COZAAR 50 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. COZAAR, 12.5 mg, film-coated tablets
3. COZAAR, 50 mg, film-coated tablets
4. COZAAR, 100 mg, film-coated tablets
   1. Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
   2. Contents of the pack and other information
5. What COZAAR is and what it is used for
6. What you need to know before you take COZAAR
   1. Do not take COZAAR:
   2. Warnings and precautions
   3. Children and adolescents
   4. COZAAR with other medicines
   5. COZAAR with food and drink
   6. Pregnancy and breast-feeding
   7. Pregnancy
   8. Breast-feeding
   9. Driving and using machines
   10. COZAAR contains lactose
7. How to take COZAAR
   1. Dosing in children and adolescents
   2. Dosing in special patient groups
   3. Administration
   4. If you take more COZAAR than you should
   5. If you forget to take COZAAR
8. Possible side effects
   1. Reporting of side effects
9. How to store COZAAR
10. Contents of the pack and other information
    1. What COZAAR contains
    2. What COZAAR looks like and contents of the pack
    3. Marketing Authorisation Holder and Manufacturer
    4. Marketing Authorisation Holder
    5. Manufacturer
    6. This medicinal product is authorised in the Member States of the European Economic Area under the following names:
    7. Member State
    8. Marketing Authorisation Holder
    9. Member State
    10. Marketing Authorisation Holder
    11. Date of last revision of the leaflet: 01/2025

Package Leaflet: 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 all of this leaflet carefully before you start 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 pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

1. What COZAAR is and what it is used for

Losartan (COZAAR) 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 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 the blood vessels to widen and thereby lowering the blood pressure. Losartan slows the progression of kidney disease 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 evidence of kidney damage and proteinuria ≥ 0.5 g/day (a condition in which the urine contains an abnormal amount of protein).
• to treat patients with chronic heart failure when treatment with certain other medicines called ACE inhibitors is not considered suitable by your doctor. If heart failure has been stabilised with an ACE inhibitor, it should not be switched to losartan.
• in patients with high blood pressure and thickening of the left ventricle of the heart, as it has been shown that COZAAR reduces the risk of stroke (the "LIFE indication").

2. What you need to know before you take COZAAR

Do not take COZAAR:

• if you are allergic to losartan or any of the other ingredients of this medicine (listed in section 6),
• if you are more than 3 months pregnant (it is also recommended to avoid COZAAR in early pregnancy - see section "Pregnancy"),
• if you have severe liver disease,
• if you have diabetes or kidney disease and are treated with a blood pressure lowering medicine containing aliskiren.

Warnings and precautions

Before taking COZAAR, tell your doctor, pharmacist, or nurse.
Inform your doctor if you are planning to become pregnant. Your doctor will normally advise you to stop taking COZAAR before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of COZAAR. You must not take COZAAR if you are more than 3 months pregnant, as it may seriously harm your baby (see section "Pregnancy").
It is important to tell your doctor before taking COZAAR:

• if you have had angioedema (swelling of the face, lips, throat, and/or tongue) (see also section 4 "Possible side effects"),
• if you have experienced excessive vomiting or diarrhoea leading to excessive loss of body water and/or electrolytes,
• if you are taking diuretics (medicines that increase the amount of water in the urine) or are on a low salt diet, leading to excessive loss of body water and/or electrolytes (see section 3 "Dose in special patient groups"),
• if you have narrowing or blockage of blood vessels leading to your kidneys or have recently had a kidney transplant,
• if you have liver disease (see sections 2 "Do not take COZAAR" and 3 "Dose in special patient groups"),
• if you have heart failure with liver disease or concomitant diseases that affect kidney function, or if you are treated with a combination of medicines that may impair kidney function.
• 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 disease associated with diabetes, or aliskiren. Your doctor may check your kidney function, blood pressure, and the levels of electrolytes (e.g., potassium) in your blood. See also section "Do not take COZAAR".
• if you are taking other medicines that may increase potassium levels in your blood (see section 2 "COZAAR with other medicines").

