Label: information for the user

COZAAR 12.5mg FILM-COATED tablets

COZAAR 50mg FILM-COATED tablets

COZAAR 100mg FILM-COATED tablets

losartan potassium

Read this label carefully before you start taking this medicine, because it contains important information for you.

• Keep this label, as 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 others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, ask your doctor, pharmacist or nurse, even if they are not listed in this label. See section 4.

Losartan (Cozaar) belongs to a group of medications called angiotensin II receptor antagonists. Angiotensin II is a substance produced in the body that binds to receptors present in blood vessels, causing them to constrict. This results in an increase in blood pressure. Losartan prevents the binding of angiotensin II to these receptors, causing blood vessels to relax, which in turn reduces blood pressure. Losartan reduces the worsening of renal function in patients with high blood pressure and type 2 diabetes.

Cozaar is used

• to treat patients with elevated 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 and clinical tests indicating renal insufficiency and proteinuria ≥ 0.5 g per day (a disease in which the urine contains an abnormal amount of proteins).
• to treat patients with chronic heart failure, when their doctor considers that treatment with specific medications, called angiotensin-converting enzyme inhibitors (ACE inhibitors, medications used to reduce elevated blood pressure) are not suitable. If their heart failure has been stabilized with an ACE inhibitor, they should not be switched to losartan.
• in patients with elevated blood pressure and left ventricular hypertrophy of the heart, Cozaar has been shown to reduce the risk of stroke (“LIFE indication”).

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 at the beginning of pregnancy - see Pregnancy),
• if your liver function is severely impaired,
• if you have diabetes or kidney failure and are being treated with a blood pressure medication that contains aliskirén.

Warnings and precautions

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

You should inform your doctor if you think you are pregnant (or may be). Cozaar is not recommended at the beginning of pregnancy, and should 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 essential that you inform your doctor before taking Cozaar:

• if you have had a history of angioedema (swelling of the face, lips, tongue and/or throat) (see also section 4 “Possible side effects”),
• if you have excessive vomiting or diarrhea, which cause excessive loss of fluid and/or salt from your body,
• if you are taking diuretics (medicines that increase the amount of water that passes through your kidneys) or if you are following a low-sodium diet that causes excessive loss of fluids and salt from your body (see section 3 “Posology in special patient groups”),
• if you know you have narrowing or blockage of the blood vessels that go to your kidneys or if you have recently had a kidney transplant,
• if your liver function is altered (see sections 2 “Do not take Cozaar” and 3 “Posology in special patient groups”),
• if you have heart failure with or without kidney failure or potentially fatal cardiac arrhythmias. Special attention is required when you are being treated at the same time with a beta-blocker,
• if you have problems with your heart valves or heart muscle,
• if you have coronary heart disease (caused by reduced blood flow in the heart's blood vessels) or cerebrovascular disease (caused by reduced blood circulation in the brain),
• if you have primary aldosteronism (a syndrome associated with an elevated secretion of the hormone aldosterone by the adrenal gland due to an alteration of this gland),
• if you are taking any of the following medicines used to treat high blood pressure:
• • a converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), in particular if you have kidney problems related to diabetes
  • aliskirén.

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 levels (see section 2 “Taking Cozaar with other medicines”).

Consult your doctor if you experience abdominal pain, nausea, vomiting or diarrhea 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 more information, talk to your doctor.

Cozaar is not recommended for use in children with kidney or liver problems, as there are limited data available in these patient groups. Cozaar is not recommended for use in children under 6 years, as it has not been shown to be effective in this age group.

Other medicines and Cozaar

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine.

Inform your doctor if you are taking potassium supplements, salt substitutes that contain potassium or potassium-sparing medicines such as certain diuretics (amilorida, triamtereno, espironolactona) or other medicines that may increase serum potassium levels (e.g. heparin, medicines containing trimetoprim), as the combination with Cozaar is not recommended.

While taking Cozaar, be especially careful 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 decrease with some of the following medicines/classes of medicines: tricyclic antidepressants, antipsychotics, baclofeno, amifostina,
• non-steroidal anti-inflammatory drugs, such as indometacina, including COX-2 inhibitors (medicines that reduce inflammation and that 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 ACE inhibitor or aliskirén (see also the information under the headings “Do not take Cozaar” and “Warnings and precautions”).

