Losacor

Leaflet attached to the packaging: patient information

Losacor, 50 mg, film-coated tablets

Losartan potassium

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• 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 any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Losacor and what is it used for

Losartan (Losacor) belongs to a group of medicines called angiotensin II receptor antagonists.
Angiotensin II is a substance produced in the body that, by binding to receptors in the walls of blood vessels, causes them to narrow. This results in an increase in blood pressure.
Losartan prevents angiotensin II from binding to these receptors, causing the blood vessels to widen and, as a result, lowering blood pressure.
Losartan slows down the deterioration of kidney function in patients with high blood pressure and type 2 diabetes.

Losacor is used:

• to treat high blood pressure (hypertension) in adults and children and adolescents from 6 to 18 years of age;
• to protect the kidneys in patients with high blood pressure and type 2 diabetes, with laboratory-confirmed kidney function disorders and proteinuria ≥ 0.5 g per day (a condition in which the urine contains an abnormal amount of protein);
• to treat patients with chronic heart failure, when treatment with certain medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors, drugs used to lower 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 thickening of the left ventricular wall, as losartan has been shown to reduce the risk of stroke (indication "LIFE").

2. Important information before taking Losacor

When not to take Losacor

• after the 3rd month of pregnancy (you should avoid taking Losacor in early pregnancy - see also section "Pregnancy");

Warnings and precautions

Before taking Losacor, tell your doctor, pharmacist, or nurse.
Inform your doctor if you think you might be pregnant or are planning to become pregnant. Losacor is not recommended in early pregnancy and should not be taken after the 3rd month of pregnancy, as it may seriously harm your baby (see section "Pregnancy").
It is important to inform your doctor before taking Losacor:

• angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), especially if you have kidney function disorders associated with diabetes;
• aliskiren.

If you experience abdominal pain, nausea, vomiting, or diarrhea after taking Losacor, discuss it with your doctor. The doctor will decide on further treatment. Do not stop taking Losacor on your own.
Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (e.g., potassium) in your blood at regular intervals.
See also section 2 "When not to take Losacor".

Children and adolescents

Studies have been conducted on the use of losartan in children. For more information, please contact your doctor.
Losartan (Losacor) 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 its efficacy has not been demonstrated in this age group.

Losacor and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, including those obtained without a prescription, herbal medicines, and natural products.
Be particularly cautious when taking the following medicines during treatment with Losacor:

• other blood pressure-lowering medicines, as they may lead to additional lowering of blood pressure. Blood pressure may also be lowered by the following medicines/groups of medicines:
• tricyclic antidepressants;
• antipsychotic medicines (used to treat mental disorders);
• baclofen (used to treat various types of muscle spasms);
• amifostine (used to prevent side effects of anticancer medicines or radiation therapy);
• potassium-sparing medicines or medicines that may increase potassium levels in the blood [e.g., potassium supplements, salt substitutes containing potassium, or certain diuretics (e.g., amiloride, triamterene, spironolactone)] or heparin;
• non-steroidal anti-inflammatory medicines 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 Losacor.

In the case of kidney function disorders, 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., periodic blood tests). Your doctor may need to adjust the dose and/or take other precautions:

• If you are taking an ACE inhibitor or aliskiren (see also sections 2 "When not to take Losacor" and 2 "Warnings and precautions").

Losacor with food and drink

Losacor can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy
Inform your doctor if you think you might be pregnant or are planning to become pregnant. Your doctor will usually advise you to stop taking Losacor before planned pregnancy or as soon as pregnancy is confirmed and recommend an alternative medicine.
Losacor is not recommended in early pregnancy and should not be taken after the 3rd month of pregnancy, as it may seriously harm your baby.
Breastfeeding
Inform your doctor if you are breastfeeding or plan to breastfeed. Losacor is not recommended during breastfeeding, especially in newborns or premature babies. Your doctor may recommend an alternative medicine.
Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines

No studies have been conducted on the effect of losartan on the ability to drive and use machines.
It is unlikely that Losacor will affect your ability to drive and use machines. However, as with many medicines used to treat high blood pressure, losartan may cause dizziness or drowsiness. If you experience dizziness or drowsiness, consult your doctor before performing such activities.

Losacor contains lactose monohydrate and sodium.

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per dose unit, which means it is essentially "sodium-free".

3. How to take Losacor

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. Your doctor will determine the appropriate dose of Losacor based on your condition and the medicines you are taking. It is important to take Losacor for as long as your doctor has prescribed it to maintain constant blood pressure control.
Adult patients with high blood pressure
Treatment usually starts with a dose of 50 mg of losartan (one Losacor 50 mg tablet) once a day. The maximum blood pressure-lowering effect should occur within 3 to 6 weeks of starting treatment. In some patients, the dose may then be increased to 100 mg of losartan (two Losacor 50 mg tablets or one Losacor 100 mg tablet) once a day.
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
Losacor is not recommended for use in children under 6 years of age, as its efficacy has not been demonstrated in this age group.
Children from 6 to 18 years of age
The recommended initial dose for patients with a body weight of 20 kg to 50 kg is 0.7 mg of losartan per kg of body weight, taken once a day (up to 25 mg of Losacor). Your doctor may increase the dose if blood pressure is not controlled.
For children, a different formulation of this medicine may be more suitable. Consult your doctor or pharmacist.

