LOSARTAN/HYDROCHLOROTHIAZIDE NORMON 100 mg/12.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Losartan/Hydrochlorothiazide Normon100 mg/12.5 mg film-coated tablets EFG

losartan potassium/hydrochlorothiazide

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Losartan/Hydrochlorothiazide Normon and what is it used for

Losartan/Hydrochlorothiazide Normon 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 the binding of angiotensin II to these receptors, which causes the blood vessels to relax, thereby decreasing blood pressure. Hydrochlorothiazide causes the kidneys to eliminate more water and salts. This also helps to reduce blood pressure.

Losartan/hydrochlorothiazide is indicated for the treatment of essential hypertension (high blood pressure).

2. What you need to know before taking Losartan/Hydrochlorothiazide Normon

Do not take Losartan/Hydrochlorothiazide Normon

• If you are allergic to losartan, hydrochlorothiazide, or any of the other ingredients of this medication (listed in section 6).
• If you are allergic to other sulfonamide-derived substances (e.g., other thiazides, certain antibacterial medications such as cotrimoxazole; ask your doctor if you are unsure).
• If you have severe liver 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 best to avoid losartan/hydrochlorothiazide at the beginning of pregnancy; see the Pregnancy section).
• If you have severe kidney impairment or your kidneys do not produce urine.
• If you have diabetes or kidney impairment and are being treated with a blood pressure medication containing aliskiren.

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to take this medication.

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 an increase in eye pressure, and can occur within a few hours to a few weeks after taking losartan/hydrochlorothiazide. If left untreated, this can lead to permanent vision loss. You may be at greater risk if you have previously been allergic to penicillin or sulfonamides.

You must inform your doctor if you think you are pregnant (or might be). Losartan/hydrochlorothiazide 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 during this period (see the Pregnancy section).

It is essential that you inform your doctor before taking this medication:

• 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 losartan/hydrochlorothiazide, 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 Losartan/Hydrochlorothiazide Normon").
• If you have narrow arteries that supply 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 had an allergic disorder, asthma, or a disease that causes joint pain, skin rashes, 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 undergo anesthesia (even at the dentist) or surgery, or if you are to undergo tests to determine your parathyroid function, you must 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 medications used to treat high blood pressure:
• • An angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), especially 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 Losartan/Hydrochlorothiazide Normon".

• If you are taking other medications that may increase serum potassium levels (see section 2 "Other medications and Losartan/Hydrochlorothiazide Normon").
• 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 losartan/hydrochlorothiazide.

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

Children and Adolescents

There is no experience with the use of losartan/hydrochlorothiazide in children. Therefore, losartan/hydrochlorothiazide should not be administered to children.

Other Medications and Losartan/Hydrochlorothiazide Normon

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

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

Diuretics such as hydrochlorothiazide in losartan/hydrochlorothiazide may interact with other medications.

Preparations containing lithium should not be taken with losartan/hydrochlorothiazide without close medical supervision.

Special precautions may be necessary (e.g., blood tests) if you are taking other diuretics ("water pills"), certain laxatives, medications for gout, medications to control heart rhythm, or diabetes medications (oral or insulin).

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

• Other medications to reduce your blood pressure.
• Corticosteroids.
• Cancer medications.
• Pain medications.
• Medications for fungal infections.
• Medications for arthritis.
• Cholesterol-lowering resins such as cholestyramine.
• Muscle relaxants.
• Sleeping pills.
• Opioid medications such as morphine.
• "Pressor amines" such as adrenaline or other medications of the same group.
• Oral diabetes medications 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 Losartan/Hydrochlorothiazide Normon" and "Warnings and Precautions").

When taking losartan/hydrochlorothiazide, inform your doctor if you are to undergo a radiographic test with an iodine-containing contrast medium.

Taking Losartan/Hydrochlorothiazide Normon with Food and Drink

It is recommended that you do not drink alcohol while taking these tablets: alcohol and losartan/hydrochlorothiazide tablets may increase the effects of each other.

Excessive salt in the diet may counteract the effect of losartan/hydrochlorothiazide tablets.

