Cozaar Plus 50 mg/12.5 mg film-coated tablets

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

COZAAR PLUS 50mg/12.5mg Film-coated Tablets

losartan potassium and hydrochlorothiazide

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

• Keep this leaflet, 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 must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Cozaar Plus is and what it is 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 present in blood vessels, causing them to narrow. This leads to an increase in blood pressure. Losartan prevents angiotensin II from binding to these receptors, resulting in relaxation of the blood vessels, thereby lowering blood pressure. Hydrochlorothiazide causes the kidneys to eliminate increased amounts of water and salts. This also helps reduce blood pressure.

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

2. What you need to know before taking 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, certain antibacterial medicines 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 3 months pregnant (Cozaar Plus is also best avoided in early pregnancy – see section Pregnancy),
• if you have severe renal failure or your kidneys are not producing urine,
• 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 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 eye pressure, which may occur within hours to weeks after taking Cozaar Plus. If untreated, this may lead to permanent vision loss. Your risk may be higher if you have previously had an allergy to penicillin or sulfonamides.

You should inform your doctor if you think you are pregnant (or might be). Cozaar Plus is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to your baby if used at this stage (see section Pregnancy).

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

• if you have previously had breathing or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking Cozaar Plus, seek medical help immediately.
• if you have previously experienced swelling of the face, lips, tongue, or throat;
• if you are taking diuretics (medicines to increase urine production);
• 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 narrowing of the arteries leading to the kidneys (renal artery stenosis), only one functioning kidney, or have recently undergone a kidney transplant;
• if you have narrowed arteries (atherosclerosis), angina (chest pain due to poor heart function);
• if you have “aortic or mitral valve stenosis” (narrowing of heart valves) or “hypertrophic cardiomyopathy” (a condition causing 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 causing joint pain, skin rashes, and fever (systemic lupus erythematosus);
• if you have high levels of calcium or low levels of potassium, or if you are on a low-potassium diet;
• if you require anesthesia (even at the dentist) or prior to surgery, or if you are undergoing tests to assess parathyroid function, you must inform your doctor or healthcare provider that you are taking losartan potassium and hydrochlorothiazide tablets;
• 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 for high blood pressure:
  • an angiotensin-converting enzyme (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 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 (see section 2 “Taking Cozaar Plus with other medicines”);
• if you have had skin cancer or 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 non-melanoma skin cancer and lip cancer. Protect your skin from sun and UV exposure 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 need to take any other medicines.

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

Diuretics such as hydrochlorothiazide contained in Cozaar Plus may interact with other medicines.

Lithium-containing preparations should not be taken with Cozaar Plus unless your doctor closely monitors you.

Special precautions (e.g. blood tests) may be needed if you are taking other diuretics (“water tablets”), certain laxatives, medicines for gout, medicines to control heart rhythm, or medicines for diabetes (oral medicines or insulin).

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

• other medicines to lower your blood pressure;
• steroids;
• medicines for cancer;
• pain medicines;
• medicines for fungal infections;
• medicines for arthritis;
• cholesterol-lowering resins such as cholestyramine;
• muscle relaxants;
• sleeping tablets;
• opioid medicines such as morphine;
• "pressor amines" such as adrenaline or other medicines in the same group;
• oral medicines for diabetes or insulin.

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

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

When taking Cozaar Plus, inform your doctor if you are scheduled for a radiographic procedure using iodine-containing contrast agents.

Taking Cozaar Plus with food and drinks

You are advised not to drink alcohol while taking these tablets: alcohol and Cozaar Plus tablets may increase each other's effects.

Excessive dietary salt intake 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

Inform your doctor if you think you are pregnant (or might be). Your doctor will usually advise you to stop taking Cozaar Plus before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Cozaar Plus is not recommended during pregnancy and must not be taken after the third month of pregnancy, 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 planning to breastfeed. Cozaar Plus is not recommended for breastfeeding mothers, and your doctor may choose an alternative 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 and younger adult patients. 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 operating dangerous machinery) until you know how you react to the medicine.

Cozaar Plus contains lactose

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

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

3. How to take Cozaar Plus

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Your doctor will determine 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 as prescribed by your doctor to maintain consistent blood pressure control.

