Hyzaar

Patient Information Leaflet

HYZAAR, 50 mg + 12.5 mg, film-coated tablets
HYZAAR Forte, 100 mg + 25 mg, film-coated tablets
losartan potassium + hydrochlorothiazide
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you personally. Do not share it with others. This medicine may harm others even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet Contents

1. What Hyzaar and Hyzaar Forte are and what they are used for
2. What you need to know 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 Hyzaar and Hyzaar Forte are and what they are used for

Hyzaar and Hyzaar Forte are combination medicines containing 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 vessel walls, causing them to narrow. This leads to increased blood pressure. Losartan prevents angiotensin II from binding to these receptors, resulting in blood vessel dilation and consequently lowering blood pressure. Hydrochlorothiazide works by increasing the excretion of water and salts through the kidneys. This also helps reduce blood pressure.
Hyzaar and Hyzaar Forte are indicated for the treatment of essential hypertension (high blood pressure).

2. Important information before using Hyzaar or Hyzaar Forte

When not to use 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-derived substances (e.g. other thiazide drugs, some antibacterial medicines such as co-trimoxazole; consult your doctor if in doubt),
• if the patient has severe liver dysfunction,
• if the patient has low blood potassium, low blood sodium, or high blood calcium levels that cannot be corrected by treatment,
• if the patient has gout,
• after the third month of pregnancy (It is also advisable to avoid using Hyzaar and Hyzaar Forte in early pregnancy – see section “Pregnancy”),
• if the patient has severe kidney dysfunction or kidneys that do not produce urine,
• if the patient has diabetes or kidney problems and is being treated with 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 the patient experiences worsening vision or eye pain, these may be symptoms of fluid accumulation
in the vascular layer surrounding the eye (excessive fluid accumulation between choroid and sclera)
or increased intraocular pressure – these may occur within hours to weeks after taking Hyzaar or
Hyzaar Forte. Untreated symptoms may lead to permanent vision loss. Patients who previously
experienced allergy to penicillin or sulfonamides may be at higher risk of developing these symptoms.
Inform your doctor if you suspect (or are planning) pregnancy. Use of Hyzaar and Hyzaar Forte is not
recommended during early pregnancy and must not be used after the third month of pregnancy,
as it may seriously harm the unborn child (see section “Pregnancy”).
Before starting treatment with Hyzaar or Hyzaar Forte, inform your doctor:

• if the patient previously experienced breathing problems or lung issues (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If the patient develops severe shortness of breath or difficulty breathing after taking Hyzaar or Hyzaar Forte, seek immediate medical help.
• if the patient has previously 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 had or currently has severe vomiting and/or diarrhoea;
• if the patient has heart failure;
• if the patient has liver dysfunction (see section 2 “When not to use Hyzaar or Hyzaar Forte”);
• if the patient has renal artery stenosis (narrowing of blood vessels leading to the kidneys), has only one functioning kidney, or has recently undergone kidney transplantation;
• if the patient has arterial narrowing (arteriosclerosis) or angina pectoris (chest pain due to impaired heart function);
• if the patient has “aortic or mitral valve stenosis” (narrowing of heart valves) or “hypertrophic cardiomyopathy” (a disease causing weakened heart muscle);
• if the patient has diabetes;
• if the patient has previously had gout;
• if the patient has or has had allergies, asthma, or symptoms causing joint pain, skin rash, and fever (systemic lupus erythematosus);
• if the patient has high blood calcium or low blood potassium levels, or if the patient is on a low-potassium diet;
• if the patient requires anesthesia (even at the dentist), is undergoing surgery, or is scheduled for parathyroid function testing, the patient must inform the doctor or medical staff about taking tablets containing potassium losartan and hydrochlorothiazide;
• if the patient has primary hyperaldosteronism (a condition associated with increased aldosterone hormone excretion by adrenal glands due to adrenal abnormalities);
• 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), particularly if the patient has kidney problems related to diabetes,

or aliskiren.
The doctor may recommend regular monitoring of kidney function, blood pressure, and blood electrolyte
levels (e.g. potassium).
See also the section “When not to use Hyzaar or Hyzaar Forte”.

• if the patient is taking other medicines that may increase serum potassium levels (see section 2 “Hyzaar or Hyzaar Forte with other medicines”).
• if the patient has previously had skin cancer or develops unexpected skin changes during treatment. Treatment with hydrochlorothiazide, especially at high doses over a long period, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. While taking Hyzaar or Hyzaar Forte, protect the skin from sunlight and UV radiation.

