Losartan/hydrochlorothiazide Ababor 100/25 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Losartan/Hydrochlorothiazide Ababor 100 mg/25 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 you should not give it to others, even if they have the same symptoms as you, because it may 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. Storage of 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 (losartan) 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. Losartan prevents angiotensin II from binding to these receptors, resulting in relaxation of the blood vessels, thereby lowering blood pressure. Hydrochlorothiazide causes the kidneys to eliminate increased amounts of water and salts. This also helps reduce blood pressure.

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

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

Do not take Losartán/Hidroclorotiazida Ababor

• if you are allergic to losartan, hydrochlorothiazide, or any of the other ingredients 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. (It is also advisable to avoid Losartán/Hidroclorotiazida Ababor during early pregnancy – see Pregnancy section).
• if you have severe liver failure.
• if you have severe renal 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 renal impairment and are being treated with an antihypertensive medicine containing aliskiren.

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

If you experience vision changes 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 starting 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 may be pregnant (or could become pregnant). 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 the unborn 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 (angioedema)

• if you are taking diuretics ("water pills")

• if you are on a low-salt diet

• if you 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 (including at the dentist), 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 aldosterone hormone secretion from the adrenal gland due to adrenal dysfunction)

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

• an angiotensin-converting enzyme (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 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, 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 Ababor.

  • If you have had respiratory 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 experience abdominal pain, nausea, vomiting, or diarrhea after taking losartan, consult your doctor. 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 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 should not be taken with Losartán/Hidroclorotiazida Ababor unless your doctor closely monitors your condition.

Special precautions (e.g. blood tests) may be necessary if you are taking other diuretics ("water pills"), certain laxatives, gout treatments, heart rhythm control medicines, or diabetes medicines (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 treatments;
• pain medicines;
• antifungal medicines;
• arthritis medicines;
• cholesterol-lowering resins such as cholestyramine;
• muscle relaxants;
• sleeping pills;
• opioid medicines such as morphine;
• "pressor amines" 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 (ACE) inhibitor or aliskiren (see also information under the headings “Do not take Losartán/Hidroclorotiazida Ababor” and “Warnings and precautions”).

When taking Losartán/Hidroclorotiazida Ababor, inform your doctor if you are scheduled for an X-ray examination with iodine-containing contrast agents.

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 reduce the effectiveness 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 breast-feeding

Pregnancy

Inform your doctor if you think you may be pregnant (or could become pregnant). 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 the unborn baby if used from the third month of pregnancy onward.

Breast-feeding

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 dosage 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.

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

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

3. How to take Losartán/Hidroclorotiazida Ababor

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will decide the appropriate dose of losartán/hidroclorotiazida depending on your condition and whether you are taking other medicines. It is important to keep taking losartán/hidroclorotiazida 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 losartán/hidroclorotiazida 50 mg/12.5 mg once daily to control blood pressure over 24 hours. This may be increased to 2 film-coated tablets of losartán/hidroclorotiazida 50 mg/12.5 mg daily or switched to 1 film-coated tablet of losartán/hidroclorotiazida 100 mg/25 mg (a stronger dose) once daily. The maximum daily dose is 2 tablets of losartán 50 mg/hydrochlorothiazide 12.5 mg per day or 1 tablet of losartán 100 mg/hydrochlorothiazide 25 mg 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 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 medicine 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 losartán/hidroclorotiazida every day as prescribed. However, if you miss a dose, do not take a double dose to make up for the missed dose. The next day, take your usual amount of the medicine at the regular time.

4. Possible adverse effects

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

If you experience the following, stop taking Losartan/Hydrochlorothiazide Ababor tablets immediately and contact your doctor 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 rare but serious 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 include:

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 an abnormal heart rhythm), decreased haemoglobin levels,
• changes in kidney function including kidney failure,
• low blood sugar (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 the hands and feet and abdominal pain), bruising, reduced white blood cells, bleeding disorders, low 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 disturbance,
• tingling or similar sensations, pain in the limbs, tremor, migraine, fainting,
• blurred vision, stinging or itching in the eyes, conjunctivitis, worsening of vision, seeing things in yellow,
• ringing, buzzing, noise 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, breathlessness, bronchitis, pneumonia, fluid in the lungs (causing difficulty breathing), nosebleed, runny nose, congestion,
• constipation, chronic constipation, flatulence, stomach disorders, stomach spasms, vomiting, dry mouth,
• inflammation of a salivary gland, toothache,
• jaundice (yellowing of the 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 the arms, shoulders, hip, knee 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 appetite, impotence,
• facial swelling, localized swelling (oedema), fever.

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 causing symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

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

• flu-like symptoms;
• unexplained muscle pain 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 the original packaging.

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

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

6. Contents of the pack and other information

Composition of Losartan/Hydrochlorothiazide Ababor 100 mg/25 mg

• The active substances are potassium losartan and hydrochlorothiazide. Each tablet contains 100 mg of potassium losartan and 25 mg of hydrochlorothiazide.
• The other components are: microcrystalline cellulose, monohydrate lactose, pregelatinized corn starch, magnesium stearate, hydroxypropylcellulose (E 464), hypromellose, titanium dioxide (E 171), yellow iron oxide (E-172), and talc.

Each tablet of Losartan/Hydrochlorothiazide Ababor 100 mg/25 mg contains 8.48 mg (0.216 mEq) of potassium.

Appearance of the product and contents of the pack

Yellow, round, film-coated tablets.

PVC blister packs containing 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Ababor Pharmaceuticals, S.L.
C/ Chile No. 4, 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 medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/