Losartan/hydrochlorothiazide Normon 100 mg/12.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Losartán/Hidroclorotiazida Normon 100 mg/12.5 mg film-coated tablets EFG

losartan potassium/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 they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Losartán/Hidroclorotiazida Normon is and what it is used for

Losartán/Hidroclorotiazida Normon is a combination of an angiotensin II receptor antagonist (losartán) and a diuretic (hidroclorotiazida). Angiotensin II is a substance produced in the body that binds to receptors in the blood vessels, causing them to narrow. This leads to an increase in blood pressure. Losartán prevents angiotensin II from binding to these receptors, allowing blood vessels to relax, thereby lowering blood pressure. Hidroclorotiazida causes the kidneys to eliminate more water and salts, which also helps reduce blood pressure.

Losartán/hidroclorotiazida is indicated for the treatment of essential hypertension (high blood pressure).

2. What you need to know before taking Losartán/Hidroclorotiazida Normon

Do not take Losartán/Hidroclorotiazida Normon

• If you are allergic to losartan, hydrochlorothiazide, or any of the other components 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 levels of calcium that cannot be corrected with treatment.
• If you have gout.
• If you are more than 3 months pregnant (losartan/hydrochlorothiazide should also be avoided early in pregnancy; see Pregnancy section).
• If you have severe renal failure or your kidneys do not produce 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 starting this medicine.

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

You must inform your doctor if you think you are pregnant (or could be). Losartan/hydrochlorothiazide 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 Pregnancy section).

It is important to inform your doctor before taking this medicine:

• If you have had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you develop shortness of breath or severe difficulty breathing after taking losartan/hydrochlorothiazide, seek medical attention immediately.
• If you have previously experienced 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 or have had excessive vomiting and/or diarrhea.
• If you have heart failure.
• If your liver function is impaired (see section 2 “Do not take Losartán/Hidroclorotiazida Normon”).
• 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 (including 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 (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 blood electrolyte levels (e.g., potassium) at regular intervals.

See also the information under the heading "Do not take Losartán/Hidroclorotiazida Normon."

• If you are taking other medicines that may increase serum potassium (see section 2 “Other medicines and Losartán/Hidroclorotiazida Normon”).
• If you have had skin cancer or 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 and lip cancers. Protect your skin from sun exposure and UV radiation while taking losartan/hydrochlorothiazide.

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

Children and adolescents

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

Other medicines and Losartán/Hidroclorotiazida Normon

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, salt substitutes containing potassium, potassium-sparing medicines, or other medicines that may increase serum potassium (e.g., medicines containing trimethoprim), as combination with losartan/hydrochlorothiazide is not recommended.

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

Lithium-containing preparations should not be taken with losartan/hydrochlorothiazide unless your doctor closely monitors you.

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

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

• Other medicines to lower your blood pressure.
• Steroids.
• Medicines to treat cancer.
• Painkillers.
• Medicines to treat fungal infections.
• Medicines for arthritis.
• Resins used for high cholesterol, such as cholestyramine.
• Muscle relaxants.
• Sleeping tablets.
• Opioid medicines such as morphine.
• "Pressor amines" such as adrenaline or other medicines in the same group.
• Oral medicines for diabetes or insulin.

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

If you are taking an angiotensin-converting enzyme (ACE) inhibitor or aliskiren (see also information under the headings "Do not take Losartán/Hidroclorotiazida Normon" and "Warnings and precautions").

When taking losartan/hydrochlorothiazide, inform your doctor if you are scheduled for a radiographic procedure using iodinated contrast media.

Taking Losartán/Hidroclorotiazida with food and drinks

You are advised not to drink alcohol while taking these tablets: alcohol and losartan/hydrochlorothiazide tablets may enhance each other's effects.

Excessive dietary salt intake may counteract the effect of losartan/hydrochlorothiazide tablets.

