Losartan/hydrochlorothiazide Normon 100/25 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the User

Losartan/Hydrochlorothiazide Normon 100 mg/25 mg Film-coated Tablets EFG

Read the entire leaflet carefully before you start taking this medicine.

• Keep this leaflet, as you may need to refer to it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you and must not be given to others, even if they have the same symptoms, as it may harm them.
• If you think any of the side effects you experience are serious, 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 taking Losartan/Hydrochlorothiazide Normon

Do not take Losartan/Hydrochlorothiazide Normon

• if you are allergic (hypersensitive) to losartan, hydrochlorothiazide, or any of the other ingredients 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 Losartan/Hydrochlorothiazide 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 calcium levels 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 Losartan/Hydrochlorothiazide Normon

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

It is important that you inform your doctor before taking Losartan/Hydrochlorothiazide 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 narrowing of the arteries supplying the kidneys (renal artery stenosis), only one functioning kidney, or have recently undergone a kidney transplant.

• if you have narrowing of 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 rash, 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, 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 intraocular pressure, occurring within hours to a week after taking Losartan/Hydrochlorothiazide. This may lead to permanent vision loss if not treated. 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 cancer and lip cancer. Protect your skin from sun exposure and UV radiation while taking Losartan/Hydrochlorothiazide.

• if you have previously experienced respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking Losartan/Hydrochlorothiazide 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 Losartan/Hydrochlorothiazide Normon. Your doctor will decide whether to continue treatment. Do not stop taking Losartan/Hydrochlorothiazide Normon as monotherapy without medical advice.

See also the information under the heading “Do not take Losartan/Hydrochlorothiazide 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 Losartan/Hydrochlorothiazide Normon can interact with other medicines. Preparations containing lithium should not be taken with Losartan/Hydrochlorothiazide Normon without careful monitoring by your doctor. Special precautionary measures (e.g., blood tests) may be appropriate if you are taking potassium supplements, potassium-containing salt substitutes, potassium-sparing medicines, diuretics (water tablets), certain laxatives, medicines for treating gout, 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, corticosteroids, cancer treatments, pain medicines, antifungal medicines, arthritis medicines, cholesterol-lowering resins such as cholestyramine, muscle relaxants, sleeping tablets, opioid medicines such as morphine, pressor amines such as adrenaline, or other medicines in the same group, or 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 inhibitor (ACE inhibitor) or aliskiren (see also information under the headings “Do not take Losartan/Hydrochlorothiazide Normon” and “Take special care with Losartan/Hydrochlorothiazide Normon”).

Please inform your doctor when you are scheduled to receive an iodinated contrast medium while taking Losartan/Hydrochlorothiazide Normon.

Taking Losartan/Hydrochlorothiazide Normon with food and drinks

You are advised not to drink alcohol while taking these tablets: alcohol and Losartan/Hydrochlorothiazide Normon tablets may increase each other's effects.

Excessive dietary salt intake may counteract the effect of Losartan/Hydrochlorothiazide Normon tablets.

Losartan/Hydrochlorothiazide 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 Losartan/Hydrochlorothiazide Normon before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Use of Losartan/Hydrochlorothiazide Normon is not recommended during early pregnancy, and must not be used from the third month of pregnancy onward, as it may cause serious harm to your baby from that stage.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to breastfeed. Use of Losartan/Hydrochlorothiazide 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, Losartan/Hydrochlorothiazide Normon must not be given to children.

Use in elderly patients

Losartan/Hydrochlorothiazide Normon is equally effective and well tolerated in most elderly and younger patients. Most elderly patients require the same dosage 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.

Losartan/Hydrochlorothiazide Normon contains lactose and potassium.

This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him 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 as indicated by your doctor. Your doctor will decide the appropriate dose of Losartán/Hidroclorotiazida Normon depending on your condition and whether you are taking other medications. It is important to continue 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 dose 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) once daily. 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 overdose, contact your doctor immediately or go directly to the hospital to receive immediate medical attention.

In the event 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 medication 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 dosing 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, Losartan/Hydrochlorothiazide Normon may cause adverse effects, although not everyone will experience them.

If you experience the following, stop taking Losartan/Hydrochlorothiazide 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 in 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 people):

• 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 people):

• 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, reduced white blood cells, blood clotting problems and bruising,
• Loss of appetite, elevated uric acid levels or manifest gout, elevated blood glucose levels, abnormal blood electrolyte levels,
• Anxiety, nervousness, panic disorders (recurrent panic attacks), confusion, depression, abnormal dreams, sleep disorders, drowsiness, memory disturbance,
• Tingling or similar sensations, limb pain, tremor, migraine, fainting,
• Blurred vision, eye irritation or itching, 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 eyes and skin), inflammation of the pancreas,
• Hives, itching, skin inflammation, skin 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 desire, impotence,
• Facial swelling, fever.

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

• Hepatitis (liver inflammation), 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 Medicinal Products: 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 out of the reach and sight of children.

Do not use Losartan/Hydrochlorothiazide 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.

Keep Losartan/Hydrochlorothiazide Normon in the original container.

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

Medicines should not be disposed of via wastewater drains or household waste. Ask your pharmacist how to properly dispose of medicines and packaging 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 100 mg of losartan (potassium) and 25 mg of hydrochlorothiazide as active substances.

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).

Nature 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 blisters, 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)

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

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.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 carton. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/69994/P_69994.html