HYZAAR 100 mg /12.5 Mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. HYZAAR, 50 mg + 12.5 mg, film-coated tablets
3. HYZAAR, 100 mg + 12.5 mg, film-coated tablets
4. HYZAAR Forte, 100 mg + 25 mg, film-coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
5. What is Hyzaar and Hyzaar Forte and what is it used for
6. Important information before taking Hyzaar or Hyzaar Forte
   1. When not to take Hyzaar or Hyzaar Forte
   2. Warnings and precautions
   3. Children and adolescents
   4. Hyzaar or Hyzaar Forte and other medicines
   5. Hyzaar or Hyzaar Forte with food, drink, and alcohol
   6. Pregnancy and breastfeeding
   7. Pregnancy
   8. Breastfeeding
   9. Elderly patients
   10. Driving and operating machinery
   11. Hyzaar and Hyzaar Forte contain lactose monohydrate
7. How to take Hyzaar or Hyzaar Forte
   1. High blood pressure
   2. Administration
   3. Taking a higher dose of Hyzaar or Hyzaar Forte than recommended
   4. Missing a dose of Hyzaar or Hyzaar Forte
8. Possible side effects
   1. Reporting side effects
9. How to store Hyzaar and Hyzaar Forte
10. Contents of the pack and other information
    1. What Hyzaar or Hyzaar Forte contains
    2. What Hyzaar and Hyzaar Forte look like and contents of the pack
    3. Marketing authorization holder and manufacturer
    4. Marketing authorization holder
    5. Manufacturer
    6. This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
    7. Member State
    8. Product name
    9. Date of last revision of the leaflet: 11/2022

Leaflet accompanying the packaging: patient information

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

HYZAAR, 100 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 specifically for you. 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 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. Contents of the pack 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 the walls of blood vessels, causes them to constrict. 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

• if the patient is allergic to losartan, hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6),
• if the patient is allergic to sulfonamide derivatives (e.g., other thiazide diuretics, certain antibacterial drugs such as cotrimoxazole; in case of doubt, consult a doctor),
• if the patient has severe liver dysfunction,
• if the patient has low potassium, low sodium, or high calcium levels in the blood that cannot be corrected by treatment,
• if the patient has gout,
• after the third month of pregnancy (it is also recommended to avoid taking Hyzaar and Hyzaar Forte in early pregnancy - see "Pregnancy"),
• if the patient has severe kidney dysfunction or if the kidneys do not produce urine,
• if the patient has diabetes and is being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Before starting treatment with Hyzaar or Hyzaar Forte, consult a doctor, pharmacist, or nurse. If the patient experiences 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. Patients 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 seriously harm the fetus (see "Pregnancy"). Before starting treatment with Hyzaar or Hyzaar Forte, inform your doctor:

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

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 is taking other medicines that may increase potassium levels in the blood (see section 2 "Hyzaar or Hyzaar Forte and other medicines").
• if the patient has a history of malignant skin tumors 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 and lip cancer (non-melanoma skin cancer). During treatment with Hyzaar or Hyzaar Forte, the skin should be protected from sunlight and UV radiation.

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 you are taking other diuretics, certain laxatives, gout medicines, medicines for controlling heart rhythm or diabetes (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 treating 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").

You should also inform your doctor about taking Hyzaar or Hyzaar Forte before planned 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 effects of Hyzaar and Hyzaar Forte tablets. Hyzaar or Hyzaar Forte can be taken with or without food. Grapefruit juice should be avoided 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 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 intention to breastfeed. It is not recommended to take Hyzaar or Hyzaar Forte during breastfeeding. If the patient wants to breastfeed, the doctor may recommend alternative 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 operating machinery

When starting treatment with this medicine, the patient should not perform activities that require special attention (e.g., driving or operating hazardous machinery) until it is known how the patient tolerates the 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 exactly as prescribed by your doctor or pharmacist. In case of doubt, 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 for as long as the doctor recommends, 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. 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 prescribed by your 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 you experience any of the following side effects, 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:

• Frequent side effects (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;
• 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).

Less common side effects (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, bleeding 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 or numbness, limb pain, tremors, migraine, fainting;
• blurred vision, burning or stinging in the eye, conjunctivitis, decreased visual acuity, yellow vision;
• ringing, buzzing, humming, or cracking 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, stomach cramps, 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, 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 side effects (may occur in up to 1 in 1,000 people taking the medicine):

• 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 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 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 package to protect from light and moisture. Do not store blister packs at temperatures above 30°C. Bottle: Store in the original package 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 no longer required. This will help protect the environment.

6. Contents of the pack 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 100 mg + 12.5 mg contains 100 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.

• Excipients 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 100 mg + 12.5 mg and Hyzaar Forte 100 mg + 25 mg contain 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). Hyzaar 100 mg + 12.5 mg also contains titanium dioxide (E171) and carnauba wax (E903).

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

Hyzaar 50 mg + 12.5 mg is available in yellow, oval, film-coated tablets marked "717" on one side and smooth or scored on the other side. The score line is not intended for breaking the tablet. Hyzaar 100 mg + 12.5 mg is available in white, oval, film-coated tablets marked "745" on one side and smooth on the other side. Hyzaar Forte 100 mg + 25 mg is available in 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 100 mg + 12.5 mg - PVC/PE/PVDC blister packs with aluminum foil in cartons containing 14, 15, 28, 30, 50, 56, 84, 90, 98, or 280 tablets. 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 film-coated tablets Belgium COZAAR PLUS 100 mg/12.50 mg film-coated tablets Belgium COZAAR PLUS FORTE 100 mg/25 mg film-coated 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 film-coated tablets Luxembourg COZAAR PLUS 100 mg/12.50 mg film-coated tablets Luxembourg COZAAR PLUS FORTE 100 mg/25 mg film-coated 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: 11/2022