Fortzaar 100 mg/25 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

FORTZAAR 100 mg/25 mg film-coated tablets

losartan potassium and hydrochlorothiazide

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to other people even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if these are effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Fortzaar is and what it is used for

Fortzaar 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 present in blood vessels, causing them 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, which in turn lowers blood pressure. Hydrochlorothiazide causes the kidneys to eliminate increased amounts of water and salts. This also helps reduce blood pressure.

Fortzaar is indicated for the treatment of essential hypertension (high blood pressure).

2. What you need to know before taking Fortzaar

Do not take Fortzaar

• 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 cotrimoxazole; ask your doctor if you are unsure),
• if you have severe liver failure,
• if you have low levels of potassium or sodium or high calcium levels that cannot be corrected with treatment,
• if you have gout,
• if you are more than 3 months pregnant (Fortzaar should also be avoided in early pregnancy – see section Pregnancy),
• if you have severe kidney failure or your kidneys are not producing urine,
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Fortzaar.

If you experience blurred vision or eye pain, these may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur within hours to weeks after taking Fortzaar. If left untreated, this may lead to permanent vision loss. Your risk may be higher if you have previously had an allergy to penicillin or sulfonamides.

Inform your doctor if you think you may be pregnant (or could become pregnant). Fortzaar is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to your baby if used at this stage (see section Pregnancy).

It is important to inform your doctor before taking Fortzaar:

• if you have previously experienced breathing or lung problems (such as lung inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking Fortzaar, seek medical attention immediately.

• if you have previously had swelling of the face, lips, tongue, or throat;

• if you are taking diuretics (medicines to increase urine production);

• if you are on a low-salt diet;

• if you have had excessive vomiting and/or diarrhea;

• if you have heart failure;

• if your liver function is impaired (see section 2 “Do not take Fortzaar”);

• if you have narrowed arteries supplying the kidneys (renal artery stenosis), only one functioning kidney, or have recently undergone a kidney transplant;

• if you have narrowed arteries (atherosclerosis), angina (chest pain due to poor heart function);

• if you have aortic or mitral valve stenosis (narrowing of heart valves) or hypertrophic cardiomyopathy (a condition causing thickening of the heart muscle);

• if you are diabetic;

• if you have had gout;

• if you have or have had an allergic disorder, asthma, or a disease causing joint pain, skin rashes, 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 require anesthesia (even at the dentist) or before surgery, or if you are undergoing tests to assess parathyroid function, inform your doctor or healthcare provider that you are taking losartan potassium and hydrochlorothiazide tablets;

• if you have primary hyperaldosteronism (a syndrome associated with excessive aldosterone hormone secretion from the adrenal gland due to adrenal dysfunction);

• if you are taking any of the following medicines for high blood pressure:

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes;

• aliskiren.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.

See also the information under the heading “Do not take Fortzaar”.

• if you are taking other medicines that may increase serum potassium (see section 2 “Taking Fortzaar with other medicines”);
• if you have 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 and lip cancer. Protect your skin from sun exposure and UV radiation while taking Fortzaar.

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

Children and adolescents

There is no experience with the use of Fortzaar in children. Therefore, Fortzaar must not be given to children.

Other medicines and Fortzaar

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to 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 Fortzaar is not recommended.

Diuretics such as hydrochlorothiazide contained in Fortzaar may interact with other medicines.

Lithium-containing preparations must not be taken with Fortzaar unless your doctor closely monitors you.

Special precautions (e.g. blood tests) may be necessary if you are taking other diuretics (“water tablets”), certain laxatives, gout treatments, medicines to control heart rhythm, or medicines for diabetes (oral agents or insulin).

It is also important that your doctor knows if you are taking:

• other medicines to lower your blood pressure;
• steroids;
• cancer treatments;
• pain medicines;
• antifungal medicines;
• arthritis medicines;
• cholesterol-lowering resins such as cholestyramine;
• muscle relaxants;
• sleeping tablets;
• opioid medicines such as morphine;
• pressor amines such as adrenaline or other medicines in the same class;
• oral diabetes medicines or insulin.

Your doctor may need to adjust your dose and/or take additional precautions:

If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also information under the headings “Do not take Fortzaar” and “Warnings and precautions”).

If you are taking Fortzaar, inform your doctor if you are scheduled for a radiographic procedure using iodinated contrast medium.

Taking Fortzaar with food and drink

You are advised not to drink alcohol while taking these tablets: alcohol and Fortzaar tablets may increase each other's effects.

Excessive dietary salt may counteract the effect of Fortzaar tablets.

Fortzaar tablets may be taken with or without food.

Grapefruit juice should be avoided while taking Fortzaar.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you think you may be pregnant (or could become pregnant). Your doctor will usually advise you to stop taking Fortzaar before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Fortzaar is not recommended during pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to your baby if used from the third month of pregnancy onwards.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to breastfeed. Fortzaar is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to continue breastfeeding.

Use in elderly patients

Fortzaar works in the same way and is equally well tolerated by most elderly and younger adult patients. Most elderly patients require the same dose as younger patients.

Driving and use of 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.

Fortzaar contains lactose

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult your doctor before taking this medicine.

Use in athletes: this medicine contains hydrochlorothiazide, which may result in a positive doping test.

3. How to take Fortzaar

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again. Your doctor will decide the appropriate dose of Fortzaar, depending on your condition and whether you are taking other medicines. It is important to keep taking Fortzaar as prescribed by your doctor to maintain consistent blood pressure control.

