Cozaar

Leaflet accompanying the packaging: information for the user

COZAAR, 12.5 mg, film-coated tablets

COZAAR, 50 mg, film-coated tablets

COZAAR, 100 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.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is COZAAR and what is it used for

Losartan (COZAAR) 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 constrict. This results in an increase in blood pressure. Losartan prevents angiotensin II from binding to these receptors, causing blood vessels to dilate and, as a result, reducing blood pressure. Losartan slows down the deterioration of kidney function in patients with high blood pressure and type 2 diabetes.
COZAAR is used

• to treat high blood pressure (hypertension) in adults and in 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, medicines used to reduce 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 it has been shown that COZAAR reduces the risk of stroke (LIFE indication).

2. Important information before taking COZAAR

When not to take COZAAR:

• if the patient is allergic to losartan or any of the other ingredients of this medicine (listed in section 6),
• after the 3rd month of pregnancy (COZAAR should also be avoided in early pregnancy; see section Pregnancy),
• if the patient has severe liver function disorders,
• if the patient has diabetes or kidney function disorders and is being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Before starting treatment with COZAAR, consult a doctor, pharmacist, or nurse.
Inform the doctor about suspected or planned pregnancy. The doctor will usually recommend stopping COZAAR before planned pregnancy or immediately after confirming pregnancy and recommend taking another medicine instead of COZAAR. COZAAR should not be taken in early pregnancy and should not be taken after the 3rd month of pregnancy, as it may seriously harm the fetus (see section Pregnancy).
It is essential to inform the doctor before taking COZAAR:

• if the patient has 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 diarrhea leading to excessive fluid and/or electrolyte loss,
• if the patient is taking diuretics (medicines that increase the amount of water excreted by the kidneys) or is on a low-salt diet leading to excessive fluid and electrolyte 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 function disorders (see sections 2 "When not to take COZAAR" and 3 "Dosage in special patient groups"),
• if the patient has heart failure with kidney function disorders or without kidney function disorders or co-existing, life-threatening heart rhythm disorders. Particular caution is required when co-administering beta-blockers,
• if the patient has valvular heart disease or heart muscle disease,
• if the patient has coronary heart disease (caused by reduced blood flow in the coronary arteries) or cerebrovascular disorders (caused by reduced blood flow in the brain),
• if the patient has primary hyperaldosteronism (a syndrome caused by increased aldosterone secretion by the adrenal glands, caused by adrenal gland abnormalities),
• if the patient is taking any of the following blood pressure-lowering medicines: an angiotensin-converting enzyme inhibitor (ACE inhibitor, e.g., enalapril, lisinopril, ramipril), particularly if the patient has kidney function disorders associated with diabetes, or aliskiren. The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood. See also subsection "When not to take COZAAR".
• if the patient is taking other medicines that may increase potassium levels in the blood (see section 2 "COZAAR and other medicines").

If the patient experiences stomach pain, nausea, vomiting, or diarrhea after taking COZAAR, they should discuss this with their doctor. The doctor will decide on further treatment. Do not stop taking COZAAR without consulting a doctor.

Children and adolescents

Studies have been conducted on the use of COZAAR in children. For more information, consult a doctor.
COZAAR is not recommended for use in children and adolescents with kidney or liver function disorders due to limited data available for these patient groups. COZAAR is not recommended for use in children under 6 years of age, as its efficacy has not been demonstrated in this age group.

COZAAR and other medicines

Inform the doctor or pharmacist about all medicines currently being taken or recently taken, as well as any medicines planned to be taken.
Inform the doctor about any potassium supplements, salt substitutes containing potassium, potassium-sparing diuretics (e.g., amiloride, triamterene, spironolactone), or other medicines that may increase potassium levels in the blood (e.g., heparin, trimethoprim-containing medicines), as concomitant use with COZAAR is not recommended.
Particular caution is required when taking the following medicines during treatment with COZAAR:

• other blood pressure-lowering medicines, as they may cause additional blood pressure reduction. Blood pressure may also be reduced by the following medicines/groups of medicines: tricyclic antidepressants, antipsychotic medicines, baclofen, amifostine,
• 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 losartan.

The doctor may recommend a dose change and/or take other precautions:

• if the patient is taking an ACE inhibitor or aliskiren (see also subsections "When not to take COZAAR" and "Warnings and precautions").

In case of kidney function disorders, concomitant use of these medicines may lead to worsening of kidney function.
COZAAR should not be taken with lithium-containing medicines without close medical supervision. Special precautions (e.g., blood tests) may be necessary.

COZAAR with food and drink

COZAAR can be taken with or without food.
Grapefruit juice should be avoided during treatment with COZAAR.

