PATIENT INFORMATION LEAFLET

Losartán/Hydrochlorothiazide Mabo 50mg/12.5mg film-coated tablets

Read this leaflet carefully before you start taking the 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 experience any side effects, talk to your doctor or pharmacist. See section 4.

1.What Losartán/Hydrochlorothiazide Mabo is and what it is used for

2.What you need to know before you start taking Losartán/Hydrochlorothiazide Mabo

3.How to take Losartán/Hydrochlorothiazide Mabo

4.Possible side effects

5Storage of Losartán/Hydrochlorothiazide Mabo

6.Contents of the pack and additional information

Losartán/Hidroclorotiazida Mabois 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 present in blood vessels, causing them to constrict. This results in an increase in blood pressure. Losartán prevents the binding of angiotensin II to these receptors, causing blood vessels to relax, which in turn reduces blood pressure. Hidroclorotiazida causes the kidneys to eliminate a greater amount of water and salts. This also helps to reduce blood pressure.

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

Do not takeLosartán/Hidroclorotiazida Mabo

• if you are allergic (hypersensitive) to losartan, to hydrochlorothiazide or to any of the other components 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 unsure)
• if you are more than 3 months pregnant. (It is best to avoid Losartán/Hidroclorotiazida Mabo 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 blood pressure-lowering medicine that contains aliskiren.

Warnings and precautions

Inform your doctor if you are pregnant (or if you suspect that you may be). Losartán/Hidroclorotiazida Mabo is not recommended for use at the start 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 time onwards (see Pregnancy section).

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

• if you have previously experienced swelling of the face, lips, tongue or throat
• 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 this medicine, seek medical attention immediately.
• if you are taking diuretics (urine-producing medicines)
• if you are following a low-sodium diet
• if you have excessive vomiting and/or diarrhoea
• if you have heart failure
• if you have narrowed arteries (arterial stenosis), angina (chest pain due to poor heart function)
• if you have aortic or mitral valve stenosis (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 an allergic reaction, asthma or a condition that causes 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 to have anaesthesia (even for dental procedures) or before surgery, or if you are to have tests to determine your parathyroid function, inform your doctor or healthcare professional 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 an alteration of this gland)
• if you are taking any of the following medicines used to treat high blood pressure (hypertension):

• an angiotensin-converting enzyme (ACE) inhibitor (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes
• aliskiren.

• if you experience a decrease in vision or eye pain, these may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in eye pressure and may occur within a few hours to several weeks after taking losartan/hydrochlorothiazide. This can lead to permanent loss of vision if not treated. You may be at a higher risk of developing this if you have previously had an allergy to penicillin or sulfonamides.
• 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 exposure to the sun and UV rays while taking Losartán/Hidroclorotiazida Mabo.

Your doctor may monitor your renal function, blood pressure, and electrolyte levels in the blood (e.g. potassium) at regular intervals. See also the information under the heading “Do not takeLosartán/Hidroclorotiazida Mabo”.

Other medicines and Losartán/Hidroclorotiazida Mabo

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

Diuretics such as hydrochlorothiazide inLosartán/Hidroclorotiazida Mabomay interact with other medicines.

Preparations containing lithium should not be taken withLosartán/Hidroclorotiazida Mabowithout your doctor closely monitoring you.

Special precautions may be necessary (e.g. blood tests) if you take potassium supplements, salt substitutes containing potassium or potassium-sparing medicines, diuretics (urine-producing tablets), some laxatives, medicines for gout treatment, heart rhythm-controlling medicines or diabetes medicines (oral or insulin).

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

• other medicines to lower your blood pressure
• steroids
• medicines for cancer treatment
• pain medicines
• medicines for fungal infections
• medicines for arthritis
• cholesterol-lowering resins, such as cholestyramine
• muscle-relaxing medicines
• sleeping tablets
• opioid medicines such as morphine
• "pressor amines" such as adrenaline or other medicines in the same group.
• oral diabetes medicines 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 takeLosartán/Hidroclorotiazida Mabo” and “Be careful withLosartán/Hidroclorotiazida Mabo”).

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

Consult your doctor if you experience abdominal pain, nausea, vomiting or diarrhoea after taking Losartán/Hidroclorotiazida Mabo. Your doctor will decide whether to continue treatment. Do not stop taking Losartán/Hidroclorotiazida Mabo on your own.

TakingLosartán/Hidroclorotiazida Mabowith food and drinks

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

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

Losartán/Hidroclorotiazida Mabo 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 that you may be). Your doctor will usually recommend that you stop taking Losartán/Hidroclorotiazida Mabo before becoming pregnant or as soon as you know you are pregnant and will recommend that you take another medicine instead of Losartán/Hidroclorotiazida Mabo. Losartán/Hidroclorotiazida Mabo is not recommended for use at the start of pregnancy, and in any case, it should not be administered from the third month of pregnancy onwards as it may cause serious harm to your baby when administered from that time onwards.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start breastfeeding. Losartán/Hidroclorotiazida Mabo 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 medicine.

