COZAAR PLUS 50 mg/12.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

COZAAR PLUS 50mg/12.5mg film-coated tablets

losartan potassium and hydrochlorothiazide

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 Plus and what is it used for
2. What you need to know before you take Cozaar Plus
3. How to take Cozaar Plus
4. Possible side effects
5. Storage of Cozaar Plus
6. Contents of the pack and other information

1. What is Cozaar Plus and what is it used for

Cozaar Plus is a combination of an angiotensin II receptor antagonist (losartan) and a diuretic (hydrochlorothiazide). 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. Hydrochlorothiazide causes the kidneys to remove more water and salts. This also helps to lower blood pressure.

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

2. What you need to know before you take Cozaar Plus

Do not take Cozaar Plus

• if you are allergic to losartan, hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6),
• if you are allergic to other sulfonamide-derived substances (e.g., other thiazides, some antibacterial medicines such as cotrimoxazole; ask your doctor if you are not sure),
• if you have severe hepatic impairment,
• if you have low levels of potassium or sodium or high levels of calcium that cannot be corrected by treatment,
• if you have gout,
• if you are more than 3 months pregnant (it is also better to avoid Cozaar Plus at the beginning of pregnancy – see the section on Pregnancy),
• if you have severe renal impairment or your kidneys are not producing urine,
• if you have diabetes or renal impairment and are being treated with a blood pressure-lowering medicine that contains aliskiren.

Warnings and precautions

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

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

You should inform your doctor if you think you are pregnant (or might become pregnant). Cozaar Plus is not recommended during 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.

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

• if you have had respiratory or lung 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 suffered from swelling of the face, lips, tongue, or throat;
• if you are taking diuretics (water pills);
• if you are on a low-salt diet;
• if you have had excessive vomiting and/or diarrhea;
• if you have heart failure;
• if your liver function is impaired (see section 2 "Do not take Cozaar Plus");
• if you have narrow arteries that supply blood to the kidneys (renal artery stenosis), if you only have one functioning kidney, or if you have recently had a kidney transplant;
• if you have narrowing of the arteries (atherosclerosis), angina pectoris (chest pain due to poor heart function);
• if you have "aortic or mitral valve stenosis" (narrowing of the heart valves) or "hypertrophic cardiomyopathy" (a disease that causes thickening of the heart muscle);
• if you are diabetic;
• if you have had gout;
• if you have or have had an allergic disorder, asthma, or a disease that causes joint pain, skin rashes, and fever (systemic lupus erythematosus);
• if you have high levels of calcium or low levels of potassium or are on a low-potassium diet;
• if you need to have anesthesia (even at the dentist) or before surgery, or if you are to have tests to determine your parathyroid function, you should inform your doctor or healthcare staff that you are taking losartan potassium and hydrochlorothiazide tablets;
• 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), particularly if you have diabetes-related kidney problems;
  • aliskiren.

Your doctor may check 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 Plus".

• if you are taking other medicines that may increase serum potassium levels (see section 2 "Taking Cozaar Plus with other medicines");
• 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 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 given to children.

Other medicines and Cozaar Plus

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, potassium-sparing medicines, or other medicines that may increase serum potassium levels (e.g., trimetoprim-containing medicines), as combination with Cozaar Plus is not recommended.

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

Preparations containing lithium should not be taken with Cozaar Plus without close supervision by your doctor.

Special precautions may be necessary (e.g., blood tests) if you are taking other diuretics ("water pills"), certain laxatives, medicines for treating gout, medicines for controlling heart rhythm, or diabetes medicines (oral or insulin).

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

• other medicines to lower your blood pressure;
• corticosteroids;
• medicines to treat cancer;
• medicines for pain relief;
• medicines to treat fungal infections;
• medicines for arthritis;
• cholesterol-lowering resins such as cholestyramine;
• muscle relaxants;
• sleeping pills;
• opioid medicines like morphine;
• "pressor amines" like adrenaline or other medicines of the same group;
• oral diabetes medicines or insulins.

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 Plus" and "Warnings and precautions").

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

Taking Cozaar Plus with food and drink

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

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

Cozaar Plus tablets can be taken with or without food.

Grapefruit juice should be avoided while taking Cozaar Plus.

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you think you are pregnant (or might become pregnant). Normally, your doctor will advise you to stop taking Cozaar Plus before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Cozaar Plus. Cozaar Plus is not recommended during 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 Plus is not recommended for breastfeeding mothers, and your doctor may choose another treatment if you wish to continue 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 using machines

When starting treatment with this medicine, do not perform tasks that require special attention (e.g., driving a car or using hazardous machinery) until you know how your medicine affects you.

Cozaar Plus contains lactose

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

Use in athletes: this medicine contains hydrochlorothiazide, which may produce a positive result in doping tests.

