Package Leaflet: Information for the Patient

Losartán/Hidroclorotiazida Krka 50 mg/12,5 mg Film-Coated Tablets

losartán potassium/hydrochlorothiazide

Read this leaflet carefully before you start to take this medicine because 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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

Losartán/Hidroclorotiazida Krkais a combination of an angiotensin II receptor antagonist (losartán) and a diuretic (hidroclorotiazida).The 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 works by causing the kidneys to eliminate a greater amount of water and salts. This also helps to reduce blood pressure.

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

Do not takeLosartán/Hidroclorotiazida Krka

• if you are allergic to losartan and/or 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 cotrimoxazole, ask your doctor if you are unsure);
• if you have severe liver failure;
• 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 are more than three months pregnant. (It is also recommended to avoid this medicine in the first trimester of pregnancy, see also pregnancy),
• if you have severe kidney failure or your kidneys do not produce urine;
• if you have diabetes or kidney failure and are being treated with a medicine that lowers blood pressure containing aliskiren.

Warnings and precautions

Consult your doctor or pharmacist before starting to takeLosartán/Hidroclorotiazida Krka.

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 can occur within a few hours to several weeks after taking losartan/hydrochlorothiazide. If left untreated, this can lead to permanent loss of vision. You may have a higher risk of developing this if you have previously had an allergy to penicillin or sulfonamide.

You must inform your doctor if you think you may be pregnant (or could be). Losartán/Hidroclorotiazida Krka is not recommended for use at the beginning of pregnancy and should not be taken if you are more than 3 months pregnant because it can cause serious harm to your baby if used during this period, (see pregnancy section).

It is essential to inform your doctor before takingLosartán/Hidroclorotiazida Krka:

• 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 Losartán/Hidroclorotiazida Krka, see your doctor immediately,
• 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 had excessive vomiting and/or diarrhea,
• if you have heart failure,
• if your liver function is altered (see section 2 “Do not take Losartán/Hidroclorotiazida Krka”)
• 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 disease 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 professional 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 these medicines used to treat high blood pressure:
• angiotensin-converting enzyme (ACE) inhibitors (e.g. enalapril, lisinopril, ramipril), particularly if you have diabetes-related kidney problems,
• aliskiren.

Your doctor may need to 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 Krka”.

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

Children and adolescents

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

Other medicines and Losartán/Hidroclorotiazida Krka

Inform your doctor or pharmacist ifyou are taking, havetaken 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 (e.g. trimethoprim), as the combination with Losartán/Hidroclorotiazida Krka is not recommended.

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

Lithium preparations should not be taken with Losartán/Hidroclorotiazida Krka without your doctor's careful monitoring.

Special precautions may be necessary (e.g. blood tests) if you are taking diuretics (urine-producing medicines), 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 medicines that lower blood pressure,
• steroids,
• medicines for cancer,
• analgesics,
• medicines for fungal infections,
• medicines for arthritis,
• resins used for high cholesterol, 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 or insulin agents.

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 Krka” and “Warnings and precautions”).

Please inform your doctor if you are to undergo a radiographic examination with a contrast medium containing iodine.

Taking Losartán/Hidroclorotiazida Krka with food, drinks, and alcohol

It is recommended not to drink alcohol while taking these tablets: alcohol and Losartán/Hidroclorotiazida Krka tablets may increase the effects of each other.

Excessive salt in the diet may counteract the effect of losartan and hydrochlorothiazide tablets.

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

It is recommended to avoid grapefruit juice while taking losartan/hydrochlorothiazide.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant (or could be), consult your doctor or pharmacist before using this medicine.

Pregnancy

You must inform your doctor if you think you may be pregnant (or could be). Your doctor will usually advise you to stop taking Losartán/Hidroclorotiazida Krka before becoming pregnant or as soon as you know you are pregnant and recommend that you take another medicine instead of losartan/hydrochlorothiazide.Losartán/Hidroclorotiazida Krka is not recommended during pregnancy, and should not be taken if you are more than three months pregnant, as it can cause serious harm to your baby if used after the third month of pregnancy.

Breastfeeding

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

Use in elderly patients

Losartán/Hidroclorotiazida Krka acts in the same way and is equally well tolerated by most elderly patients and young patients. 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 may require special attention (e.g. driving a car or using hazardous machinery) until you know how you tolerate your medicine.

Losartán/Hidroclorotiazida Krka contains lactose.

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

Use in athletes: this medicine contains hydrochlorothiazide, which may produce a positive result in doping control tests.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will decide the appropriate dose oflosartán/hidroclorotiazidadepending on your condition and if you are taking other medications. It is important to continue taking this medication as prescribed by your doctor to maintain constant control of blood pressure.

