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

Patient Information Leaflet

Introduction

Patient Information Leaflet

Losartan/Hydrochlorothiazide Ababor 50 mg/12.5 mg film-coated tablets EFG

losartan potassium/hydrochlorothiazide

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if the effects are not listed in this leaflet. See section 4.

Leaflet Contents

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

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

Losartán/Hidroclorotiazida Ababor 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 present in blood vessels, causing them to narrow. This leads to an increase in blood pressure. Losartán prevents angiotensin II from binding to these receptors, resulting in relaxation of the blood vessels, thereby lowering blood pressure. Hydrochlorothiazide increases the excretion of water and salts by the kidneys. This also helps reduce blood pressure.

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

2. What you need to know before starting to take Losartán/Hidroclorotiazida Ababor

Do not take Losartán/Hidroclorotiazida Ababor

• if you are allergic to losartan, hydrochlorothiazide, or any of the other components of this medicine (listed in section 6),
• if you are allergic to other sulfonamide-derived substances (e.g., other thiazides, certain antibacterial medicines such as cotrimoxazole; ask your doctor if you are unsure),
• if you are more than 3 months pregnant. (Losartán/Hidroclorotiazida Ababor should also be avoided in early pregnancy – see Pregnancy section),
• if you have severe liver impairment,
• if you have severe renal impairment 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 impairment and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before starting to take Losartán/Hidroclorotiazida Ababor.

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 intraocular pressure, which may occur within hours to weeks after taking Losartán/Hidroclorotiazida Ababor. If left untreated, this may lead to permanent vision loss. Your risk may be higher if you have previously had an allergy to penicillin or sulfonamides.

You must inform your doctor if you think you are pregnant (or might be). Losartán/Hidroclorotiazida Ababor is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to your baby if used at this stage (see Pregnancy section).

It is important to 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 (medicines to increase urine),

• if you are on a low-salt diet,

• if you have or have had excessive vomiting and/or diarrhea,

• if you have heart failure,

• if your liver function is impaired (see section 2 “Do not take Losartán/Hidroclorotiazida Ababor”),

• if you have narrowed 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 pectoris (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 disease causing joint pain, skin rashes, 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), before surgery, or if you are undergoing tests to assess parathyroid function, you must inform the doctor or healthcare personnel 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 used to treat high blood pressure:

  • 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 blood electrolyte levels (e.g., potassium) at regular intervals.

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

• if you are taking other medicines that may increase serum potassium (see section 2 “Other medicines and Losartán/Hidroclorotiazida Ababor”).

• if you have had skin cancer or 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 non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Losartán/Hidroclorotiazida Ababor.

  • If you have had breathing or lung problems (such as 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, 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 must not be given to children.

Other medicines and Losartán/Hidroclorotiazida Ababor

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

Diuretics such as hydrochlorothiazide contained in Losartán/Hidroclorotiazida Ababor may interact with other medicines.

Lithium-containing preparations must not be taken with Losartán/Hidroclorotiazida Ababor unless your doctor performs close monitoring.

Special precautionary measures (e.g., blood tests) may be appropriate if you are taking other diuretics (“water tablets”), certain laxatives, gout treatments, medicines to control heart rhythm, or diabetes medicines (oral medicines or insulins).

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

• other medicines to lower your blood pressure,
• steroids,
• cancer treatments,
• pain medicines,
• antifungal medicines,
• arthritis medicines,
• cholesterol-lowering resins such as cholestyramine,
• muscle relaxants,
• sleeping tablets,
• opioid medicines such as morphine,
• "vasopressor amines" such as adrenaline or other medicines in the same group,
• oral diabetes medicines or insulins.

Your doctor may need to adjust your dose and/or take other precautions:

If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also information under the headings “Do not take Losartán/Hidroclorotiazida Ababor” and “Warnings and precautions”).

If you are undergoing a radiographic procedure with iodinated contrast medium, inform your doctor that you are taking Losartán/Hidroclorotiazida Ababor.

Taking Losartán/Hidroclorotiazida Ababor with food and drink

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

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

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

Grapefruit juice should be avoided while taking Losartán/Hidroclorotiazida Ababor.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you think you are pregnant (or might be). Your doctor will usually advise you to stop taking Losartán/Hidroclorotiazida Ababor before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Losartán/Hidroclorotiazida Ababor is not recommended during pregnancy, and must not be taken after the third month of pregnancy, as it may cause serious harm to your baby if used from the third month of pregnancy onward.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to breastfeed. Losartán/Hidroclorotiazida Ababor is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to continue breastfeeding.

