FORTZAAR 100 mg/25 mg FILM-COATED TABLETS

Introduction

Prospect:patient information

FORTZAAR 100mg/25mg film-coated tablets

losartan potassium and hydrochlorothiazide

Read the entire leaflet carefully before starting to take 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, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Fortzaar and what is it used for
2. What you need to know before taking Fortzaar
3. How to take Fortzaar
4. Possible side effects
5. Storage of Fortzaar
6. Package contents and additional information

1. What is Fortzaar and what is it 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, causing the blood vessels to relax, which in turn lowers blood pressure. Hydrochlorothiazide causes the kidneys to eliminate more water and salts. This also helps to 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, some antibacterial medicines such as cotrimoxazole; ask your doctor if you are not sure),
• if you have severe hepatic impairment,
• if you have low potassium or sodium levels or high calcium levels that cannot be corrected with treatment,
• if you have gout,
• if you are pregnant for more than 3 months (It is also better to avoid Fortzaar at the beginning of pregnancy – see the section Pregnancy),
• if you have severe renal impairment or your kidneys do not produce urine,
• if you have diabetes or renal impairment and are being treated with a blood pressure-lowering medicine that contains aliskiren.

Warnings and precautions

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

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

You should inform your doctor if you think you are pregnant (or might be). Fortzaar is not recommended during pregnancy and should not be taken if you are pregnant for more than 3 months, as it can cause serious harm to your baby if used from the third month of pregnancy onwards.

It is essential that you inform your doctor before taking Fortzaar:

• if you have had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking Fortzaar, seek medical attention immediately.
• if you have previously suffered from swelling of the face, lips, tongue, or throat;
• if you are taking diuretics (water pills);
• 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 narrow arteries supplying the kidneys (renal artery stenosis), if you only have one functioning kidney, or if you have recently had a kidney transplant;
• if you have narrowing of the arteries (arteriosclerosis), angina pectoris (chest pain due to poor heart function);
• if you have “aortic or mitral valve stenosis” (narrowing of the heart valves) or “hypertrophic cardiomyopathy” (a disease that causes 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 that causes joint pain, skin rash, and fever (systemic lupus erythematosus);
• if you have high calcium levels or low potassium levels or are on a low-potassium diet;
• if you need to have anesthesia (even at the dentist) or before surgery, or if you are going to have tests to determine your parathyroid function, you should inform your doctor or healthcare professional that you are taking losartan potassium and hydrochlorothiazide tablets;
• if you have primary hyperaldosteronism (a syndrome associated with high secretion of the hormone aldosterone by the adrenal gland due to a disorder of this gland);
• if you are taking any of the following medicines used to treat high blood pressure:

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), particularly if you have diabetes-related kidney problems;
• 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 levels (see section 2 “Taking Fortzaar with other medicines”);
• if you have 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 skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun and UV exposure while taking Fortzaar.

Talk to 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 should not be administered to children.

Other medicines and Fortzaar

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Tell your doctor if you are taking potassium supplements, salt substitutes that contain potassium, potassium-sparing medicines, or other medicines that may increase serum potassium levels (e.g., trimetoprim-containing medicines), as combination with Fortzaar is not recommended.

Diuretics like hydrochlorothiazide contained in Fortzaar may interact with other medicines.

Lithium-containing preparations should not be taken with Fortzaar without close medical supervision.

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

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

• other medicines to lower your blood pressure;
• steroids;
• cancer treatments;
• painkillers;
• antifungal medicines;
• arthritis medicines;
• cholesterol-lowering resins such as cholestyramine;
• muscle relaxants;
• sleeping pills;
• opioid medicines like morphine;
• "pressor amines" like adrenaline or other medicines of the same group;
• oral diabetes medicines or insulins.

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

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

When taking Fortzaar, inform your doctor if you are going to have a radiographic test with an iodine-containing contrast medium.

Taking Fortzaar with food and drinks

It is recommended that you do not drink alcohol while taking these tablets: alcohol and Fortzaar tablets may increase each other's effects.

Excessive salt in your diet may counteract the effect of Fortzaar tablets.

Fortzaar tablets can be taken with or without food.

You should avoid grapefruit juice while taking Fortzaar.

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you think you are pregnant (or might be). Your doctor will normally advise you to stop taking Fortzaar before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Fortzaar. Fortzaar is not recommended during pregnancy and should not be taken if you are pregnant for more than 3 months, as it can cause serious harm to your baby if used from the third month of pregnancy onwards.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. Fortzaar is not recommended for mothers who are breastfeeding, and your doctor may choose another 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 patients and young adults. Most elderly patients require the same dose as younger patients.