If you take COZAAR and experience stomach pain, nausea, vomiting, or diarrhoea, you should consult your doctor. Your doctor will decide whether you should continue to take COZAAR.
Do not take COZAAR without consulting your doctor.

Children and adolescents

COZAAR has been studied in children. For more information, please contact your doctor.
COZAAR is not recommended for children with kidney or liver disease, as there is limited experience with COZAAR in these patient groups. COZAAR is not recommended for use in children under 6 years of age, as the efficacy has not been established in this age group.

COZAAR with other medicines

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, and those you plan to take.
Tell your doctor about any supplements containing potassium, salt substitutes containing potassium, or potassium-sparing diuretics (such as amiloride, triamterene, spironolactone), or other medicines that may increase potassium levels in your blood (e.g., heparin, trimethoprim-containing medicines), as these should not be taken with COZAAR.
When taking COZAAR, be particularly careful when taking other blood pressure lowering medicines, as they may cause a further decrease in blood pressure.

• other blood pressure lowering medicines, as they may cause a further decrease in blood pressure. Other medicines that may lower blood pressure include tricyclic antidepressants, antipsychotics, baclofen, amifostine,
• non-steroidal anti-inflammatory drugs (NSAIDs) such as indomethacin, including COX-2 inhibitors (medicines that reduce inflammation and pain), as they may reduce the blood pressure lowering effect of losartan.

Your doctor may need to change your dose and take other precautions:

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

In patients with kidney disease, taking these medicines together may lead to worsening of kidney function.
Do not take medicines containing lithium in combination with losartan without close monitoring by your doctor.
Special precautions (e.g., blood tests) may be necessary.

COZAAR with food and drink

COZAAR can be taken with or without food.
You should avoid drinking grapefruit juice while taking COZAAR.

Pregnancy and breast-feeding

Pregnancy

Inform your doctor if you are planning to become pregnant. Your doctor will normally advise you to stop taking COZAAR before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of COZAAR. Do not take COZAAR if you are more than 3 months pregnant, as it may seriously harm your baby.

Breast-feeding

Inform your doctor if you are breast-feeding or plan to breast-feed. COZAAR is not recommended for use during breast-feeding, especially in newborns or preterm infants. Your doctor may prescribe another medicine for you.
Before taking this medicine, consult your doctor or pharmacist.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed.
It is unlikely that COZAAR will affect your ability to drive or use machines. However, as with many other medicines used to treat high blood pressure, losartan may cause dizziness or tiredness in some people.
If you experience dizziness or tiredness, you should consult your doctor before performing tasks that require alertness.

COZAAR contains lactose

COZAAR contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take COZAAR

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Your doctor will determine the appropriate dose of COZAAR, depending on your condition and any other medicines you are taking. It is important to continue taking COZAAR for as long as your doctor prescribes it to maintain control of your blood pressure.
Adult patients with high blood pressure
Treatment usually starts with 50 mg losartan (one COZAAR 50 mg tablet) once daily. The maximum effect on blood pressure usually occurs within 3-6 weeks of starting treatment. For some patients, a dose of 100 mg losartan (two COZAAR 50 mg tablets or one COZAAR 100 mg tablet) once daily may be required.

Dosing in children and adolescents

Children under 6 years of age
COZAAR is not recommended for children under 6 years of age, as the efficacy has not been established in this age group.
Children from 6 to 18 years of age
The recommended starting dose for patients weighing between 20 kg and 50 kg is 0.7 mg losartan per kg body weight per day (up to 25 mg COZAAR), given once daily. Your doctor may increase the dose if blood pressure is not controlled.

Dosing in special patient groups

Your doctor may prescribe a lower dose, especially when starting treatment in certain patients, such as those taking high doses of diuretics, patients with liver disease, or patients over 75 years of age. Do not take losartan if you have severe liver disease (see section "Do not take COZAAR").

