Hizaar

PACKAGE LEAFLET

Package leaflet: information for the patient

HIZAAR film-coated tablets

losartan potassium and hydrochlorothiazide
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet. 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. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, consult your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What HIZAAR is and what it is used for

HIZAAR 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 in blood vessels, causing the blood vessels 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 and consequently lowering blood pressure.
Hydrochlorothiazide works by increasing the amount of water and salt excreted by the kidneys. This mechanism also helps reduce blood pressure.
HIZAAR is indicated for the treatment of essential hypertension (high blood pressure).

2. What you should know before taking HIZAAR

Do not take HIZAAR

• 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 co-trimoxazole; ask your doctor if you are unsure),
• if you have severe liver dysfunction,
• if you have low potassium levels, low sodium levels, or high calcium levels that cannot be corrected by treatment,
• if you suffer from gout,
• if you are more than 3 months pregnant (HIZAAR should also be avoided during early pregnancy – see section Pregnancy),
• if you have severe kidney dysfunction or if your kidneys do not produce urine,
• if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking HIZAAR.
If you experience a decrease in vision or eye pain, seek medical advice immediately. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur from a few hours to weeks after taking HIZAAR. If left untreated, this may lead to permanent vision loss. If you have previously had an allergy to penicillin or sulfonamides, you may be at increased risk of developing these effects.
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). HIZAAR is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn baby if taken during this period (see section Pregnancy).
It is important to inform your doctor before using HIZAAR:

• if you have previously experienced breathing or lung problems (including lung inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe breathing difficulties after taking HIZAAR, contact a doctor immediately;
• if you have a history of swelling of the face, lips, throat, and/or tongue;
• if you are taking diuretics (medicines that help you urinate);
• if you are on a low-salt diet;
• if you have had or currently have severe vomiting and/or diarrhea;
• if you have heart failure;
• if your liver function is impaired (see section 2 “Do not take HIZAAR”);
• if you have narrowed kidney arteries (renal artery stenosis), only one functioning kidney, or have recently undergone a kidney transplant;
• if you have narrowed arteries (atherosclerosis), angina pectoris (chest pain due to reduced heart function);
• if you have mitral or aortic valve stenosis (narrowing of heart valves) or hypertrophic cardiomyopathy (a condition causing thickening of the heart muscle);
• if you have diabetes;
• if you have had gout;
• if you have or have had allergic conditions, asthma, or a condition causing joint pain, skin redness, and fever (systemic lupus erythematosus);
• if you have high calcium levels or low potassium levels, or if you are on a low-potassium diet;
• if you need to take an anesthetic (even from a dentist) or before undergoing surgery, or if you are scheduled for tests to assess parathyroid function, inform your doctor or medical staff that you are taking losartan potassium and hydrochlorothiazide tablets;
• if you suffer from primary hyperaldosteronism (a syndrome associated with increased aldosterone hormone secretion from the adrenal gland due to an abnormality);
• 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 kidney problems related to diabetes; or aliskiren. Your doctor may regularly monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium). See also the section “Do not take HIZAAR”;
• if you are taking other medicines that may increase serum potassium levels (see section 2 “Other medicines and HIZAAR”);
• if you have previously had skin cancer or develop unexpected skin lesions 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 exposure to sunlight and UV rays while taking HIZAAR.

Contact your doctor if, after taking HIZAAR, you experience abdominal pain, nausea, vomiting, or diarrhea. Your doctor will decide whether to continue treatment. Do not stop taking HIZAAR on your own.

Children and adolescents
There is no experience with the use of HIZAAR in children. Therefore, HIZAAR must not be given to children.

Other medicines and HIZAAR
Tell your doctor or pharmacist if you are taking, have recently taken, or might 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 HIZAAR is not recommended.
Diuretics such as hydrochlorothiazide contained in HIZAAR may interact with other medicines.
Lithium-containing preparations must not be taken with HIZAAR without close medical supervision.
Special precautionary measures (e.g., blood tests) may be appropriate if you are taking other diuretics (medicines that help you urinate), certain laxatives, gout medications, medicines to control heart rhythm, or diabetes medicines (oral medications or insulin).
It is also important for your doctor to know if you are taking:

• other medicines to lower blood pressure;
• steroids;
• cancer medicines;
• painkillers;
• antifungal medicines;
• medicines for arthritis;
• cholesterol-lowering resins such as cholestyramine;
• muscle relaxants;
• sleeping pills;
• opioids such as morphine;
• pressor amines such as adrenaline or similar medicines;
• oral antidiabetics or insulin.

