Package Insert: Information for the Patient

COZAAR PLUS 50mg/12,5mg Film-Coated Tablets

losartán potassium and hydrochlorothiazide

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section4.

Cozaar Plus is a combination of an angiotensin II receptor antagonist (losartán) and a diuretic (hydrochlorothiazide). 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. Losartán prevents the binding of angiotensin II to these receptors, causing blood vessels to relax, which in turn reduces blood pressure. Hydrochlorothiazide causes the kidneys to eliminate a greater amount of water and salts. This also helps to reduce blood pressure.

Cozaar Plus is indicated for the treatment of essential hypertension (high blood pressure).

Do not take Cozaar Plus

• if you are allergic to losartan, hydrochlorothiazide, or any of the other ingredients in this medication (listed in section6),
• if you are allergic to other sulfonamide-derived substances (e.g. other thiazides, some antibacterial medications such as cotrimoxazole, ask your doctor if you are unsure),
• if you have severe liver failure,
• if you have low levels of potassium or sodium or high levels of calcium that cannot be corrected with treatment,
• if you have gout,
• if you are more than 3months pregnant (It is also best to avoid Cozaar Plus at the beginning of pregnancy – see sectionpregnancy),
• if you have severe kidney failure or your kidneys do not produce urine,
• if you have diabetes or kidney failure and are being treated with a medication to lower blood pressure that contains aliskiren.

Warnings and precautions

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

If you experience a decrease in vision or eye pain, these may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in eye pressure, which can occur within a few hours to several weeks after taking Cozaar Plus. If left untreated, this can lead to permanent vision loss. You may be at a higher risk of developing this if you have previously had an allergy to penicillin or sulfonamide.

You should inform your doctor if you think you may be pregnant (or could be). Cozaar Plus is not recommended at the beginning of pregnancy and should not be taken if you are more than 3months pregnant, as it can cause severe damage to your baby if used during this stage (see sectionPregnancy).

It is essential to inform your doctor before taking Cozaar Plus:

• if you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking Cozaar Plus, seek medical attention immediately.
• if you have previously experienced swelling of the face, lips, tongue, or throat;
• if you are taking diuretics (medications to urinate);
• if you follow a low-sodium diet;
• if you have had excessive vomiting and/or diarrhea;
• if you have heart failure;
• if your liver function is altered (see section2 “Do not take Cozaar Plus”);
• if you have narrowed arteries (arterial stenosis), if you only have one functioning kidney, or if you have recently undergone a kidney transplant;
• if you have atherosclerosis, angina pectoris (chest pain due to heart dysfunction);
• if you have “aortic or mitral valve stenosis” (narrowing of the heart valves) or “hypertrophic cardiomyopathy” (a disease causing heart muscle thickening);
• if you are diabetic;
• if you have had gout;
• if you have or have had an allergic reaction, asthma, or a condition causing joint pain, skin eruptions, and fever (systemic lupus erythematosus);
• if you have high calcium levels or low potassium levels, or if you follow a low-potassium diet;
• if you need anesthesia (even for dental procedures) or before surgery, or if you are undergoing tests to determine your parathyroid function, inform your doctor or healthcare provider that you are taking losartan potassium and hydrochlorothiazide tablets;
• if you have primary aldosteronism (a syndrome associated with elevated aldosterone hormone secretion by the adrenal gland due to glandular alteration);
• if you are taking any of the following medications 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 electrolyte levels (e.g. potassium) at regular intervals.

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

• if you are taking other medications that may increase serum potassium levels (see section 2 “Taking Cozaar Plus with other medications”);
• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Cozaar Plus.

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

Children and adolescents

There is no experience with the use of Cozaar Plus in children. Therefore, Cozaar Plus should not be administered to children.

Other medications and Cozaar Plus

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

Inform your doctor if you are taking potassium supplements, salt substitutes containing potassium, potassium-sparing medications, or other medications that may increase serum potassium levels (e.g. trimethoprim medications), as it is not recommended to combine these with Cozaar Plus.

Diuretics like hydrochlorothiazide in Cozaar Plus may interact with other medications.