Driving and using machines

When you start treatment with this medicine, you should not perform tasks that require special attention (e.g., driving a car or using hazardous machinery) until you know how your medicine affects you.

Fortzaar contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

Use in athletes: this medicine contains hydrochlorothiazide, which can produce a positive result in doping tests.

3. How to take Fortzaar

Follow the instructions for administration of this medicine exactly as prescribed 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 essential to keep taking Fortzaar while it is prescribed by your doctor to maintain constant control of your blood pressure.

High blood pressure

For most patients with high blood pressure, the usual dose is 1 tablet of 50 mg losartan/12.5 mg hydrochlorothiazide per day to control blood pressure over 24 hours. This can be increased to 2 tablets of 50 mg losartan/12.5 mg hydrochlorothiazide per day or changed to 1 tablet of Fortzaar 100 mg/25 mg (a stronger dose) per day. The maximum daily dose is 2 tablets of 50 mg losartan/12.5 mg hydrochlorothiazide per day or 1 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 for immediate medical attention. Overdose can cause a drop in blood pressure, palpitations, slow pulse, changes in blood composition, and dehydration.

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

If you forget to take Fortzaar

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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

This is a serious but rare side effect, affecting more than 1 in 10,000 patients but fewer than 1 in 1,000 patients. You may need urgent medical attention or hospitalization.

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

Acute respiratory distress (signs include severe difficulty breathing, fever, weakness, and confusion).

Other side effects that may occur:

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

• cough, infection of the upper respiratory tract, nasal congestion, sinusitis, sinus disorder;
• diarrhea, abdominal pain, nausea, indigestion;
• muscle pain or cramps, leg pain, back pain;
• insomnia, headache, dizziness;
• weakness, fatigue, chest pain;
• high potassium levels (which can cause an abnormal heart rhythm), decrease in hemoglobin levels;
• changes in renal function including renal failure;
• low blood sugar (hypoglycemia).

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

• anemia, red or brown spots on the skin (sometimes especially on the feet, legs, arms, and buttocks, with joint pain, swelling of the hands and feet, and abdominal pain), bruising, reduced white blood cell count, blood clotting problems, low platelet count;
• loss of appetite, high uric acid levels or gout, high blood sugar levels, abnormal blood electrolyte levels;
• anxiety, nervousness, panic disorders (recurrent panic attacks), confusion, depression, abnormal dreams, sleep disorders, somnolence, memory impairment;
• tingling or similar sensations, pain in the limbs, tremor, migraine, fainting;
• blurred vision, eye irritation or itching, conjunctivitis, worsening of vision, seeing things in yellow;
• ringing, buzzing, noises, or clicking in the ears, vertigo;
• low blood pressure that may be associated with postural changes (feeling dizzy or weak when standing up), angina (chest pain), abnormal heartbeats, stroke (transient ischemic attack (TIA), “mini-stroke”), heart attack, palpitations;
• inflammation of blood vessels that is often associated with a skin rash or bruising;
• sore throat, shortness of breath, bronchitis, pneumonia, fluid in the lungs (which causes difficulty breathing), nosebleeds, runny nose, congestion;
• constipation, chronic constipation, gas, stomach disorders, stomach spasms, vomiting, dry mouth, inflammation of a salivary gland, toothache;
• jaundice (yellowing of the eyes and skin), pancreatitis;
• hives, itching, skin inflammation, skin rash, redness of the skin, sensitivity to light, dry skin, flushing, sweating, hair loss;
• pain in the 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 the urine;
• decreased sexual desire, impotence;
• swelling of the face, localized swelling (edema), fever.

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

• intestinal angioedema: swelling in the intestine that presents with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.
• hepatitis (inflammation of the liver), abnormal liver function tests.

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

• flu-like symptoms;
• muscle pain of unknown origin with dark-colored urine (tea-colored) (rhabdomyolysis);
• low sodium levels in the blood (hyponatremia);
• generally feeling unwell (malaise);
• alteration of taste (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 effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side 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 which is stated on the carton after CAD. The expiry date is the last day of the month indicated.

Blister

Store Fortzaar in the original packaging to protect it from light and moisture. Do not store the container at a temperature 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 the bottle at a temperature above 25 °C.

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

6. Package Contents and Additional Information

Composition of Fortzaar

The active ingredients are losartan potassium and hydrochlorothiazide.

Each Fortzaar tablet contains, as active ingredients, 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), yellow quinoline aluminum lake (E-104), and carnauba wax (E-903).

Appearance of the Product and Package Contents

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

Fortzaar is supplied in the following package sizes:

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

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

This medicine is authorized in the Member States of the European Economic Areaandin the United Kingdom (Northern Ireland)under the following names:

Date of the last revision of thisleaflet:03/2025.

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