LOSARTAN/HYDROCHLOROTHIAZIDE MABO 50/12.5 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

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 Mabo and what is it used for
2. What you need to know before you take Losartan/Hydrochlorothiazide Mabo
3. How to take Losartan/Hydrochlorothiazide Mabo
4. Possible side effects

5 Storage of Losartan/Hydrochlorothiazide Mabo

1. Contents of the pack and further information

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

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

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

2. What you need to know before you take Losartan/Hydrochlorothiazide Mabo

Do not takeLosartan/Hydrochlorothiazide Mabo

• 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 antibiotics such as cotrimoxazole; ask your doctor if you are not sure)
• if you are more than 3 months pregnant. (It is also recommended to avoid Losartan/Hydrochlorothiazide Mabo 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 with treatment
• if you have gout
• if you have diabetes or renal impairment and are being treated with a blood pressure-lowering medicine that contains aliskiren.

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 Mabo before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Losartan/Hydrochlorothiazide Mabo. Losartan/Hydrochlorothiazide Mabo is not recommended during the first trimester of pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby.

It is important that you inform your doctor before taking Losartan/Hydrochlorothiazide Mabo:

• if you have previously experienced swelling of the face, lips, tongue or throat
• 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 this medicine, seek medical attention immediately.
• if you are taking diuretics (water tablets)
• if you are on a low-salt diet
• if you have had excessive vomiting and/or diarrhea
• if you have heart failure
• if you have narrowed arteries that supply blood to 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 rash, 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 anesthesia (even at the dentist) or before surgery, or if you are to have tests to determine your parathyroid function, you should inform your doctor or healthcare professional that you are taking losartan potassium and hydrochlorothiazide tablets
• if you have primary hyperaldosteronism (a syndrome associated with high secretion of the hormone aldosterone by the adrenal gland due to a disorder of this gland)
• 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 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 hours to weeks after taking losartan/hydrochlorothiazide. This can lead to permanent vision loss if not treated. You may be at greater risk of developing this if you have previously been allergic to penicillin or sulfonamides.
• 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 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 Losartan/Hydrochlorothiazide Mabo”.

Other medicines and Losartan/Hydrochlorothiazide Mabo

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 Mabo can interact with other medicines.

Preparations containing lithium should not be taken with Losartan/Hydrochlorothiazide Mabo without your doctor performing careful 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), some laxatives, medicines for treating gout, medicines for controlling heart rhythm or for diabetes (oral medicines or insulins).

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

• other medicines to lower your blood pressure
• corticosteroids
• cancer medicines
• painkillers
• medicines for fungal infections
• medicines for arthritis
• cholesterol-lowering medicines such as colestyramine
• muscle relaxants
• sleeping tablets
• opioid medicines such as morphine
• "pressor amines" such as adrenaline or other medicines of the same group.
• oral medicines for diabetes 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 Mabo” and “Take special care with Losartan/Hydrochlorothiazide Mabo”).

Please, when taking Losartan/Hydrochlorothiazide Mabo, inform your doctor when you are scheduled to have a contrast medium with iodine.

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

TakingLosartan/Hydrochlorothiazide Mabowith food and drinks

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

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

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

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you are pregnant (or think you might be). Your doctor will normally advise you to stop taking Losartan/Hydrochlorothiazide Mabo before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Losartan/Hydrochlorothiazide Mabo. Losartan/Hydrochlorothiazide Mabo is not recommended during the first trimester of pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. Losartan/Hydrochlorothiazide Mabo 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.

Children and adolescents

There is no experience with the use of Losartan/Hydrochlorothiazide in children. Therefore, Losartan/Hydrochlorothiazide Mabo should not be given to children.

Use in elderly patients

Losartan/Hydrochlorothiazide Mabo works just as well and is just as well tolerated by most elderly patients and young adults. 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.

Use in athletes

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

Losartan/Hydrochlorothiazide Mabo contains lactose

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

3. How to TAKE LOSARTAN/HYDROCHLOROTHIAZIDE MABO

Follow exactly the administration instructions of Losartan/Hydrochlorothiazide Mabo given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Your doctor will decide the appropriate dose of Losartan/Hydrochlorothiazide Mabo, depending on your condition and whether you are taking other medicines. It is important to keep taking Losartan/Hydrochlorothiazide Mabo while your doctor prescribes it 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 over 24 hours. It can 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 moreLosartan/Hydrochlorothiazide Mabothan 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 ingested.

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

If you forget to takeLosartan/Hydrochlorothiazide Mabo

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

4. Possible side effects

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

If you experience the following, stop taking Losartan/Hydrochlorothiazide Mabo 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, which affects 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 (may affect up to 1 in 10 people):

• Cough, infection of the upper respiratory tract, 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.
• High levels of potassium (which can cause an abnormal heart rhythm), decrease in hemoglobin levels.
• Changes in renal function including renal failure;
• Low blood sugar (hypoglycemia).

Uncommon (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), bruising, reduction of white blood cells, coagulation 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, somnolence, memory impairment.
• Numbness or similar sensations, pain in the limbs, tremor, migraine, fainting.
• Blurred vision, itching or burning in the eyes, conjunctivitis, worsening of vision, seeing things in yellow.
• Ringing, buzzing, or other noises 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 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, flushing, 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, 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 that presents with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

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

• Acute respiratory distress (signs include severe difficulty breathing, 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 urine) (rhabdomyolysis);
• Low levels of sodium in the blood (hyponatremia);
• Generally feeling unwell (malaise);
• Altered taste (dysgeusia);

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through 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. Storage of LOSARTAN/HYDROCHLOROTHIAZIDE MABO

Keep out of the reach and sight of children.

Do not use Losartan/Hydrochlorothiazide Mabo after the expiration date stated on the packaging after CAD. The expiration date is the last day of the indicated month.

Store Losartan/Hydrochlorothiazide Mabo in its original packaging.

Keep the blister pack in 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 or household waste. Deposit the packaging and any unused medicines at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition ofLosartan/Hydrochlorothiazide Mabo

The active ingredients are losartan potassium and hydrochlorothiazide.

Each Losartan/Hydrochlorothiazide Mabo tablet contains, as active ingredients, 50 mg of losartan (potassium) and 12.5 mg of hydrochlorothiazide.

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

Losartan/Hydrochlorothiazide Mabo 50 mg/12.5 mg contains 4.24 mg (0.108 mEq) of potassium.

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

Appearance of the product and package contents

Losartan/Hydrochlorothiazide Mabo is supplied as film-coated tablets of yellow color, elongated and with a score line on one side.

Losartan/Hydrochlorothiazide Mabo is supplied in the following package sizes:

Al/PVC/PE/PVDC blister packs in packages of 28 tablets.

Marketing authorization holder

MABO-FARMA S.A.

Vía de los Poblados Street, 3,

Building 6, 28033 Madrid,

Spain.

Manufacturer

Meiji Pharma Spain S.A.

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

Date of the last revision of this leaflet:February 2025

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/