Hizaar

Leaflet accompanying 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, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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 the flow of water and salt 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

• after the third month of pregnancy (it is also recommended to avoid taking Hyzaar and Hyzaar Forte in early pregnancy - see "Pregnancy"),

Warnings and precautions

Before starting treatment with Hyzaar or Hyzaar Forte, consult a doctor, pharmacist, or nurse. If the patient experiences vision impairment 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:

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

If the patient experiences abdominal pain, nausea, vomiting, or diarrhea after taking Hyzaar or Hyzaar Forte, they should discuss this with their doctor. The doctor will decide on further treatment. The patient should not stop taking Hyzaar or Hyzaar Forte on their 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 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 medicines, or other medicines that may increase potassium levels in the 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 the patient is taking other diuretics, certain laxatives, gout medicines, heart rhythm or diabetes control medicines (oral or insulin). It is also important for the doctor to know if the patient is taking:

• other blood pressure-lowering medicines;
• corticosteroids;
• 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;

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

When not to take Hyzaar or Hyzaar Forte" and "Warnings and precautions").

The patient should also inform their doctor about taking Hyzaar or Hyzaar Forte before scheduled administration of iodine-containing contrast agents.

Hyzaar or Hyzaar Forte with food, drink, and alcohol

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

Pregnancy and breastfeeding

Pregnancy

Inform your doctor about suspected (or planned) pregnancy. The doctor will usually recommend stopping Hyzaar or Hyzaar Forte before planned pregnancy or as soon as pregnancy is confirmed, and recommend taking a different 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 during breastfeeding. If the patient wants to breastfeed, the doctor may recommend a different treatment.

Elderly patients

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

Driving and operating machinery

When starting treatment with this medicine, the patient should not perform activities that require special attention (e.g., driving a car or operating hazardous machinery) until it is known how the patient tolerates this medicine.

Hyzaar and Hyzaar Forte contain lactose monohydrate

Hyzaar and Hyzaar Forte contain lactose monohydrate. In case of intolerance to some sugars, consult a doctor before taking this medicine.

3. How to take Hyzaar or Hyzaar Forte

This medicine should always be taken as directed by a doctor or pharmacist. In case of doubts, consult a doctor or pharmacist. The doctor will decide on the appropriate dose of Hyzaar or Hyzaar Forte, depending on the patient's condition and other medicines being taken. It is important to continue taking Hyzaar or Hyzaar Forte as long as the doctor recommends, in order to maintain consistent blood pressure control.

Hypertension

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. The 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

Tablets should be swallowed whole with a glass of water.

Taking a higher dose of Hyzaar or Hyzaar Forte than recommended

In case of overdose, contact a doctor immediately to take prompt action. Overdose may cause a drop in 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 directed by the doctor. However, if a dose is missed, do not take a double dose. Return to the usual dosing schedule.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If the patient experiences any of the following side effects, they should stop taking Hyzaar or Hyzaar Forte and consult a doctor or go to the emergency department of the 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. Prompt medical attention or hospitalization may be necessary.

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

Other side effects that may occur: Common (may occur in 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;
• increased potassium levels in the blood (which can cause heart rhythm disturbances), decreased hemoglobin levels in the blood;
• kidney dysfunction, including kidney failure;
• low blood sugar (hypoglycemia).

Uncommon (may occur in 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, blood clotting disorders, decreased platelet count;
• loss of appetite, increased uric acid or gout, increased blood sugar levels, disturbed electrolyte levels in the blood;
• 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 crackling 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, heart rhythm disturbances, stroke, heart attack, rapid heartbeat;
• vasculitis, which is often associated with skin rash or purpura;
• throat pain, 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 of the skin, sensitivity to light, dry skin, hot flashes with redness;
• shoulder, hip, knee, or other joint pain, arthritis, swelling, stiffness, muscle weakness;
• frequent urination, including at night, kidney dysfunction, including kidney inflammation, urinary tract infections, sugar in the urine;
• decreased libido, impotence;
• facial swelling, localized swelling, fever.

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

• angioedema of the intestines: intestinal swelling with symptoms such as abdominal pain, nausea, vomiting, and diarrhea;
• hepatitis, changes in liver function tests.

Unknown (frequency cannot be estimated from 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;
• malignant skin tumors and lip cancer (non-melanoma skin cancer);
• worsening of vision or eye pain due to increased pressure (possible symptoms of fluid accumulation in the vascular layer surrounding the eye or acute angle-closure glaucoma).

Reporting side effects

If side effects occur, including any side effects not listed in the 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 Biocides of the Office for Registration of Medicinal 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, more information can be collected on the safety of the medicine.

5. How to store Hyzaar and Hyzaar Forte

Keep the medicine out of sight and reach of children. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the given 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 excipients are microcrystalline cellulose (E460), lactose monohydrate, maize starch, magnesium stearate (E572), hydroxypropyl cellulose (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 backing 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 backing 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 organonpolska@organon.com

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 tablets Belgium COZAAR PLUS 100 mg/12.50 mg tablets Belgium COZAAR PLUS FORTE 100 mg/25 mg tablets 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, film-coated tablet France HYZAAR 50 mg/12.5 mg, film-coated tablet France FORTZAAR 100 mg/12.5 mg, film-coated tablet Germany LORZAAR PLUS 50/12.5 mg film-coated tablets Germany LORZAAR PLUS forte 100/12.5 mg film-coated tablets Germany FORTZAAR 100/25 mg film-coated tablets 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 film-coated tablets Italy HIZAAR 100 mg + 25 mg film-coated tablets Italy FORZAAR 100 mg + 25 mg film-coated tablets Luxembourg COZAAR PLUS 50 mg/12.50 mg tablets Luxembourg COZAAR PLUS 100 mg/12.50 mg tablets Luxembourg COZAAR PLUS FORTE 100 mg/25 mg tablets 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 film-coated tablets Spain FORTZAAR 100 mg/25 mg film-coated tablets Sweden COZAAR Comp 50 mg/12.5 mg film-coated tablets Sweden COZAAR Comp 100 mg/12.5 mg film-coated tablets Sweden COZAAR Comp Forte 100 mg/25 mg film-coated tablets 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