Hizaar Forte

Leaflet attached to the packaging: patient information

HYZAAR, 50 mg + 12.5 mg, film-coated tablets

HYZAAR Forte, 100 mg + 25 mg, film-coated tablets

losartan potassium + hydrochlorothiazide

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Hyzaar and Hyzaar Forte and what is it used for
• 2. Important information before taking Hyzaar or Hyzaar Forte
• 3. How to take Hyzaar or Hyzaar Forte
• 4. Possible side effects
• 5. How to store Hyzaar and Hyzaar Forte
• 6. Package contents and other information

1. What is Hyzaar and Hyzaar Forte and what is it used for

Hyzaar and Hyzaar Forte are a combination of an angiotensin II receptor antagonist (losartan) and a diuretic (hydrochlorothiazide). Angiotensin II is a substance produced in the body that, by binding to receptors in blood vessel walls, causes them to narrow. This results in increased blood pressure. Losartan prevents angiotensin II from binding to these receptors, causing blood vessels to dilate and, as a result, lowering blood pressure. Hydrochlorothiazide works by increasing water and salt flow through the kidneys. This also helps to lower blood pressure. Hyzaar and Hyzaar Forte are indicated for the treatment of primary hypertension (high blood pressure).

2. Important information before taking Hyzaar or Hyzaar Forte

When not to take Hyzaar or Hyzaar Forte

• 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 sulfonamide derivatives (e.g., other thiazide diuretics, certain antibacterial drugs such as cotrimoxazole; in case of doubt, consult your doctor),
• if you have severe liver dysfunction,
• if you have low potassium, low sodium, or high calcium levels in your blood that cannot be corrected by treatment,
• if you have gout,
• after the third month of pregnancy (it is also recommended to avoid taking Hyzaar and Hyzaar Forte in early pregnancy - see "Pregnancy"),
• if you have severe kidney dysfunction or if your kidneys do not produce urine,
• if you have diabetes and are taking a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Before starting treatment with Hyzaar or Hyzaar Forte, consult your doctor, pharmacist, or nurse. If you experience vision disturbances or eye pain, these may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between the choroid and sclera) or increased intraocular pressure - these may occur within a few hours to weeks after taking Hyzaar or Hyzaar Forte. Untreated symptoms can lead to permanent vision loss. People who have previously been allergic to penicillin or sulfonamides may be more prone to these symptoms. Inform your doctor about suspected (or planned) pregnancy. It is not recommended to take Hyzaar or Hyzaar Forte during pregnancy and it should not be taken after 3 months of pregnancy, as it may have a very harmful effect on the fetus (see "Pregnancy"). Before starting treatment with Hyzaar or Hyzaar Forte, inform your doctor:

• if you have previously experienced breathing or lung problems after taking hydrochlorothiazide (including pneumonia or fluid accumulation in the lungs). If you experience severe shortness of breath or difficulty breathing after taking Hyzaar or Hyzaar Forte, seek medical attention immediately.
• if you have experienced angioedema (swelling of the face, lips, throat, and/or tongue) (see also section 4 "Possible side effects");
• if you are taking diuretics;
• if you are on a low-salt diet;
• if you have experienced severe vomiting and/or diarrhea;
• if you have heart failure;
• if you have liver dysfunction (see section 2 "When not to take Hyzaar or Hyzaar Forte");
• if you have narrowing or blockage of the blood vessels leading to the kidneys (renal artery stenosis) or if you have only one functioning kidney or if you have recently undergone a kidney transplant;
• if you have narrowing of the arteries (arteriosclerosis), angina pectoris (chest pain due to reduced heart function);
• if you have "aortic or mitral stenosis" (narrowing of the heart valves) or "hypertrophic cardiomyopathy" (a disease that weakens the heart muscle);
• if you have diabetes;
• if you have gout;
• if you have an allergy, asthma, or symptoms that cause joint pain, skin rash, and fever (systemic lupus erythematosus);
• if you have high calcium or low potassium levels in your blood or if you are on a low-potassium diet;
• if you need anesthesia (even at the dentist) or if you are scheduled for surgery or if you are scheduled for a parathyroid function test, you must inform your doctor or medical staff that you are taking losartan potassium and hydrochlorothiazide tablets;
• if you have primary hyperaldosteronism (a condition associated with increased aldosterone hormone secretion by the adrenal glands, caused by adrenal gland abnormalities);
• if you are taking any of the following medicines for high blood pressure: an ACE inhibitor (e.g., enalapril, lisinopril, ramipril), especially if you have diabetic kidney disease (see also sections "When not to take Hyzaar or Hyzaar Forte" and "Warnings and precautions").