Use in elderly patients

Losartán/Hidroclorotiazida Ababor works in the same way and is equally well tolerated by 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 tolerate the medicine.

Use in athletes:

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

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

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

3. How to take Losartán/Hidroclorotiazida Ababor

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

Your doctor will decide the appropriate dose of losartan/hydrochlorothiazide based on your condition and whether you are taking other medications. It is important to keep taking losartan/hydrochlorothiazide 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. The dose may be increased to 2 film-coated tablets of losartan/hydrochlorothiazide 50 mg/12.5 mg daily or changed to 1 film-coated tablet of losartan/hydrochlorothiazide 100 mg/25 mg (a stronger dose) once daily. 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.

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 overdose, contact your doctor immediately to receive immediate medical attention.

In the event of an overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the medicine package and leaflet to the healthcare professional.

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

If you forget to take Losartán/Hidroclorotiazida Ababor

Try to take losartan/hydrochlorothiazide every day as prescribed. However, if you miss a dose, do not take a double dose to make up for the missed dose. On the following day, take your usual dose at the regular time.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody gets them.

If you experience any of the following, stop taking Losartán/Hidroclorotiazida Ababor tablets immediately and contact your doctor right away 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.

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

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

Other possible adverse effects:

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

• cough, upper respiratory tract infection, nasal congestion, sinusitis, sinus disorder,
• diarrhoea, 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 (hypoglycaemia).

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

• anaemia, red or brown spots on the skin (sometimes especially on the feet, legs, arms and buttocks, with joint pain, swelling of hands and feet and abdominal pain), bruising, reduction in white blood cells, bleeding disorders, reduced platelet count,
• 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, pain in the limbs, tremor, migraine, fainting,
• blurred vision, burning or itching eyes, conjunctivitis, worsening of vision, seeing things yellow,
• ringing, buzzing, noises or crackling in the ears, vertigo,
• low blood pressure which may be associated with postural changes (feeling dizzy or weak when standing up), angina (chest pain), abnormal heartbeats, stroke (ischaemic transient attack (TIA), "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 (causing difficulty breathing), nosebleeds, runny nose, congestion,
• constipation, chronic constipation, flatulence, 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, photosensitivity, dry skin, flushing, sweating, hair loss,
• pain in arms, shoulders, hip, knee or other joints, joint swelling, stiffness, muscle weakness,
• frequent urination including at night, abnormal kidney function including kidney inflammation, urinary tract infection, sugar in urine,
• decreased sexual appetite, impotence,
• facial swelling, localized swelling (oedema), fever.

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

• hepatitis (liver inflammation), abnormal liver function tests,
• intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Not known (frequency cannot be estimated from available data):

• flu-like symptoms;
• muscle pain of unknown origin with dark-coloured urine (tea-coloured) (rhabdomyolysis);
• low sodium levels in blood (hyponatraemia);
• generally feeling unwell (malaise);
• altered taste (dysgeusia);
• skin and lip cancer (non-melanoma skin cancer);
• 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).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, 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 Ababor

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging, after EXP. The expiry date refers to the last day of the month indicated.

Store this medicine in its original packaging.

Keep the blister pack inside 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. Dispose of containers and unused medicines at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Losartan/Hydrochlorothiazide Ababor 50 mg/12.5 mg

• The active substances are potassium losartan and hydrochlorothiazide. Each tablet contains 50 mg of potassium losartan and 12.5 mg of hydrochlorothiazide.

• The other components are: microcrystalline cellulose, lactose monohydrate, pregelatinized corn starch, magnesium stearate, hydroxypropylcellulose (E 464), hypromellose, titanium dioxide (E171), yellow iron oxide (E-172), and talc.

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

Appearance of the medicine and contents of the pack

Yellow, elongated film-coated tablets.

PVC blister packs containing 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Ababor Pharmaceuticals, S.L.
C/ Chile nº4, Edif 1, Ofic 1,
Las Matas, Las Rozas (28290) Madrid, Spain

Manufacturer

Sofarimex
Av. Indústrias, Alto do Colaride
Agualva 2735-213 Cacém – Portugal

or

Industria Química y Farmacéutica VIR, S.A.
C/Laguna 66-70. Polígono Industrial Urtinsa II
28923 Alcorcón (Madrid)
Spain

This leaflet was last reviewed in: February 2025

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