PATIENT INFORMATION LEAFLET

Losartán/Hydrochlorothiazide Mabo 100mg/25mg 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 they have similar symptoms, as it may harm them.

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. 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 hidroclorotiazida or to 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 cotrimoxazol, ask your doctor if you are unsure)
• if you are more than 3 months pregnant. (It is better 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 medication to lower blood pressure that contains aliskirén.

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 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 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 hidroclorotiazida in the past. If you experience severe shortness of breath or difficulty breathing after taking this medication, seek medical attention immediately.
• if you are taking diuretics (urine 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 (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 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 hidroclorotiazida 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 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
• aliskirén

• 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 hemorrhage) or increased eye pressure and may occur within a few hours to several weeks after taking losartan/hidroclorotiazida. This can lead to permanent vision loss 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 hidroclorotiazida, particularly its 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 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 take Losartán/Hidroclorotiazida Mabo”.

Other medications and Losartán/Hidroclorotiazida Mabo

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

Diuretics like the hidroclorotiazida contained in Losartán/Hidroclorotiazida Mabo may interact with other medications.

Preparations containing lithium should not be taken with Losartán/Hidroclorotiazida Mabo 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 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
• medications for cancer treatment
• medications for pain
• medications for fungal infections
• medications for arthritis
• resins used for high cholesterol, such as colestiramina
• 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 aliskirén (see also the information under the headings “Do not take Losartán/Hidroclorotiazida Mabo” and “Be careful with Losartán/Hidroclorotiazida Mabo”).

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

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

Taking Losartán/Hidroclorotiazida Mabo with 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 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 medication instead of Losartán/Hidroclorotiazida Mabo. Losartán/Hidroclorotiazida Mabo is not recommended for use at the beginning 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 point onwards.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start. 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 medication.

Use in 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 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.

Use in athletes:

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

Losartán/Hidroclorotiazida Mabo contains lactose

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

Follow exactly the administration instructions for Losartán/Hidroclorotiazida Mabo as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Your doctor will decide on the appropriate dose of Losartán/Hidroclorotiazida Mabo, depending on your condition and if 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 one tablet of losartán/hidroclorotiazida 50 mg/12.5 mg per day to control blood pressure for 24 hours. It can be increased to two tablets of losartán/hidroclorotiazida 50 mg/12.5 mg per day or changed to one tablet of losartán/hidroclorotiazida 100 mg/25 mg (a stronger dose) per day. The maximum daily dose is two tablets of 50 mg losartán/12.5 mg hidroclorotiazida per day or one 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 of day as you were prescribed. However, if you forget 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:

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 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 tenderness.
• 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.
• Changes in renal functionincludingrenal insufficiency;
• Low blood sugar (hypoglycemia).

Poorly 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, elevated uric acid levels or manifest gout, elevated blood glucose levels, abnormal electrolyte levels in the blood.
• Anxiety, nervousness, panic attacks (recurrent panic attacks), confusion, depression, abnormal dreams, sleep disorders, somnolence, memory alteration.
• Tingling or similar sensations, limb pain, tremors, 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.
• 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.
• Arm, shoulder, hip, knee, or other joint pain, joint swelling, stiffness, muscle weakness.
• Frequent urination even at night, abnormal renal function including kidney inflammation, urinary tract infection, sugar in the urine.
• Decreased libido, 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 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. Ask your pharmacist how

to dispose of the packaging and medicines that you no longer need. This 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, 100mg of losartan (potassium) and 25mg of hydrochlorothiazide.

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

Losartán/Hidroclorotiazida Mabo 100mg/25mg contains 8.48 mg (0.216mEq) 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 film coating, round, and with a notch on one face.

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

Aluminum/PVC/PE/PVDC blister packaging in packs of 28 tablets.

Marketing Authorization Holder

MABO-FARMA S.A.

Calle Rejas 2, 1st floor

28821 Coslada Madrid

Spain

Responsible for Manufacturing

Meiji Pharma Spain S.A.

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

Last review date of this leaflet:February 2025

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