Your doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in your blood. See also subsection "When not to take Hyzaar or Hyzaar Forte".

• if you are taking other medicines that may increase potassium levels in your blood (see section 2 "Hyzaar or Hyzaar Forte and other medicines").
• if you have previously had skin cancer or if an unexpected skin change occurs during treatment. Treatment with hydrochlorothiazide, especially in high doses and for a long time, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). When taking Hyzaar or Hyzaar Forte, protect your skin from sunlight and UV radiation.

If you experience stomach pain, nausea, vomiting, or diarrhea after taking Hyzaar or Hyzaar Forte, discuss it with your doctor. Your doctor will decide on further treatment. Do not stop taking Hyzaar or Hyzaar Forte on your own.

Children and adolescents

There is no experience with the use of Hyzaar or Hyzaar Forte in children. Therefore, Hyzaar or Hyzaar Forte should not be used in children.

Hyzaar or Hyzaar Forte and other medicines

Tell your doctor or pharmacist about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take. Tell your doctor about any potassium supplements, salt substitutes containing potassium, potassium-sparing diuretics, or other medicines that may increase potassium levels in your blood (e.g., trimetoprim-containing medicines), as concomitant use with Hyzaar or Hyzaar Forte is not recommended. Diuretics such as hydrochlorothiazide in Hyzaar and Hyzaar Forte may interact with other medicines. Without close medical supervision, do not take lithium-containing preparations. Special precautions (e.g., blood tests) may be necessary if you are taking other diuretics, certain laxatives, gout medicines, heart rhythm or diabetes control medicines (oral or insulin). It is also important for your doctor to know if you are taking:

• other blood pressure-lowering medicines;
• steroids;
• anticancer medicines;
• analgesics;
• antifungal medicines;
• medicines for arthritis;
• cholesterol-lowering resins such as cholestyramine;
• muscle relaxants;
• sleeping pills;
• opioid medicines such as morphine;
• amines that increase blood pressure, such as adrenaline or other medicines from the same group;
• oral antidiabetic medicines or insulins;

Your doctor may recommend a dose change and/or take other precautions:

• if you are taking an ACE inhibitor or aliskiren (see also subsections "When not to take Hyzaar or Hyzaar Forte" and "Warnings and precautions").

Also, inform your doctor about taking Hyzaar or Hyzaar Forte before planned administration of iodine-based contrast agents.

Hyzaar or Hyzaar Forte with food, drink, and alcohol

It is recommended that you do not drink alcohol while taking these tablets: alcohol and Hyzaar or Hyzaar Forte tablets may increase their effect. Excessive salt in your diet may counteract the effect of Hyzaar and Hyzaar Forte tablets. Hyzaar or Hyzaar Forte can be taken with or without food. You should avoid drinking grapefruit juice while taking Hyzaar and Hyzaar Forte tablets.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor about suspected (or planned) pregnancy. Your doctor will usually recommend stopping Hyzaar or Hyzaar Forte before planned pregnancy or as soon as pregnancy is confirmed and recommend taking another medicine instead of Hyzaar or Hyzaar Forte. It is not recommended to take Hyzaar or Hyzaar Forte during pregnancy and it should not be taken after 3 months of pregnancy, as it may have a very harmful effect on the fetus.

Breastfeeding

Inform your doctor about breastfeeding or intending to breastfeed. It is not recommended to take Hyzaar or Hyzaar Forte while breastfeeding. If you want to breastfeed, your doctor may recommend a different treatment.

Elderly patients

Hyzaar and Hyzaar Forte work just as well and are just as well tolerated in most older and younger adult patients. Most elderly patients require the same dosage as younger patients.

Driving and using machines

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

Hyzaar and Hyzaar Forte contain lactose monohydrate

Hyzaar and Hyzaar Forte contain lactose monohydrate. If you have intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Hyzaar or Hyzaar Forte

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. Your doctor will decide on the appropriate dose of Hyzaar or Hyzaar Forte, depending on your condition and other medicines you are taking. It is important to continue taking Hyzaar or Hyzaar Forte for as long as your doctor has prescribed it, in order to maintain consistent blood pressure control.

High blood pressure

The usual dose for most patients with high blood pressure is 1 tablet of Hyzaar 50 mg + 12.5 mg per day to control blood pressure for a period of up to 24 hours. Your doctor may increase the dose to 2 tablets of Hyzaar 50 mg + 12.5 mg once a day or recommend taking 1 tablet of Hyzaar Forte 100 mg + 25 mg once a day (higher dose). The maximum daily dose is 2 tablets of Hyzaar 50 mg + 12.5 mg once a day or 1 tablet of Hyzaar Forte 100 mg + 25 mg once a day.