If the patient experiences abdominal pain, nausea, vomiting, or diarrhoea after taking Hyzaar or
Hyzaar Forte, discuss this with the doctor. The doctor will decide on further treatment. Do not
discontinue Hyzaar or Hyzaar Forte without medical advice.

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

Hyzaar or Hyzaar Forte with other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as
any medicines the patient plans to take.
Inform your doctor about potassium supplements, salt substitutes containing potassium, potassium-sparing medicines, or other medicines that may increase serum potassium levels (e.g. medicines containing trimethoprim), as concomitant use with Hyzaar or Hyzaar Forte is not recommended.
Diuretics such as hydrochlorothiazide contained in Hyzaar and Hyzaar Forte may interact with other
medicines.
Do not take lithium-containing preparations without strict medical supervision.
Special precautions (e.g. blood tests) may be appropriate if the patient is taking other diuretics, certain laxatives, medicines used to treat gout, medicines used to control heart rhythm, or diabetes medicines (oral medicines or insulin).
It is also important for the doctor to know whether the patient is taking:

• other blood pressure-lowering medicines;
• steroids;
• anticancer medicines;
• painkillers;
• medicines used to treat fungal infections;
• medicines used to treat arthritis;
• bile acid sequestrants used in high cholesterol, such as cholestyramine;
• muscle relaxants;
• sleeping tablets;
• opioid medicines such as morphine;
• amines that increase blood pressure, such as adrenaline or other medicines in the same group;
• oral antidiabetic medicines or insulin;

The doctor may recommend dose adjustment and/or additional precautions:

• if the patient is taking an ACE inhibitor or aliskiren (see also sections “When not to use Hyzaar or Hyzaar Forte” and “Warnings and precautions”).

Also inform your doctor about using Hyzaar or Hyzaar Forte before planned administration of
iodinated 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 enhance each other's effects.
Excessive dietary salt intake may counteract the effect of Hyzaar and Hyzaar Forte tablets.
Hyzaar or Hyzaar Forte may be taken independently of meals.
Avoid drinking grapefruit juice while taking Hyzaar and Hyzaar Forte tablets.

Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you suspect (or are planning) pregnancy. The doctor will usually recommend
discontinuing Hyzaar or Hyzaar Forte before planned pregnancy or as soon as pregnancy is confirmed,
and will recommend an alternative medicine instead of Hyzaar or Hyzaar Forte.
Use of Hyzaar or Hyzaar Forte is not recommended during pregnancy and must not be used after
the third month of pregnancy, as it may have very harmful effects on the unborn child.

Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Use of Hyzaar or Hyzaar Forte
is not recommended during breastfeeding. If the patient wishes to breastfeed, the doctor may
recommend alternative treatment.

Elderly patients
Hyzaar and Hyzaar Forte work equally well and are similarly well tolerated in most elderly 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 tasks requiring special
attention (e.g. driving a car or operating dangerous machinery) until it is known how the patient
tolerates this medicine.

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

3. How to take Hyzaar or Hyzaar Forte

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you
have any doubts, you should consult your doctor or pharmacist. Your doctor will decide the appropriate dose
of Hyzaar or Hyzaar Forte, depending on your condition and any other medicines you are taking.
It is important to continue taking Hyzaar or Hyzaar Forte for as long as your 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 once daily
to control blood pressure for up to 24 hours. Your doctor may increase the dose to 2 tablets of Hyzaar 50 mg + 12.5 mg
once daily or switch you to 1 tablet of Hyzaar Forte 100 mg + 25 mg once daily (a higher dose).
The maximum daily dose is 2 tablets of Hyzaar 50 mg + 12.5 mg once daily or 1 tablet of Hyzaar Forte 100 mg + 25 mg once daily.

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

Taking more Hyzaar or Hyzaar Forte than prescribed
If you take more than you should, contact your doctor immediately so that appropriate measures
can be taken without delay. Overdose may cause low blood pressure, palpitations, slow pulse,
changes in blood composition, and dehydration.

