Cozaar

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
Please read this leaflet carefully before taking this medicine, as 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 COZAAR is and what it is used for
2. What you need to know before taking 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 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 down the progression of kidney damage in patients with high blood pressure and type 2 diabetes.
COZAAR is used:

• for the treatment of 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).
• for the treatment of patients with chronic heart failure when treatment with certain medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors, drugs used to reduce high blood pressure) is considered inappropriate by the physician. If heart failure has been stabilized with an ACE inhibitor, the medication should not be switched to losartan.
• in patients with high blood pressure and left ventricular hypertrophy, because COZAAR has been shown to reduce the risk of stroke ("LIFE indication").

2. Important information before using the medicine COZAAR

When not to use 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 during early pregnancy – see Pregnancy section),
• if the patient has severe liver function impairment,
• if the patient has diabetes or kidney function impairment 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 your doctor if you suspect (or are planning) pregnancy. Use of COZAAR 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 Pregnancy section).
It is important to inform your doctor before taking COZAAR:

• 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 is experiencing 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, which may lead to excessive fluid and salt loss from the body (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 impairment (see sections 2 "When not to use COZAAR" and 3 "Dosage in special patient groups"),
• if the patient has heart failure with or without kidney function impairment, or has concomitant severe, life-threatening heart rhythm disorders. Particular caution is required when treating concomitantly with β-blockers,
• if the patient has heart valve or myocardial (heart muscle) disorders,
• if the patient has ischaemic heart disease (caused by reduced blood flow in the blood vessels of the heart) or cerebrovascular disorders (caused by reduced blood circulation in the brain),
• if the patient has primary hyperaldosteronism (a syndrome caused by increased aldosterone secretion from the adrenal glands due to adrenal gland abnormalities),
• if the patient is taking any of the following medicines used to treat high blood pressure: an angiotensin-converting enzyme (ACE) inhibitor (e.g. enalapril, lisinopril, ramipril), particularly if the patient has kidney impairment related to diabetes, or aliskiren. The doctor may recommend regular monitoring of kidney function, blood pressure, and blood electrolyte levels (e.g. potassium). See also the section "When not to use COZAAR".
  • if the patient is taking other medicines that may increase serum potassium levels (see section 2 "COZAAR with other medicines").

If the patient experiences abdominal pain, nausea, vomiting, or diarrhoea after taking COZAAR, discuss this with the doctor. The doctor will decide whether to continue treatment. Do not make independent decisions to stop taking COZAAR.

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

COZAAR with other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
Inform your doctor about potassium supplements, potassium-containing salt substitutes, potassium-sparing medicines such as certain diuretics (amiloride, triamterene, spironolactone), or other medicines that may increase serum potassium levels (e.g. heparin, trimethoprim-containing medicines), as concomitant use with COZAAR is not recommended.
Exercise particular caution when using the following medicines during COZAAR treatment:

• other blood pressure-lowering medicines, as they may lead to additional blood pressure reduction. The following medicines/groups of medicines may also reduce blood pressure: tricyclic antidepressants, antipsychotics, baclofen, amifostine,
• non-steroidal anti-inflammatory drugs (NSAIDs) such as indomethacin, including COX-2 inhibitors (medicines reducing inflammation and used to relieve pain), as they may weaken the blood pressure-lowering effect of losartan.

The doctor may recommend adjusting the dose and/or taking additional precautions:

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

In patients with kidney function impairment, concomitant use of these medicines may lead to worsening of kidney function.
Do not use lithium-containing medicines in combination with losartan without strict medical supervision.
Special precautions (e.g. blood tests) may be necessary.

COZAAR with food and drink
COZAAR may be taken independently of meals.
Avoid drinking grapefruit juice while taking COZAAR.

Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you suspect (or are planning) pregnancy. The doctor will usually recommend discontinuing COZAAR before planned pregnancy or immediately after pregnancy is confirmed, and will recommend an alternative medicine. Use of COZAAR is not recommended during early pregnancy and must be avoided after the 3rd month of pregnancy, as it may seriously harm the unborn child.

Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Use of COZAAR is not recommended during breastfeeding, especially when breastfeeding a newborn or premature infant. The doctor may recommend an alternative medicine.
Consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
No studies have been conducted on the effect of COZAAR on the ability to drive or operate machinery.
It is unlikely that COZAAR 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.