Dosage in special patient groups

Your doctor may recommend a lower dose, especially when starting treatment in certain patients, such as those taking high doses of diuretics, patients with liver function disorders, or patients over 75 years of age.
Losartan should not be used in patients with severe liver function disorders (see section 2 "When not to take Losacor").

Method of administration

Swallow the tablets with a glass of water.
Try to take your daily dose of Losacor at the same time each day. It is important to continue taking Losacor unless your doctor tells you to stop.
The tablet can be divided into two equal doses.

Overdose of Losacor

If you have accidentally taken too many tablets, contact your doctor immediately. Symptoms of overdose are low blood pressure, rapid heartbeat, or less frequently, slow heartbeat.

Missed dose of Losacor

If you miss a dose, take the next dose at the usual time. Do not take a double dose to make up for a missed dose.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Losacor can cause side effects, although not everybody gets them.
In the event of the following serious side effects, stop taking Losacor and consult your doctor or go to the emergency department of your nearest hospital:

• severe allergic reactions:rash, itching, swelling of the face, lips, mouth, or throat, which may cause difficulty swallowing or breathing. These are serious but rare side effects, occurring in 1 to 10 out of 10,000 patients. Immediate medical attention or hospitalization may be required.

The following side effects have been reported for Losacor:
Common(occurring in 1 to 10 out of 100 patients):

• dizziness,
• low blood pressure (especially after excessive loss of fluids, e.g., in patients with severe heart failure or those treated with high doses of diuretics),
• dose-dependent orthostatic symptoms, such as decreased blood pressure when standing up from a lying or sitting position,
• weakness,
• fatigue,
• low blood sugar (hypoglycemia),
• high potassium levels in the blood (hyperkalemia),
• changes in kidney function, including kidney failure,
• decreased red blood cell count (anemia),
• increased levels of urea, creatinine, and potassium in the blood in patients with heart failure.

Uncommon(occurring in 1 to 10 out of 1,000 patients):

• drowsiness,
• headache,
• sleep disorders,
• palpitations (rapid or irregular heartbeat),
• severe chest pain (angina pectoris),
• shortness of breath (dyspnea),
• abdominal pain,
• constipation,
• diarrhea,
• nausea,
• vomiting,
• hives,
• itching (pruritus),
• rash,
• localized swelling,
• cough.

Rare(occurring in 1 to 10 out of 10,000 patients):

• hypersensitivity,
• angioedema,
• vasculitis (including Henoch-Schönlein purpura),
• numbness or tingling (paresthesia),
• fainting,
• very rapid and irregular heartbeat (atrial fibrillation),
• stroke,
• hepatitis,
• increased activity of the liver enzyme alanine aminotransferase (ALT) in the blood, usually reversible after discontinuation of treatment.
• angioedema of the intestine: swelling in the intestine with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Frequency not known(cannot be estimated from the available data):

• decreased platelet count,
• migraine,
• liver function disorders,
• muscle and joint pain,
• flu-like symptoms,
• back pain and urinary tract infections,
• increased sensitivity to sunlight (photosensitivity),
• unexplained muscle pain with dark (tea-colored) urine (rhabdomyolysis),
• impotence,
• pancreatitis,
• low sodium levels in the blood (hyponatremia),
• depression,
• general feeling of being unwell,
• ringing, buzzing, or other persistent noises in the ears (tinnitus),
• taste disorders.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported 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 Losacor

Store in a temperature below 25°C.
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 month.
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 Losacor contains

• The active substance of Losacor is losartan potassium. Each Losacor 50 mg film-coated tablet contains 50 mg of losartan potassium.
• The other ingredients are: lactose monohydrate, povidone K30, crospovidone type A, sodium stearyl fumarate. The ingredients of the tablet coating AquaPolish white 010 are: hypromellose (substitution type 2910), titanium dioxide (E 171), macrogol 400.

What Losacor looks like and contents of the pack

Film-coated tablets, white, oblong, biconvex, with a score line on one side, with a smooth surface and minor roughness resulting from the structure of the tablet coating.
Losacor film-coated tablets are packaged in PVC/PVDC/Aluminum blisters, placedin a cardboard box.
Pack size

30 or 60 film-coated tablets

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
tel.: +48 61 66 51 500
fax: +48 61 66 51 505
biofarm@biofarm.pl

Date of last revision of the leaflet: 24.01.2025