Losartan/hydrochlorothiazide Normon 50/12.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Losartan/Hydrochlorothiazide Normon 50 mg/12.5 mg film-coated tablets EFG

Read the entire 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 and should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you think any of the side effects you experience is severe or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Losartan/Hydrochlorothiazide Normon is and what it is 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. How to store Losartan/Hydrochlorothiazide 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 (losartan) and a diuretic (hydrochlorothiazide).

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

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

Do not take Losartán/Hidroclorotiazida Normon

• if you are allergic (hypersensitive) to losartan, hydrochlorothiazide, or any of the other components of this medicine.
• if you are allergic (hypersensitive) to other sulfonamide-derived substances (e.g. other thiazides, certain antibiotics such as cotrimoxazole; ask your doctor if you are unsure).
• if you are more than 3 months pregnant. (It is also best to avoid Losartán/Hidroclorotiazida Normon during the first months of pregnancy – see Pregnancy section).
• if you have severe liver impairment.
• if you have severe renal impairment or your kidneys do not produce urine.
• 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 have diabetes or kidney impairment and are being treated with a blood pressure-lowering medicine containing aliskiren.

Take special care with Losartán/Hidroclorotiazida Normon

Inform your doctor if you are pregnant (or suspect you might be). Use of Losartán/Hidroclorotiazida Normon is not recommended during early pregnancy, and you must not take it after the third month of pregnancy, as it may cause serious harm to your baby when used from that stage onward (see Pregnancy section).

It is important 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 (medicines to increase urine production)

• 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 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 pectoris (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 condition causing 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 require anesthesia (even at the dentist) or prior to surgery, or if you are undergoing tests to assess parathyroid function, you must inform the doctor or healthcare professional that you are taking losartan potassium and hydrochlorothiazide tablets

• if you have primary hyperaldosteronism (a syndrome associated with excessive secretion of the hormone aldosterone by the adrenal gland due to a disorder of this gland)

• 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, occurring within hours to one week after taking Losartán/Hidroclorotiazida. This may lead to permanent vision loss if untreated. Your risk may be higher if you have previously been allergic to penicillin or sulfonamides.

• if you are taking any of the following medicines 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 develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use at high doses, may increase the risk of certain types of non-melanoma skin and lip cancer. Protect your skin from sun exposure and UV radiation while taking Losartán/Hidroclorotiazida.

• if you have previously experienced breathing or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop 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 blood electrolyte levels (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 as monotherapy without medical advice.

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

Taking other medicines

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

Diuretics such as hydrochlorothiazide contained in Losartán/Hidroclorotiazida Normon may interact with other medicines. Preparations containing lithium should not be taken with Losartán/Hidroclorotiazida Normon unless your doctor performs careful monitoring. Special precautionary measures (e.g. blood tests) may be required if you are taking potassium supplements, potassium-containing salt substitutes, potassium-sparing medicines, diuretics (water tablets), certain laxatives, gout treatments, medicines to control heart rhythm, or medicines for diabetes (oral agents or insulin).

It is also important that your doctor knows if you are taking other blood pressure-lowering medicines, steroids, cancer treatments, painkillers, antifungal medicines, arthritis medicines, cholesterol-lowering resins such as cholestyramine, muscle relaxants, sleeping tablets, opioid medicines such as morphine, "vasopressor amines" such as adrenaline, or other medicines in the same class, or oral antidiabetic medicines or insulin.

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 information under the headings “Do not take Losartán/Hidroclorotiazida Normon” and “Take special care with Losartán/Hidroclorotiazida Normon”).

Please inform your doctor when you plan to undergo an iodinated contrast medium procedure while taking Losartán/Hidroclorotiazida Normon.

Taking Losartán/Hidroclorotiazida Normon with food and drink

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

Excessive dietary salt intake may counteract the effect of Losartán/Hidroclorotiazida Normon tablets.

Losartán/Hidroclorotiazida Normon may be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant (or suspect you might be). Your doctor will usually advise you to stop taking Losartán/Hidroclorotiazida Normon before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Use of Losartán/Hidroclorotiazida Normon is not recommended during early pregnancy, and must not be used after the third month of pregnancy, as it may cause serious harm to your baby when administered from that stage onward.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to breastfeed. Use of Losartán/Hidroclorotiazida Normon is not recommended during breastfeeding, and your doctor will choose an alternative treatment if you wish to breastfeed.

Consult your doctor or pharmacist before using any medicine.

Use in children and adolescents

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

Use in elderly patients

Losartán/Hidroclorotiazida Normon is equally effective and well tolerated in most elderly and younger 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 you react to the medicine.

Losartán/Hidroclorotiazida Normon contains lactose and potassium.

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

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

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 administration instructions for Losartán/Hidroclorotiazida Normon given by your doctor. Your doctor will decide the appropriate dose of Losartán/Hidroclorotiazida Normon, depending on your condition and whether you are taking other medicines. It is important to keep taking Losartán/Hidroclorotiazida Normon 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/12.5 mg once daily to control blood pressure over 24 hours.

This may be increased to 2 film-coated tablets of losartan/hydrochlorothiazide 50 mg/12.5 mg daily or switched to 1 film-coated tablet of losartan/hydrochlorothiazide 100 mg/25 mg (a stronger dose) daily. The maximum daily dose is 2 tablets of losartan 50 mg/hydrochlorothiazide 12.5 mg daily or 1 tablet of losartan 100 mg/hydrochlorothiazide 25 mg daily.

If you take more Losartán/Hidroclorotiazida Normon than you should

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

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

Overdose may cause low 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 daily as prescribed. However, if you miss a dose, do not take an extra dose. Simply return to your regular schedule.

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

4. Possible adverse effects

Like all medicines, Losartán/Hidroclorotiazida Normon can cause adverse effects, although not everyone experiences them.

If you experience the following, stop taking Losartán/Hidroclorotiazida Normon tablets and contact your doctor immediately 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.

The following adverse effects have been reported:

Common (affecting less than 1 in 10 but more than 1 in 100):

• Cough, respiratory 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.

Uncommon (affecting less 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 hands and feet and abdominal pain), bruising, reduction in white blood cells, blood clotting problems and bruising,
• 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, somnolence, 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,
• 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, "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 (which may cause difficulty breathing), nosebleed, runny nose, congestion,
• Constipation, gas, stomach disorders, stomach spasms, vomiting, dry mouth, swelling of a salivary gland, toothache,
• Jaundice (yellowing of the 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, hip, knee 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, fever.

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

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

Frequency not known:

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

Very rare:

• Acute breathing difficulty (signs include severe shortness of breath, fever, weakness and confusion).

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 Losartán/Hidroclorotiazida Normon

Keep out of the reach and sight of children.

Do not use Losartán/Hidroclorotiazida Normon after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Store below 30°C.

Store Losartán/Hidroclorotiazida Normon in the original container.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Losartán/Hidroclorotiazida Normon

The active substances are losartan potassium and hydrochlorothiazide.

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

Losartán/Hidroclorotiazida Normon contains the following inactive ingredients:

Microcrystalline cellulose, pregelatinized corn starch, lactose monohydrate and magnesium stearate.

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

Appearance of the product and contents of the pack

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

Losartán/Hidroclorotiazida Normon is available in the following pack sizes:

Al/PVC/PE/PVDC blister packs containing 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)

Date of the most recent review of this leaflet: February 2025

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/69993/P_69993.html