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

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Losartan/Hydrochlorothiazide Mabo 50mg/12.5mg 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 only and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

1. What Losartán/Hidroclorotiazida MABO is and what it is used for

Losartán/Hidroclorotiazida Mabo is a combination of an angiotensin II receptor antagonist (losartán) and a diuretic (hydrochlorothiazide). Angiotensin II is a substance produced in the body that binds to receptors in the blood vessels, causing them to narrow. This leads to an increase in blood pressure. Losartán blocks angiotensin II from binding to these receptors, resulting in relaxation of the blood vessels, which in turn lowers blood pressure. Hydrochlorothiazide causes the kidneys to eliminate increased amounts of water and salts. This also helps reduce blood pressure.

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

2. What you need to know before taking Losartán/Hidroclorotiazida MABO

Do not take Losartán/Hidroclorotiazida Mabo if:

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

Warnings and precautions

Inform your doctor if you are pregnant (or suspect you might be). Use of Losartán/Hidroclorotiazida Mabo 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 the unborn baby from that stage onward (see Pregnancy section).

It is important 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 breathing or lung problems (such as lung inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you develop shortness of breath or severe difficulty breathing after taking this medicine, contact your doctor immediately.

• if you are taking diuretics (medicines to increase urine production)

• if you are on a low-salt diet

• if you have had or currently have 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 narrowed arteries (atherosclerosis), angina (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 (even at the dentist) or before surgery, or if you are undergoing tests to assess parathyroid function, you must inform your doctor or healthcare provider 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 gland dysfunction)

• if you are taking any of the following medicines for high blood pressure (hypertension):

  • an angiotensin-converting enzyme inhibitor (ACEI) (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, which could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, occurring within hours to weeks after taking losartan/hydrochlorothiazide. 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 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 Losartán/Hidroclorotiazida Mabo.

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

Other medicines and Losartán/Hidroclorotiazida Mabo

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 Mabo may interact with other medicines.

Lithium-containing preparations should not be taken with Losartán/Hidroclorotiazida Mabo unless your doctor closely monitors you.

Special precautionary measures (e.g. blood tests) may be required if you are taking potassium supplements, potassium-containing salt substitutes, potassium-sparing diuretics, other diuretics (water tablets), certain laxatives, gout medications, medicines to control heart rhythm, or diabetes medications (oral agents or insulin).

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

• other medicines to lower your blood pressure
• steroids
• cancer treatment medicines
• painkillers
• antifungal medicines
• arthritis medicines
• cholesterol-lowering resins such as cholestyramine
• muscle relaxants
• sleeping tablets
• opioid medicines such as morphine
• "vasopressors" 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 angiotensin-converting enzyme inhibitor (ACEI) or aliskiren (see also information under the headings “Do not take Losartán/Hidroclorotiazida Mabo” and “Take special care with Losartán/Hidroclorotiazida Mabo”).

Please inform your doctor if you are scheduled to receive an iodinated contrast agent.

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 drink

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

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

Losartán/Hidroclorotiazida Mabo 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 generally advise you to stop taking Losartán/Hidroclorotiazida Mabo before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Use of Losartán/Hidroclorotiazida Mabo 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 from that stage onward.

Breastfeeding

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

Consult your doctor or pharmacist before taking any medicine.

Children and adolescents

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

Use in elderly patients

Losartán/Hidroclorotiazida Mabo is equally effective and well tolerated in most elderly and younger adult 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 that require special attention (e.g. driving a car or operating dangerous machinery) until you know how you react to the medicine.

Use in athletes

This medicine contains hydrochlorothiazide, which may result in a positive doping test.

Losartán/Hidroclorotiazida Mabo contains lactose

This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult with him before taking this medicine.

3. HOW TO TAKE LOSARTAN/HYDROCHLOROTHIAZIDE MABO

Follow exactly the instructions for use of Losartan/Hydrochlorothiazide Mabo as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Your doctor will determine the appropriate dose of Losartan/Hydrochlorothiazide Mabo depending on your condition and whether you are taking other medications. It is important to continue taking Losartan/Hydrochlorothiazide Mabo 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 per day or switched 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 losartan/12.5 mg hydrochlorothiazide per day or 1 tablet of 100 mg losartan/25 mg hydrochlorothiazide per day.

If you take more Losartan/Hydrochlorothiazide Mabo 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 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 Losartan/Hydrochlorothiazide Mabo

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

4. Possible adverse effects

Like all medicines, Losartán/Hidroclorotiazida Mabo may produce adverse effects, although not everyone experiences them.

If you experience the following, stop taking Losartán/Hidroclorotiazida Mabo 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:

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

• Cough, upper respiratory tract 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.
• Changes in kidney function including renal failure;
• Blood sugar too low (hypoglycemia).

Uncommon (may affect up to 1 in 100 people):

• Anemia, red or brown spots on the skin (sometimes especially on feet, legs, arms and buttocks, with joint pain, swelling of hands and feet and abdominal pain), bruising, reduction in white blood cells, coagulation disorders 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, drowsiness, 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, inflammation of a salivary gland, toothache.
• Jaundice (yellowing of eyes and skin), inflammation of the pancreas.
• Urticaria, itching, skin inflammation, skin rash, redness of the skin, photosensitivity, dry skin, flushing, sweating, hair loss.
• Pain in arms, shoulders, hips, knees or other joints, joint swelling, stiffness, muscle weakness.
• Frequent urination even during the night, abnormal kidney function including kidney inflammation, urinary tract infection, sugar in the urine.
• Decreased sexual appetite, impotence.
• Facial swelling, fever, localized swelling (edema).

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

• 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.

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

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

Frequency not known (frequency cannot be estimated from available data):

• Decreased vision or eye pain due to increased pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).
• Skin and lip cancer (non-melanoma skin cancer).
• Flu-like symptoms;
• Muscle pain of unknown origin with dark-colored urine (tea-colored) (rhabdomyolysis);
• Low sodium levels in blood (hyponatremia);
• Generally feeling unwell (malaise);
• Taste disturbance (dysgeusia);

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can 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 LOSARTAN/HYDROCHLOROTHIAZIDE MABO

Keep out of the reach and sight of children.

Do not use Losartan/Hydrochlorothiazide Mabo after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Store Losartan/Hydrochlorothiazide Mabo in the original packaging.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Losartán/Hidroclorotiazida Mabo

The active substances are losartan potassium and hydrochlorothiazide.

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

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

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

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

Appearance of the product and contents of the pack

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

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

Al/PVC/PE/PVDC blisters in packs of 28 tablets.

Marketing Authorization Holder

MABO-FARMA S.A.
Calle Vía de los Poblados, 3,
Edificio 6, 28033 Madrid,
Spain.

Manufacturer

Meiji Pharma Spain S.A.
Avda. de Madrid 94
Alcalá de Henares (Madrid) - 28802 – 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 of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/