COZAAR 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

COZAAR 12.5mg STARTING coated tablets

COZAAR 50mg coated tablets

COZAAR 100mg 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

1. What is Cozaar and what is it used for
2. What you need to know before you take Cozaar
3. How to take Cozaar
4. Possible side effects
5. Storing Cozaar
6. Contents of the pack 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 binds to receptors in blood vessels, causing them to narrow. This results in an increase in blood pressure. Losartan prevents angiotensin II from binding to these receptors, which causes the blood vessels to relax, thereby lowering blood pressure. Losartan reduces 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 from 6 to 18 years.
• to protect the kidneys in hypertensive patients with type 2 diabetes with clinical laboratory evidence of renal impairment and proteinuria ≥ 0.5 g/day (a disease in which the urine contains an abnormal amount of protein).
• to treat patients with chronic heart failure, when your doctor considers that treatment with specific medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors, medicines used to lower high blood pressure) is not suitable. 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 increased thickness 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 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 better to avoid Cozaar at the start of pregnancy - see Pregnancy),
• if your liver function is severely impaired,
• if you have diabetes or kidney impairment and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you start taking Cozaar.

You should inform your doctor if you think you are pregnant (or might become pregnant). Cozaar is not recommended at the start of 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 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 causes 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 on a low-salt diet that causes excessive loss of fluids and salt in your body (see section 3 "Dosage in special patient groups"),
• if you know you have narrowing or blockage of the blood vessels that supply your kidneys or if you have recently had a kidney transplant,
• if your liver function is impaired (see sections 2 "Do not take Cozaar" and 3 "Dosage in special patient groups"),
• if you have chronic heart failure with or without kidney impairment or potentially life-threatening heart rhythm disorders. Special attention is needed when you are being treated at the same time with a beta-blocker,
• if you have problems with the valves in your heart or with the heart muscle,
• 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 high secretion of the hormone aldosterone by the adrenal gland due to a disorder of this gland),
• 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), especially if you have kidney problems related to diabetes
  • aliskiren.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (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 potassium levels in your blood (see section 2 "Taking Cozaar with other medicines").

Talk to 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 is limited data available in these patient groups. Cozaar is not recommended for use in children under 6 years of age, as it has not been shown to work in this age group.

Other medicines and Cozaar

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

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

While you are being treated with Cozaar, be particularly careful if you are taking any of the following medicines:

• other medicines that lower blood pressure, as they may cause additional lowering of 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 medicines, such as indomethacin, including COX-2 inhibitors (medicines that reduce inflammation and can be used to relieve pain), as they may reduce the blood pressure-lowering effect of losartan.

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

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

If your kidney function is impaired, taking these medicines together may lead to a worsening of kidney function.

Medicines that contain lithium should not be taken in combination with losartan without your doctor's close supervision. It may be necessary to take special precautions (e.g., blood tests).

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

Tell your doctor if you think you are pregnant (or might become pregnant). Normally, your doctor will 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. Cozaar is not recommended at the start of 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.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. Cozaar is not recommended for mothers who are breastfeeding, and your doctor may choose another treatment if you want to continue breastfeeding. Especially if your child is a newborn or was born prematurely.

Talk to 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, as with many medicines used to treat high blood pressure, losartan may cause dizziness or drowsiness in some people. If you experience dizziness or drowsiness, talk to your doctor before performing these activities.

Cozaar contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, talk to your doctor before taking this medicine.

3. How to take Cozaar

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist. Your doctor will decide the appropriate dose of Cozaar, depending on your condition and whether you are taking other medicines. It is important to keep taking Cozaar while your doctor prescribes it to you to maintain constant control of your blood pressure.

Adult patients with high blood pressure

Normally, treatment starts 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. After that, 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 think the effect of losartan is too strong or too weak, talk to your doctor or pharmacist.