Your doctor may consider it necessary to adjust your dose and/or take additional precautions:
If you are taking an ACE inhibitor or aliskiren (see also sections: “Do not take HIZAAR” and “Warnings and precautions”).
Inform your doctor that you are taking HIZAAR if you are scheduled for a radiographic procedure involving iodinated contrast agents.

HIZAAR with food and drink
You are advised not to drink alcoholic beverages while taking HIZAAR tablets: alcohol and HIZAAR tablets may enhance each other’s effects.
A diet particularly high in salt may reduce the effectiveness of HIZAAR tablets.
HIZAAR may be taken with or without food.
Grapefruit juice should be avoided during treatment with HIZAAR.

Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking HIZAAR before starting pregnancy or as soon as you learn you are pregnant, and will recommend an alternative medicine.
HIZAAR is not recommended during pregnancy and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn baby if taken after the third month of pregnancy.

Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. HIZAAR is not recommended for women who are breastfeeding, and your doctor may choose an alternative treatment if you wish to breastfeed.

Use in elderly patients
HIZAAR works the same way and is equally well tolerated in most elderly and younger adult patients. Most elderly patients require the same dosage 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.

HIZAAR contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

For athletes: using this medicine without a medical need constitutes doping and may result in a positive anti-doping test.

3. How to take HIZAAR

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist. Your doctor will determine the appropriate dose of HIZAAR based on
your condition and any other medicines you may be taking. It is important to continue taking HIZAAR for the entire duration prescribed by your doctor, as this will maintain stable control of high blood pressure.
High blood pressure
The usual dose for most patients with high blood pressure is 1 tablet of HIZAAR 50 mg + 12.5 mg daily to maintain blood pressure control over 24 hours. The dose may be increased to 2 tablets of Losartan/Hydrochlorothiazide 50 mg + 12.5 mg film-coated tablets once daily, or adjusted to 1 tablet daily of Losartan/Hydrochlorothiazide 100 mg + 25 mg film-coated tablets (a higher strength). The maximum daily dose is 2 tablets of Losartan/Hydrochlorothiazide 50 mg + 12.5 mg film-coated tablets per day or 1 tablet per day of Losartan/Hydrochlorothiazide 100 mg + 25 mg film-coated tablets.
Administration
The tablets should be swallowed whole with a glass of water.
If you take more HIZAAR than you should
In case of overdose, contact your doctor immediately to receive immediate medical treatment. Overdose may cause low blood pressure, palpitations, slow pulse rate, changes in blood electrolytes, and dehydration.
If you forget to take HIZAAR
Try to take HIZAAR once daily as prescribed. However, if you miss a dose, do not take a double dose. Skip the missed tablet and take the next tablet at the usual time on the following day.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience the following side effect, stop taking Hizaar tablets and contact your doctor immediately or go to the nearest hospital Emergency Department:
A severe allergic reaction (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. Immediate medical treatment or hospitalisation is required.

The following side effects have been reported:

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

• 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 (which may cause an abnormal heart rhythm), decreased haemoglobin levels;
• changes in kidney function including kidney failure;
• blood sugar levels too low (hypoglycaemia).