Pregnancy and breastfeeding

Pregnancy

Inform the doctor about suspected or planned pregnancy. The doctor will usually recommend stopping COZAAR before planned pregnancy or immediately after confirming pregnancy and recommend taking another medicine instead of COZAAR. COZAAR should not be taken in early pregnancy and should not be taken after the 3rd month of pregnancy, as it may seriously harm the fetus.

Breastfeeding

Inform the doctor about breastfeeding or intention to breastfeed. COZAAR is not recommended during breastfeeding, especially in newborns or premature babies. The doctor may recommend another medicine.
Consult a doctor or pharmacist before taking this medicine.

Driving and using machines

No studies have been conducted on the effects on driving and using machines.
It is unlikely that COZAAR will affect driving and using machines. However, as with many medicines used to treat high blood pressure, losartan may cause dizziness or drowsiness.
In case of dizziness or drowsiness, consult a doctor before engaging in such activities.

COZAAR contains lactose

COZAAR contains lactose. If you have been told that you have an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take COZAAR

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist. The doctor will determine the appropriate dose of COZAAR based on the patient's condition and other medicines being taken. It is essential to take COZAAR for as long as the doctor recommends to maintain constant blood pressure control.
Adult patients with high blood pressure
Treatment usually starts with a dose of 50 mg of losartan (one COZAAR 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 be increased to 100 mg of losartan (two COZAAR 50 mg tablets or one COZAAR 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.

Dosage in children and adolescents

Children under 6 years of age
COZAAR 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, given once a day (up to 25 mg of COZAAR). The doctor may increase the dose if blood pressure is not controlled.
For children, another form of this medicine may be more suitable. Consult a doctor or pharmacist.
Adult patients with high blood pressure and type 2 diabetes
Treatment usually starts with a dose of 50 mg of losartan (one COZAAR 50 mg tablet) once a day. The dose may be increased to 100 mg of losartan (two COZAAR 50 mg tablets or one COZAAR 100 mg tablet) once a day, depending on the blood pressure response.
Losartan tablets 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 glucose-lowering medicines (e.g., sulfonylurea derivatives, glitazones, and glucose inhibitors).
Adult patients with heart failure
Treatment usually starts with a dose of 12.5 mg of losartan (one COZAAR 12.5 mg tablet) once a day. The dose is usually increased weekly (i.e., 12.5 mg per day during the first week, 25 mg per day during the second week, 50 mg per day during the third week, 100 mg per day during the fourth week, and 150 mg per day during the fifth week) until the maintenance dose is reached, as recommended by the doctor. The maximum recommended dose is 150 mg of losartan (e.g., three COZAAR 50 mg tablets or one COZAAR 100 mg tablet and one COZAAR 50 mg tablet) once a day.
Losartan is usually taken with diuretics (medicines that increase the amount of water excreted by the kidneys) and/or digitalis glycosides (medicines that strengthen and regulate heart function) and/or beta-blockers.

Dosage in special patient groups

The 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 taken by patients with severe liver function disorders (see section "When not to take COZAAR").

Administration

Tablets should be swallowed whole with a glass of water. Try to take the daily dose of COZAAR at the same time every day. It is essential to continue taking COZAAR as long as the doctor recommends, to maintain constant blood pressure control.

Overdose

In case of accidental overdose, consult a doctor immediately. Symptoms of overdose include low blood pressure, rapid heart rate, and possibly slow heart rate.

Missed dose

In case of a missed dose, take the next dose at the usual time. Do not take a double dose to make up for the missed tablet. If you have any further doubts about taking this medicine, consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, COZAAR can cause side effects, although not everybody gets them.
In case of the following side effects, stop taking COZAAR and consult a doctor or go to the emergency department of the nearest hospital immediately:
Severe allergic reactions (rash, itching, swelling of the face, lips, mouth, or throat, which may cause difficulty swallowing or breathing).
This is a severe but rare side effect, occurring in more than 1 in 10,000 patients but less than 1 in 1,000 patients. Immediate medical attention or hospitalization may be necessary.
The following side effects have been reported for COZAAR:
Common (may affect up to 1 in 10 people):

• dizziness,
• low blood pressure (especially after excessive fluid loss, e.g., in patients with severe heart failure or those taking 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,
• reduced red blood cell count (anemia),
• increased levels of urea, creatinine, and potassium in the blood in patients with heart failure.

Uncommon (may affect up to 1 in 100 people):

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

Rare (may affect up to 1 in 1,000 people):

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

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

• reduced 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 malaise,
• ringing, buzzing, or hissing in the ears (tinnitus),
• taste disorders.

