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

Introduction

Package Leaflet: Information for the User

Losartan/Hydrochlorothiazide Ababor 50 mg/12.5 mg Film-Coated Tablets EFG

losartan potassium/hydrochlorothiazide

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist or nurse.
• 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, pharmacist or nurse. 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 Ababor and what is it used for
2. What you need to know before you take Losartan/Hydrochlorothiazide Ababor
3. How to take Losartan/Hydrochlorothiazide Ababor
4. Possible side effects

5 Storage of Losartan/Hydrochlorothiazide Ababor

1. Contents of the pack and further information

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

Losartan/Hydrochlorothiazide Ababor is a combination of an angiotensin II receptor antagonist (losartan) and a diuretic (hydrochlorothiazide). Angiotensin II is a substance produced in the body which binds to receptors 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 the blood vessels relaxing, which in turn lowers the blood pressure. Hydrochlorothiazide makes the kidneys remove more water and salts. This also helps to lower blood pressure.

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

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

Do not take Losartan/Hydrochlorothiazide 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, some antibacterial medicines such as co-trimoxazole, ask your doctor if you are not sure).
• if you are more than 3 months pregnant. (It is also better to avoid Losartan/Hydrochlorothiazide Ababor at the beginning of pregnancy – see the 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, or high levels of calcium that cannot be corrected by treatment.
• if you have gout.
• if you have diabetes or renal impairment and are being treated with a blood pressure medicine that contains aliskiren.

Warnings and precautionsTalk to your doctor, pharmacist or nurse before taking Losartan/Hydrochlorothiazide 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 an increase in eye pressure and can occur within hours to weeks after taking Losartan/Hydrochlorothiazide Ababor. If left untreated, this can lead to permanent vision loss. You may be at greater risk if you have previously had an allergy to penicillin or sulfonamide

You must inform your doctor if you think you are pregnant (or might be). Your doctor will normally advise you to stop taking Losartan/Hydrochlorothiazide Ababor 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 Ababor. Losartan/Hydrochlorothiazide Ababor is not recommended during pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

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

• if you have previously suffered from swelling of the face, lips, tongue or throat
• if you are taking diuretics (water tablets)
• if you are on a low-salt diet
• if you have had excessive vomiting and/or diarrhoea
• if you have heart failure
• if your liver function is impaired (see section 2 “Do not take Losartan/Hydrochlorothiazide Ababor”)
• if you have narrowings of the arteries that supply 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 (atherosclerosis), angina pectoris (chest pain due to poor heart function)
• if you have narrowing of the aortic or mitral valve (valve stenosis) 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 disease that causes joint pain, skin rashes 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 an anaesthetic (even at the dentist) or before surgery, or if you are going to have tests to determine your parathyroid function, you must 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 an alteration of this gland)
• 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 check your kidney function, blood pressure and levels of electrolytes in your blood (e.g. potassium) at regular intervals.

See also the information under the heading “Do not take Losartan/Hydrochlorothiazide Ababor”

• if you are taking other medicines that may increase serum potassium levels (see section 2 “Other medicines and Losartan/Hydrochlorothiazide Ababor”.

• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, in particular long-term use at high doses, may increase the risk of some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Losartan/Hydrochlorothiazide Ababor.
• • 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 difficulty breathing severely after taking this medicine, seek medical attention immediately.
  • If you experience abdominal pain, nausea, vomiting or diarrhoea 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 Losartan/Hydrochlorothiazide Ababor in children. Therefore, Losartan/Hydrochlorothiazide Ababor must not be given to children.

Other medicines and Losartan/Hydrochlorothiazide Ababor

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

.

Tell your doctor if you are taking potassium supplements, salt substitutes that contain potassium, potassium-sparing medicines or other medicines that may increase serum potassium levels (e.g. trimethoprim-containing medicines), as these are not recommended to be taken with Losartan/Hydrochlorothiazide Ababor.

Diuretics like hydrochlorothiazide contained in Losartan/Hydrochlorothiazide Ababor may interact with other medicines.

Lithium-containing preparations should not be taken with Losartan/Hydrochlorothiazide Ababor without close supervision by your doctor.

Special precautions may be necessary if you are taking other diuretics (“water tablets”), certain 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 reduce your blood pressure;
• corticosteroids;
• medicines to treat cancer;
• medicines for pain,
• medicines to treat fungal infections;
• medicines for arthritis;
• cholesterol-lowering resins such as cholestyramine;
• 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 Ababor” and “Warnings and precautions”

When taking Losartan/Hydrochlorothiazide Ababor, inform your doctor if you are going to have a radiographic examination with an iodine-containing contrast medium.

