Patient Information

FORTZAAR 100mg/25mg Film-Coated Tablets

losartán potassium and hydrochlorothiazide

Read this 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. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse. See section 4.

1.What is Fortzaar 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.Storage of Fortzaar

6.Contents of the pack and additional information

Fortzaar is a combination of an angiotensin receptor antagonist (losartán) and a diuretic (hydrochlorothiazide).II(angiotensin II) is a substance produced in the body that binds to receptors present in blood vessels, causing them to constrict. This results in an increase in blood pressure. Losartán prevents the binding of angiotensinII to these receptors, causing blood vessels to relax, which in turn reduces blood pressure.Hydrochlorothiazide causes the kidneys to eliminate a greater amount of water and salts. This also helps to reduce blood pressure.

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

Do not take Fortzaar

• if you are allergic to losartan, hydrochlorothiazide, or any of the othercomponents of this medication(listed in section6),
• if you are allergic to other sulfonamide-derived substances (e.g. other thiazides, some antibacterial medications 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 levels of calcium that cannot be corrected with treatment,
• if you have gout,
• if you are more than 3months pregnant (It is also best to avoid Fortzaar at the beginning of pregnancy – see the sectionPregnancy),
• if you have severe kidney failure or your kidneys do not produce urine,
• if you have diabetes or kidney failure and are being treated with a medication to lower blood pressure that contains aliskiren.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to takeFortzaar.

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 eye pressure, and may occur within a few hours to several weeks after takingFortzaar. If left untreated, this can lead to permanent vision loss. You may be at a higher risk of developing this if you have previously had an allergy to penicillin or sulfonamide.

You should inform your doctor if you think you may be pregnant (or could be). Fortzaar is not recommended at the beginning of pregnancy and should not be taken if you are more than 3months pregnant, as it may cause serious harm to your baby if used during this stage (see the sectionPregnancy).

It is essential to inform your doctor before takingFortzaar:

• if you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience severe shortness of breath or difficulty breathing after taking Fortzaar, seek medical attention immediately.
• if you have previously experienced swelling of the face, lips, tongue, or throat;
• if you are taking diuretics (medications to increase urine production);
• if you are following a low-sodium diet;
• if you have had excessive vomiting and/or diarrhea;
• if you have heart failure;
• if your liver function is impaired (see section2 “Do not take Fortzaar”);
• if you have narrowed arteries (renal artery stenosis), if you only have one functioning kidney, or if you have recently had a kidney transplant;
• if you have atherosclerosis, angina pectoris (chest pain due to heart dysfunction);
• if you have aortic or mitral valve stenosis (narrowing of the heart valves) or hypertrophic cardiomyopathy (a disease causing thickening of the heart muscle);
• if you are diabetic;
• if you have had gout;
• if you have or have had an allergic reaction, asthma, or a condition causing joint pain, skin eruptions, and fever (systemic lupus erythematosus);
• if you have high calcium levels or low potassium levels, or if you are following a low-potassium diet;
• if you need anesthesia (even for dental procedures) or before surgery, or if you are undergoing tests to determine your parathyroid function, inform your doctor or healthcare provider that you are taking losartan potassium and hydrochlorothiazide tablets;
• if you have primary aldosteronism (a syndrome associated with excessive aldosterone hormone secretion by the adrenal gland due to glandular alteration);
• if you are taking any of the following medications used to treat high blood pressure:

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

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

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

• if you are taking other medications that may increase serum potassium levels (see section 2 “Taking Fortzaar with other medications”);
• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. The use of hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays 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 ofFortzaar in children. Therefore, Fortzaar should not be administered to children.

Fortzaar and other medications

Inform your doctor or pharmacist if you are taking, have taken recentlyor may need to takeany other medication.

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

Diuretics like hydrochlorothiazide in Fortzaar may interact with other medications.

Preparations containing lithium should not be taken with Fortzaar without close monitoring by your doctor.

You may need to take special precautions (e.g. blood tests) if you are taking other diuretics (“urine tablets”), some laxatives, medications for gout, medications to control heart rhythm or diabetes (oral medications or insulin).

Your doctor should also be aware if you are taking:

• other medications to lower your blood pressure;
• steroids;
• medications for cancer;
• medications for pain;
• medications for fungal infections;
• medications for arthritis;
• resins used for high cholesterol, such as cholestyramine;
• muscle relaxants;
• sleeping pills;
• opioid medications such as morphine;
• "pressor amines" such as adrenaline or other medications in the same group;
• oral diabetes medications or insulin.

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

If you are taking an 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 to undergo a radiographic examination with a contrast medium containing iodine.

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 the effects of each other.

Excessive salt in the 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 may be pregnant (or could be). Normally, your doctor will advise you to stop taking Fortzaar before becoming pregnant or as soon as you know you are pregnant and will advise you to take another medication instead of Fortzaar. Fortzaar is not recommended during pregnancy and should not be taken if you are more than 3months pregnant, as it may cause serious harm to your baby if used during this stage.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start breastfeeding. Fortzaar is not recommended for breastfeeding mothers, and your doctor may choose another treatment if you wish to continue breastfeeding.

Use in elderly patients

Fortzaaracts 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 operating machinery

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

Fortzaar contains lactose

This medication contains lactose. If your doctor has told you that you have anintolerance to certain sugars, consult with them before taking this medication.

