Forzaar

Package leaflet: Information for the patient

FORZAAR 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 other people, 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, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Forzaar is and what it is used for

Forzaar 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 eliminated through the kidneys. This mechanism also helps reduce blood pressure.
Forzaar is indicated for the treatment of essential hypertension (high blood pressure).

2. What you should know before taking FORZAAR

Do not take Forzaar

• 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 impairment of liver function,
• 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 (Forzaar should also be avoided during early pregnancy – see section Pregnancy),
• if you have severe impairment of kidney function 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 Forzaar.
If you experience a decrease in vision or eye pain, these may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure within the eye, which may occur from a few hours to several weeks after taking Forzaar. This may lead to permanent vision loss if not treated. If you have previously had an allergy to penicillin or sulfonamides, you may be at higher 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). Forzaar is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn child if taken during this period (see section Pregnancy).
It is important to inform your doctor before using Forzaar:

• if you have previously experienced breathing or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide. If, after taking Forzaar, you develop shortness of breath or severe breathing difficulties, consult 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 diarrhoea;
• if you have heart failure;
• if liver function is impaired (see section 2 “Do not take Forzaar”);
• if you have narrowed arteries to the kidneys (renal artery stenosis), only one functioning kidney, or have recently undergone a kidney transplant;
• if you have narrowing of the 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 an allergic condition, 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 anaesthetic (even from a dentist) or before undergoing surgery, or if you are about to have tests to assess parathyroid function, you must 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 secretion of the hormone aldosterone by the adrenal gland due to an abnormality);
• if you are taking any of the following medicines used to treat high blood pressure: or an ACE inhibitor (e.g. enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes; or aliskiren. Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals. See also the section “Do not take Forzaar”.
• if you are taking other medicines that may increase serum potassium (see section 2 “Other medicines and Forzaar”).
• if you have previously had skin cancer or if you develop an unexpected skin lesion 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 of the lips. Protect your skin from exposure to sunlight and UV rays while taking Forzaar.

Talk to your doctor if, after taking Forzaar, you experience abdominal pain, nausea, vomiting, or diarrhoea. Your doctor will decide whether treatment should continue. Do not stop taking Forzaar on your own.

Children and adolescents
There is no experience regarding the use of Forzaar in children. Therefore, Forzaar must not be administered to children.

Other medicines and Forzaar
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
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 Forzaar is not recommended.
Diuretics such as hydrochlorothiazide contained in Forzaar may interact with other medicines.
Lithium-containing preparations must not be taken with Forzaar 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, medicines for the treatment of gout, medicines to control heart rhythm, or medicines for diabetes (oral medicines 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;
• medicines for fungal infections;
• medicines for the treatment of arthritis;
• cholesterol-lowering resins such as cholestyramine;
• muscle relaxants;
• sleeping pills;
• opioids such as morphine;
• pressor amines such as adrenaline or similar medicines.

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

Forzaar with food and drinks
It is recommended not to drink alcoholic beverages while taking the tablets: alcohol and Forzaar tablets may increase each other's effects.
A diet particularly high in salt may counteract the effect of Forzaar tablets.
Forzaar may be taken with or without food.
Grapefruit juice should be avoided during treatment with Forzaar.

Pregnancy and breastfeeding
Pregnancy
You must 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 Forzaar before starting pregnancy or as soon as you know you are pregnant, and will recommend another medicine instead of Forzaar.
Forzaar is not recommended during pregnancy, and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn child if taken beyond the third month of pregnancy.

Breast-feeding
Inform your doctor if you are breast-feeding or planning to breast-feed. Forzaar is not recommended for women who are breast-feeding, and your doctor may choose another treatment if you wish to breast-feed.

Use in elderly patients
Forzaar works in 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 activities requiring special attention (e.g. driving a car or operating dangerous machinery) until you know how you react to the medicine.

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

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

3. How to take FORZAAR

Take this medicine exactly as prescribed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. Your doctor will determine the appropriate dose of Forzaar based on your condition and any other medicines you may be taking. It is important to continue taking Forzaar for the full 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 Losartan/Hydrochlorothiazide 50 mg + 12.5 mg once 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 daily 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 FORZAAR 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 FORZAAR
Try to take FORZAAR 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 your usual time 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 Forzaar 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 in 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 intervention 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 abnormal heart rhythm), decreased haemoglobin levels;
• changes in kidney function including renal failure;
• low blood sugar (hypoglycaemia).

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

• anaemia, red or brownish spots on the skin (sometimes mainly on 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 disorders (recurrent panic attacks), confusion, depression, abnormal dreams, sleep disturbances, insomnia, memory impairment;
• pins and needles sensation or similar feeling, extremity pain, tremor, migraine, fainting;
• blurred vision, burning or painful eyes, conjunctivitis, worsening of vision, yellow vision;
• sensation of hearing a sound, ringing, buzzing or clicking in the ears, dizziness;
• low blood pressure, which may be associated with postural changes (feeling lightheaded or weak when standing up), angina (chest pain), abnormal 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 breathing difficulties), nosebleeds, runny nose, congestion;
• constipation, persistent constipation, flatulence, stomach discomfort, stomach spasms, vomiting, dry mouth, inflammation of a salivary gland, toothache;
• jaundice (yellowing of eyes and skin), pancreatitis (inflammation of the pancreas);
• urticaria, itching, skin inflammation, rash, skin redness, photosensitivity, 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), changes in liver function tests.

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

• acute respiratory distress (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 elevated 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 FORZAAR

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of that month.
Blister
Store Forzaar in the original packaging to protect the medicine from light and moisture.
Do not store 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 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 Forzaar contains
The active substances are losartan potassium and hydrochlorothiazide.
Forzaar 100 mg + 25 mg contains 100 mg of losartan potassium and 25 mg of hydrochlorothiazide as active substances.
Forzaar 100 mg + 25 mg contains the following excipients: microcrystalline cellulose (E460), lactose monohydrate, pregelatinized corn starch, magnesium stearate (E572), hydroxypropylcellulose (E463), hypromellose (E464).
Forzaar 100 mg + 25 mg also contains 8.48 mg (0.216 mEq) of potassium.
Forzaar 100 mg + 25 mg also contains titanium dioxide (E171), quinoline yellow adsorbed on aluminium hydrate (E104) and carnauba wax (E903).

Description of the appearance of Forzaar and contents of the pack
Forzaar 100 mg + 25 mg is supplied as light yellow, oval, film-coated tablets, with "747" printed on one side and the other side smooth.
Forzaar is available in the following pack sizes:
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 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 Roma
Italy

Manufacturer
Merck Sharp & Dohme B.V.
Waarderweg 39
2031BN, Haarlem
The Netherlands

Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium

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

| Member State | Trade 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 | | 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 |