Administration

Swallow the tablets whole with a glass of water.

Taking a higher dose of Hyzaar or Hyzaar Forte than recommended

In case of overdose, contact your doctor immediately to take prompt action. Overdose may cause low blood pressure, rapid heartbeat, slow pulse, changes in blood composition, and dehydration.

Missing a dose of Hyzaar or Hyzaar Forte

Try to take Hyzaar or Hyzaar Forte every day as prescribed by your doctor. However, if you miss a dose, do not take a double dose. Return to your usual dosing schedule.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience any of the following side effects, stop taking Hyzaar or Hyzaar Forte and consult your doctor or go to the emergency department of your nearest hospital immediately: Severe allergic reactions (rash, itching, swelling of the face, lips, mouth, or throat, which may cause difficulty swallowing or breathing). This is a serious, but rare side effect, occurring in more than 1 in 10,000 patients, but less than 1 in 1,000 patients. It may require urgent medical attention or hospitalization.

• Acute respiratory failure (symptoms include severe shortness of breath, fever, weakness, and confusion).

Other side effects that may occur: Common (may affect up to 1 in 10 people taking the medicine):

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

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

• anemia, red or brown spots on the skin (sometimes mainly on the feet, legs, arms, and buttocks with joint pain, swelling of the hands and feet, and stomach pain), bruising, decreased white blood cell count, bleeding disorders, decreased platelet count;
• loss of appetite, increased uric acid or gout, increased blood sugar, disturbed electrolyte levels;
• anxiety, nervousness, panic disorders (recurring panic attacks), disorientation, depression, unusual dreams, sleep disturbances, drowsiness, memory disorders;
• tingling and numbness, limb pain, tremors, migraine, fainting;
• blurred vision, burning or stinging in the eye, conjunctivitis, decreased visual acuity, yellow vision;
• ringing, buzzing, humming, or clicking in the ears, dizziness of labyrinthine origin;
• low blood pressure, which may be associated with postural changes (feeling of emptiness in the head or weakness when standing up, angina pectoris, disturbed heart rhythm, stroke, heart attack, rapid heartbeat;
• vasculitis, which is often associated with skin rash or purpura;
• sore throat, shortness of breath, bronchitis, pneumonia, fluid in the lungs (which can cause breathing difficulties), nosebleeds, colds, congestion;
• constipation, inability to pass stools, gas, stomach upset, vomiting, dry mouth, salivary gland inflammation, toothache;
• jaundice (yellowing of the eyes and skin), pancreatitis;
• hives, itching, skin inflammation, rash, redness, sensitivity to light, dry skin, hot flashes with redness;
• shoulder, arm, hip, knee, or other joint pain, arthritis, swelling, stiffness, muscle weakness;
• frequent urination, including at night, kidney dysfunction, including kidney inflammation, urinary tract infections;
• decreased libido, impotence;
• facial swelling, localized swelling, fever.

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

• intestinal angioedema: intestinal swelling with symptoms such as abdominal pain, nausea, vomiting, and diarrhea;
• hepatitis, changed liver function test results.

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

• flu-like symptoms;
• unexplained muscle pain with dark (tea-colored) urine (rhabdomyolysis);
• low sodium levels in the blood (hyponatremia);
• general malaise;
• taste disorders;
• skin cancer and lip cancer (non-melanoma skin cancer);
• worsening vision or eye pain due to increased pressure (possible symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between the choroid and sclera) or acute angle-closure glaucoma).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Hyzaar and Hyzaar Forte

Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month. Blister packs Store Hyzaar and Hyzaar Forte in the original packaging to protect from light and moisture. Do not store blister packs at temperatures above 30°C. Bottle Store in the original packaging to protect from light. Store the bottle tightly closed to protect from moisture. Do not store bottles at temperatures above 25°C. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Hyzaar or Hyzaar Forte contains

• The active substances are losartan potassium and hydrochlorothiazide.

Hyzaar 50 mg + 12.5 mg contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide as active substances. Hyzaar Forte 100 mg + 25 mg contains 100 mg of losartan potassium and 25 mg of hydrochlorothiazide as active substances.

• The other ingredients are: microcrystalline cellulose (E460), lactose monohydrate, cornstarch, magnesium stearate (E572), hydroxypropylcellulose (E463), hypromellose (E464).