If you miss a dose of Hyzaar or Hyzaar Forte
You should try to take Hyzaar or Hyzaar Forte every day as directed by your doctor.
However, if you miss a dose, do not take a double dose. Resume your regular dosing schedule.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur, stop taking
the medicine Hyzaar or Hyzaar Forte and immediately consult a doctor or go to the emergency department
of the nearest hospital:
Severe allergic reactions (rash, itching, swelling of the face, lips, mouth or throat, which may
cause difficulty swallowing or breathing).
This is a serious, although rare, adverse reaction occurring in more than 1 in 10,000
patients, but in fewer than 1 in 1,000 patients. Urgent medical intervention
or hospitalization may be required.
Very rare (may affect up to 1 in 10,000 people):

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

Other possible adverse reactions include:
Common (may affect up to 1 in 10 people taking the medicine):

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

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

• anaemia, red or brown spots on the skin (sometimes mainly on feet, legs, arms and buttocks with joint pain, swelling of hands and feet, and stomach pain), bruising, decreased white blood cell count, bleeding disorders, decreased platelet count;
• loss of appetite, increased uric acid levels or gout, increased blood glucose levels, disturbed electrolyte levels in blood;
• anxiety, nervousness, panic attacks (recurrent panic attacks), disorientation, depression, unusual dreams, sleep disturbances, drowsiness, memory disturbances;
• tingling and numbness, limb pain, tremors, migraine, fainting;
• blurred vision, burning or stinging sensation in the eye, conjunctivitis, reduced visual acuity, yellow vision;
• sensation of ringing, buzzing, noise or crackling in the ears, vertigo (dizziness of labyrinthine origin);
• low blood pressure, which may be related to postural changes (feeling of emptiness in the head or weakness upon standing), angina (chest pain), irregular heartbeat, stroke (‘mini-stroke’), heart attack, palpitations;
• vasculitis (inflammation of blood vessels), often associated with skin rash or purpura;
• sore throat, shortness of breath, bronchitis, pneumonia, pulmonary oedema (causing breathing difficulties), nosebleeds, runny nose, congestion;
• constipation, inability to pass stools, flatulence, upset stomach, stomach cramps, vomiting, dry mouth, sialadenitis (inflammation of salivary glands), toothache;
• jaundice (yellowing of eyes and skin), pancreatitis;
• urticaria, itching, dermatitis, rash, skin redness, photosensitivity, dry skin, hot flushes with redness, sweating, hair loss;
• pain in arms, shoulders, hips, knees or other joints, arthritis, swelling, stiffness, muscle weakness;
• frequent urination, including at night, kidney function disorders, including nephritis, urinary tract infection, presence of glucose in urine;
• decreased libido, impotence;
• facial oedema, localized swelling, fever.

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

• angioedema of the intestine: intestinal swelling with symptoms such as abdominal pain, nausea, vomiting and diarrhoea;
• hepatitis, altered liver function test results.

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

• influenza-like symptoms;
• unexplained muscle pain accompanied by dark (tea-coloured) urine (rhabdomyolysis);
• low sodium levels in blood (hyponatraemia);
• general malaise;
• taste disturbances;
• skin and lip malignancies (non-melanoma skin cancers);
• worsening of vision or eye pain due to elevated pressure (possible symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between choroid and sclera) or acute angle-closure glaucoma).

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions
can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration 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 .
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Hyzaar and Hyzaar Forte

Keep this 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 the specified month.
Blister packs
Store Hyzaar and Hyzaar Forte in the original packaging to protect from light and moisture. Do not store blisters at temperatures above 30°C.
Bottle
Store in the original packaging to protect from light. Keep the bottle tightly closed to protect from moisture. Do not store the bottle at temperatures above 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Hyzaar or Hyzaar Forte contains

• The active substances are potassium losartan and hydrochlorothiazide.

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

• The other ingredients are: microcrystalline cellulose (E460), monohydrate lactose, pregelatinized corn starch, 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), quinoline yellow aluminium lake (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 dividing line on the other side.
The break line on the tablet is not intended for splitting 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 of Hyzaar and Hyzaar Forte are available:
Hyzaar 50 mg + 12.5 mg – PVC/PE/PVDC blisters with aluminium foil lid in cartons containing 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 98, or 280 tablets, and unit packs of 28, 56 and 98 tablets for hospital use. HDPE bottles with 100 tablets.
Hyzaar Forte 100 mg + 25 mg – PVC/PE/PVDC blisters with aluminium foil lid in cartons containing 7, 14, 28, 30, 50, 56, 84, 90, 98, or 280 tablets, and unit packs of 28, 56 and 98 tablets for hospital use. HDPE bottles with 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Organon Polska Sp. z o.o.
Marszałkowska Street 126/134
00-008 Warsaw
Tel.: + 48 22 306 57 64
[email protected]

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

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

| Country | 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 | | The Netherlands | HYZAAR 50/12.5 | | The Netherlands | COZAAR Plus 100/12.5 | | The 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 |