Use in children and adolescents

Children under 6 years

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

Children aged 6-18 years

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

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

Adult patients with high blood pressure and type 2 diabetes

Normally, treatment starts with 50 mg of losartan (one Cozaar 50 mg tablet) once a day. After that, 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 given with other medicines that lower blood pressure (e.g., diuretics, calcium channel blockers, alpha or beta blockers, and centrally acting agents), as well as with insulin and other medicines frequently used to lower blood glucose levels (e.g., sulfonylureas, glitazones, and glucosidase inhibitors).

Adult patients with heart failure

Normally, treatment starts with 12.5 mg of losartan (one Cozaar 12.5 mg STARTING tablet) once a day. Normally, the dose should be gradually 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, 150 mg per day 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 and one Cozaar 50 mg tablet) can be used once a day.

In the treatment of heart failure, losartan is normally combined with a diuretic (a medicine that increases the amount of water that passes through your kidneys) and/or digitalis (a medicine that helps your heart be 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 treated with high-dose diuretics, patients with liver impairment, or patients over 75 years of age. The use of losartan is not recommended in patients with severe liver 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 keep taking Cozaar until your doctor tells you to stop.

If you take more Cozaar than you should

If you accidentally take too many tablets, contact your doctor immediately. The symptoms of overdose are 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 medicine and the amount taken. It is recommended to take the packaging and the leaflet of the medicine to the healthcare professional.

If you forget to take Cozaar

If you accidentally miss a dose, simply take the next dose as normal. Do not take a double dose to make up for missed doses. If you have any other 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 all people suffer from them.

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

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

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

The following adverse effects have been reported with Cozaar:

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

• dizziness,
• low blood pressure (especially after excessive loss of water from the body within the blood vessels, e.g., in patients with severe heart failure or undergoing high-dose diuretic treatment),
• dose-related orthostatic effects, such as decreased 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 renal function, including renal failure,
• reduced red blood cell count (anemia),
• increased blood urea, serum creatinine, and serum potassium levels in patients with heart failure.

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

• drowsiness,
• headache,
• sleep disorders,
• 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 the blood vessels (vasculitis, including Schönlein-Henoch purpura),
• numbness or tingling sensation (paresthesia),
• fainting (syncope),
• very rapid and irregular heartbeats (atrial fibrillation),
• stroke (stroke),
• inflammation of the liver (hepatitis),
• elevation of alanine aminotransferase (ALT) levels in blood, which usually resolves upon discontinuation of treatment.

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

• reduced platelet count,
• migraine,
• abnormal liver function,
• muscle and joint pain,
• flu-like symptoms,
• back pain and urinary tract infection,
• increased sensitivity to sunlight (photosensitivity),
• muscle pain of unknown origin with dark-colored urine (tea-colored) (rhabdomyolysis),
• impotence,
• inflammation of the pancreas (pancreatitis),
• low sodium levels in blood (hyponatremia),
• depression,
• generally feeling unwell (malaise),
• ringing, buzzing, noise, or clicking in the ears (tinnitus),
• alteration of taste (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 can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Cozaar

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date stated on the packaging or on the label of the bottle. The expiration date is the last day of the month indicated.

Blister:

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

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

Bottles:

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

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Cozaar

The active ingredient is losartan potassium.

Each Cozaar 12.5 mg INITIAL 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 (E-460), lactose monohydrate (see section 2 "Cozaar contains lactose"), pregelatinized corn starch, magnesium stearate (E-572), hydroxypropyl cellulose (E-463), and hypromellose (E-464).

Cozaar 12.5 mg INITIAL, 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 INITIAL tablets also contain carnauba wax (E-903), titanium dioxide (E-171), and aluminum lake of 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 Package Contents

Cozaar 12.5 mg INITIAL is supplied as film-coated tablets without a score, 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, non-scored tablets containing 100 mg of losartan potassium.

Cozaar is available in the following package sizes:

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

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

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

Date of Last Revision of this Leaflet:03/2025.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)