Cozaar 50 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

COZAAR 12.5mg INICIO film-coated tablets

COZAAR 50mg film-coated tablets

COZAAR 100mg 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 questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. 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 called angiotensin II receptor antagonists. Angiotensin II is a substance produced in the body that binds to receptors in the blood vessels, causing them to narrow. This leads to an increase in blood pressure. Losartan blocks angiotensin II from binding to these receptors, resulting in relaxation of the blood vessels, which in turn lowers blood pressure. Losartan slows the worsening of kidney function in patients with high blood pressure and type 2 diabetes.

Cozaar is used

• to treat patients with high blood pressure (hypertension) in adults and in children and adolescents aged 6 to 18 years.
• to protect the kidneys in hypertensive patients with type 2 diabetes who have laboratory test results indicating kidney impairment 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 your doctor considers treatment with specific medicines called angiotensin-converting enzyme (ACE) inhibitors (medicines used to lower high blood pressure) to be unsuitable. If your heart failure has been stabilized with an ACE inhibitor, you should not be switched to losartan.
• in patients with high blood pressure and thickening of the left ventricle of the heart, Cozaar has been shown to reduce the risk of stroke (“LIFE indication”).

2. What you need to know before taking 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 (Cozaar should also be avoided at the beginning of pregnancy – see Pregnancy),
• if you have severely impaired liver function,
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to take Cozaar.

You must inform your doctor if you think you may be pregnant (or could become pregnant). Cozaar is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at this stage (see section “Pregnancy”).

It is important that you inform your doctor before taking Cozaar:

• if you have previously had angioedema (swelling of the face, lips, tongue, and/or throat) (see also section 4 “Possible side effects”),
• if you are experiencing excessive vomiting or diarrhoea, which may lead to excessive fluid and/or salt loss from your body,
• if you are taking diuretics (medicines that increase the amount of fluid passing through your kidneys) or are on a low-salt diet that may cause excessive fluid and salt loss from your body (see section 3 “Dosage in special patient populations”),
• if you know you have narrowing or blockage of the blood vessels supplying your kidneys or have recently undergone a kidney transplant,
• if you have impaired liver function (see sections 2 “Do not take Cozaar” and 3 “Dosage in special patient populations”),
• if you have heart failure with or without kidney failure or potentially life-threatening concomitant cardiac arrhythmias. Special care is needed if you are also being treated with a beta-blocker,
• if you have heart valve problems or heart muscle disease,
• if you have coronary heart disease (caused by reduced blood flow in the blood vessels of the heart) or cerebrovascular disease (caused by reduced blood circulation in the brain),
• if you have primary hyperaldosteronism (a syndrome associated with excessive secretion of the hormone aldosterone by the adrenal gland due to adrenal dysfunction),
• if you are taking any of the following medicines used to treat high blood pressure:
  • an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes
  • aliskiren.

Your doctor may monitor your kidney function, blood pressure, and blood levels of electrolytes (e.g. potassium) at regular intervals.

See also the information under the heading “Do not take Cozaar”.

• if you are taking other medicines that may increase serum potassium (see section 2 “Taking Cozaar with other medicines”).

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhoea after taking Cozaar. Your doctor will decide whether to continue treatment. Do not stop taking Cozaar on your own.

Children and adolescents

Cozaar has been studied in children. For further information, speak with your doctor.

Cozaar is not recommended for use in children with kidney or liver problems, as there is limited data available in 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.

Other medicines and Cozaar

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Inform your doctor if you are taking potassium supplements, salt substitutes containing potassium, or potassium-sparing medicines such as certain diuretics (amiloride, triamterene, spironolactone), or other medicines that may increase serum potassium (e.g. heparin, medicines containing trimethoprim), as combination with Cozaar is not recommended.

While being treated with Cozaar, take special care if you are taking any of the following medicines:

• other medicines that lower blood pressure, as they may cause an additional reduction in blood pressure. Blood pressure may also be lowered by some of the following medicines/classes of medicines: tricyclic antidepressants, antipsychotics, baclofen, amifostine,
• non-steroidal anti-inflammatory drugs (NSAIDs), such as indomethacin, including COX-2 inhibitors (medicines that reduce inflammation and may be used to relieve pain), as they may reduce the blood pressure-lowering effect of losartan.

Your doctor may need to adjust your dose and/or take other precautions:

If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also information under the headings “Do not take Cozaar” and “Warnings and precautions”).