High blood pressure

For most patients with high blood pressure, the usual dose is 1 tablet of Losartán/HidroclorotiazidaKrka50 mg/12.5 mg per day to control your blood pressure for 24 hours.The dose may be increasedto 2 tabletscoated with filmof Losartán/HidroclorotiazidaKrka50 mg/12.5 mg per day orchangedto 1tablet coated with film ofLosartán/Hidroclorotiazida 100 mg/25 mg(a stronger dose)per day. The maximumdailydose is 2 tabletscoated with film ofLosartán/HidroclorotiazidaKrka50 mg/12.5 mg per day or 1 tabletcoated with film ofLosartán/Hidroclorotiazida 100 mg/25 mg per day.

Administration

The tablets should be swallowed with a glass of water.

If you take more Losartán/HidroclorotiazidaKrkathan you should

In case of an overdose, contact your doctor immediately or go directly to the hospital for immediate medical attention. An overdose may cause a drop in blood pressure, palpitations, slow pulse, changes in blood composition, and dehydration.

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.

If you forgot to take Losartán/HidroclorotiazidaKrka

Do not take a double dose to compensate for the missed doses.

Try to take this medication at the same time each day as prescribed. However, if you forget a dose, do not take an extra dose. Simply return to your regular schedule.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

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

If you experience the following, stop taking Losartán/Hidroclorotiazida Krka 50 mg/12.5 mg 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 can affect more than 1 in 10,000 people but less than 1 in 1,000. You may need urgent medical attention or hospitalization.

The following side effects have been reported:

Frequent (can affect up to 1 in 10 people):

• Cough, respiratory infection, nasal congestion, sinusitis, breast disorder.
• 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 rhythm), decreased hemoglobin levels.
• Changes in renal function, including renal insufficiency.
• Low blood sugar (hypoglycemia).

Occasional (can 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 cells, coagulation problems, reduced platelets.
• Loss of appetite, elevated uric acid levels or manifest gout, elevated blood glucose levels, abnormal electrolyte levels in the blood.
• Anxiety, nervousness, panic disorder (recurring panic attacks), confusion, depression, abnormal dreams, sleep disorders, drowsiness, memory alteration.
• Tickling or similar sensations, limb pain, tremor, migraine, fainting.
• Blurred vision, eye itching or stinging, conjunctivitis, worsening vision, seeing yellow.
• Ringing, buzzing, or clicking sounds 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 (mini-stroke), heart attack, palpitations.
• Inflammation of blood vessels that often occurs with a skin rash or hematoma.
• Sore throat, shortness of breath, bronchitis, pneumonia, fluid in the lungs (which may cause 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 inflammation.
• Hives, itching, skin inflammation, skin rash, redness, sensitivity to light, dry skin, flushing, sweating, hair loss.
• Arm, shoulder, hip, knee, or other joint pain, joint swelling, stiffness, muscle weakness.
• Frequent urination even at night, abnormal renal function, including kidney inflammation, urinary tract infection, sugar in the urine.
• Decreased libido, impotence.
• Swelling of the face, localized swelling (edema), fever.

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

• Hepatitis (liver inflammation), abnormal liver function tests.

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

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

Frequency unknown(cannot be estimated from available data):

• Flu-like symptoms.
• Muscle pain of unknown origin with dark-colored urine (rhabdomyolysis).
• Low sodium levels in the blood (hyponatremia).
• General feeling of being unwell (malaise).
• Altered taste (dysgeusia).
• Skin 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 hemorrhage) or acute angle-closure glaucoma].

If you consider that any of the side effects you experience are severe or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting side effects

If you experienceany 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 national notification system: Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety ofthis medicine.

Keep this medication 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.

Do not store above 30°C.Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy.Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

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

• The active principles are losartan potassium and hydrochlorothiazide.

Each film-coated tablet contains 50 mg of losartan potassium (equivalent to 45.76 mg of losartan) and 12.5 mg of hydrochlorothiazide.

• The other components are pregelatinized cornstarch, microcrystalline cellulose, lactose monohydrate, and magnesium stearate in the tablet core and hypromellose, macrogol 4000, quinoline yellow (E104), talc, and titanium dioxide (E171) in the film coating.

Appearance of the product and contents of the packaging

The film-coated tablets are yellow, oval, moderately biconvex with a groove on one face and with dimensions of 6 mm x 12 mm (oval shape) and thickness 3.8 – 4.7 mm.

The groove is only for breaking and facilitating swallowing, but not for dividing into equal doses.

Package size:28 film-coated tablets in a PVC/PVDC blister pack//Al and in a box.

Holder of the marketing authorization and responsible for manufacturing

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

Date of the last review of this leaflet:November 2023

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