3. How to take Cozaar Plus

Follow exactly the instructions of administration of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Your doctor will decide the appropriate dose of Cozaar Plus, depending on your condition and whether you are taking other medicines. It is important to keep taking Cozaar Plus while your doctor prescribes it to maintain constant blood pressure control.

High blood pressure

For most patients with high blood pressure, the usual dose is 1 Cozaar Plus 50 mg/12.5 mg tablet per day to control blood pressure over 24 hours. This can be increased to 2 film-coated tablets of 50 mg losartan/12.5 mg hydrochlorothiazide per day or changed to 1 film-coated tablet of 100 mg losartan/25 mg hydrochlorothiazide (a stronger dose) per day. The maximum daily dose is 2 film-coated tablets of 50 mg losartan/12.5 mg hydrochlorothiazide per day or 1 film-coated tablet of 100 mg losartan/25 mg hydrochlorothiazide per day.

Administration

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

If you take more Cozaar Plus than you should

In case of overdose, contact your doctor immediately to receive immediate medical attention. Overdose can cause low blood pressure, palpitations, slow pulse, changes in blood composition, and dehydration.

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

If you forget to take Cozaar Plus

Try to take Cozaar Plus every day as prescribed. However, if you miss a dose, do not take an extra dose. Simply return to your usual schedule.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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

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

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

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

Other side effects that may occur:

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

• cough, infection of the upper respiratory tract, nasal congestion, sinusitis, sinus disorder;
• diarrhea, abdominal pain, nausea, indigestion;
• muscle pain or cramps, leg pain, back pain;
• insomnia, headache, dizziness;
• weakness, fatigue, chest pain;
• high levels of potassium (which can cause an abnormal heart rhythm), decrease in hemoglobin levels;
• changes in kidney function, including kidney failure;
• low blood sugar (hypoglycemia).

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

• 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), bruising, reduced white blood cell count, coagulation problems, low platelet count;
• loss of appetite, high levels of uric acid or gout, high blood sugar levels, abnormal blood electrolyte levels;
• anxiety, nervousness, panic disorders (recurrent panic attacks), confusion, depression, abnormal dreams, sleep disorders, somnolence, memory impairment;
• tingling or similar sensations, pain in the limbs, tremor, migraine, fainting;
• blurred vision, itching or burning in the eyes, conjunctivitis, worsening of vision, seeing things in yellow;
• ringing, buzzing, noises, or clicking in the ears, vertigo;
• low blood pressure that may be associated with postural changes (feeling dizzy or weak when standing up), angina (chest pain), abnormal heartbeats, stroke (transient ischemic attack (TIA), "mini-stroke"), heart attack, palpitations;
• inflammation of blood vessels that is often associated with a skin rash or bruising;
• sore throat, shortness of breath, bronchitis, pneumonia, fluid in the lungs (which can cause difficulty breathing), nosebleeds, runny nose, congestion;
• constipation, chronic constipation, gas, stomach disorders, stomach spasms, vomiting, dry mouth, inflammation of a salivary gland, toothache;
• jaundice (yellowing of the eyes and skin), pancreatitis;
• hives, itching, skin inflammation, skin rash, redness of the skin, sensitivity to light, dry skin, flushing, sweating, hair loss;
• pain in the arms, shoulders, hips, knees, or other joints, joint swelling, stiffness, muscle weakness;
• frequent urination even at night, abnormal kidney function, including kidney inflammation, urinary tract infection, sugar in the urine;
• decreased sexual desire, impotence;
• swelling of the face, localized swelling (edema), fever.

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

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

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

• flu-like symptoms;
• muscle pain of unknown origin with dark-colored urine (tea-colored) (rhabdomyolysis);
• low levels of sodium in the blood (hyponatremia);
• generally feeling unwell (malaise);
• alteration of taste (dysgeusia);
• skin 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 effusion) or acute angle-closure glaucoma).

Reporting of side effects:

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cozaar Plus

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

Do not use this medicine after the expiry date which is stated on the carton after CAD. The expiry 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 container at a temperature above 30 °C.

Bottle

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Cozaar Plus

The active ingredients are losartan potassium and hydrochlorothiazide.

Each Cozaar Plus tablet 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 corn starch, 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 quinoline aluminum lake (E-104), and carnauba wax (E-903).

Appearance of the Product and Package Contents

Cozaar Plus is supplied as film-coated tablets, yellow in color, oval in shape, engraved with "717" on one side and smooth or scored on the other. The score line is not intended for breaking the tablet.

Cozaar Plus is supplied in the following package sizes:

PVC/PE/PVDC blister pack with an aluminum foil, in boxes containing 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 98, or 280 tablets, and unit-dose packages of 28, 56, and 98 tablets for hospital use. HDPE bottle of 100 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 Areaandin the United Kingdom (Northern Ireland)under the following names:

Date of the last revision of thisleaflet: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/)