If you have impaired kidney function, concomitant use of these medicines may lead to worsening of kidney function.

Medicines containing lithium should not be taken together with losartan without close monitoring by your doctor. Special precautionary measures (e.g. blood tests) may be appropriate.

Taking Cozaar with food and drink

Cozaar can be taken with or without food.

Grapefruit juice should be avoided while taking Cozaar.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you think you may be pregnant (or could become pregnant). Your doctor will normally advise you to stop taking Cozaar before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of Cozaar. Cozaar is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used from the third month of pregnancy onwards.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding. Cozaar is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to continue breastfeeding, especially if your baby is a newborn or was born prematurely.

Consult your doctor or pharmacist before using this medicine.

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, like many medicines used to treat high blood pressure, losartan may cause dizziness or drowsiness in some people. If you experience dizziness or drowsiness, consult your doctor before carrying out such activities.

Cozaar contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Cozaar

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again. Your doctor will decide the appropriate dose of Cozaar depending on your condition and whether you are taking other medications. It is important to keep taking Cozaar as prescribed by your doctor to maintain consistent blood pressure control.

Adult patients with high blood pressure

Treatment usually starts with 50 mg of losartan (one Cozaar 50 mg tablet) once daily. The maximum blood pressure-lowering effect should be achieved within 3 to 6 weeks after starting treatment. Afterwards, 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 daily.

If you feel that the effect of losartan is too strong or too weak, inform 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 effectiveness has not been demonstrated in this age group.

Children aged 6–18 years

The recommended starting dose for patients weighing between 20 and 50 kg is 0.7 mg of losartan per kg of body weight, administered once daily (up to 25 mg of Cozaar). Your doctor may increase the dose if blood pressure is not adequately controlled.

Other pharmaceutical forms 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 50 mg of losartan (one Cozaar 50 mg tablet) once daily. Afterwards, the dose may be increased to 100 mg of losartan (two Cozaar 50 mg tablets or one Cozaar 100 mg tablet) once daily, depending on your blood pressure response.

Losartan may be administered together with other antihypertensive medicines (e.g., diuretics, calcium antagonists, alpha or beta blockers, and centrally acting agents), as well as with insulin and other commonly used glucose-lowering agents (e.g., sulfonylureas, glitazones, and alpha-glucosidase inhibitors).

Adult patients with heart failure

Treatment usually starts with 12.5 mg of losartan (one Cozaar 12.5 mg START tablet) once daily. The dose should usually be gradually increased on a weekly basis (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, and 150 mg daily during the fifth week), up to a maintenance dose determined by your doctor. A maximum dose of 150 mg of losartan (e.g., three Cozaar 50 mg tablets or one Cozaar 100 mg tablet plus one Cozaar 50 mg tablet) once daily may be used.

In the treatment of heart failure, losartan is usually combined with a diuretic (a medicine that increases the amount of fluid passing through your kidneys) and/or digitalis (a medicine that helps your heart to become stronger and more efficient) and/or a beta-blocker.

Dosage in special patient groups

Your doctor may recommend a lower dose, especially when starting treatment in certain patients, such as those receiving high-dose diuretics, patients with hepatic impairment, or patients over 75 years of age. The use of losartan is not recommended in patients with severe hepatic impairment (see section “Do not take Cozaar”).

Administration

The tablets should be swallowed whole with a glass of water. You should try to take your daily dose at approximately the same time each day. It is important that you continue taking Cozaar unless your doctor tells you otherwise.

If you take more Cozaar than you should

If you accidentally take too many tablets, contact your doctor immediately. Symptoms of overdose include low blood pressure, increased heart rate, and possibly decreased heart rate.

You may also call the Toxicology Information Service. Telephone: (91) 562 04 20, stating the name of the medicine and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you forget to take Cozaar

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

If you experience the following, stop taking losartan tablets immediately and contact your doctor right away or go to the nearest hospital emergency department:

A severe allergic reaction (rash, itching, swelling of the face, lips, mouth or throat, which may cause difficulty swallowing or breathing).

This is a serious but rare adverse effect, affecting more than 1 in 10,000 patients but less than 1 in 1,000. It may require urgent medical attention or hospitalization.