If your kidney function is impaired, the concomitant use of these medicines may lead to a worsening of kidney function.

Lithium-containing medicines should not be taken in combination with losartan without close supervision by your doctor. It may be necessary to take special precautions (e.g. blood tests).

Taking Cozaar with food and drinks

Cozaar can be taken with or without food.

Avoid grapefruit juice while taking Cozaar.

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you think you are pregnant (or may be). Normally, your doctor will advise you to stop taking Cozaar before becoming pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Cozaar. Cozaar is not recommended at the beginning of pregnancy, and should 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.

Breastfeeding

Inform your doctor if you are breastfeeding or are about to start breastfeeding. Cozaar is not recommended for use in breastfeeding mothers and your doctor may choose another treatment if you wish to continue breastfeeding. Especially if your baby is a newborn or premature.

Consult your doctor or pharmacist before using this medicine.

Driving and operating machines

No studies have been conducted on the effects on the ability to drive and use machines.

It is unlikely that Cozaar will affect your ability to drive or use machines. However, as 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 performing these activities.

Cozaar contains lactose

This medicine contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult him before taking this medicine.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Your doctor will decide the appropriate dose of Cozaar, depending on your condition and if you are taking other medications. It is essential to continue taking Cozaar as prescribed by your doctor to maintain constant blood pressure control.

Adult patients with high blood pressure

Typically, treatment begins with 50 mg of losartan (one Cozaar 50 mg tablet) once a day. The maximum blood pressure-lowering effect should be achieved within 3-6 weeks of 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 a day.

If you estimate that the losartan action is too strong or too weak, inform your doctor or pharmacist.

Use in children and adolescents

Children under 6 years

Cozaar is not recommended for use in children under 6 years, as it has not been shown to be effective in this age group.

Children aged 6-18 years

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

Other forms of this medication may be more suitable for children; ask your doctor or pharmacist.

Adult patients with high blood pressure and type 2 diabetes

Typically, treatment begins with 50 mg of losartan (one Cozaar 50 mg tablet) once a day. Afterwards, 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 your blood pressure response.

Losartan can be taken with other medications that lower blood pressure (e.g., diuretics, calcium channel blockers, alpha or beta blockers, and central-acting medications), as well as with insulin and other medications frequently used to reduce blood glucose levels (e.g., sulfonylureas, glitazones, and glucosidase inhibitors).

Adult patients with heart failure

Typically, treatment begins with 12.5 mg of losartan (one Cozaar 12.5 mg INIT tablet) once a day. Typically, the dose should be increased gradually, 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, 150 mg per day during the fifth week), 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 and one Cozaar 50 mg tablet) once a day may be used.

In the treatment of heart failure, losartan is usually combined with a diuretic (a medication that increases the amount of water that passes through your kidneys) and/or digitalis (a medication that helps your heart be stronger and more efficient) and/or a beta blocker.

Posology in special patient groups

Your doctor may recommend a lower dose, especially when starting treatment in certain patients, such as those treated with high doses of diuretics, in patients with liver insufficiency, or in patients over 75 years old. Losartan is not recommended for use in patients with severe liver insufficiency (see "Do not take Cozaar").

Administration

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 essential to continue taking Cozaar until 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 can also call the Toxicology Information Service. Phone: (91) 562 04 20, indicating the medication and the amount taken. You will be advised to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Cozaar

If you accidentally forget a dose, simply take the next dose as usual. Do not take a double dose to compensate for the missed doses. If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines,this medicinecan cause side effects, although not everyone will experience them.

If you experience any of the following, stop taking losartan tablets and inform your doctor immediately or go to the emergency service of your nearest hospital:

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

This is a serious but rare side effect that affects more than 1 in 10,000 patients but fewer than 1 in 1,000. You may need urgent medical attention or hospitalization.