Hyzaar 50 mg + 12.5 mg contains 4.24 mg (0.108 mEq) of potassium. Hyzaar Forte 100 mg + 25 mg contains 8.48 mg (0.216 mEq) of potassium. Hyzaar 50 mg + 12.5 mg and Hyzaar Forte 100 mg + 25 mg also contain titanium dioxide (E171), aluminum lake of quinoline yellow (E104), and carnauba wax (E903).

What Hyzaar and Hyzaar Forte look like and contents of the pack

Hyzaar 50 mg + 12.5 mg is available as yellow, oval, film-coated tablets marked "717" on one side and smooth or with a score line on the other side. The score line is not intended for breaking the tablet. Hyzaar Forte 100 mg + 25 mg is available as light yellow, oval, film-coated tablets marked "747" on one side and smooth on the other side. The following pack sizes are available for Hyzaar and Hyzaar Forte: Hyzaar 50 mg + 12.5 mg - PVC/PE/PVDC blister packs with aluminum foil in cartons containing 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 98, or 280 tablets, and single-dose packs of 28, 56, and 98 tablets for hospital use. HDPE bottles of 100 tablets. Hyzaar Forte 100 mg + 25 mg - PVC/PE/PVDC blister packs with aluminum foil in cartons containing 7, 14, 28, 30, 50, 56, 84, 90, 98, or 280 tablets, and single-dose packs of 28, 56, and 98 tablets for hospital use. HDPE bottles of 100 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Organon Polska Sp. z o.o. ul. Marszałkowska 126/134 00-008 Warsaw Tel.: +48 22 105 50 01 [email protected]

Manufacturer

Merck Sharp & Dohme B.V. PO Box 581, Waarderweg 39 2031 BN Haarlem, Netherlands Organon Heist bv Industriepark 30 2220 Heist-op-den-Berg Belgium

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Member State

Product name

Belgium COZAAR PLUS 50 mg/12.50 mg comprimés pelliculés Belgium COZAAR PLUS 100 mg/12.50 mg comprimés pelliculés Belgium COZAAR PLUS FORTE 100 mg/25 mg comprimés pelliculés Denmark Cozaar Comp. Denmark Cozaar Comp 100 mg / 12.5 mg Denmark Cozaar Comp Forte Finland COZAAR Comp Finland COZAAR Comp Forte France FORTZAAR 100 mg/25 mg, comprimé pelliculé France HYZAAR 50 mg/12.5 mg, comprimé pelliculé France FORTZAAR 100 mg/12.5 mg, comprimé pelliculé Germany LORZAAR PLUS 50/12.5 mg Filmtabletten Germany LORZAAR PLUS forte 100/12.5 mg Filmtabletten Germany FORTZAAR 100/25 mg Filmtabletten Greece HYZAAR Greece HYZAAR Forte Greece HYZAAR Extra Forte Hungary HYZAAR Iceland Cozaar Comp Iceland Cozaar Comp 100 mg/12.5 mg Iceland Cozaar Comp Forte Ireland COZAAR Comp 50mg/12.5mg film-coated tablets Ireland COZAAR Comp 100mg/12.5mg film-coated tablets Ireland COZAAR Comp 100mg/25mg film-coated tablets Italy HIZAAR 50 mg + 12.5 mg compresse rivestite con film Italy HIZAAR 100 mg + 25 mg compresse rivestite con film Italy FORZAAR 100 mg + 25 mg compresse rivestite con film Luxembourg COZAAR PLUS 50 mg/12.50 mg comprimés pelliculés Luxembourg COZAAR PLUS 100 mg/12.50 mg comprimés pelliculés Luxembourg COZAAR PLUS FORTE 100 mg/25 mg comprimés pelliculés Netherlands HYZAAR 50/12.5 Netherlands COZAAR Plus 100/12.5 Netherlands FORTZAAR 100/25 Norway Cozaar Comp Norway Cozaar Comp Forte Poland HYZAAR Poland HYZAAR FORTE Portugal Cozaar Plus Portugal Fortzaar Spain COZAAR Plus 50 mg/12.5 mg comprimidos recubiertos con película Spain FORTZAAR 100 mg/25 mg comprimidos recubiertos con película Sweden COZAAR Comp 50 mg/12.5 mg filmdragerade tabletter Sweden COZAAR Comp 100 mg/12.5 mg filmdragerade tabletter Sweden COZAAR Comp Forte 100 mg/25 mg filmdragerade tabletter United Kingdom (Northern Ireland) COZAAR COMP 50mg/12.5mg film-coated tablets United Kingdom (Northern Ireland) COZAAR Comp 100mg/12.5mg film-coated tablets United Kingdom (Northern Ireland) COZAAR Comp 100mg/25mg film-coated tablets

Date of last revision of the leaflet: 01/2025