LOSARTAN/HYDROCHLOROTHIAZIDE NORMON 100/25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

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

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Losartan/Hydrochlorothiazide Normon and what is it used for
2. What you need to know before you take Losartan/Hydrochlorothiazide Normon
3. How to take Losartan/Hydrochlorothiazide Normon
4. Possible side effects
5. Storing Losartan/Hydrochlorothiazide Normon
6. Contents of the pack and other 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).

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

2. What you need to know before you take 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, some antibacterials such as cotrimoxazole; ask your doctor if you are not sure).
• if you are more than 3 months pregnant. (It is also better to avoid Losartan/Hydrochlorothiazide Normon during the first months of pregnancy – see section on Pregnancy).
• if you have severe hepatic impairment.
• if you have severe renal impairment or your kidneys are not producing urine.
• if you have low levels of potassium or sodium, high levels of calcium that cannot be corrected by treatment.
• if you have gout.
• if you have diabetes or renal impairment and are being treated with a blood pressure medicine that contains aliskiren.

Special warnings and precautions

Tell your doctor if you are pregnant (or think you might be). Your doctor will normally advise you to stop taking Losartan/Hydrochlorothiazide Normon before you become pregnant or as soon as you find out that you are pregnant and will advise you to take another medicine instead of Losartan/Hydrochlorothiazide Normon. Losartan/Hydrochlorothiazide Normon should not be used during the first trimester of pregnancy and must not be used from the second trimester onwards as it may cause harm to your baby if used after the third month of pregnancy (see section on Pregnancy).

It is important that you tell your doctor before taking Losartan/Hydrochlorothiazide Normon:

• if you have previously suffered swelling of the face, lips, tongue or throat
• if you are taking diuretics (water tablets)
• if you are on a low salt diet
• if you have had excessive vomiting and/or diarrhoea
• if you have heart failure
• if you have narrowings of the 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 narrowing of the aortic or mitral valve (narrowing of the heart valves) or hypertrophic cardiomyopathy (a disease that causes thickening of the heart valves)
• if you are diabetic
• if you have had gout
• if you have had an allergic disorder, asthma or a condition that causes joint pain, skin rashes and fever (systemic lupus erythematosus)
• if you have high levels of calcium or low levels of potassium or if you are on a low potassium diet
• if you need to have anaesthesia (even at the dentist) or before surgery, or if you are to have tests to check your parathyroid function, you should inform your doctor or hospital that you are taking losartan/hydrochlorothiazide tablets
• if you have primary hyperaldosteronism (a syndrome associated with high secretion of the hormone aldosterone by the adrenal gland due to an alteration of this gland).
• 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 increased pressure in the eye and can occur within a few hours to a week after taking Losartan/Hydrochlorothiazide Normon. This can lead to permanent vision loss if not treated. If you have previously been allergic to penicillin or sulfonamide, you may be at greater risk of developing it.

• 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 diabetes-related kidney problems.
  • aliskiren.

• 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 exposure and UV rays while taking Losartan/Hydrochlorothiazide Normon.
• 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 Normon, seek medical attention immediately.

Your doctor may check 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 diarrhoea after taking Losartan/Hydrochlorothiazide Normon. Your doctor will decide whether to continue treatment. Do not stop taking Losartan/Hydrochlorothiazide Normon on your own.

See also the information under the heading “Do not take Losartan/Hydrochlorothiazide Normon”.

Taking other medicines

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

Diuretics like hydrochlorothiazide in Losartan/Hydrochlorothiazide Normon can interact with other medicines. Preparations containing lithium should not be taken with Losartan/Hydrochlorothiazide Normon without your doctor carrying out close monitoring. Special precautions may be necessary (e.g. blood tests) if you are taking potassium supplements, salt substitutes that contain potassium or potassium-sparing medicines, diuretics (water tablets), certain laxatives, gout treatments, heart rhythm or diabetes medicines (oral or insulin).

It is also important that your doctor knows if you are taking other medicines to lower your blood pressure, steroids, cancer medicines, painkillers, antifungal medicines or 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 class; (oral diabetes medicines or insulins).

Your doctor may need to change 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 “Special warnings and precautions”).

Please, when taking Losartan/Hydrochlorothiazide Normon, inform your doctor when you are scheduled to have an iodine 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 Normon tablets may increase the effects of each other.

Excessive salt in the diet may counteract the effect of Losartan/Hydrochlorothiazide Normon tablets.

Losartan/Hydrochlorothiazide Normon can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

You should tell your doctor if you are pregnant (or think you might be). Your doctor will normally advise you to stop taking Losartan/Hydrochlorothiazide Normon before you become pregnant or as soon as you find out that you are pregnant and will advise you to take another medicine instead of Losartan/Hydrochlorothiazide Normon. Losartan/Hydrochlorothiazide Normon should not be used during the first trimester of pregnancy and must not be used from the second trimester onwards as it may cause harm to your baby if used after the third month of pregnancy.

