Leaflet: information for the user

Losartán/Hidroclorotiazida Ababor 50 mg/12.5 mg film-coated tablets EFG

losartan potassium/hydrochlorothiazide

Read this leaflet carefully before you start taking the medicine, because it contains important information for you

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

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

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

3. How to take Losartán/Hidroclorotiazida Ababor

4. Possible side effects

5. Storage of Losartán/Hidroclorotiazida Ababor

6. Contents of the pack and additional information

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

Do not take Losartán/Hidroclorotiazida Ababor

• if you are allergic to losartan, hydrochlorothiazide, or any of the other ingredients in this medicine (listed in section 6),
• if you are allergic to other sulfonamide-derived substances (e.g. other thiazides, some antibacterial medicines such as cotrimoxazole, ask your doctor if you are unsure),
• if you are more than 3 months pregnant (It is also best to avoid Losartán/Hidroclorotiazida Ababor at the beginning of pregnancy – see the 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, or 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 precautionsConsult your doctor, pharmacist, or nurse before starting to take Losartán/Hidroclorotiazida Ababor.

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 Losartán/Hidroclorotiazida Ababor. If left untreated, this can lead to permanent loss of vision. You may be at a higher risk of developing this if you have previously had an allergy to penicillin or sulfonamide.

You should inform your doctor if you think you may be pregnant (or could be). Losartán/Hidroclorotiazida Ababor is not recommended at the beginning of pregnancy, and should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used in this stage (see the Pregnancy section).

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

• if you have previously experienced swelling of the face, lips, tongue, or throat
• if you are taking diuretics (urine-producing medicines)
• if you are following a low-sodium diet
• if you have excessive vomiting and/or diarrhea
• if you have heart failure
• if your liver function is altered (see section 2 “Do not take Losartán/Hidroclorotiazida Ababor”)
• if you have narrowed arteries (arterial stenosis), if you only have one functioning kidney, or if you have recently had a kidney transplant
• if you have atherosclerosis, angina (chest pain due to heart dysfunction)
• 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 or have had 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 staff 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 blood pressure-lowering medicines:

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

Your doctor may monitor your kidney function, blood pressure, and electrolyte levels in your blood (e.g. potassium) at regular intervals.

See also the information under the heading “Do not take Losartán/Hidroclorotiazida Ababor”

• 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 Ababor.
• • 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 experience abdominal pain, nausea, vomiting, or diarrhea after taking losartan. Your doctor will decide whether to continue treatment. Do not stop taking losartan on your own.

Children and adolescents

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

Other medicines and Losartán/Hidroclorotiazida Ababor

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

.

Inform your doctor if you are taking potassium supplements, salt substitutes containing potassium, potassium-sparing medicines, or other medicines that may increase serum potassium levels (e.g. trimetoprim-containing medicines), as the combination with Losartán/Hidroclorotiazida Ababor is not recommended.

Diuretics like hydrochlorothiazide in Losartán/Hidroclorotiazida Ababor may interact with other medicines.

Lithium preparations should not be taken with Losartán/Hidroclorotiazida Ababor without close monitoring by your doctor.

You may need to take special precautions (e.g. blood tests) if you are taking other diuretics (“urine-producing tablets”), some laxatives, medicines for gout, heart rhythm control medicines, or diabetes medicines (oral or insulin).

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

• other blood pressure-lowering medicines;
• steroids;
• medicines for cancer;
• pain medicines;
• medicines for fungal infections;
• medicines for arthritis;
• cholesterol-lowering resins, such as cholestyramine;
• muscle relaxants;
• sleeping tablets;
• opioid medicines like morphine;
• "pressor amines" like adrenaline or other medicines in the same group;
• oral diabetes or insulin medicines.

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 take Losartán/Hidroclorotiazida Ababor” and “Warnings and precautions”

Inform your doctor if you are to undergo a radiographic test with a contrast medium containing iodine.

Taking Losartán/Hidroclorotiazida Ababor with food and drinks

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

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

Losartán/Hidroclorotiazida Ababor tablets can be taken with or without food.

You should avoid grapefruit juice while taking Losartán/Hidroclorotiazida Ababor

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you think you may be pregnant (or could be). Normally, your doctor will advise you to stop taking Losartán/Hidroclorotiazida Ababor before becoming pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Losartán/Hidroclorotiazida Ababor. Losartán/Hidroclorotiazida Ababor is not recommended during pregnancy, and should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used in this stage.