High blood pressure

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

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 so that immediate medical care can be provided. Overdose may cause low blood pressure, palpitations, slow pulse, changes in blood composition, and dehydration.

You may also call the Toxicology Information Service. Telephone: (91) 562 04 20, stating the medication and the amount taken. It is recommended to bring the medicine package and leaflet 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 regular schedule.

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 Cozaar Plus tablets immediately and contact your doctor or go to the nearest hospital emergency department:

A severe allergic reaction (skin 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.

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

Acute breathing difficulty (symptoms include severe shortness of breath, fever, weakness and confusion).

Other possible adverse effects include:

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

• cough, upper respiratory tract infection, nasal congestion, sinusitis, sinus disorder;
• diarrhoea, abdominal pain, nausea, indigestion;
• muscle pain or cramps, leg pain, back pain;
• insomnia, headache, dizziness;
• weakness, fatigue, chest pain;
• elevated potassium levels (which may cause abnormal heart rhythm), decreased haemoglobin levels;
• changes in kidney function including kidney failure;
• blood sugar too low (hypoglycaemia).

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

• anaemia, red or brown spots on the skin (sometimes especially on the feet, legs, arms and buttocks, with joint pain, swelling of hands and feet and abdominal pain), bruising, reduction in white blood cells, bleeding problems, reduced platelet count;
• loss of appetite, elevated uric acid levels or overt gout, elevated blood glucose 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, limb pain, tremor, migraine, fainting;
• blurred vision, burning or itching in the eyes, conjunctivitis, worsening of vision, seeing things in yellow;
• ringing, buzzing, noises or crackling in the ears, dizziness;
• low blood pressure which may be associated with postural changes (feeling dizzy or weak when standing up), angina (chest pain), abnormal heartbeats, stroke (transient ischaemic attack (TIA), “mini-stroke”), heart attack, palpitations;
• inflammation of blood vessels often associated with a skin rash or bruising;
• sore throat, shortness of breath, bronchitis, pneumonia, fluid in the lungs (causing difficulty breathing), nosebleeds, runny nose, congestion;
• constipation, chronic constipation, flatulence, stomach disorders, stomach spasms, vomiting, dry mouth, inflammation of a salivary gland, toothache;
• jaundice (yellowing of the eyes and skin), inflammation of the pancreas;
• urticaria, itching, skin inflammation, skin rash, skin redness, photosensitivity, dry skin, flushing, sweating, hair loss;
• pain in arms, shoulders, hips, knees or other joints, joint swelling, stiffness, muscle weakness;
• frequent urination including at night, abnormal kidney function including kidney inflammation, urinary tract infection, sugar in the urine;
• decreased sexual appetite, impotence;
• facial swelling, localized swelling (oedema), fever.

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

• intestinal angioedema: swelling in the intestine presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhoea;
• hepatitis (liver inflammation), abnormal liver function tests.

Not known (frequency cannot be estimated from available data):

• flu-like symptoms;
• unexplained muscle pain with dark-coloured urine (tea-coloured) (rhabdomyolysis);
• low sodium levels in the blood (hyponatraemia);
• generally feeling unwell (malaise);
• altered taste (dysgeusia);
• skin and lip cancer (non-melanoma skin cancer);
• decreased vision or eye pain due to increased pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).

Reporting of adverse effects:

If you experience any type of adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can 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 Plus

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to 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 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 above 25 °C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Cozaar Plus

The active substances are losartan potassium and hydrochlorothiazide.

Each Cozaar Plus tablet contains, as active substances, 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), quinoline yellow aluminum lake (E-104), and carnauba wax (E-903).

Appearance of the product and pack contents

Cozaar Plus is supplied as yellow, oval, film-coated tablets, marked with "717" on one side and smooth or scored on the other. The score line is not intended to divide the tablet into equal doses.

Cozaar Plus is available in the following pack sizes:

PVC/PE/PVDC blisters with an aluminum foil lid, in cartons containing 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 98, or 280 tablets; and unit-dose packs of 28, 56, and 98 tablets for hospital use. HDPE bottle containing 100 tablets.

Only certain pack 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:

Date of the most recent review of this package leaflet: 03/2025.

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