The following adverse effects have been reported with Cozaar:

Common (may affect up to 1 in 10 people):

• dizziness,
• low blood pressure (especially after excessive loss of fluid from the blood vessels, e.g. in patients with severe heart failure or those receiving high doses of diuretics),
• dose-related orthostatic effects, such as decreased blood pressure occurring after 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,
• reduced number of red blood cells (anaemia),
• increased blood urea, serum creatinine and serum potassium levels in patients with heart failure.

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

• somnolence,
• headache,
• sleep disorders,
• sensation of very rapid heartbeat (palpitations),
• severe chest pain (angina pectoris),
• difficulty breathing (dyspnoea),
• abdominal pain,
• constipation,
• diarrhoea,
• nausea,
• vomiting,
• hives (urticaria),
• itching (pruritus),
• rash,
• localized swelling (oedema),
• cough.

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

• hypersensitivity,
• angioedema,
• intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting and diarrhoea,
• inflammation of blood vessels (vasculitis, including Schönlein-Henoch purpura),
• numbness or tingling sensation (paraesthesia),
• fainting (syncope),
• very rapid and irregular heartbeat (atrial fibrillation),
• stroke (cerebrovascular accident),
• liver inflammation (hepatitis),
• increased levels of alanine aminotransferase (ALT) in blood, which usually resolves upon discontinuation of treatment.

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

• reduced number of platelets,
• migraine,
• abnormalities in liver function,
• muscle and joint pain,
• flu-like symptoms,
• back pain and urinary tract infection,
• increased sensitivity to sunlight (photosensitivity),
• unexplained muscle pain with dark-coloured urine (tea-coloured) (rhabdomyolysis),
• impotence,
• inflammation of the pancreas (pancreatitis),
• low sodium levels in blood (hyponatraemia),
• depression,
• general feeling of being unwell (malaise),
• ringing, buzzing, noise or clicking in the ears (tinnitus),
• taste disturbance (dysgeusia).

Adverse effects in children are similar to those observed in adults.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Cozaar

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the pack or on the label of the bottle. The expiry date refers to the last day of the month indicated.

Blister packs:

Store Cozaar in the original packaging to protect it from light and moisture.

Do not open the blister pack until you are ready to take the medicine.

Bottles:

Store Cozaar in the original packaging to protect it from light.

Do not store above 25 °C. Keep the bottle tightly closed to protect it from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point located at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Cozaar

The active substance is losartan potassium.

Each Cozaar 12.5 mg INICIO 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 components are microcrystalline cellulose (E-460), lactose monohydrate (see section 2 “Cozaar contains lactose”), pregelatinized maize starch, magnesium stearate (E-572), hydroxypropyl cellulose (E-463), hypromellose (E-464).

Cozaar 12.5 mg INICIO, 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 INICIO tablets also contain carnauba wax (E-903), titanium dioxide (E-171) and indigo carmine aluminium lake (E-132).

Cozaar 50 mg tablets also contain carnauba wax (E-903) and titanium dioxide (E-171).

Cozaar 100 mg tablets also contain carnauba wax (E-903) and titanium dioxide (E-171).

Nature of the product and pack sizes

Cozaar 12.5 mg INICIO is supplied as film-coated, unmarked tablets containing 12.5 mg of losartan potassium.

Cozaar 50 mg is supplied as film-coated, scored tablets containing 50 mg of losartan potassium. The score line is not intended for breaking the tablet.

Cozaar 100 mg is supplied as film-coated, unmarked tablets containing 100 mg of losartan potassium.

Cozaar is available in the following pack sizes:

• Cozaar 12.5 mg INICIO – PVC/PE/PVDC blister with an aluminium foil backing, in packs of 7, 14, 21, 28, 50, 98, 210 or 500 tablets and unit packs of 28 tablets for hospital use. HDPE bottle containing 100 tablets.
• Cozaar 50 mg – PVC/PE/PVDC blister with an aluminium foil backing, in packs of 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 280 or 500 tablets and unit packs of 28, 56 and 98 tablets for hospital use. HDPE bottles containing 100 or 300 tablets.
• Cozaar 100 mg – PVC/PE/PVDC blister with an aluminium foil backing, in packs of 7, 10, 14, 15, 20, 28, 30, 50, 56, 84, 90, 98 or 280 tablets and unit packs of 28, 56 and 98 tablets for hospital use. HDPE bottle containing 100 tablets.

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

This medicinal product is authorized in the European Economic Area member states under the following names:

Date of the last revision of this leaflet: 03/2025.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)