Children and adolescents

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

Use in elderly patients

Losartán/Hidroclorotiazida Mabo acts with equal efficacy and is equally well tolerated by most elderly patients and young adults. Most elderly patients require the same dose as younger patients.

Driving and operating 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 you tolerate your medicine.

Use in athletes

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

Losartán/Hidroclorotiazida Mabo contains lactose

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

Follow exactly the administration instructions for LOSARTÁN/HIDROCLOROTIAZIDA MABO as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Your doctor will decide the appropriate dose of LOSARTÁN/HIDROCLOROTIAZIDA MABO based on your condition and whether you are taking other medications. It is essential to continue taking LOSARTÁN/HIDROCLOROTIAZIDA MABO 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 losartán/hidroclorotiazida 50 mg/12.5 mg per day to control blood pressure for 24 hours. It can be increased to 2 tablets of losartán/hidroclorotiazida 50 mg/12.5 mg per day or changed to 1 tablet of losartán/hidroclorotiazida 100 mg/25 mg (a higher dose) per day. The maximum daily dose is 2 tablets of 50 mg losartán/12.5 mg hidroclorotiazida per day or 1 tablet of 100 mg losartán/25 mg hidroclorotiazida per day.

If you take more LOSARTÁN/HIDROCLOROTIAZIDA MABO 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 forgot to take LOSARTÁN/HIDROCLOROTIAZIDA MABO

Try to take LOSARTÁN/HIDROCLOROTIAZIDA MABO 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.

Like all medications,Losartán/Hidroclorotiazida Mabomay cause side effects, although not everyone will experience them.

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

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 less than 1 in 1,000. You may need urgent medical attention or hospitalization.

The following side effects have been reported:

Frequent (may affect up to 1 in 10 people):

• Cough, upper respiratory tract 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.
• High potassium levels (which may cause abnormal heart rhythm), decreased hemoglobin levels.
• Changes in renal function that include renal insufficiency;
• Low blood sugar (hypoglycemia).

Less frequent (may affect up to 1 in 100 people):

• 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, high uric acid levels or manifest gout, high blood glucose levels, abnormal electrolyte levels in the blood.
• Anxiety, nervousness, panic disorders (recurring panic attacks), confusion, depression, abnormal dreams, sleep disorders, somnolence, memory alteration.
• Tingling or similar sensations, limb pain, tremor, migraine, fainting.
• Blurred vision, eye itching or stinging, 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.
• Sore throat, 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, redness, 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 renal function including kidney inflammation, urinary tract infection, sugar in the urine.
• Decreased sexual appetite, impotence.
• Swelling of the face, fever, localized swelling (edema).

Rare (may affect up to 1 in 1,000 people):

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

Very rare (may affect up to 1 in 10,000 people)

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

Frequency "unknown" (the frequency cannot be estimated from available data):

• Decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma).
• Skin and lip cancer (non-melanoma skin cancer).
• Symptoms similar to the flu;
• Muscle pain of unknown origin with dark-colored urine (tea-colored urine) (rhabdomyolysis);
• Low sodium levels in the blood (hyponatremia);
• Generally feeling unwell (malaise);
• Alteration of taste (dysgeusia);

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep out of the reach and sight of children.

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

StoreLosartán/Hidroclorotiazida Maboin 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. Dispose of the packaging andthe medicines that you no longer need at the SIGREcollection point at the pharmacy. If in doubtask your pharmacist how to dispose of the packaging and the medicines that you no longer need. By doing so, you will help protect the environment.

Composition ofLosartán/Hidroclorotiazida Mabo

The active principles are losartan potassium and hydrochlorothiazide.

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

Losartán/Hidroclorotiazida Mabo contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized cornstarch, magnesium stearate.

Losartán/Hidroclorotiazida Mabo 50mg/12.5mg contains 4.24 mg (0.108mEq) of potassium.

Losartán/Hidroclorotiazida Mabo also contains hydroxypropyl cellulose (hypromellose), hydroxypropyl methylcellulose (hypromellose), titanium dioxide (E-171), talc, iron oxide yellow (E-172).

Appearance of the product and content of the packaging

Losartán/Hidroclorotiazida Mabo is supplied as yellow-coated tablets with a score line on one face, elongated.

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

Aluminum/PVC/PE/PVDC blister packs containing 28 tablets.

Marketing Authorization Holder

MABO-FARMA S.A.

Calle Rejas 2, 1st floor28821

Coslada Madrid

Spain

Responsible for Manufacturing

Meiji Pharma Spain S.A.

Avda. de Madrid 94 Alcala de Henares (Madrid) - 28802 – Spain

Last revision date of this leaflet:February 2025

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