Losartan/hydrochlorothiazide tablets can be taken with or without food. You should avoid grapefruit juice while taking Losartan/Hydrochlorothiazide.

Pregnancy and Breastfeeding

Pregnancy

You must inform your doctor if you think you are pregnant (or might be). Your doctor will normally advise you to stop taking losartan/hydrochlorothiazide before becoming pregnant or as soon as you know you are pregnant and will advise you to take another medication instead of losartan/hydrochlorothiazide. Losartan/hydrochlorothiazide 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.

Breastfeeding

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

Use in Elderly Patients

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

Losartan/Hydrochlorothiazide Normon contains Lactose

This medication contains lactose. If your doctor has told you that you have an intolerance 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 tests.

3. How to Take Losartan/Hydrochlorothiazide Normon

Follow the instructions for administration of this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will decide the appropriate dose of losartan/hydrochlorothiazide, depending on your condition and whether you are taking other medications. It is essential to continue taking losartan/hydrochlorothiazide as 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 losartan/hydrochlorothiazide 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 100 mg of losartan/25 mg of hydrochlorothiazide (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.

Losartan/Hydrochlorothiazide Normon 100 mg/12.5 mg is intended for patients treated with losartan 100 mg, and for those the healthcare professional considers need additional blood pressure control.

Take this medication exactly as your doctor has indicated.

Administration

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

If you take more Losartan/Hydrochlorothiazide Normon than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Losartan/Hydrochlorothiazide Normon

Try to take losartan/hydrochlorothiazide every day as prescribed. Do not take a double dose to make up for forgotten doses. Simply return to your regular schedule.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

If you experience the following, stop taking the losartan/hydrochlorothiazide tablets and inform your doctor immediately or go to the emergency 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 adverse effect, affecting more than 1 patient in 10,000, but less than 1 patient 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 (signs include severe respiratory distress, fever, weakness, and confusion).

Other adverse effects that may occur:

Frequent (may affect up to 1 in 10 people)

• Cough, upper respiratory tract infection, 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), decreased hemoglobin levels.
• Changes in renal function, including renal failure.
• Low blood sugar (hypoglycemia).

Uncommon (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 blood electrolyte levels.
• Anxiety, nervousness, panic disorders (recurrent panic attacks), confusion, depression, abnormal dreams, sleep disorders, somnolence, memory impairment.
• Numbness or similar sensations, pain in the limbs, tremor, migraine, fainting.
• Blurred vision, itching or burning in the eyes, conjunctivitis, worsening 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, often associated with a skin rash or hematoma.
• Sore throat, 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, inflammation of a salivary gland, toothache.
• Jaundice (yellowish color 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 renal function, including kidney inflammation, urinary tract infection, sugar in the urine.
• Decreased sexual appetite, impotence.
• Swelling of the face, localized swelling (edema), fever.

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

• Intestinal angioedema: swelling in the intestine with 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.
• Muscle pain of unknown origin with dark-colored urine (tea-colored) (rhabdomyolysis).
• Low sodium levels in the blood (hyponatremia).
• 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 Adverse Effects

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

5. Storage of Losartan/Hydrochlorothiazide Normon

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at 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 Losartan/Hydrochlorothiazide

The active ingredients are losartan potassium and hydrochlorothiazide.

The other ingredients (excipients) are:

• Core of the tablet: microcrystalline cellulose, lactose monohydrate, pregelatinized corn starch, and magnesium stearate.
• Coating material: hypromellose, titanium dioxide (E-171), and macrogol.

Each Losartan/Hydrochlorothiazide Normon tablet contains 100 mg of losartan potassium and 12.5 mg of hydrochlorothiazide.

Appearance of the Product and Package Contents

The film-coated Losartan/Hydrochlorothiazide Normon tablets are white, round, engraved with "L" on one side and smooth on the other, with a diameter of 10.5 mm.

Aluminum-PVC/PE/PVDC blisters in packages of 28 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos-Madrid

Spain

Manufacturer

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos-Madrid

Spain

O

LABORATORIOS LICONSA S.A.

Avda. Miralcampo, Nº 7, Pol. Ind. Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

Date of the Last Revision of this Leaflet: July 2025

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