Breastfeeding

Tell your doctor if you are breastfeeding or plan to breastfeed. Losartan/Hydrochlorothiazide Normon is not recommended during breastfeeding, and your doctor will choose another treatment for you if you want 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 should not be given to children.

Use in elderly patients

Losartan/Hydrochlorothiazide Normon works as well and is as well tolerated by most elderly patients as it is by younger patients. Most elderly patients require the same dose as younger patients.

Driving and using machines

When you start treatment with this medicine, you should not perform tasks that require special attention (e.g. driving a car or using hazardous machinery) until you know how your medicine affects you.

Losartan/Hydrochlorothiazide Normon contains lactose and potassium.

This medicine contains lactose. If your doctor has told you that you have an intolerance to some 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 produce a positive result in doping tests.

3. How to take Losartan/Hydrochlorothiazide Normon

Follow exactly the instructions of administration of Losartan/Hydrochlorothiazide Normon indicated by your doctor. Your doctor will decide the appropriate dose of Losartan/Hydrochlorothiazide Normon, depending on your condition and whether you are taking other medicines. It is important to keep taking Losartan/Hydrochlorothiazide Normon while your doctor prescribes it to you 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/12.5 mg per day to control blood pressure for 24 hours.

This may be increased to 2 film-coated tablets of losartan/hydrochlorothiazide 50 mg/12.5 mg per day or changed to 1 film-coated tablet of losartan/hydrochlorothiazide 100 mg/25 mg (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.

If you take more Losartan/Hydrochlorothiazide Normon than you should

In case of 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 Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

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

If you forget to take Losartan/Hydrochlorothiazide Normon

Try to take Losartan/Hydrochlorothiazide Normon as prescribed. However, if you miss a dose, do not take an extra dose. Simply return to your usual schedule.

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

4. Possible side effects

Like all medicines, Losartan/Hydrochlorothiazide Normon can cause side effects, although not everybody gets them.

If you experience any of the following, stop taking Losartan/Hydrochlorothiazide Normon tablets and inform your doctor immediately or go to the casualty department of your nearest hospital:

A severe allergic reaction (skin rash, itching, swelling of the face, lips, mouth or throat that can cause difficulty in swallowing or breathing); This is a serious but rare side 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.

The following side 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,
• Diarrhoea, abdominal pain, nausea, indigestion,
• Muscle or leg cramps, back pain,
• Insomnia, headache, dizziness,
• Weakness, fatigue, chest pain,
• High levels of potassium (which can cause an abnormal heart rhythm), decrease in haemoglobin levels.

Uncommon (affecting less than 1 in 100 but more than 1 in 1,000):

• Anaemia, 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), bruising, reduction in white blood cells, blood clotting problems and bruising,
• Loss of appetite, high levels of uric acid or gout, high blood sugar levels, abnormal blood electrolyte levels,
• Anxiety, nervousness, panic disorders (recurrent panic attacks), confusion, depression, abnormal dreams, sleep disorders, drowsiness, memory problems,
• Numbness or similar sensations, pain in the limbs, tremor, migraine, fainting,
• Blurred vision, burning or itching in the eyes, conjunctivitis, worsening of vision, seeing things in yellow,
• Ringing, buzzing, noise or clicking 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, stroke (transient stroke, "mini-stroke"), heart attack, palpitations,
• Inflammation of the blood vessels that is often associated with a skin rash or bruising,
• Sore throat, shortness of breath, bronchitis, pneumonia, fluid in the lungs (which can cause difficulty breathing), nosebleeds, runny nose, congestion,
• Constipation, gas, stomach disorders, stomach spasms, vomiting, dry mouth, inflammation of a salivary gland, toothache,
• Jaundice (yellowing 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 kidney function including kidney inflammation, urinary tract infection, sugar in the urine,
• Decreased sexual desire, impotence,
• Swelling of the face, fever.

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

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

Frequency not known:

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

Very rare:

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

If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing 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 carton after EXP. The expiry date refers to the last day of the month stated.

Store below 30°C.

Keep Losartan/Hydrochlorothiazide Normon in the original package.

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

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

6. Container Content and Additional Information

Composition of Losartan/Hydrochlorothiazide Normon

The active ingredients are losartan potassium and hydrochlorothiazide.

Each Losartan/Hydrochlorothiazide Normon tablet contains as active ingredients, 100 mg of losartan (potassium) and 25 mg of hydrochlorothiazide.

Losartan/Hydrochlorothiazide Normon contains the following inactive ingredients:

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

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

Product Appearance and Container Content

Losartan/Hydrochlorothiazide Normon is supplied as round, yellow, film-coated tablets.

Losartan/Hydrochlorothiazide Normon is supplied in the following container sizes:

Al/PVC/PE/PVDC blister pack, in containers 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 Last Revision of this Leaflet:February 2025

Detailed and updated information on this medicinal product 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 updated information about this medicinal product by scanning the QR code included in the leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address:

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