Preparations containing lithium should not be taken with Cozaar Plus without close medical supervision.

You may need to take special precautions (e.g. blood tests) if you are taking other diuretics (“urine tablets”), some laxatives, medications for gout, medications to control heart rhythm or diabetes (oral medications or insulin).

It is also essential that your doctor knows if you are taking:

• other medications to lower your blood pressure;
• steroids;
• medications for cancer;
• medications for pain;
• medications for fungal infections;
• medications for arthritis;
• resins used for high cholesterol, such as cholestyramine;
• muscle relaxants;
• sleeping pills;
• opioid medications like morphine;
• "pressor amines" like adrenaline or other medications in the same group;
• oral diabetes medications or insulin.

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

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

When taking Cozaar Plus, inform your doctorif you are to have a radiographic examination with a contrast medium containing iodine.

Taking Cozaar Plus with food and drinks

It is recommended that you do not drink alcohol while taking these tablets: alcohol and Cozaar Plus tablets may increase the effectsofeach other.

Excessive salt in the diet may counteract the effect of Cozaar Plus tablets.

Cozaar Plus tablets can be taken with or without food.

You should avoid grapefruit juice while taking Cozaar Plus.

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you think you may be pregnant (or could be). Normally, your doctor will advise you to stop taking Cozaar Plus before becoming pregnant or as soon as you know you are pregnant and will advise you to take another medicationinsteadof Cozaar Plus. Cozaar Plus is not recommended during pregnancy and should not be taken if you are more than 3months pregnant, as it can cause severe damage to your baby if used from the third month of pregnancy.

Breastfeeding

Inform your doctor if you arebreastfeedingor are about to startbreastfeeding. Cozaar Plus is not recommended for breastfeeding mothers and your doctor may choose another treatment if you wish tocontinue breastfeeding.

Use in elderly patients

Cozaar Plus works in the same way and is equally well tolerated by most elderly patients and young adults. Most elderly patients require the same dose as younger patients.

Driving and operating machinery

When starting treatment with this medication, you should not perform tasks that require special attention (e.g. driving a car or operating hazardous machinery) until you know how you tolerate your medication.

Cozaar Plus contains lactose

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

Use in athletes: This medication contains hydrochlorothiazide, which may produce a positive result in doping control tests.

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

Hypertension

For most patients with high blood pressure, the usual dose is 1tablet of Cozaar Plus 50mg/12,5mg per day to control blood pressure for 24hours. It can be increased to 2film-coated tablets of 50mg of losartan/12,5mg of hydrochlorothiazide per day or changed to 1film-coated tablet of 100mg of losartan/25mg of hydrochlorothiazide (a higher dose) per day. The maximum daily dose is 2film-coated tablets of 50mg of losartan/12,5mg of hydrochlorothiazide per day or 1film-coated tablet of 100mg of losartan/25mg of hydrochlorothiazide per day.

Administration

The tablets should be swallowed whole with a glass of water.

If you takemoreCozaar Plus than you should

In case of an overdose, contact your doctor immediately for immediate medical attention. An overdose may cause a drop in blood pressure, palpitations, slow pulse, changes in blood composition, and dehydration.

You can also call the Toxicological Information Service. Phone: (91) 562 04 20, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Cozaar Plus

Try to take Cozaar Pluseveryday, as prescribed. However, if you forget a dose, do not take an extra dose. Simply return to your regular schedule.

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

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

Severe allergic reaction (skin 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 1patient in 10,000, but fewer than 1patient in 1,000. You may need urgent medical attention or hospitalization.

Very rare (may affect up to 1 in 10,000people):

Acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion).

Other side effectsthat may occur:

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

• Cough, upper respiratory tract infection, nasal congestion, sinusitis, breast tenderness;
• Diarrhea, abdominal pain, nausea, indigestion;
• Muscle pain or cramps, leg pain, back pain;
• Insomnia, headache, dizziness;
• Weakness, fatigue, chest pain;
• High potassium levels (which may cause abnormal heart rhythm), decreased hemoglobin levels;
• Changes in renal functionthat includerenal insufficiency;
• Low blood sugar (hypoglycemia).