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 COZAAR unless your doctor tells you to stop.

If you take more COZAAR than you should

If you have taken too many tablets, contact your doctor or pharmacist immediately. Symptoms of overdose include low blood pressure, fast heart rate, and possibly slow heart rate.

If you forget to take COZAAR

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, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following side effects, stop taking COZAAR and contact your doctor or go to the emergency department at your nearest hospital immediately:
Severe allergic reactions (rash, itching, swelling of the face, lips, throat, and/or tongue, 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 fewer than 1 in 1,000 patients. You may need urgent medical attention or hospitalisation.
The following side effects have been reported with COZAAR:

• dizziness,
• low blood pressure (especially after excessive loss of body water, e.g., in patients with severe heart failure or treated with high doses of diuretics),
• dose-related orthostatic effects, such as low blood pressure when standing up from a lying or sitting position,
• weakness,
• fatigue,
• low blood sugar (hypoglycaemia),
• high potassium levels in the blood (hyperkalaemia),
• changes in kidney function, including kidney failure,
• low red blood cell count (anaemia),
• increased levels of urea, creatinine, and potassium in the blood in patients with heart failure.

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

• sleepiness,
• headache,
• sleep disorders,
• rapid heartbeat (palpitations),
• severe chest pain (angina pectoris),
• shortness of breath (dyspnoea),
• abdominal pain,
• constipation,
• diarrhoea,
• nausea,
• vomiting,
• hives,
• itching (pruritus),
• rash,
• local swelling
• cough.

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

• allergic reactions,
• angioedema,
• gastrointestinal angioedema: swelling in the gut with symptoms such as abdominal pain, nausea, vomiting, and diarrhoea,
• inflammation of blood vessels (including vasculitis),
• numbness or tingling (paraesthesia),
• fainting,
• very fast and irregular heartbeat (atrial fibrillation),
• stroke,
• inflammation of the liver (hepatitis),
• increased levels of liver enzymes (transaminases) in the blood, usually resolving after stopping treatment.

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

• low platelet count,
• migraine,
• liver 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-coloured) urine (rhabdomyolysis),
• impotence,
• pancreatitis,
• low sodium levels in the blood (hyponatraemia),
• depression,
• general feeling of being unwell,
• ringing, buzzing, whistling, or other persistent sounds in the ears (tinnitus),
• taste disorders.

Side effects in children are similar to those in adults.
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the "Contact details for the reporting of side effects" section below.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store COZAAR

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton or blister after "EXP". The expiry date refers to the last day of that month.
Blisters:
Store COZAAR in the original package to protect from light and moisture.
Do not open the blisters until you are ready to take the medicine.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What COZAAR contains

The active substance is losartan potassium.
Each COZAAR 12.5 mg tablet contains 12.5 mg losartan potassium.
Each COZAAR 50 mg tablet contains 50 mg losartan potassium.
Each COZAAR 100 mg tablet contains 100 mg losartan potassium.
The other ingredients are microcrystalline cellulose (E460), lactose monohydrate (see section "COZAAR contains lactose"), maize starch, magnesium stearate (E572), hydroxypropylcellulose (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) aluminium 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 pack

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

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

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Organon Polska Sp. z o.o.
Marszałkowska 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 medicinal product is authorised in the Member States of the European Economic Area under the following names:

Member State

Marketing Authorisation Holder

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 kalvopäällysteiset tabletit
Finland
Cozaar 50 mg kalvopäällysteiset tabletit
Finland
Cozaar 100 mg kalvopäällysteiset tabletit
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 Authorisation Holder

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 filmdragerade tabletter
Sweden
COZAAR 50 mg filmdragerade tabletter
Sweden
COZAAR 100 mg filmdragerade tabletter

Date of last revision of the leaflet: 01/2025