Breastfeeding

Inform your doctor if you are breastfeeding or are about to start breastfeeding. Losartán/Hidroclorotiazida Ababor is not recommended for breastfeeding mothers, and your doctor may choose another treatment if you wish to continue breastfeeding

Use in elderly patients

Losartán/Hidroclorotiazida Ababor acts in the same way 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 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.

Important information about some of the components of Losartán/Hidroclorotiazida Ababor

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will decide on the suitable dose of losartan/hidroclorotiazide, depending on your condition and if you are taking other medications. It is essential to continue taking losartan/hidroclorotiazide 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/hidroclorotiazide 50 mg/12.5 mg per day to control blood pressure for 24 hours. It can be increased to 2 tablets of losartan/hidroclorotiazide 50 mg/12.5 mg per day or changed to 1 tablet of losartan/hidroclorotiazide 100 mg/25 mg (a higher dose) per day. The maximum daily dose is 2 tablets of 50 mg losartan/12.5 mg hidroclorotiazide per day or 1 tablet of 100 mg losartan/25 mg hidroclorotiazide per day.

Administration

The tablets should be swallowed whole with a glass of water.

If you take more Losartán/Hidroclorotiazida Ababor than you should

In case of an overdose, contact your doctor immediately 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. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

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 Ababor

Try to take losartan/hidroclorotiazide every day as prescribed. However, if you forget a dose, do not take a double dose to compensate for the missed dose. The next day, take your usual amount of medication at the usual time.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you experience any of the following, stop taking Losartán/Hidroclorotiazida Ababor tablets and inform your doctor immediately or go to the nearest hospital emergency department:

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.

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

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

Other side effects that may occur:

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 abnormal heart rhythms), decreased

hemoglobin levels.

changes in renal function that include renal insufficiency

• hypoglycemia (low blood sugar).

Occasional (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 cell count, coagulation problems, reduced platelet count,

,

• loss of appetite, elevated uric acid levels or gout, elevated blood glucose levels, abnormal electrolyte levels in the blood,

• anxiety, nervousness, panic attacks (recurring panic attacks), confusion,

depression, abnormal dreams, sleep disorders, drowsiness, memory alteration,

• tingling or similar sensations, pain in the extremities, tremors, migraine, fainting,

• blurred vision, eye itching or stinging, conjunctivitis, worsening vision, seeing things in yellow

• ringing, buzzing, noises, or crackling in the ears, vertigo

• 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 (TIA), "mini stroke," heart attack, palpitations.

,

• inflammation of blood vessels that often occurs with a skin rash or

hematoma,

• throat pain, shortness of breath, bronchitis, pneumonia, fluid in the lungs (causing difficulty breathing), nasal bleeding, runny nose, congestion,

• constipation, chronic constipation, gas, stomach disorders, stomach spasms, vomiting, dry mouth,

salivary gland inflammation, tooth pain,

• jaundice (yellow discoloration of the eyes and skin), pancreatitis,

• urticaria, itching, skin inflammation, skin rash, skin 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,

• facial swelling,localized swelling (edema),fever.

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.

Unknown (frequency cannot be estimated from available data)

• 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);

• altered taste (dysgeusia);

• skin cancer 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).

Reporting side effects

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

Keep out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

Conserve this medication in the original packaging.

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and the

medications you no longer need at the SIGREpoint of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and the medications you no longer need. By doing so, you will help protect the environment.

Composition of Losartán/Hidroclorotiazida Ababor 50 mg/12,5 mg

- The active principles are losartan potassium and hydrochlorothiazide. Each tablet

contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide.

- The other components are: microcrystalline cellulose, lactose monohydrate, pregelatinized cornstarch, magnesium stearate, hydroxypropylcellulose (E 464),

hypromellose, titanium dioxide (E171), yellow iron oxide (E-172), and talc.

Each tablet of Losartán/Hidroclorotiazida Ababor 50 mg/12.5 mg contains 4.24 mg (0.108 mEq) of potassium.

Appearance of the product and content of the packaging

Coated tablets with a yellow film coating and elongated shape.

PVC blister in packs of 28 tablets

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Ababor Pharmaceuticals, S.L.

C/ Chile nº4,Edif 1,Ofic 1,

Las Matas, Las Rozas (28290) Madrid - Spain

Responsible for manufacturing

Sofarimex

Av. Indústrias, Alto do Colaride

Agualva 2735-213 Cacém – Portugal

Or

Industrial Química y Farmacéutica VIR, S.A.

C/Laguna 66-70. Polígono Industrial Urtinsa II

28923 Alcorcón (Madrid)

Spain

This leaflet has been revised in:February 2025

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