Package Leaflet: Information for the User

Losartán/Hidroclorotiazida Normon 50 mg/12.5 mg Film-Coated Tablets EFG

Read this leaflet carefully before you start taking this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If you think you have suffered a side effect, you can help us by reporting it directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Losartán/Hidroclorotiazida Normon is a combination of an angiotensin II receptor antagonist (losartan) and a diuretic (hydrochlorothiazide).

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

Do not take Losartán/Hidroclorotiazida Normon

• if you are allergic (hypersensitive) to losartan, hydrochlorothiazide, or any of the other components of this medication.
• if you are allergic (hypersensitive) to other sulfonamide-derived substances (e.g. other thiazides, some antibacterials such as cotrimoxazole, ask your doctor if you are unsure).
• if you are more than 3 months pregnant. (It is better to avoid Losartán/Hidroclorotiazida Normon during the first months of pregnancy – see Pregnancy section).
• if you have severe liver failure.
• if you have severe kidney failure or your kidneys do not produce urine.
• if you have low levels of potassium or sodium, high levels of calcium that cannot be corrected with treatment.
• if you have gout.
• if you have diabetes or kidney failure and are being treated with a medication to lower blood pressure that contains aliskiren.

Be especially careful with Losartán/Hidroclorotiazida Normon

Inform your doctor if you are pregnant (or if you suspect you may be). Losartán/Hidroclorotiazida Normon is not recommended for use at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant as it may cause serious harm to your baby when administered from that point onwards (see Pregnancy section).

It is essential that you inform your doctor before taking Losartán/Hidroclorotiazida Normon:

• if you have previously experienced swelling of the face, lips, tongue, or throat.
• if you are taking diuretics (urine-producing medications).
• if you are following a low-sodium diet.
• if you have excessive vomiting and/or diarrhea.
• if you have heart failure.
• if you have narrowed arteries leading to the kidney (renal artery stenosis), if you only have one functioning kidney, or if you have recently undergone a kidney transplant.
• if you have atherosclerosis (narrowing of the arteries), angina (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 valves).
• 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 levels of calcium or low levels of potassium, 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 an elevated secretion of aldosterone hormone by the adrenal gland due to a glandular alteration).
• if you experience a decrease in vision or eye pain, which could 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 a week after taking Losartán/Hidroclorotiazida. This can lead to permanent vision loss if not treated. If you have previously had an allergy to penicillin or sulfonamide, you may be at a higher risk of developing it.
• if you are taking any of the following medications used to treat high blood pressure (hypertension):
• • an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
  • aliskiren.

• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with 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 Losartán/Hidroclorotiazida.
• 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 Losartán/Hidroclorotiazida Normon, seek medical attention immediately.

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

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Losartán/Hidroclorotiazida Normon. Your doctor will decide whether to continue treatment. Do not stop taking Losartán/Hidroclorotiazida Normon in monotherapy.

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

Use of other medications

Inform your doctor or pharmacist if you are taking or have recently taken other medications, including those purchased without a prescription.

Diuretics like hydrochlorothiazide in Losartán/Hidroclorotiazida Normon may interact with other medications. Preparations containing lithium should not be taken with Losartán/Hidroclorotiazida Normon without your doctor's careful monitoring. Special precautions may be necessary (e.g. blood tests) if you take potassium supplements, salt substitutes containing potassium, or potassium-sparing medications, diuretics (urine-producing tablets), some laxatives, medications for gout treatment, medications for heart rhythm control or diabetes (oral medications or insulin).

It is also essential that your doctor knows if you are taking other medications to lower your blood pressure, steroids, cancer medications, pain medications, fungal infection medications, or arthritis medications, cholesterol-lowering resins like cholestyramine, muscle relaxants, sleeping pills; opioid medications like morphine, "pressor amines" like 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 Losartán/Hidroclorotiazida Normon” and “Be especially careful with Losartán/Hidroclorotiazida Normon”).

Please inform your doctor when you plan to undergo a contrast medium with iodine.

Use of Losartán/Hidroclorotiazida Normon with food and beverages

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

Excessive salt in the diet may counteract the effect of Losartán/Hidroclorotiazida Normon tablets.

Losartán/Hidroclorotiazida Normon tablets can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you are pregnant (or if you suspect you may be). Your doctor will usually recommend that you stop taking Losartán/Hidroclorotiazida Normon before becoming pregnant or as soon as you know you are pregnant and will recommend that you take another medication instead of Losartán/Hidroclorotiazida Normon. Losartán/Hidroclorotiazida Normon is not recommended for use at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant as it may cause serious harm to your baby when administered from that point onwards.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start. Losartán/Hidroclorotiazida Normon is not recommended for use during breastfeeding, and your doctor will choose another treatment for you if you wish to breastfeed.

Consult your doctor or pharmacist before using any medication.

Use in children and adolescents

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

Use in elderly patients

Losartán/Hidroclorotiazida Normon acts with equal efficacy and is equally well tolerated by most elderly patients and young patients. 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 you tolerate your medication.

Losartán/Hidroclorotiazida Normon contains lactose and potassium.