COZAAR contains lactose
COZAAR contains lactose. If you have been diagnosed with an intolerance to certain 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,
you should consult your doctor or pharmacist. Your doctor will determine the appropriate dose of COZAAR
depending on your condition and other medicines you are taking. It is important to take COZAAR 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 tablet of COZAAR 50 mg) once daily.
The maximum blood pressure-lowering effect should occur within 3 to 6 weeks after starting treatment.
In some patients, the dose may then be increased to 100 mg losartan (two tablets of COZAAR 50 mg or one tablet of COZAAR 100 mg) once daily.
If you feel that 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
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 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,
given once daily (up to 25 mg of COZAAR). 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 tablet of COZAAR 50 mg) once daily.
The dose may then be increased to 100 mg losartan (two tablets of COZAAR 50 mg or one tablet of COZAAR 100 mg) once daily,
depending on the achieved change in blood pressure values.

Tablets containing losartan may be taken together 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 alpha-glucosidase inhibitors).

Adult patients with heart failure
Treatment usually starts with a dose of 12.5 mg losartan (one tablet of COZAAR 12.5 mg) once daily.
This dose should generally be gradually increased 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, 100 mg daily during the fourth week, 150 mg daily during the fifth week) until the maintenance dose is reached, as directed by your doctor. A maximum dose of 150 mg losartan (e.g. three tablets of COZAAR 50 mg or one tablet of COZAAR 100 mg and one tablet of COZAAR 50 mg) once daily may be used.

In the treatment of heart failure, losartan is usually used together with diuretics (medicines that increase the amount of water excreted by the kidneys) and/or digitalis glycosides (medicines that strengthen the heart, increase the force of heart contractions and improve heart function) and/or beta-blockers.

Dosing in special patient groups
Your doctor may recommend a lower dose, especially at the beginning of 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 hepatic impairment (see section "When not to take COZAAR").

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

Taking more COZAAR than recommended
If you accidentally take too many tablets, you should contact your doctor immediately. Symptoms of overdose include low blood pressure, rapid heartbeat, and possibly slow heartbeat.

Missing a dose of COZAAR
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 tablet.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

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 tablets
containing losartan immediately and consult a doctor or go to the emergency department
of the nearest hospital:
Severe allergic reactions (rash, itching, swelling of the face, lips, mouth or throat, which may cause
difficulty in swallowing or breathing).
This is a serious, but rare adverse effect occurring in more than 1 in 10,000
patients, but in fewer than 1 in 1,000 patients. Immediate medical attention
or hospitalization may be required.
The following adverse effects have been reported for the medicine 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 treated with high doses of diuretics),
• dose-dependent orthostatic symptoms, such as reduced blood pressure occurring when standing up from lying or sitting position,
• weakness,
• fatigue,
• low blood sugar (hypoglycaemia),
• high blood potassium (hyperkalaemia),
• changes in kidney function, including kidney failure,
• reduced number of red blood cells (anaemia),
• increased blood urea, serum creatinine and potassium levels in patients with heart failure.

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

• drowsiness,
• headache,
• sleep disorders,
• sensation of rapid heartbeat (palpitations),
• severe chest pain (angina pectoris),
• shortness of breath (dyspnoea),
• abdominal pain,
• constipation,
• diarrhoea,
• nausea,
• vomiting,
• urticaria,
• itching (pruritus),
• rash,
• localised 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 diarrhoea,
• vasculitis (including Schönlein-Henoch purpura),
• sensation of numbness or tingling (paraesthesiae),
• fainting,
• very fast and irregular heartbeat (atrial fibrillation),
• stroke,
• hepatitis,
• increased alanine aminotransferase (AlAT) activity in blood, usually resolving after discontinuation of treatment.

Unknown frequency (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),
• impotence,
• pancreatitis,
• low blood sodium levels (hyponatraemia),
• depression,
• general malaise,
• ringing, buzzing, humming or crackling in the ears (tinnitus),
• taste disturbances.

Adverse effects occurring in children are similar to those observed in adults.
If any adverse effects occur, including any possible adverse effects
not listed in the leaflet, consult a doctor, pharmacist or nurse.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed
in the 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 181C, 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 the medicine COZAAR

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or label of the bottle.
The expiry date refers to the last day of the specified month.
Blister packs:
Store COZAAR tablets in the original packaging to protect from light and moisture.
Do not open the blister packs until ready to take the medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Package contents and other information

What COZAAR contains
The active substance 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), monohydrate lactose (see section 2 "COZAAR contains lactose"), maize starch gelatinised, 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 aluminium lake (E132).
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 breakline, 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 division line is not intended for breaking the tablet.
COZAAR 100 mg is available as film-coated tablets without a breakline, containing 100 mg of losartan potassium.

The following pack sizes of COZAAR are available:

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

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Organon Polska Sp. z o.o.
ul. Marszałkowska 126/134
00-008 Warszawa
Tel.: +48 22 306 57 64
[email protected]

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

This medicinal product is authorised in the European Economic Area under the following trade names:

| Member State | Trade 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 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 | | 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 | | The Netherlands | COZAAR 12.5 mg | | The Netherlands | COZAAR 50 mg | | The 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 |