Use in athletes: this medication contains hydrochlorothiazide, which may produce a positive result in doping control tests.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist.If in doubt, consult your doctor or pharmacist again.Your doctor will decide on the appropriate dose of Fortzaar, depending on your condition and whether you are taking other medications.It is essential to continue 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 of losartan/12.5 mg of hydrochlorothiazide per day to control blood pressure for 24 hours.The dose can be increased to 2 tablets of 50 mg of losartan/12.5 mg of 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 of losartan/12.5 mg of hydrochlorothiazide per day or 1 tablet of 100 mg of losartan/25 mg of hydrochlorothiazide per day.

Administration

Tablets should be swallowed whole with a glass of water.

If You Take More Fortzaar Than You Should

In case of an overdose, contact your doctor immediately for immediate medical attention.An overdose may cause a drop in blood pressure, palpitations, slow pulse, changes in blood composition, and dehydration.

You can also call the Toxicological Information Service.Phone: (91) 562 04 20, indicating the medication and the amount taken.It is recommended to bring the packaging and the medication leaflet 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 regular schedule.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

Severe allergic reaction (skin rash, itching, facial swelling, lip, mouth, or throat swelling that may cause difficulty swallowing or breathing).

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

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

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

Other side effects that may occur:

Frequent (may affect up to 1 in 10 people)

• cough, upper respiratory tract infection, nasal congestion, sinusitis, breast tenderness;
• diarrhea, abdominal pain, nausea, indigestion;
• muscle pain or cramps, leg pain, back pain;
• insomnia, headache, dizziness;
• weakness, fatigue, chest pain;
• high potassium levels (which may cause abnormal heart rhythms), decreased hemoglobin levels;
• renal function changes that include kidney failure;
• low blood sugar (hypoglycemia).

Occasional (may affect up to 1 in 100 people)

• 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), hematoma, reduced white blood cell count, coagulation problems, reduced platelet count;
• loss of appetite, high uric acid levels or gout, high blood glucose levels, abnormal electrolyte levels in the blood;
• anxiety, nervousness, panic attacks (recurring panic attacks), confusion, depression, abnormal dreams, sleep disorders, drowsiness, memory impairment;
• tingling or similar sensations, limb pain, tremors, migraine, fainting;
• blurred vision, eye itching or stinging, conjunctivitis, worsening vision, seeing things in yellow;
• ringing, buzzing, sounds, or crackling in the ears, vertigo;
• low blood pressure that may be associated with changes in posture (feeling dizzy or weak when standing up), angina (chest pain), abnormal heart rhythms, transient ischemic attack (TIA), "mini-stroke," heart attack, palpitations;
• inflammation of blood vessels that often occurs with a skin rash or hematoma;
• throat pain, shortness of breath, bronchitis, pneumonia, fluid in the lungs (causing difficulty breathing), nasal bleeding, runny nose, congestion;
• constipation, chronic constipation, gas, stomach disorders, stomach spasms, vomiting, dry mouth, salivary gland inflammation, tooth pain;
• jaundice (yellow discoloration of the eyes and skin), pancreatitis;
• urticaria, itching, skin inflammation, skin rash, skin redness, light sensitivity, dry skin, rubefaction, sweating, hair loss;
• arm, shoulder, hip, knee, or other joint pain, joint swelling, stiffness, muscle weakness;
• frequent urination even at night, abnormal renal function that includes kidney inflammation, urinary tract infection, sugar in the urine;
• decreased libido, impotence;
• facial swelling, localized swelling (edema), fever.

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

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

Unknown (frequency cannot be estimated from available data)

• flu-like symptoms;
• unknown muscle pain with dark-colored urine (rhabdomyolysis);
• low sodium levels in the blood (hyponatremia);
• usually feeling unwell (malaise);
• alteration of taste (dysgeusia);
• skin cancer and lip cancer (non-melanoma skin cancer);
• vision impairment 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 side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Blister

Store Fortzaar in the original packagingto protect it from light and moisture. Do not store the packagingat a temperature above30°C.

Bottle

Store in the original packagingto protect it from light. Keep the bottle perfectly closedto protect it from moisture. Do not store the bottleat a temperature above25°C.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and medicines that you no longer need at the SIGRE collection pointat the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. In this way, you will help protect the environment..

Fortzaar Composition

The active principles are losartan potassium and hydrochlorothiazide.

EachFortzaartablet contains, as active ingredients, 100mg of losartan potassium and 25mg of hydrochlorothiazide.

Fortzaarcontains the following inactive ingredients: microcrystalline cellulose (E‑460), lactose monohydrate, pregelatinized cornstarch, magnesium stearate (E‑572), hydroxypropyl cellulose (E‑463), hypromellose (E‑464).

Fortzaarcontains 8.48mg (0.216mEq) of potassium.

Fortzaaralso contains titanium dioxide (E‑171), quinoline yellow lake (E‑104) and carnauba wax (E‑903).

Product Appearance and Packaging Contents

Fortzaaris supplied as film-coated, yellowish, oval-shaped tablets, engraved with “747” on one side and smooth on the other.

Fortzaaris supplied in the following packaging sizes:

PVC/PE/PVDC blister with an aluminum foil, in boxes containing7, 14, 28, 30, 50, 56, 84, 90, 98, or 280tablets and hospital use single-dose packs of 28, 56 and 98tablets. HDPE bottle of 100tablets.

Only some packaging sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

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

Last update of thissummary of product characteristics:03/2025.

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)