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

• Anemia, red or brown spots on the skin (sometimes especially on the feet, legs, arms, and buttocks, with joint pain, swelling of the hands and feet, and abdominal pain), hematoma, reduced white blood cells, coagulation problems, reduced platelets;
• Loss of appetite, high uric acid levels or manifest gout, high blood glucose levels, abnormal electrolyte levels in the blood;
• Anxiety, nervousness, panic attacks (recurring panic attacks), confusion, depression, abnormal dreams, sleep disorders, somnolence, memory alteration;
• Tickling or similar sensations, limb pain, tremor, migraine, fainting;
• Blurred vision, eye itching or stinging, conjunctivitis, worsening vision, seeing things in yellow;
• Ringing, buzzing, noises, or crackling in the ears, vertigo;
• Low blood pressure that may be associated with changes in posture (feeling dizzy or weak when standing up), angina (chest pain), abnormal heartbeats, stroke (transient ischemic attack (TIA), "mini-ictus"), heart attack, palpitations;
• Inflammation of blood vessels that often occurs with a skin rash or hematoma;
• Throat pain, shortness of breath, bronchitis, pneumonia, fluid in the lungs (causing difficulty breathing), nasal bleeding, runny nose, congestion;
• Constipation, chronic constipation, gas, stomach disorders, stomach spasms, vomiting, dry mouth, salivary gland inflammation, tooth pain;
• Jaundice (yellow discoloration of the eyes andskin), pancreatitis;
• Urticaria, itching, skin inflammation, skin rash, skin redness, light sensitivity, dry skin, flushing, sweating, hair loss;
• Arm, shoulder, hip, knee, or other joint pain, joint swelling, stiffness, muscle weakness;
• Frequent urination even at night, abnormal renal functionthat includeskidney inflammation, urinary tract infection, sugar in the urine;
• Decreased libido, impotence;
• Swelling of the face, localized swelling (edema), fever.

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

• Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.
• Hepatitis (liver inflammation), abnormal liver function tests.

Unknown (frequency cannot be estimated from available data):

• Symptoms similar to the flu;
• Muscle pain of unknown origin with dark-colored urine (tea-colored urine) (rhabdomyolysis);
• Low sodium levels in the blood (hyponatremia);
• Generally feeling unwell (malaise);
• Alteration of taste (dysgeusia);
• Skin cancer and lip cancer (non-melanoma skin cancer);
• Decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma).

Reporting of 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 after CAD. The expiration date is the last day of the month indicated.

Blister

Store Cozaar Plus in the original packaging to protect it from light and moisture. Do not store the packaging at a temperature above 30 °C.

Bottle

Store in the original packaging to protect it from light. Keep the bottle perfectly closed to protect it from moisture. Do not store the bottle at a temperature above 25 °C.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and medicines that you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. In this way, you will help protect the environment.

Composition of Cozaar Plus

The active ingredients are losartan potassium and hydrochlorothiazide.

Each tablet of Cozaar Plus contains, as active ingredients, 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide.

Cozaar Plus contains the following inactive ingredients: microcrystalline cellulose (E-460), lactose monohydrate, pregelatinized cornstarch, magnesium stearate (E-572), hydroxypropyl cellulose (E-463), hypromellose (E-464).

Cozaar Plus contains 4.24 mg (0.108 mEq) of potassium.

Cozaar Plus also contains titanium dioxide (E-171), yellow iron oxide (E-104) and carnauba wax (E-903).

Appearance of the product and contents of the package

Cozaar Plus is supplied as film-coated tablets, yellow, oval-shaped, engraved with “717” on one face and smooth or scored on the other.The score should not be used to break the tablet.

Cozaar Plus is supplied in the following package sizes:

PVC/PE/PVDC blister with an aluminum foil, in boxes containing 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 98, or 280 tablets and hospital unit dose 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 and in the United Kingdom (Northern Ireland) under the following names:

Last revision date of thissummary of product characteristics:03/2025.

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