Taking Losartan/Hydrochlorothiazide Ababor with food and drink

You are advised not to drink alcohol while taking these tablets: alcohol and Losartan/Hydrochlorothiazide Ababor tablets may increase the effects of each other.

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

Losartan/Hydrochlorothiazide Ababor tablets can be taken with or without food.

Grapefruit juice should be avoided while taking Losartan/Hydrochlorothiazide Ababor

Pregnancy and breast-feeding

Pregnancy

You must inform your doctor if you think you are pregnant (or might be). Your doctor will normally advise you to stop taking Losartan/Hydrochlorothiazide Ababor 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 Ababor. Losartan/Hydrochlorothiazide Ababor is not recommended during pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Losartan/Hydrochlorothiazide Ababor is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment if you wish to continue breast-feeding.

Use in elderly patients

Losartan/Hydrochlorothiazide Ababor works 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 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 dangerous 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.

Important information about some of the ingredients of Losartan/Hydrochlorothiazide Ababor

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

3. How to take Losartan/Hydrochlorothiazide Ababor

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Your doctor will decide the appropriate dose of losartan/hydrochlorothiazide, depending on your condition and whether you are taking other medicines. It is important to keep taking losartan/hydrochlorothiazide 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 one losartan/hydrochlorothiazide 50 mg/12.5 mg tablet per day to control blood pressure over 24 hours. This may be increased to two losartan/hydrochlorothiazide 50 mg/12.5 mg film-coated tablets per day or changed to one losartan/hydrochlorothiazide 100 mg/25 mg film-coated tablet (a stronger dose) per day. The maximum daily dose is two losartan/hydrochlorothiazide 50 mg/12.5 mg tablets per day or one losartan/hydrochlorothiazide 100 mg/25 mg tablet per day.

Administration

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

If you take more Losartan/Hydrochlorothiazide 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, telephone 91 562 04 20, indicating the medicine and the amount taken. It is recommended to take the package and the leaflet of the medicine to the healthcare professional.

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

If you forget to take Losartan/Hydrochlorothiazide Ababor

Try to take losartan/hydrochlorothiazide every day, as prescribed by your doctor. 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 medicine at the usual time.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

A severe allergic reaction (skin rash, itching, swelling of the face, lips, mouth, or throat that can cause difficulty swallowing or breathing).

This is a serious but rare adverse effect, affecting more than 1 patient in 10,000, but less than 1 patient in 1,000. It may require urgent medical attention or hospitalization.

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

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

Other adverse effects that may occur:

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,
• high potassium levels (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), hematoma, reduced white blood cell count, coagulation problems, reduced platelet count,

loss of appetite, high uric acid levels or gout, high blood glucose levels, abnormal blood electrolyte levels,

• anxiety, nervousness, panic disorders (recurrent panic attacks), confusion,

depression, abnormal dreams, sleep disorders, somnolence, memory impairment,

• tingling 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, noises, or clicking in the ears, vertigo
• low blood pressure that may be associated with postural changes (feeling dizzy or weak when standing up), angina (chest pain), abnormal heartbeats, cerebrovascular accident (transient ischemic attack (TIA), "mini-stroke"), heart attack, palpitations.

,

• inflammation of the blood vessels, often associated with a skin rash or hematoma,

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

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

inflammation of a salivary gland, toothache,

• jaundice (yellowish color of the eyes and skin), pancreatitis,
• hives, itching, skin inflammation, skin rash, redness of the skin,

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,
• swelling of the face, 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)

• flu-like symptoms;
• muscle pain of unknown origin with dark-colored urine (tea-colored) (rhabdomyolysis);
• low sodium levels in the blood (hyponatremia);
• 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 Adverse Effects

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

5. Storage of Losartán/Hidroclorotiazida Ababor

Keep out of sight and reach of children.

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

Store this medicine 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 in the SIGRE collection point at 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. Packaging Contents and Additional Information

Composition of Losartán/Hidroclorotiazida Ababor 50 mg/12.5 mg

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

The other ingredients are: microcrystalline cellulose, lactose monohydrate, pregelatinized corn starch, magnesium stearate, hypromellose (E 464),

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

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

Appearance and Packaging of the Product

Yellow, film-coated, and elongated tablets.

PVC blister packs in packs of 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 revised 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/.