LOSACOR

Package leaflet: Information for the user

Losacor 50 mg, coated tablets
Losartanum kalicum
Please read all of this leaflet carefully before taking this medicine because 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it 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, tell your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

1. What Losacor is and what it is used for
2. Before you take 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 Losacor is and what it is used for

Losartan (Losacor) 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.
Losacor is used:

• to treat 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, 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 called angiotensin-converting enzyme (ACE) inhibitors (medicines used to reduce high blood pressure) is considered inappropriate 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 left ventricular hypertrophy (thickening of the wall of the left ventricle of the heart), because it has been shown that losartan reduces the risk of stroke (the "LIFE" indication).

2. Important information before using Losacor

When not to use Losacor

• if the patient is allergic to losartan potassium 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 of Losacor should be avoided during early pregnancy – see also section “Pregnancy”);
• if the patient has diabetes or kidney dysfunction and is being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions
Before starting treatment with Losacor, consult a doctor, pharmacist, or
nurse.
Inform your doctor if you suspect (or are planning) pregnancy. Losacor is not recommended during
early pregnancy and must not be used after the 3rd month of pregnancy, as it may seriously harm the unborn child (see section “Pregnancy”).
It is important to inform your doctor before starting treatment with Losacor:

• if the patient has previously experienced angioedema [swelling of the face, lips, throat, and (or) tongue] (see also section 4. “Possible side effects”);

• if the patient has 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 resulting in excessive fluid and salt loss from the body
  (see section 3. “Dosage in special patient groups”);

• if the patient has narrowing or blockage of blood vessels leading to the kidneys or has recently undergone kidney transplantation;

• if the patient has liver function impairment (see sections 2. “When not to use Losacor” and 3. “Dosage in special patient groups”);

• if the patient has heart failure with or without kidney dysfunction, or has severe, life-threatening cardiac arrhythmias. Particular caution is required when Losacor is used concomitantly with beta-blockers (medicines used, among others, in heart diseases);

• 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 clinical syndrome caused by excessive aldosterone secretion from the adrenal glands due to adrenal abnormalities);

• 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 impairment related to diabetes;

• aliskiren.

If abdominal pain, nausea, vomiting, or diarrhoea occur after taking Losacor, discuss this with your doctor. The doctor will decide on further treatment. Do not discontinue Losacor on your own initiative.
Your doctor may monitor kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.
See also information under section 2. “When not to use Losacor”.
Children and adolescents
Studies on the use of losartan in children have been conducted. For additional information, please consult your doctor.
Losartan (Losacor) is not recommended for use in children and adolescents with kidney or liver impairment 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.

Losacor and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including medicines intended for future use, whether prescription or over-the-counter, herbal remedies, and natural products.
Exercise particular caution when using the following medicines concomitantly with Losacor:

• other medicines that lower blood pressure, as additional reduction in blood pressure may occur. The following medicines/groups of medicines may also reduce blood pressure:

• tricyclic antidepressants;

• antipsychotics (used to treat psychiatric disorders);

• baclofen (used for various types of muscle spasms);

• amifostine (used to prevent adverse effects following anticancer drugs or radiotherapy);

• 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 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 patients with kidney impairment, 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 additional precautions:

• If the patient is taking an ACE inhibitor or aliskiren (see also information under section 2. “When not to use Losacor” and section 2. “Warnings and precautions”).

Losacor with food and drink
Losacor can be taken independently of meals.
Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you suspect (or are planning) pregnancy. Your doctor will usually advise discontinuation of Losacor before planned pregnancy or immediately after pregnancy is confirmed and will recommend an alternative medicine. Losacor is not recommended during early pregnancy and must not be used after the 3rd month of pregnancy, as it may seriously harm the unborn child.
Breastfeeding
Inform your doctor if you are breastfeeding or intend to breastfeed. Losacor is not recommended during breastfeeding, especially when nursing a newborn or preterm infant. Your doctor may recommend an alternative medicine.
Before taking any medicine, consult your doctor or pharmacist.
Driving and operating machinery
No studies have been conducted on the effect of losartan on the ability to drive or operate machinery.
It is unlikely that Losacor affects the ability to drive or 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.
Losacor contains monohydrate lactose and sodium.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per dosage unit, meaning the medicine is considered “sodium-free”.