High blood pressure

For most patients with high blood pressure, the usual dose is 1 tablet of 50 mg losartan/12.5 mg hydrochlorothiazide once daily to control blood pressure over 24 hours. This dose may be increased to 2 film-coated tablets of 50 mg losartan/12.5 mg hydrochlorothiazide per day or changed to 1 film-coated tablet of Fortzaar 100 mg/25 mg (a stronger dose) once daily. The maximum daily dose is 2 film-coated tablets of 50 mg losartan/12.5 mg hydrochlorothiazide per day or 1 film-coated tablet of 100 mg losartan/25 mg hydrochlorothiazide per day.

Administration

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

If you take more Fortzaar than you should

In case of overdose, contact your doctor immediately to receive immediate medical attention. Overdose may cause low blood pressure, palpitations, slow pulse, changes in blood composition, and dehydration.

You may also call the Toxicology Information Service. Telephone: (91) 562 04 20, stating the medication and amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you forget to take Fortzaar

Try to take Fortzaar every day as prescribed. However, if you miss a dose, do not take an extra dose. Simply return to your regular schedule.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

If you experience the following, stop taking Fortzaar tablets and contact your doctor immediately or go to the nearest hospital emergency department:

A severe allergic reaction (skin rash, itching, swelling of the face, lips, mouth or throat which may cause difficulty swallowing or breathing).

This is a serious but rare adverse effect, affecting more than 1 in 10,000 patients but less than 1 in 1,000. It may require urgent medical attention or hospitalization.

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

Acute breathing difficulty (symptoms include severe shortness of breath, fever, weakness and confusion).

Other possible adverse effects include:

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

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

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

• anaemia, red or brown spots on the skin (sometimes especially on feet, legs, arms and buttocks, with joint pain, swelling of hands and feet and abdominal pain), bruising, reduction in white blood cells, bleeding disorders, reduced platelet count;
• loss of appetite, elevated uric acid levels or overt gout, elevated blood glucose levels, abnormal blood electrolyte levels;
• anxiety, nervousness, panic disorders (recurrent panic attacks), confusion, depression, abnormal dreams, sleep disorders, somnolence, memory disturbance;
• tingling or similar sensations, limb pain, tremor, migraine, fainting;
• blurred vision, burning or itching eyes, conjunctivitis, worsening of vision, seeing things in yellow;
• ringing, buzzing, noise or crackling in the ears, vertigo;
• low blood pressure which may be associated with postural changes (feeling dizzy or weak upon standing), angina (chest pain), abnormal heartbeats, stroke (transient ischaemic attack (TIA), “mini-stroke”), heart attack, palpitations;
• inflammation of blood vessels often associated with a skin rash or bruising;
• sore throat, shortness of breath, bronchitis, pneumonia, fluid in the lungs (causing difficulty breathing), nosebleed, runny nose, congestion;
• constipation, chronic constipation, flatulence, stomach disorders, stomach spasms, vomiting, dry mouth, inflammation of a salivary gland, toothache;
• jaundice (yellowing of eyes and skin), inflammation of the pancreas;
• urticaria, itching, skin inflammation, skin rash, redness of the skin, photosensitivity, dry skin, flushing, sweating, hair loss;
• pain in arms, shoulders, hips, knees or other joints, joint swelling, stiffness, muscle weakness;
• frequent urination even at night, abnormal kidney function including kidney inflammation, urinary tract infection, sugar in urine;
• decreased sexual appetite, impotence;
• swelling of the face, localized swelling (oedema), fever.

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

• intestinal angioedema: swelling in the intestine presenting symptoms such as abdominal pain, nausea, vomiting and diarrhoea;
• hepatitis (inflammation of the liver), abnormal liver function tests.

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

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

Reporting of adverse effects:

If you experience any type of adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fortzaar

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 the month indicated.

Blister

Store Fortzaar in the original packaging to protect it from light and moisture. Do not store above 30 °C.

Bottle

Store in the original packaging to protect it from light. Keep the bottle tightly closed to protect it from moisture. Do not store above 25 °C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fortzaar

The active substances are losartan potassium and hydrochlorothiazide.

Each tablet of Fortzaar contains, as active substances, 100 mg of losartan potassium and 25 mg of hydrochlorothiazide.

Fortzaar contains the following inactive ingredients: microcrystalline cellulose (E-460), lactose monohydrate, pregelatinized corn starch, magnesium stearate (E-572), hydroxypropyl cellulose (E-463), hypromellose (E-464).

Fortzaar contains 8.48 mg (0.216 mEq) of potassium.

Fortzaar also contains titanium dioxide (E-171), quinoline yellow aluminum lake (E-104), and carnauba wax (E-903).

Appearance of the product and contents of the pack

Fortzaar is supplied as film-coated tablets, light yellow in color, oval-shaped, marked with "747" on one side and smooth on the other.

Fortzaar is available in the following pack sizes:

PVC/PE/PVDC blister packs with an aluminum foil backing, in cartons containing 7, 14, 28, 30, 50, 56, 84, 90, 98, or 280 tablets and unit-dose packs of 28, 56, and 98 tablets for hospital use. HDPE bottle containing 100 tablets.

Some pack sizes may not be marketed.

Marketing Authorization Holder and Manufacturer

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

Date of the most recent review of this leaflet: 03/2025.

Detailed and up-to-date information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)