Losartan/hydrochlorothiazide tablets can be taken with or without food. Grapefruit juice should be avoided while taking Losartán/Hidroclorotiazida.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you think you are pregnant (or could be). Your doctor will usually advise you to stop taking losartan/hydrochlorothiazide before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Losartan/hydrochlorothiazide 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 onward.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to breastfeed. Losartan/hydrochlorothiazide is not recommended for breastfeeding mothers, and your doctor may choose a different 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 and younger adult patients. Most elderly patients require the same dose as younger patients.

Driving and using machines

When starting treatment with this medicine, do not perform tasks requiring special attention (e.g., driving a car or operating dangerous machinery) until you know how this medicine affects you.

Losartán/Hidroclorotiazida Normon contains lactose

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

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

3. How to take Losartán/Hidroclorotiazida Normon

Follow exactly the instructions for taking this medicine as given by your doctor or pharmacist. If in 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 medicines. It is important to keep taking losartan/hydrochlorothiazide 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 losartan/hydrochlorothiazide 50 mg losartan/12.5 mg hydrochlorothiazide daily to control blood pressure over 24 hours. This may be increased to 2 film-coated tablets of 50 mg losartan/12.5 mg hydrochlorothiazide daily or changed to 1 film-coated tablet of 100 mg losartan/25 mg hydrochlorothiazide (a stronger dose) daily. The maximum daily dose is 2 film-coated tablets of 50 mg losartan/12.5 mg hydrochlorothiazide daily or 1 film-coated tablet of 100 mg losartan/25 mg hydrochlorothiazide daily.

Losartán/Hidroclorotiazida Normon 100 mg/12.5 mg is intended for patients already treated with losartan 100 mg, and for whom the healthcare professional considers additional blood pressure control necessary.

Take this medicine exactly as your doctor has instructed.

Administration

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

If you take more Losartán/Hidroclorotiazida Normon 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.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Losartán/Hidroclorotiazida Normon

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

4. Possible adverse effects

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

If you experience the following, stop taking losartan/hydrochlorothiazide tablets immediately and contact your doctor right away 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 (signs 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.
• Diarrhea, 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 hemoglobin levels.
• Changes in kidney function including kidney 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 feet, legs, arms and buttocks, with joint pain, swelling of hands and feet, and abdominal pain), bruising, reduced white blood cells, blood clotting problems, 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, drowsiness, memory impairment.
• Tingling or similar sensations, limb pain, tremor, migraine, fainting.
• Blurred vision, burning or itching in the eyes, conjunctivitis, worsening of vision, seeing things in yellow.
• Ringing, buzzing, noises or crackling in the ears, dizziness.
• Low blood pressure which 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 bruising.
• Sore throat, shortness of breath, bronchitis, pneumonia, fluid in the lungs (causing 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 eyes and skin), inflammation of the pancreas.
• Hives, itching, skin inflammation, rash, skin redness, photosensitivity, dry skin, flushing, 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 appetite, impotence.
• Facial swelling, localized swelling (edema), 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 diarrhea.
• Hepatitis (liver inflammation), abnormal liver function tests.

Not known (frequency cannot be estimated from available data)

• Flu-like symptoms.
• Unexplained muscle pain with dark-colored urine (tea-colored) (rhabdomyolysis).
• Low sodium levels in blood (hyponatremia).
• General feeling of being 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 adverse effects, talk to your doctor, pharmacist, or nurse, even if they are possible adverse effects 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 Losartan/Hydrochlorothiazide Normon

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.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Losartan/Hydrochlorothiazide

The active substances are losartan potassium and hydrochlorothiazide.

The other components (excipients) are:

• Core of the tablet: microcrystalline cellulose, monohydrate lactose, 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 contents of the container

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

Aluminum-PVC/PE/PVDC blisters in packs containing 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

Or

LABORATORIOS LICONSA S.A.

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

19200 Azuqueca de Henares (Guadalajara)

Spain

Date of the most recent revision of this leaflet: July 2025

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