serious harm to the unborn child (see section “Pregnancy and breastfeeding”).
Children and adolescents
Studies on the use of losartan in children have been conducted. For additional information, please consult your doctor. Use of losartan is not recommended in children with impaired kidney or liver function due to limited data in these patient groups. Use of losartan is not recommended in children under 6 years of age, as efficacy has not been demonstrated in this age group.
Loreblok and other medicines
Tell your doctor or pharmacist about any medicines you are currently taking, have recently taken, or plan to take.
The treating physician may recommend adjusting the dose and/or taking additional precautions:

• if the patient is taking an ACE inhibitor or aliskiren (see also subsections “When not to use Loreblok” and “Warnings and precautions”).

Exercise particular caution when using the following medicines during treatment with Loreblok:

• other medicines that lower blood pressure, as they may further reduce the patient's blood pressure. Blood pressure may also be lowered by the following medicines/groups of medicines: tricyclic antidepressants, antipsychotics, baclofen, amifostine,
• potassium-sparing medicines or those that may increase blood potassium levels (e.g. potassium supplements, potassium-containing salt substitutes, or potassium-sparing diuretics such as amiloride, triamterene, spironolactone, or heparin),
• non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or acetylsalicylic acid, 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 lithium-containing medicines concomitantly with losartan without strict medical supervision.
Special precautions (e.g. blood tests) may be necessary.
Loreblok with food and drink
Loreblok may be taken with or without food.
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.
The doctor will usually advise stopping treatment with Loreblok before a planned pregnancy or immediately after pregnancy is confirmed, and will recommend an alternative medicine. Use of Loreblok is not recommended during early pregnancy and is contraindicated after the 3rd month of pregnancy, as it may cause serious harm to the unborn child.
Inform your doctor if you are breastfeeding or intend to breastfeed. Use of Loreblok is not recommended during breastfeeding, especially when breastfeeding a newborn or preterm infant. The doctor may recommend an alternative medicine.
Driving and operating machinery
No studies have been conducted on the effect of Loreblok on the ability to drive or operate machinery.
It is unlikely that Loreblok affects the ability to drive or operate machinery. However, as with many other medicines used to lower blood pressure, losartan may cause dizziness or drowsiness in some individuals.
If dizziness or drowsiness occurs, consult your doctor before engaging in such activities.
Loreblok contains lactose
Loreblok contains 102 mg of lactose per 50 mg tablet. If the patient has been diagnosed with an intolerance to certain sugars, consult a doctor before starting this medicine.

3. How to use Loreblok

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

Recommended dose:
Patients with high blood pressure
Treatment usually starts with a dose of 50 mg 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, your doctor may then increase the dose to 100 mg 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 losartan (one 50 mg tablet) once daily. Your doctor may then increase the dose to 100 mg losartan once daily, depending on changes in your blood pressure.

Loreblok may be used together with other antihypertensive medicines (e.g. diuretics, calcium antagonists, 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).

Patients with heart failure
Treatment usually starts with a dose of 12.5 mg losartan once daily.
Your doctor will usually increase the dose gradually 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 reaching the usual maintenance dose of 50 mg losartan (one 50 mg tablet) once daily, depending on your 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) cardiac glycosides (medicines that strengthen the heart and improve its function) and (or) beta-blockers.

Dosing 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 must not be used in patients with severe impairment of liver function (see section "When not to use Loreblok").

Administration
Tablets should be swallowed with a glass of water. Try to take the daily dose at the same time each day. It is important to continue taking Loreblok unless your doctor advises otherwise.

Overdose of Loreblok
If you take more than the recommended dose or if a child accidentally takes the medicine, contact your doctor immediately or go to the nearest hospital emergency department. Symptoms of overdose may include low blood pressure, rapid heartbeat, or possibly slow heartbeat.

Missed dose of Loreblok
If you accidentally miss a daily dose, take the next dose at your usual time. Do not take a double dose to make up for the missed tablet.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
If any of the following adverse effects occur, stop taking the
Loreblok and immediately consult a doctor or go to the emergency department of the
nearest hospital:
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, although rare, adverse effect occurring in more than 1 in 10,000 patients, but in fewer than 1 in 1,000 patients. Urgent medical assistance or hospitalization may be required.

The following adverse effects have been reported for losartan:
Common (occurring in fewer than 1 in 10 people):

• central dizziness, labyrinthine dizziness,
• low blood pressure, which may cause dizziness upon standing,
• weakness,
• fatigue,
• low blood sugar (hypoglycaemia),
• high blood potassium levels (hyperkalaemia),
• increased blood urea, creatinine and potassium levels in patients with heart failure,
• reduced number of red blood cells (anaemia),
• kidney function disorders, kidney failure.

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

• drowsiness,
• headache,
• sleep disorders,
• sensation of rapid heartbeat (palpitations),
• severe chest pain (angina pectoris),
• shortness of breath,
• cough,
• abdominal pain,
• constipation,
• diarrhoea,
• nausea,
• vomiting,
• localised swelling,
• urticaria (raised pale-red skin lesions),
• skin itching,
• rash.

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

• inflammation of blood vessels (including Henoch-Schönlein purpura),
• sensation of numbness or tingling (paraesthesia),
• irregular heart rhythm (atrial fibrillation), stroke,
• hepatitis,
• increased alanine aminotransferase (AlAT) activity in blood (liver function test), usually resolving after discontinuation of treatment,
• hypersensitivity,
• fainting (loss of consciousness),
• angioedema,
• allergy (anaphylactic reactions).

Not known (frequency cannot be estimated from available data):

• ringing, buzzing, noise or clicking in the ears (tinnitus),
• pancreatitis,
• general malaise,
• urinary tract infection,
• rash,
• photosensitivity,
• erectile dysfunction/impotence,
• depression,
• reduced platelet count,
• migraine,
• liver function disorders,
• muscle or joint pain,
• serious muscle damage associated with pain and dark-coloured urine, possibly leading to kidney failure (rhabdomyolysis),
• influenza-like symptoms,
• decreased serum sodium concentration (hyponatraemia),
• back pain,
• taste disturbances.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Loreblok

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer and immediate packaging.
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines should 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 Loreblok contains

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

What Loreblok looks like and contents of the pack
White, oval, biconvex 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.
Pack sizes: 28 or 98 coated tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Orion Pharma Poland Sp. z o.o.
[email protected]

This medicinal product is authorised in the EEA countries under the following names:
Finland: Losartan Orion 12.5 mg, 50 mg, 100 mg, tabletti, kalvopäällysteinen; Losartan Orion 12.5 mg, 50 mg, 100 mg filmdragerad tablett
Poland: Loreblok 50 mg, coated tablets