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

• anaemia, red or brownish spots on the skin (sometimes mainly on the feet, legs, arms and buttocks, with joint pain, swelling of hands and feet, and stomach pain), bruising, reduced white blood cells, coagulation problems, reduced platelet count;
• loss of appetite, increased uric acid levels or clinically evident gout, increased blood sugar levels, abnormal blood electrolyte levels;
• anxiety, nervousness, panic disorder (recurrent panic attacks), confusion, depression, abnormal dreams, sleep disorders, insomnia, memory disturbance;
• pins and needles sensation or similar feeling, pain in extremities, tremor, migraine, fainting;
• blurred vision, burning or painful eyes, conjunctivitis, worsening of vision, seeing things in yellow;
• sensation of hearing a sound, ringing, buzzing or clicking noises in the ears, vertigo;
• low blood pressure, which may be associated with changes in posture (feeling lightheaded or weak when standing up), angina (chest pain), irregular heartbeat, stroke (TIA, "mini-stroke"), heart attack, palpitations;
• inflammation of blood vessels, often associated with rash and bruising;
• sore throat, shortness of breath, bronchitis, pneumonia, fluid in the lungs (causing difficulty breathing), nosebleeds, runny nose, congestion;
• constipation, persistent constipation, flatulence, stomach discomfort, stomach spasms, vomiting, dry mouth, inflammation of a salivary gland, tooth pain;
• jaundice (yellowing of eyes and skin), inflammation of the pancreas;
• urticaria, itching, skin inflammation, rash, skin redness, light sensitivity, dry skin, hot flushes, 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 urine;
• decreased sexual desire, 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.

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

• acute breathing difficulty (signs include severe shortness of breath, fever, weakness and confusion).

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

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store HIZAAR

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after EXP. The expiry
date refers to the last day of that month.

Blister
Store Hizaar in the original packaging to protect the medicine from light and moisture.
Do not store the packaging at temperatures above 30°C.

Bottle
Store in the original container to protect the medicine from light. Keep the bottle tightly closed to protect the medicine from moisture. Do not store the bottle at temperatures above 25°C.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Hizaar contains
The active substances are losartan potassium and hydrochlorothiazide.
Hizaar 50 mg + 12.5 mg contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide as active substances.
Hizaar 100 mg + 25 mg contains 100 mg of losartan potassium and 25 mg of hydrochlorothiazide as active substances.
Hizaar 50 mg + 12.5 mg and Hizaar 100 mg + 25 mg contain the following excipients: microcrystalline cellulose (E460), lactose monohydrate, pregelatinized maize starch, magnesium stearate (E572), hydroxypropylcellulose (E463), hypromellose (E464).
Hizaar 50 mg + 12.5 mg contains 4.24 mg (0.108 mEq) of potassium.
Hizaar 100 mg + 25 mg contains 8.48 mg (0.216 mEq) of potassium.
Hizaar 50 mg + 12.5 mg and Hizaar 100 mg + 25 mg also contain titanium dioxide (E171), quinoline yellow lake on hydrated aluminium (E104), and carnauba wax (E903).

Description of the appearance of Hizaar and contents of the pack
Hizaar 50 mg + 12.5 mg is supplied as yellow, oval, film-coated tablets, marked with "717" on one side and the other side either smooth or with a breakline. The breakline is not intended to divide the tablet into two equal doses.
Hizaar 100 mg + 25 mg is supplied as light yellow, oval, film-coated tablets, marked with "747" on one side and the other side smooth.

Hizaar is available in the following pack sizes:
Hizaar 50 mg + 12.5 mg – PVC/PE/PVDC blisters with aluminium foil lidding, in cartons containing 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 98 or 280 tablets, and unit dose packs containing 28, 56 and 98 tablets for hospital use. HDPE bottles containing 100 tablets.
Hizaar 100 mg + 25 mg – PVC/PE/PVDC blisters with aluminium foil lidding, in cartons containing 7, 14, 28, 30, 50, 56, 84, 90, 98 or 280 tablets, and unit dose packs containing 28, 56 and 98 tablets for hospital use. HDPE bottles containing 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Organon Italia S.r.l.
Piazza Carlo Magno, 21
00162 Rome
Italy

Manufacturer
Merck Sharp & Dohme B.V.
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 European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

| Member State | Brand 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 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 | | 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 | | Iceland | Cozaar Comp | | Iceland | Cozaar Comp 100 mg/12.5 mg | | Iceland | Cozaar Comp Forte | | 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 | | Norway | Cozaar Comp | | Norway | Cozaar Comp Forte | | The Netherlands | HYZAAR 50/12.5 | | The Netherlands | COZAAR Plus 100/12.5 | | The Netherlands | FORTZAAR 100/25 | | 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/12.5 mg film-coated tablets | | United Kingdom (Northern Ireland) | COZAAR Comp 100mg/25mg film-coated tablets |