3. How to use Losacor

This medicine should always be taken exactly as instructed by your doctor or pharmacist. If in doubt,
you should consult your doctor or pharmacist. Your doctor will determine the appropriate dose of Losacor
depending on your condition and other medications you are taking. It is important to continue taking Losacor
for as long as your doctor recommends, in order to maintain consistent blood pressure control.
Adult patients with high blood pressure
Treatment usually starts with a dose of 50 mg losartan (one Losacor 50 mg tablet) once
daily. Maximum blood pressure-lowering effect should occur within 3 to 6 weeks
after starting treatment. In some patients, the dose may later be increased to 100 mg
losartan (two Losacor 50 mg tablets or one Losacor 100 mg tablet) once daily.
If you feel the effect of losartan is too strong or too weak, you should 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 aged 6 to 18 years
The recommended initial dose for patients with body weight between 20 kg and 50 kg is 0.7 mg losartan
per kg of body weight, taken once daily (up to 25 mg of Losacor). Your doctor may increase the dose
if blood pressure is not adequately controlled.
Another formulation of this medicine may be more suitable for children. Please consult your
doctor or pharmacist.
Adult patients with high blood pressure and type 2 diabetes
Treatment usually starts with a dose of 50 mg losartan (one Losacor 50 mg tablet) once
daily. The dose may then be increased to 100 mg losartan (two Losacor 50 mg tablets
or one Losacor 100 mg tablet) once daily, depending on the achieved blood pressure
response.
Tablets containing 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 glucosidase inhibitors).
Adult patients with heart failure
Treatment usually starts with a dose of 12.5 mg losartan (one Losacor 12.5 mg tablet)
once daily. This dose should generally be gradually increased at weekly intervals, as follows:

• 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 reaching the maintenance dose, as directed by your doctor. The maximum recommended daily dose is 150 mg losartan (e.g. three 50 mg Losacor tablets or one 100 mg Losacor tablet plus one 50 mg Losacor tablet) once daily.

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 function impairment (see section
2. "When not to use Losacor").

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
Losacor unless your doctor advises otherwise.
Tablets may be divided into two equal doses.
Taking more Losacor than recommended
If you accidentally take too many tablets, contact your doctor immediately. Symptoms of overdose include low blood pressure, rapid heartbeat, or less commonly, slow heartbeat.
Missing a dose of Losacor
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, please consult your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody will experience them.
If any of the following serious side effects occur, stop taking the medicine and consult your doctor immediately 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 (occur in 1 to 10 out of 100 patients):

• dizziness,
• low blood pressure (especially after excessive fluid loss, e.g. in patients with severe heart failure or those treated with high doses of diuretics),
• dose-dependent orthostatic symptoms, such as a drop in blood pressure upon standing up from a lying or sitting position,
• weakness,
• fatigue,
• low blood sugar (hypoglycaemia),
• high potassium levels in the blood (hyperkalaemia),
• kidney function changes, including kidney failure,
• reduced number of red blood cells (anaemia),
• increased blood urea, serum creatinine and potassium levels in patients with heart failure.

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

• 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 (occur in 1 to 10 out of 10,000 patients):

• hypersensitivity,
• angioedema,
• vasculitis (including Schönlein-Henoch purpura),
• sensation of numbness or tingling (paraesthesia),
• fainting,
• very rapid and irregular heartbeat (atrial fibrillation),
• stroke,
• hepatitis,
• increased blood activity of an enzyme called alanine aminotransferase (AlAT), usually resolving after discontinuation of treatment,
• intestinal angioedema: swelling in the intestine with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

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

• reduced platelet count,
• migraine,
• liver function disorders,
• muscle and joint pain,
• influenza-like symptoms,
• back pain and urinary tract infections,
• increased sensitivity to sunlight (photosensitivity),
• unexplained muscle pain with dark (tea-coloured) urine (rhabdomyolysis),
• sexual dysfunction (impotence),
• pancreatitis,
• low sodium levels in blood (hyponatraemia),
• depression,
• general malaise,
• ringing, buzzing, noise or clicking in the ears (tinnitus),
• taste disturbances.

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. 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 Authorisation Holder.
Reporting side effects helps provide more information on the safety of this medicine.
5. How to store Losacor
Store below 25°C.
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.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. These measures help protect the environment.
6. Contents of the pack and other information
What Losacor contains

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

What Losacor looks like and contents of the pack
Coated tablets, white, elongated, biconvex, with a score line on one side,
smooth surface with slight roughness due to the tablet coating structure.
Losacor coated tablets are packed in PVC/PVDC/Aluminium blisters, housed in a cardboard box.
Pack sizes
30 or 60 coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation 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
[email protected]