The following side effects have been reported with Cozaar:

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

• dizziness,
• low blood pressure (especially after excessive loss of body water within blood vessels, e.g. in patients with severe heart failure or those taking high doses of diuretics),
• orthostatic effects related to the dose, such as a decrease in blood pressure that occurs after standing up from lying down or sitting,
• weakness,
• fatigue,
• low blood sugar (hypoglycemia),
• high potassium levels in the blood (hyperkalemia),
• changes in kidney function that include kidney failure,
• reduced red blood cell count (anemia),
• increased urea in the blood, serum creatinine, and serum potassium in patients with heart failure.

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

• drowsiness,
• headache,
• sleep disturbances,
• feeling of very rapid heartbeats (palpitations),
• severe chest pain (angina pectoris),
• difficulty breathing (dyspnea),
• abdominal pain,
• constipation,
• diarrhea,
• nausea,
• vomiting,
• hives (urticaria),
• itching (pruritus),
• rash,
• localized swelling (edema),
• cough.

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

• hypersensitivity,
• angioedema,
• intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea,
• inflammation of blood vessels (vasculitis, including Schönlein-Henoch purpura),
• numbness or tingling (paresthesia),
• syncope (fainting),
• very rapid and irregular heartbeats (atrial fibrillation),
• stroke (cerebral infarction),
• inflammation of the liver (hepatitis),
• elevation of alanine aminotransferase (ALT) levels in the blood, which usually resolves upon discontinuing treatment.

Unknown frequency (frequency cannot be estimated from available data):

• reduced platelet count,
• migraine,
• liver function abnormalities,
• muscle and joint pain,
• flu-like symptoms,
• back pain and urinary tract infection,
• increased sensitivity to sunlight (photosensitivity),
• unknown muscle pain with dark-colored urine (rhabdomyolysis),
• impotence,
• pancreatitis (inflammation of the pancreas),
• low sodium levels in the blood (hyponatremia),
• depression,
• usually feeling unwell (malaise),
• ringing, buzzing, or clicking sounds in the ears (tinnitus),
• alteration of taste (dysgeusia).

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

Reporting side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging or on the bottle label. The expiration date is 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 medication.

Bottles:

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

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

Medicines should not be disposed of through the drains or in the trash. Dispose of the containers and unused medications at the SIGRE drop-off point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medications. By doing so, you will help protect the environment.

Cozaar Composition

The active ingredient is losartan potassium.

Each Cozaar tablet 12.5 mg INICIO contains 12.5 mg of losartan potassium.

Each Cozaar tablet 50 mg contains 50 mg of losartan potassium.

Each Cozaar tablet 100 mg contains 100 mg of losartan potassium.

The other components are microcrystalline cellulose (E-460), lactose monohydrate (see section 2 “Cozaar contains lactose”), pregelatinized cornstarch, magnesium stearate (E-572), hydroxypropyl cellulose (E-463), and 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 aluminum lake of indigo carmine (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).

Appearance of the product and contents of the package

Cozaar 12.5 mg INICIO is supplied as uncoated tablets with a film coating that contain 12.5 mg of losartan potassium.

Cozaar 50 mg is supplied as scored coated tablets that contain 50 mg of losartan potassium. The score line should not be used to break the tablet.

Cozaar 100 mg is supplied as uncoated tablets with a film coating that contain 100 mg of losartan potassium.

Cozaar is supplied in the following package sizes:

• Cozaar 12.5 mg INICIO - blister PVC/PE/PVDC with an aluminum foil, in boxes of 7, 14, 21, 28, 50, 98, 210, or 500 tablets and a 28-tablet hospital pack. HDPE bottle of 100 tablets.
• Cozaar 50 mg - blister PVC/PE/PVDC with an aluminum foil, in boxes of 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 280, or 500 tablets and hospital packs of 28, 56, and 98 tablets. HDPE bottles of 100 or 300 tablets.
• Cozaar 100 mg - blister PVC/PE/PVDC with an aluminum foil, in boxes of 7, 10, 14, 15, 20, 28, 30, 50, 56, 84, 90, 98, or 280 tablets and hospital packs of 28, 56, and 98 tablets. HDPE bottle of 100 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

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

Last revision date of this leaflet:03/2025.

For detailed and updated information on this medicinal product, please consult the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)(http://www.aemps.gob.es/)