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

This medication contains less than 39 mg of potassium (1 mmol) per tablet; it is essentially “potassium-free”.

Use in athletes:

This medication contains hydrochlorothiazide, which may produce a positive result in doping control tests.

Follow exactly the administration instructions for Losartán/Hidroclorotiazida Normon as indicated by your doctor. Your doctor will decide the appropriate dose of Losartán/Hidroclorotiazida Normon based on your condition and if you are taking other medications. It is essential to continue taking Losartán/Hidroclorotiazida Normon as prescribed by your doctor to maintain consistent blood pressure control.

Hypertension

For most patients with high blood pressure, the usual dose is 1 tablet of losartan/hydrochlorothiazide 50 mg/12.5 mg per day to control blood pressure for 24 hours.

The dose may be increased to 2 tablets of losartan/hydrochlorothiazide 50 mg/12.5 mg per day or changed to 1 tablet of losartan/hydrochlorothiazide 100 mg/25 mg (a higher 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.

If You Take More Losartán/Hidroclorotiazida Normon Than You Should

In case of an overdose, contact your doctor immediately or go directly to the hospital for immediate medical attention.

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

An overdose may cause a drop in blood pressure, palpitations, slow pulse, changes in blood composition, and dehydration.

If You Forget to Take Losartán/Hidroclorotiazida Normon

Try to take Losartán/Hidroclorotiazida Normon at the same time each day as prescribed. However, if you miss a dose, do not take an extra dose. Simply return to your regular schedule.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medicines, Losartán/Hidroclorotiazida Normon can cause side effects, although not everyone will experience them.

If you experience the following, stop taking Losartán/Hidroclorotiazida Normon tablets and inform your doctor immediately or go to the emergency service of your nearest hospital:

A severe allergic reaction (skin rash, itching, swelling of the face, lips, mouth, or throat 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.

The following side effects have been reported:

Frequent (affecting fewer than 1 in 10 but more than 1 in 100):

• Cough, respiratory infection, nasal congestion, sinusitis, breast 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 an abnormal heart rhythm), decreased hemoglobin levels.

Less frequent (affecting fewer than 1 in 100 but more than 1 in 1,000):

• 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 cells, coagulation problems, and hematomas,
• Loss of appetite, elevated uric acid levels or overt gout, elevated blood glucose levels, abnormal electrolyte levels in the blood,
• Anxiety, nervousness, panic disorders (recurrent panic attacks), confusion, depression, abnormal dreams, sleep disorders, drowsiness, memory alteration,
• Tingling or similar sensations, pain in the extremities, tremor, migraine, fainting,
• Blurred vision, eye itching or prickling, conjunctivitis, worsening vision, seeing things in yellow,
• Ringing, buzzing, sounds, or crackling in the ears,
• Low blood pressure that may be associated with changes in posture (feeling dizzy or weak when standing up), angina (chest pain), abnormal heartbeats, transient ischemic attack (mini-stroke), heart attack, palpitations,
• Inflammation of blood vessels that often occurs with a skin rash or hematoma,
• Throat itching, shortness of breath, bronchitis, pneumonia, fluid in the lungs (which may cause difficulty breathing), nasal bleeding, runny nose, congestion,
• Constipation, gas, stomach disorders, stomach spasms, vomiting, dry mouth, salivary gland inflammation, tooth pain,
• Jaundice (yellow discoloration of the eyes and skin), pancreatitis inflammation,
• Hives, itching, skin inflammation, skin rash, skin redness, light sensitivity, 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 libido, impotence,
• Swelling of the face, fever.

Rare (affecting more than 1 in 10,000 and fewer than 1 in 1,000):

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

Frequency unknown:

• Skin and lip cancer (non-melanoma skin cancer).
• Decreased vision or eye pain due to high pressure [possible signs of a fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma].

Very rare:

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

If you consider any of the side effects you are experiencing to be severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, 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.

Keep out of reach and sight of children.

Do not use Losartán/Hidroclorotiazida Normon after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Store below 30°C.

Store Losartán/Hidroclorotiazida Normon in the original packaging.

Keep the blister in the outer packaging. Do not open the blister until ready to take the tablet.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This will help protect the environment.

Composition of Losartán/Hidroclorotiazida Normon

The active principles are losartan potassium and hydrochlorothiazide.

Each Losartán/Hidroclorotiazida Normon tablet contains as active principles, 50 mg of losartan (potassium) and 12.5 mg of hydrochlorothiazide.

Losartán/Hidroclorotiazida Normon contains the following inactive ingredients:

Microcrystalline cellulose, pregelatinized cornstarch, lactose monohydrate, and magnesium stearate.

Losartán/Hidroclorotiazida Normon also contains hydroxypropylcellulose, hypromellose, titanium dioxide (E-171), and iron oxide yellow (E-172).

Appearance of the product and content of the packaging

Losartán/Hidroclorotiazida Normon is supplied as yellow-coated, round film-coated tablets.

Losartán/Hidroclorotiazida Normon is supplied in the following packaging sizes:

Aluminum/PVC/PE/PVDC blister pack, in packs of 28 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)

This leaflet was approved in February 2025

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