Side effects in children are similar to those observed in adults.
If any side effects occur, including any side effects not listed in this leaflet, consult a doctor, pharmacist, or nurse.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, inform a doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 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.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store COZAAR

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging or blister.
The expiry date refers to the last day of the month.
Blisters:
Store COZAAR in its original packaging to protect it from light and moisture.
Do not open blisters until you are ready to take the medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What COZAAR contains

The active substance of COZAAR is losartan potassium.
Each COZAAR 12.5 mg tablet contains 12.5 mg of losartan potassium.
Each COZAAR 50 mg tablet contains 50 mg of losartan potassium.
Each COZAAR 100 mg tablet contains 100 mg of losartan potassium.
The other ingredients are microcrystalline cellulose (E460), lactose monohydrate (see section "COZAAR contains lactose"), maize starch, magnesium stearate (E572), hydroxypropyl cellulose (E463), hypromellose (E464).
COZAAR 12.5 mg, 50 mg, and 100 mg contain potassium in the following amounts: 1.06 mg (0.027 mEq), 4.24 mg (0.108 mEq), and 8.48 mg (0.216 mEq), respectively.
COZAAR 12.5 mg tablets also contain carnauba wax (E903), titanium dioxide (E171), and indigo carmine (E132) aluminum lake.
COZAAR 50 mg tablets also contain carnauba wax (E903) and titanium dioxide (E171).
COZAAR 100 mg tablets also contain carnauba wax (E903) and titanium dioxide (E171).

What COZAAR looks like and contents of the packaging

COZAAR 12.5 mg is available as film-coated tablets containing 12.5 mg of losartan potassium.
COZAAR 50 mg is available as film-coated tablets with a score line, containing 50 mg of losartan potassium. The score line is not intended for breaking the tablet.
COZAAR 100 mg is available as film-coated tablets without a score line, containing 100 mg of losartan potassium.
The following pack sizes are available for COZAAR:

• COZAAR 12.5 mg - PVC/PE/PVDC blisters with aluminum foil, in packs of 21 or 28 tablets.
• COZAAR 50 mg - PVC/PE/PVDC blisters with aluminum foil, in packs of 28 tablets.
• COZAAR 100 mg - PVC/PE/PVDC blisters with aluminum foil, in packs of 14 and 28 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Organon Polska Sp. z o.o.
Marszałkowska Street 126/134
00-008 Warsaw
Tel.: +48 22 105 50 01
[email protected]

Manufacturer

Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
Netherlands
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium

This medicine is authorized in the Member States of the European Economic Area under the following names:

Member State

Marketing authorization name

Austria
Cosaar 12.5 mg - Filmtabletten
Austria
Cosaar 50 mg - Filmtabletten
Austria
Cosaar 100 mg - Filmtabletten
Belgium
COZAAR 12.5 mg
Belgium
COZAAR 50 mg
Belgium
COZAAR 100 mg
Bulgaria
COZAAR 12.5 mg film-coated tablets
Cyprus
COZAAR
Czech Republic
COZAAR 50 mg
Czech Republic
COZAAR 100 mg
Denmark
Cozaar
Finland
Cozaar 12.5 mg film-coated tablets
Finland
Cozaar 50 mg film-coated tablets
Finland
Cozaar 100 mg film-coated tablets
France
COZAAR 50 mg scored coated tablets
France
COZAAR 100 mg film-coated tablets
Germany
LORZAAR PROTECT 100 mg Filmtabletten
Germany
LORZAAR PROTECT 50 mg Filmtabletten
Germany
LORZAAR START 12.5 mg Filmtabletten
Greece
COZAAR
Hungary
COZAAR
Iceland
COZAAR
Ireland
COZAAR 12.5 mg film-coated tablets
Ireland
COZAAR 50 mg film-coated tablets
Ireland
COZAAR 100 mg film-coated tablets

Member State

Marketing authorization name

Italy
LORTAAN 12.5 mg compresse rivestite con film
Italy
LORTAAN 50 mg compresse rivestite con film
Italy
LORTAAN 100 mg compresse rivestite con film
Luxembourg
COZAAR 12.5 mg
Luxembourg
COZAAR 50 mg
Luxembourg
COZAAR 100 mg
Malta
COZAAR 12.5 mg film-coated tablets
Malta
COZAAR 50 mg film-coated tablets
Malta
COZAAR 100 mg film-coated tablets
Netherlands
COZAAR 12.5 mg
Netherlands
COZAAR 50 mg
Netherlands
COZAAR 100 mg
Norway
Cozaar
Poland
COZAAR
Portugal
Cozaar
Portugal
Cozaar 100 mg
Portugal
Cozaar IC
Spain
COZAAR 12.5 mg Inicio comprimidos recubiertos con película
Spain
COZAAR 50 mg comprimidos recubiertos con película
Spain
COZAAR 100 mg comprimidos recubiertos con película
Sweden
COZAAR 12.5 mg film-coated tablets
Sweden
COZAAR 50 mg film-coated tablets
Sweden
COZAAR 100 mg film-coated tablets

Date of last revision of the leaflet: 01/2025